Q4 2020 Compugen Ltd Earnings Call
Well review the data we disclosed earlier today and the Ollie's will review our financial statement on position of lap Henry.
Ali and Iran will be available for the Q&A session.
Unknown Executive: will review the data we disclosed earlier today, and Ali will review our financial statement and position. Anat, Henry, Ari, and Eran will be available for the Q&A session.
Before we begin I would like to read the following regarding forward looking statements.
Unknown Executive: Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections or other forward-looking statements regarding future events or future business outlooks, our development efforts and their outcome, anticipated progress and the timeline of our programs, financial and accounting-related matters, as well as statements regarding our cash position. We wish to caution you that such statements reflect only the company's current expectations and that actual events or results may differ materially.
During the course of this conference call the company May make projections or other forward looking statements regarding future events or future business outlook, our development efforts and their outcome anticipated progress and the timeline of our programs the financial and accounting related matters as well the statements regarding our cash position.
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We wish to caution you the such statements reflect only the company's current expectations and the actual events or results may.
Yeah for materially Youre kind of referred to the risk factors and cautionary language contained in the documents the company files with the Securities and Exchange Commission, including the company's most recent annual report filed on form 20-F, with the Securities and Exchange Commission. The company undertakes no obligation to update projections.
Unknown Executive: You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission, including the company's most recent annual report filed on Form 20-F with the SEC. The company undertakes no obligation to update projections or forelooking statements in the future. I will now turn the call over to Anat.
All forward looking statements in the future I will now turn the call over to enact on that.
Anat Cohen: Thank you, Ilana. Good morning and good afternoon, everyone, and welcome to our fourth quarter and full year 2020 Corporate and Financial Update. 2020 was another important year of execution and progress at Compugen, in which we strengthened our positioning in the cancer immunotherapy space, and Solidified is standing as the leader in targeting genome-access signaling tasks. Based on our years of research in this axis, we're executing a strategic and comprehensive clinical development program to evaluate our internally discovered and wholly-owned anti-PVRIG and TIGIT assets across settings and combination regimens to elucidate Our work has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the denim axis, which also intersects with the PD-1 pathway.
Thank you Lena good morning, and good afternoon, everyone and welcome to our fourth quarter and full year 2020, corporate and financial update.
'twenty 'twenty was another important year of execution and progress of the competition in.
In which we strengthened our positioning in the cancer immunotherapy space.
And solidified our standing as the leader in targeting denim X just signaling pathways.
Based on our years of research of these axes, we're executing the strategic and comprehensive clinical development programs.
To evaluate our internally discovered and wholly owned N T. P V. R. A G and T G I sit across settings and combination regimens to elucidate the role of the deed on excess members P V. Our IGN T G as potentially foundational immunotherapy checkpoint targets.
Our work has identified the P V. Our IGN teach it is key partners and complementary inhibitory pathways in the denim axis, which also intersect with the PD one pathway.
Anat Cohen: Importantly, our data suggest that these three inhibitory pathways have different dominance in different tumor types and patient populations, which means certain patient populations may require the blockade of different combinations of the three pathways in order to induce an effective anti-tumor immune response. This is the underlying rationale for our comprehensive clinical program designed to develop new treatment solutions. Earlier today, we shared data from the combination arm of the phase 1 dose escalation study of COM701 in combination with Bristol-Myers Squibb's nivolumab, as well as follow-up on our monotherapy dose escalation study and data from the COM701 monotherapy cohort expansion. While Henry will provide a more detailed review of the data later in the call, I would like to present a high-level overview of our data and highlight certain results which we view as particularly encouraging.
Importantly, our data suggest the D. Three inhibitory pathways have different dominance in different tumor types in patient populations, which means certain patient populations may require the blockade of different combinations of the three pathways.
In order to induce effective anti tumor immune responses.
This is the underlying rationale for our comprehensive clinical program designed to develop new treatment solutions.
Earlier today, we shared the data from the combination arm of the phase one dose escalation study of comfort and of one in combination with Bristol Myers Squibb's, the volume up ex.
Well as follow up on our monotherapy dose escalation study and data from the comfort of and one monotherapy cohort expansion.
Well Henry will provide a more detailed review of the data later in the call I would like to present, a high level overview of our data and highlight southern results, which we view as particularly encouraging.
Anat Cohen: We plan to present updated data along with initial correlative data from patient samples at ASCO 2021, to which an abstract was submitted, starting with the combination arm dose escalation data. The updated data disclosed today now include complete data from all five dose levels in the study, which we believe are highly encouraging. Overall, we see a disease control rate of approximately 67%, which given the highly refractory nature of this population, is a meaningful accomplishment.
We plan to present updated data along with initial correlative data from patients centers at the ethical 2021 to reach an abstract was submitted.
Yeah.
Starting with the combination arm dose escalation data.
The update the data disclosed today now include complete data from all five dose levels in the study, which we believe are highly encouraging.
Overall, we see of disease control rate of approximately 67%.
Which given the highly refractory nature of these population.
Is the meaningful accomplishment.
Anat Cohen: We observed durable responses, including the partial response we reported at ASL last year, with two patients still remaining on the study since our last data presentation in April 2020 for approximately 10 additional months. In addition, and most excitingly, one of these two patients who progressed on an immune checkpoint inhibitor prior to enrolling in our study has converted to a confirmed complete response. Based on this data, we're excited to expand our collaboration with BMS to include a Phase 1b Cohort Expansion Combination Study evaluating COM701 with nivolumab in parallel to our ongoing triplex study.
We observed durable responses, including.
Including the partial response, we reported at the ACR last year.
With two patients still remaining on the study since our last data presentation in April of 'twenty 'twenty for approximately 10 additional months.
In addition, and most Excitingly one of these two patients who progressed on an immune checkpoint inhibitor price.
Prior to enrolling tour of study has converted to a confirmed complete response.
Based on the data we're excited to expand our collaboration with BMS to include the phase one B cohort expansion combination study evaluating comps of in the one with the volume up in parallel to our ongoing triplet study.
Anat Cohen: This dual-combination expansion study will continue our clinical momentum, and we'll add an additional layer to our clinical strategy, expanding this potentially promising combination regimen as a possible unique and effective treatment opportunity. It will also provide additional insights into the contribution of the different components of the DNAM axis across our ongoing and future COM71 studies, and specifically, our ongoing triplet study. We're also happy that the amendment of our agreement with BMS was revised to include a specific date for the expiration of the exclusivity period, so that it ends at the earlier of six months after the study's completion or on December 31st, 2023.
This dual combination expansion study, we'll continue our clinical momentum and.
And we will add an additional layer to our clinical strategy expanding these potentially promising combination regimen as a possible unique and effective treatment opportunity.
It will also provide additional insights to the contribution of the different components of the DRAM axis of course, our ongoing and future comps of in one studies and specifically our ongoing triplet study.
We're also happy that the amendment of our agreement with BMS was revised to include a specific date for the expiration of the exclusivity period.
So that he and the area of six months after the study's completion of.
On December 31st 2023.
This will ensure termination of exclusivity period in the event that the ongoing dual and Triple studies continue beyond their current expected time frame.
Anat Cohen: This will ensure the termination of the exclusivity period in the event that the ongoing dual and triple studies continue beyond their currently expected time frames. This doublet expansion study is expected to begin in the second quarter of 2021 and will enroll patients with ovarian, breast, endometrial, and microsatellite-stable colorectal cancer. Our recent results, including the complete response in a patient who relapsed on PD-1 therapy, increase our confidence that there are certain patient subpopulations which are likely to respond to a PVR-IG PD-1 dual blockade in a clinical setting, including those progressed on immune checkpoint blocks.
This doublet expansion study is expected to begin in the second quarter of 'twenty 'twenty, one and will enroll patients with ovarian breast endometrial and microsatellite stable colorectal cancer.
Our recent results, including the complete response in a patient who relapsed on PD one therapy.
Increase our confidence that there are certain patient subpopulations, which are likely to respond to the P. P. R. I G. P. D. One dual blockade in the clinical setting including dose progressed on immune checkpoint blockers.
We also shared initial data from our comps of in the one monotherapy cohort expansion.
Anat Cohen: We also shared initial data from our COMM701 monotherapy cohort expansion. While this study was designed as a safety and tolerability study, we used a biomarker-informed strategy to select tumor types likely to respond to treatment alone or in combination, based on preclinical expression data and clinical results from the dose escalation arm. These indications are endometrial, breast, ovarian, colorectal, and non-small cell cancer.
While this study was designed as a safety and Tolerability study.
We used a biomarker informed strategy to select tumor types likely to respond to treatment alone or in combination.
Based on preclinical expression data and clinical results from the dose escalation.
These indications are endometrial breast ovarian colorectal and non small cell lung cancer.
In this study of 20 patients for reach enrollment was completed in Q4 'twenty 'twenty, we had six patients with the best response of stable disease across endometrial.
Anat Cohen: In this study of 20 patients, for which enrollment was completed in Q4 2020, we had six patients with the best response of stable disease across endometrial, non-small cell lung, and ovarian cancer. We also had durable antitumor activity in two patients on treatment as of the data cut. The combined data of this cohort expansion study with data from a previously reported monotherapy dose escalation study that includes a patient with a durable confirmed partial response still on study treatment for more than a year.
Non small cell lung and ovarian cancer.
We also had durable antitumor activity in two patients on treatment as of the data cut.
The combined data of this cohort expansion study with data from previously reported monotherapy dose escalation study the.
That includes the patient with a durable confirmed partial response still on study treatment for more than a year.
Anat Cohen: We demonstrate signals of anti-tumor activity of COM701 treatment in patients with highly refractory disease and in tumor types typically unresponsive to immune checkpoint inhibitors, as previously suggested by us. While information from a small monotherapy study may be limited, this data supports the potential role of PVRIG inhibition in patients who have exhausted all available standard therapies, and sets the basis for our next combination study. We're now performing correlative assessment.
Demonstrating signals of antitumor activity of comps of the one treatment in patients with highly refractory disease and in tumor types typically unresponsive to immune checkpoint inhibitors as previously suggested by us.
One information from the smaller monotherapy study may be limited.
This data supports the potential role of P. The era of gene he bishop in patients who have exhausted all available on the therapies.
And that's the basis for our next combination studies.
We're now performing correlative assessments.
Anat Cohen: Based on data from patient centers, to gain insights relating to COM701 and the PVRIG-PVRL2 pathway biology, particularly in indications that are typically not responsive to PD-1. This will allow us to further learn about COM71 activity, as well as to inform our COM 701 and COM 902 clinical program development path in indications with preliminary encouraging signals of antitumor activity. Our initial assessment of patients' peripheral blood samples suggests that COM701 may enhance immune activation in cancer patients alone or in combination with nivolumab. These initial findings assessing for the first time the PVRIG blockade effect in human biological samples are encouraging. Data analysis is still ongoing and is planned to be presented at ASCO 2021, to which an abstract was submitted.
Based on data from patient samples.
To gain insights relating to come sort of in the one and the P. P era of G. P V or the two pathway biology.
Particularly in indications that are typically not responsive to PD one.
This will allow us to further learn about come sort of in the one activity.
As well as to inform our come sort of in the one income and I know two clinical program development path.
Any indications with preliminary encouraging signals of antitumor activity.
Our initial assessment of patients' peripheral blood centers.
Suggest that the comps are in the one main hence immune activation.
Cancer patients alone or in combination with the volume of them.
These initial findings assessing for the first time P. D. R. I G blockade the effect in new in the biologic because centers are encouraging.
Data analysis is still ongoing and is planned to be presented at the ethical 2021 to reach an uptick for submitted.
In summary, the data derived from our various studies is an important milestone in our overall clinical strategy.
Anat Cohen: In summary, the data derived from our various studies is an important milestone in our overall clinical strategy, which demonstrates that COM701 and thus PVRIG blockade are presenting signals of anti-tumor activity in a clinical setting that can serve as a basis for our next study. The patients enrolled in these studies had diverse tumor types and were treated with various doses of COM701, with or without nivolumab. But the indications in which we observe responses, as well as the number of highly durable stable diseases, are indications that are typically PD-L1 low or negative and generally have low response rates to available immune checkpoint inhibitors.
Which demonstrate that comes out of in the one and thus P. D. R. I G blockade is presenting signals of antitumor activity in the clinical setting the conserve as a basis for our next studies.
The patients enrolled in these studies had day first tumor types and were treated with various doses of comfort on the one where the without the volume up.
But the indications in which we observed the responses as well as the number of highly durable stable diseases are.
Our indications, which are typically PDL, one low or negative and generally have low response rates to available immune checkpoint inhibitors.
Since the immunotherapy has been most transformative in PDL one positive patients.
Anat Cohen: Since immunotherapy has been transformative in PD-L1-positive patients, to see these first signals in indications with such high unmet need that generally do not respond to immune checkpoint inhibitors is encouraging and strengthens our conviction in our approach to moving to the next stage of executing a broad clinical strategy.
To see these for fitness and indications for such high unmet need the generally do not respond to immune checkpoint inhibitors is encouraging and strengthens our conviction in our approach.
Moving to the next stage of executing on a broad clinical strategy.
Anat Cohen: Our studies now include our ongoing triplet study of COM701 with nivolumab and BMS TGT inhibitor and the planned initiation of both the doublet expansion study of COM701 with nivolumab and a doublet study of COM701 and COM902 later this year. In addition, the comprehensive biomarker assessment from the various cohort expansion studies will provide insights into the PVRIG-PVRL2 pathway biology and shed light on specific contributors to antitumor activity, which may guide us to specific expanded tumor indications.
Our studies now include our ongoing triplet study of come serving the one with the volume up and BMS teaching inhibitor.
And the planned initiation of both the doublet expansion study of comes out of the one with the volume of them and the doublet study of Com 701 and come in I know two later this year.
In addition, the comprehensive biomarker assessment from the various cohorts expansion studies will provide us insights into the P. P. R. I G P V or the two pathway biology and.
And shed light on specific contributors to antitumor activity, which May guide us to specific expanded tumor indications.
Anat Cohen: This next phase of our comprehensive clinical program will allow us to quickly generate multiple data readouts and maintain our competitive edge in developing genome-access-based new cancer immunotherapy treatments, with our initial supportive clinical data for PVRIG and clinical validation of TIGID by others.
This next phase of our comprehensive clinical program.
Will allow us to quickly generate multiple data readouts and maintain our competitive edge in developing the access base you cancer immunotherapy treatments.
Yeah.
With our emissions supportive clinical data for P. B R E G and clinical validation of ticket by others.
Anat Cohen: We're excited to witness what we believe is a growing interest in the biopharma industry for both PVRIG and TGIT, which we discovered independently as new immunotherapy targets. We believe that our leadership position in the D-NAM axis, our clinical programs, our initial clinical data, and perhaps most importantly, our ability to execute on this broad combination clinical strategy, testing the synergy of these two pathways and in combination with PD-1, places us in a differentiated position in the crowded space of immuno-oncology. Specifically, we are the only company with wholly-owned clinical-stage assets targeting both PVRIG and TIGIT.
We're excited to witness what we believe is the growing interest in the Biopharma industry in both P. B R. I G N T G, which we discovered independently of immunotherapy targets.
We believe that our leadership position in the day named Axis of work.
Clinical programs, our initial clinical data and perhaps most importantly, our ability to execute on these broad combination clinical strategy testing the synergy of these two pathways and in combination with PD one play.
Places us in a differentiated position in the crowded space of immune oncology.
Specifically, we're the only company with wholly owned clinical stage assets targeting both P. V origin tickets and death were the only company capable of evaluating P. J of our AG mono therapy dual blockade of P V or a Jew with PD, one or T J.
Anat Cohen: Thus, we're the only company capable of evaluating PVRIG monotherapy, dual blockade of PVRIG with PD-1 or TIGIT, and triple blockade of PVRIG with PD-1 and TIGIT. With our expanded collaboration with BMS, we're rapidly advancing our clinical programs, and we believe that we will be the first to generate data that will maintain our position in developing DNA-axis-based new cancer immunotherapie Moving next to a brief overview of the status of our ongoing clinical trials and our expected clinical milestones in 2021, starting with our COM701 Monotherapy Cohort Expansion.
And triple blockade of P. Vera G with PD, one and T J.
With our expanded collaboration with BMS will rapidly advancing our clinical programs and we believe that will be the first to generate data, which will maintain our position in developing DRAM axis based you can see immunotherapy treatment.
Moving next to a brief overview.
Anat Cohen: Additional clinical data and initial correlative assessments based on data from patient samples collected in our clinical studies are planned to be presented at ASCO 2020. Additionally, our recently announced Phase 1B cohort expansion combination study, evaluating COMP701 with nivolumab, is planned to begin during the second quarter of 2021. Our Phase 1-2 Triple Combination Study, evaluating the safety, tolerability, and preliminary antitumor activity of COM701 in combination with BMS-Tigit antibody and Evolumab, is currently enrolling patients, and we expect to share initial data from the study in the fourth quarter of 2021.
Of the status of our ongoing clinical trials and our expected clinical milestones in 2021.
Starting with our current 71 monotherapy cohort expansion.
Additional clinical data and the Michelle correlative assessments based on data from patient samples collected in our clinical studies.
The planned to be presented at the <unk> 2021.
Our recently announced phase one b cohort expansion combination study evaluating comps are in the one with the volume of is planned to begin during the second quarter of 2021.
Our phase one two triple combination study evaluating the safety Tolerability and preliminary antitumor activity of come seven of the one in combination with BMS TGF antibody.
And the volume up is currently enrolling patients and we expect to share initial data from the study.
In the fourth quarter of 2021.
Anat Cohen: This study rapidly propels forward the evaluation of our triple blockade hypothesis, which we believe is the ultimate way to test our hypothesis that blocking the three intersecting pathways has the potential to synergistically enhance anti-tumor immune responses in selected patient populations not responsive or refractory to PD-1 blockers alone.
The study rapidly prepares Ford devaluation of our triple the Brocade hypothesis, which we believe is an alternate way to test our hypothesis the blocking the three intersecting pathways has the potential to synergistically enhance antitumor immune responses.
In selected patient populations, not responsive or refractory to PD, one blockers alone.
And finally touching of pone or come nine O two monotherapy dose escalation study.
Anat Cohen: And finally, touching upon our COM902 monotherapy dose escalation study. While there are currently other clinical programs evaluating PIDGET inhibitors, we have always believed it is important to pursue the development of our own candidate to maintain our control of what we believe are two key arms of the DINAM Act and our ability to independently evaluate multiple combination approaches, which include TGIT in the clinic. COM 902 enables us to advance this strategy, and our study is currently on track with enrollment. We expect to provide initial data from the study in the fourth quarter of 2021.
What they are currently other clinical programs evaluating T. G. T inhibitors. We have always believed it is important to pursue the development of our own candidate to maintain out of control of what we believe.
The two key arms of the DRAM axis and our ability to independently evaluate multiple combination approaches which include T. J in the clinic.
Come on I know two enables us to advance the strategy and our study is currently on track with enrollment.
We expect to provide initial data from the study in the fourth quarter of 2021.
Importantly, as we disclosed on our last call. We also intend to begin studies evaluating come sort of in the one in combination would come in I know two in the second half of 2021.
Anat Cohen: Importantly, as we disclosed on our last call, we also intend to begin studies evaluating COM701 in combination with COM902 in the second half of 2021. This study will further expand the breadth of our combination programs, allowing us to evaluate the dual blockade of PVRIG and TIGIT, which we believe may enhance anti-tumor immune responses in a subset of patients. We look forward to providing additional details on this study in the coming months.
This study will further expand the breadth of for a combination programs, allowing us to evaluate the dual blockade of PV air of Gen. T G, which we believe may enhance anti tumor immune responses in a subset of patients.
We look forward to providing additional adidas on of the study in the coming months.
Before we move on I'd like to briefly touch upon the characteristics and biology that underlies our two clinical assets.
Anat Cohen: Before we move on, I'd like to briefly touch upon the characteristics and biology that underlie our two clinical aspects. As I mentioned earlier, it is our clinical programs, combined with our deep scientific expertise and preclinical data, that position us as leaders in the genome-access immunotherapy space. As a reminder, both COM701 and COM902 were discovered and developed in-house, giving us the unique opportunity to rationally design these candidates in ways we believe will position them to be successful in the clinic.
As I mentioned earlier.
It is our clinical programs combined with our deep scientific expertise and preclinical data the position us as leaders in the day named Axis immunotherapy space.
As a reminder, both come seven of one income nine O. Two were discovered and developed in house, giving us the unique opportunity to rationally designed these candidates in ways, we believe will position them to be successful in the clinic.
Anat Cohen: There has been a fair amount of scientific debate regarding the role of the isotypes of therapeutic checkpoint antibodies and the function of their respective FC ports. Our position has been, and remains, that an antibody with a factor function carries the risk of depleting CD8+ T cells, which we know are crucial for driving immune responses in the tumor set. Because of this, both COM701 and COM902 were developed as IgG4 antibodies which have reduced FC effector function. So starting with COM 701.
There has been a fair amount of scientific debate.
Regarding the role of the eyes of types of therapeutic checkpoint antibodies and the function of their respective FC portions.
Our position has been and remains the antibody with the effector function carries the risk to deplete T. The eight plus pieces, which we know are crucial for driving immune responses in the tumor setting.
Because of these both come sort of in the one income nine O two well developed because ITG for antibodies, which have reduced F effector function.
So starting we'd come sort of in the one we know the P. B R. E. G is highly expressed on CD eight plus thesis on N cases.
Anat Cohen: We know that PVR-IG is highly expressed in CD8 plasticers and N cases. Thus, we believe moving forward with IgG4 is important to avoid the potential risk of depleting the target cell population, which we want to reactivate. Our initial clinical data, even in patients with highly refractory disease who are not expected to respond to checkpoint inhibitors, suggests that PVRID antibody with an IgG4 isotype is active in the clinic. However, it is yet to be demonstrated whether the potential additional modulatory effects of effector function active antibodies will outweigh possible depletion of CD8+ T-cells required for activity.
And thus we believe moving forward with IGT for what was important to avoid the potential risk of depleting the target cell population, which you want to reactivate.
Our initial clinical data even in patients with highly refractory disease.
Who are not expected to respond to checkpoint inhibitors.
Suggest the P V R. A D antibody. We then I did you for either type is active in the clinic.
However, it is yet to be demonstrated in the clinic, where the potential additional mobile tour effects of effector function active antibodies will outweigh possible depletion of CD eight plus piece of required for activity.
It is important to highlight that the underlying clinical strategy of choosing guide you want antibodies is largely driven by preclinical data in mice, where we know the biology of FC receptors differ significantly from humans.
Anat Cohen: It is important to highlight that the underlying clinical strategy of choosing IgG1 antibodies is largely driven by preclinical data in mice, where the biology of Fc receptors differs significantly from humans. In fact, we have seen multiple examples where this preclinical activity did not translate to the clinic, specifically in the case of both CTLA-4 and PD-L1 antibodies, for which the preclinical activity of Antibirth with Effective Function did not translate clinically The story with digits becomes a bit more complicated, as opposed to PVRA.
In fact, we've seen multiple examples where these preclinical activity did not translate to the clinic specifically in the case of both of the tea leaves for and PDL, one antibodies for which preclinical activity.
Of antibodies with effects of function did not translate clinically.
The story the teach it becomes a bit more complicated as opposed to PV array of G. P.
Anat Cohen: TGIT and PVRIG are expressed on different cell populations, specifically TGIT on Tregs, which may be a target for anti-TGIT depleting antibodies. While there is activity in the clinic with IgG1 antibodies that do have a factor function, our hypothesis is that enhancing CD8+ T cell activity, not depleting Tregs, will ultimately be responsible for driving the activity of anti-TGIT antibodies. Based on our strong conviction that enhancing CD8 plus T cell activity is critical in driving the anti-tumor immune response, we have advanced ADG candidates for both PVRAG and TIG.
Ticketing PV era of G are expressed on different set of population specifically with TG on T regs.
Which may be a target for NTT depleting antibodies.
Well there is activity in the clinic, we did you want antibodies the do have effector function.
Our hypothesis is that enhancing see the eight plus T cell activity not the depleting T. Regs will ultimately be responsible for driving activity of anti <unk> antibodies.
Based on our strong conviction that enhancing see the eight plus T cell activity is critical in driving antitumor immune responses, we have advance agg for candidates for both be the origin ticket.
Anat Cohen: We believe this will enable the reactivation of CD8 plasticity function in the tumor setting. However, it is yet to be demonstrated whether such antibodies will present superior activity in the clinic. Next, I'd like to highlight some corporate accomplishments outside of our scientific and clinical programs. In 2020, we will continue to invest in our early stage pipeline, which serves as our growth engine. Our early-stage pipeline consists of multiple programs targeting the immunosuppressive tumor microenvironment via various mechanisms of action, including myeloid biology.
We believe this will enable the reactivation of CB eight plus pieces function.
In the tumor setting however, it is yet to be demonstrated.
For the such antibodies would present superior activity in the clinic.
Yeah.
Next I'd like to highlight some corporate accomplishments outside of our scientific and clinical progress.
Anat Cohen: These are early-stage programs, but as they progress, some may serve as the future of our preclinical and clinical programs. This past year, we were also granted multiple patents to protect our pipeline candidates. And we now have composition of matter and use patents protecting COM902 and COM701 in the US, Europe, and other jurisdictions, such as COM902 in China, as well as a patent covering the use of anti-PVRG antibody that activates T-cells and or N-cases for the treatment of cancer in Europe and other jurisdictions.
In 2020, we continued to invest in our early stage pipeline, which served as our growth engine.
Our early stage pipeline consists of multiple programs targeting of the immunosuppressive tumor microenvironment.
The various mechanisms of action, including myeloid biology.
These are early stage programs, but as they progressed some may serve as the future of our preclinical and clinical programs.
This past year, we were also granted multiple patents to protect our pipeline candidates and we now have composition of matter and use patents protecting come sign on to income of 701 in the U S Europe and other jurisdictions such as come now to <unk>.
China as well as our patents covering the use of MTP Vieira of G antibody that activate T cells and or N cases for using the treatment of cancer and.
In Europe and other jurisdictions.
We're pleased to announce the first for a clinical milestones through our ongoing license agreement with Astrazeneca for the development of bi specific or multi specific antibodies.
Anat Cohen: We're pleased to announce the first preclinical milestone through our ongoing license agreement with AstraZeneca for the development of bispecific and multispecific antibodies. As a reminder, we provided an exclusive license to AstraZeneca for the development of bispecific and multispecific antibody products based on one of our pipeline programs, and AstraZeneca was responsible for all research, development, and commercial activities. In connection with this first milestone, we received a $2 million payment from AstraZeneca. Last quarter, we also reported that Bayer decided to focus on treating IOM Nave first-line head and neck squamous cell carcinoma patients with a combination of Bay 1-90-52-54 and Keytruda in the Phase 1 study. This antibody against ILDR2 was licensed by us to Bayer and is targeting the third novel immunotherapy target we discovered computationally.
As a reminder, we provided an exclusive license to astrazeneca for the development of bi specific or multi specific antibody products based on one of our pipeline programs.
And with Astrazeneca responsible for all of research development and commercial activities.
In connection with the first milestone received a $2 million payment from Astrazeneca.
The last quarter. We also updated the bear decided to focus on tweaking I O naive first line had the next squamous cell carcinoma patients.
With the combination of Bay 119, 50 to 54 and Keytruda in the Phase one study.
This antibody against <unk> two was licensed by us to Bayer and he's targeting the third novel immunotherapy targets, we discovered computationally.
We're proud to partner with three global pharmaceutical companies and believe the day agreements we have in place service the validation of the power of our internal discovery and development capabilities.
Anat Cohen: We're proud to partner with three global pharmaceutical companies and believe that the agreements we have in place serve as a validation of the power of our internal discovery and development capabilities. These agreements reflect our strategy of collaborating with biopharma to monetize pipeline candidates, while also advancing drug candidates internally to develop novel cancer immunotherapies. Finally, before turning the call over to Henry, I would like to very briefly touch upon the ongoing COVID-19 pandemic. As in previous quarters, we're incredibly unfortunate to have avoided significant impacts on our activities in 2020.
These agreements reflect our strategy of collaborating with Biopharma to monetize pipeline candidates, while also advancing drug candidates internally to develop novel cancer Immunotherapies.
Finally, before turning the call over to Henry.
I would like to very briefly touch upon the ongoing COVID-19 pandemic.
As in previous quarters, we're incredibly fortunate to have avoided significant impact on our activities in 'twenty 'twenty.
Anat Cohen: With prior guidance for enrollment and data across our studies unchanged, I remain proud of the commitment and dedication shown by our team at Compugen, who together have enabled our continued steady progress throughout this notable year. In addition, we're grateful to our partners, investigators, and shareholders, and look forward to continued progress. And with that, I'll turn the call over to Henry to provide additional details on our recently presented data.
With prior guidance for enrollment and data across our studies unchanged.
I remain proud of the commitment and dedication.
So they are a team at the competition, who together have enabled our continued steady progress swaths of these notable year.
In addition, we're grateful to our partners investigators and shareholders and look forward to continued progress.
And with that I'll turn the call over to Henri to provide additional details on the recently presented data.
Thank you and I'm glad to everyone.
Henry Adewoye: Thank you, Anat, and good day to everyone. As Anat reviewed this morning, we disclosed data from the combination arm of COM701 with Nivolumab and the COM701 immunotherapy expansion cohort. In April 2020 at AACR, we reported data in patients enrolled in the dose escalation arms of the ongoing Phase I study of COM-71 monotherapy, in combination with nivolumab in patients with advanced solid tumors. This included data from all monotherapy dose escalation cohorts through 20 mg per kg IVQ4 weeks, and four of the five dose levels from the Dual Combination Dose Escalation Arm. We were encouraged by both the preliminary acceptable safety and tolerability profile and the preliminary Antitumor Activity of COMP701 Monotherapy and in combination with Nivolumab. Notably, there were two durable partial responses.
That's the amount reviewed this morning, we disclosed it up on the combination of all of it comes up on the one with Ebola and comes out of them. The one monotherapy expansion cohort.
The Liberal 20 twin.
We reported data in Houston, and moving the dose escalation of arms of the bundle.
And the phase one study of confirmed on monotherapy.
The combination with Ebola in patients with advanced solid tumors.
This included data from all of them on the therapy dose escalation cohorts, who suites of milligrams per kilogram IV Q4 weeks.
And for all of the size of those levels from the <unk> combination dose escalation of.
We are encouraged with the preliminary acts of people safety and Tolerability profile.
On preliminary on thank you want to the deal comes on the one of the therapy.
And in combination with Nicola.
Notably there were two durable partial responses.
Henry Adewoye: One partial response in the combination arm of a patient with colorectal cancer that's marked for satellite stable, with treatment ongoing for more than 10 months. Typically, patients with colorectal cancer that has MSS are unresponsive to immune checkpoint inhibitors. And published data demonstrate a median PFS of approximately eight weeks in this patient population. We reported another partial response in the monotherapy arm of a patient with primary peritoneal cancer that is also platinum-resistant and with micro-satellite-stable status, with treatment ongoing at 24 weeks at the time of the presentation.
The muscle response in the combination arm of a patient who rectal cancer. That's most of the Sutlej stable.
With the treatment of going for more than 10 months.
So for the patient.
Rectal cancer that hub and Mr. <unk>.
On the responses to the immune checkpoint inhibitors and publish the that those students and the median PFS of approximately.
And the patient population.
We reported another bunch of response in the mood of the therapy all of a breach of the birds on El cancer.
Also of block numerous system on with microsatellite stable status, which was on O'guinn of twin boom of the time of the presentation.
Overall, we are encouraged with the durability of the answer is due on the Philippine on responses.
Henry Adewoye: Overall, we were encouraged by the durability of anti-tumor activity and response, with a number of patients in the combination arm remaining on study for over 200 days. I can share that there were no reported dose-limiting toxicities at dose level 5 of the dual-combination dose-escalation arm of CROM 701, 20 mg per kg body weight, plus nivolumab 480 mg, both IVQ for weeks, and there were no Additionally, the PK profile of COM701 was similar to what we previously reported at the COM701 20 mg per kg IVQ 4-week dose in the monotherapy dose escalation cohort.
The renewable business and the combination of mom, who many of the study for over 200 days.
I can share, but there were no reported dose limiting toxicities and dose level five of the duo combination dose escalation.
Of course of in the 120 milligrams per kilogram.
Most of the volume of 42 milligrams boost the Q4 weeks, although the new news of the funding of these doors.
Additionally, the big of proof of concept when no one was similar to what we previously reported on the call.
So the new 120 milligrams per kilogram IV Q4 weeks dose in the monotherapy dose escalation cohorts.
Today, we announced the results of all of them to patients who are enrolled in the combination dose escalation schools.
Henry Adewoye: Today, we announce the results of all 15 patients who were enrolled in the Combination Dose Escalation Program. Two other patients had a clinical response of CR or PR. And the disease control rate, i.e., best time point assessment of ST or better, was reported in 10 out of 15 patients, mainly 67%. This preliminary antitumor activity is encouraging considering this is an all-comer, heavily pre-treated patient population with a median of five prior therapies. In addition, 5 of 15 patients, or 33%, had a terrible best response of stable disease of six months or greater.
Two of the patients how the tumor response for CR or PR on the.
Is this going to read on based.
Based on bonuses for the SBA.
Or better was reported instead of 15 patients than the 67%.
This preliminary antitumor activity in colleges.
This is on all comer hasn't improved with the addition for condition with the median of five prior.
Prior studies.
In addition, five of the supervision.
For the person how durable those disposal of supervision.
Of six months or greater.
Well all of the lesser of both of them on digital fundings from individual patients in the combination dose escalation arm.
Henry Adewoye: I would also like to report some additional findings from individual patients in the combination dose escalation path. Starting first with a patient with enal squamous cell carcinoma with initial assessments of confirmed stable disease at AACR last year for over a year on 0.3 milligrams per kilogram IVQ for three weeks plus Levonumab 360 milligrams IVQ for three weeks. We're encouraged to share that this patient now has a confirmed complete response on imaging and is continuing on study treatment for more than 18 months.
Starting first with the patient with female squamous cell carcinoma with the initial assessments of confirmed stable disease of PCR last year for work the year on <unk> three milligrams per kilogram IV Q3 weeks plus the a little low 360 milligram the Q3 weeks.
We're encouraged to share this vision the house confirmed complete response for imaging and is continuing on study of more.
On the next two months.
Henry Adewoye: Before enrolling in our ongoing study, this patient received last prior treatment with nivolumab, achieving a confirmed complete response, and then progressed while on nivolumab. This confirmed complete response, following progression on an immune checkpoint inhibitor, suggests that treatment with COM701 may broaden the defagget patient population for COM701 therapy. In addition, this complete response, along with the rest of this combination study data, also supports our underlying hypothesis that drug inhibition with COM701 and APD1 inhibitor may offer increased clinical benefit versus monotherapy with an immune checkpoint inhibitor in certain genotypes by inhibiting two parallel non-redundant checkpoint pathways.
Before enrolling in a hunger in the study this patient received loss for treatment with Ebola on children of compute.
Affirmed the complete response, and then progressed well on the rule of law.
Does this go from complete response following progression on of immune checkpoint inhibitor. So just a simple would come sort of in the one the brunt of the target patient population for comes up on the one therapy.
Henry Adewoye: Specifically, NL squamous dell carcinoma is an often cancer and an indication of high or medical need for new treatment options. In addition to this complete response and a previously reported confirmed partial response in a patient with colorectal cancer with microsatellite-stable status, we reported stable disease in 8 of 15 patients.
Henry Adewoye: Of note are three patients with durable stable disease. One patient with renal cell carcinoma who remains on combination treatment for over 13 months. A patient with squamous cell lung cancer who had prior treatment with PD-1, PD-L1, and CTLA-4 inhibitors who was on study treatment with COM-701 plus nivolumab for over 8 months, and a patient with endometrial cancer who was on study treatment for over 10 months. Taken together, this data suggests that COM701 in combination with nivolumab may provide meaningful and durable clinical benefits to patients, including in tumor types typically unresponsive to immune checkpoint inhibitors, such as ovarian cancer and colorectal cancer, specifically microsatellite-stable, and in patients who have had prior treatment with immune checkpoint inhibitors.
The benefits of patients, including the tumor typically unresponsive to Egypt inhibitors suggest ovarian cancer and colorectal cancer, specifically microsatellite stable.
In patient of high priority for the immune checkpoint inhibitors.
This results for the support of our ongoing commission strategy for the Triple combination study and our recently announced blow comes out of the one plus the rollmop cohort expansion.
Henry Adewoye: These results further support our ongoing combination strategy for the triple combination study and our recently announced DWAL, COM701 plus Nivolumab cohort expansion. Before reviewing the initial data from the Monotherapy Cohort Expansion, I would like to provide additional follow-up data from the Monotherapy Dose Escalation Cohorts that were reported at AACR last year. The patient with primary peritoneal cancer, a type of ovarian cancer that is also platinum-resistant and microsatellite-stable status, remains on steroid treatment with confirmed partial response ongoing for more than 14 months. Typically, in this patient population, with standard-of-care treatment with chemotherapy, the reported median PFS, or progression-free survival, is approximately four months, with a reported median overall survival of approximately 12 months.
Before reviewing the initial data from immunotherapy court expansion I would like to provide additional follow up data from the monotherapy. This escalation cohorts that we reported on <unk> last year.
The patient with private better than out cancer. The type of ovarian cancer that is also platinum resistance of Microsatellites stable status remains of star treatment with confirmed partial response ongoing for more than 14 months.
Typically in this patient population with standard of care treatment with chemotherapy. The reported on PFS on progression for survival is approximately for months women of reported wounded overall survival of approximately 12 months.
Efficient with contracted adenocarcinoma would confirm stable disease hordes of study treatment for seven months.
Henry Adewoye: A patient with pancreatic adenocarcinoma with confirmed stable disease who was on study treatment for 7 months. This patient was refractory to all three prior lines of standard of care therapy. These data are encouraging, considering that the anti-tumor activity reported with COM-71 immunotherapy is an air tumor type that is typically unresponsive to immune checkpoint inhibitors, which represents a high unmet medical need for new treatment or, and also in a patient refractory to multiple lines of prior therapy.
This patient was refractory to all three of prior like on the standard of care therapies.
This data encouraging considering that the anti tumor activity reported Conservatoire immunotherapy. These in Ed Talbotype that is typically unresponsive to balloon Chaplin inhibitors, which represents a high of medical needs for the new treatment options on.
Also on inefficient refractory to multiple lines of prior therapy.
Henry Adewoye: The time on study treatment would come 7 to 1, 20 milligrams per kilogram of IVQ for weeks in this patient until disease progression is significantly longer than the time on study treatment for each line of prior therapy that the patient received and was refractory to.
The time on study treatment will come 701, 20 milligrams per kilogram of Ivy queue for weeks and this patient onto the this progression is significantly longer than the time on for the treatment for each line of private therapy that the patient received and was the fractured too.
Moving next two preliminary results from the come several of one will the therapy court expansion whichever of the total of 20 patients with advanced solid tumors, including adult those most of lung cancer ovarian breath endometrial on colorectal cancer was exhausted all available standard therapies.
Henry Adewoye: Moving next to preliminary results from the COM701 immunotherapy cohort expansion, which enrolled a total of 20 patients with advanced solid tumors, including advanced non-small cell lung cancer, ovarian breast, endometrial, and colorectal cancer, who have exhausted all available standard therapies. The key objective of the study was to evaluate the safety and tolerability of COM701 at the recommended dose for the expansion of COM701, that is, An additional exploratory objective is the preliminary evaluation of the anti-tumor activity of COM-7-1 monotherapy as a recommended dose for expansion.
Henry Adewoye: I can report that 6 of 20 patients, or 30% of the patients, had the best assessment of stable disease, with one patient with endometrial cancer, three patients with non-small cell lung cancer, and two patients with ovarian cancer. Two patients with stable disease remain on study as of the date at cut off of December 14, 2020. One patient with non-small cell lung cancer with treatment ongoing at six months, and a patient with ovarian cancer with treatment ongoing at 20 weeks.
The key objective of the study was to evaluate the safety on some of our ability of calm 71 of the recommended dose for expansion of cost of in the one that is 20 milligrams per kilogram Ivy queue for weeks.
An additional exploratory objective is the preliminary evaluation of the anti too on activity of calm some of the one one of the therapy at the recommended dose for expansion.
I can report that six of 20 patients or 30% of the patients had best assessment of simple disease with one patient with endometrial cancer for patients with non small cell lung cancer and two patients with ovarian cancer.
Two patients with some of the these women on study as of the day that cost of December 14th 2021 patient with non small cell of lung cancer would treatment on weight at six months and efficient with with the encounter with treatment Odeon that 20 weeks.
Particularly noteworthy is the patient with non smart of lung cancer, who remains on treatment and of received one of them for the prior lots of therapy, including price immune checkpoints inhibitors.
Henry Adewoye: Particularly noteworthy is the patient with non-small cell lung cancer who remains on treatment and has received more than three prior lines of therapy, including prior immune checkpoint inhibitors. Two additional patients who are still on the study have not reached their first assessment at the time of the data collection. Twelve patients have stopped study treatment, with the majority due to progressive disease. There were no new safety findings at this date.
Two additional patients who are still on the study of of the reached the first assistant of the time of the day Records.
For patients of stock study treatment with the majority due to progressive disease.
There were no new safety findings at this dose.
Henry Adewoye: Overall, the disease control rate in the monotherapy, dose escalation, and expansion cohort was 47%, with best responses of durable and tangible activity, including a patient response. Further analysis of this study data is ongoing. As Anat mentioned, we are now performing correlative study patient samples, including preliminary assessment of blood cytokines and immunofeminotyping with the objective of complementing our research on how COM701 modulates the tumor microenvironment, particularly in indications that are typically not responsive to PD-1, to further learn about COM701 activity, which will inform on additional studies to be conducted in indications with preliminary encouraging signals of anti-tumor activity.
Overall, the disease control right in the middle of therapy.
A solution and expansion court was for the 70 day would be best responses of durable and the two of activity, including the pasture response.
For the analogy of the study that is ongoing.
At the not mention we are now performing current <unk> study patient samples, including preliminary assessment of blood site of guidance on any of the typing with the objective of complimenting a research on how come 71, one of the links the tumor microenvironment, particularly indications that typically not responsive to PD one to for.
They're about comfortable on activity, which will inform on additional studies to be conducted indications with preliminary encouraging signals of anti channel activity.
As of not indicated.
Henry Adewoye: As Annette indicated, initial assessments of patients' peripheral blood samples suggest that COM701 may enhance immune activation in cancer patients alone or in combination with bone marrow. Initial data from this assessment, along with updated data, are planned to be presented at ASCO 2021, for which an abstract has been submitted.
Initial assessments of patients for for a blood samples suggest that comes up on the one may announce immune activation and cancer patients a low on combination will be Lola.
The initial data from the the assessment along with of data data of plan to be presented of ask of 2021 for we can abstract has been submitted.
Henry Adewoye: In conclusion, in the ongoing physician study evaluating COM701 immunotherapy and in combination with the roadmap, we have now reported encouraging signals of anti-tumor activity in patients that are heavily pre-treated, in patients who have received prior immune checkpoint treatment, in patients refracted to prior treatment, and in tumor types typically unresponsive to immune checkpoint inhibitors. These signals of anti-tumor activity across our studies include stable disease, including durable stable disease, confirmed partial responses, and a confirmed complete response in diverse tumor types, such as primary peritoneal cancer slash ovarian cancer, anal squamous cell cancer, endometrial cancer, non-small cell lung cancer, pancreatic cancer, colorectal cancer, that is, microsatellite stable status, renal cell cancer, adrenergic cystic cancer, and cervical cancer.
In conclusion and the.
The incision study evaluate income several of hormonal therapy on in combination with the roadmap. We have now reported encouraging signals of anti tumor activity and patients that are heavily per treated.
Envision too, obviously price immediate treatment and patients reflected to prior treatment I mean tumor types of typically unresponsive to be in checkpoint inhibitors.
The signals of anti channel activity of course studies include student disease, including durable table disease confirm pass your responses and confirm complete response in diverse tumor types, such as private afraid of toenail cancer Slash ovarian cancer announced the motel cancer endometrial cancer non most of lung cancer.
Contracted cancer colorectal cancer values microsatellite stimulus daughters.
The cancer.
Cystic cancer on cervical cancer.
Henry Adewoye: For the most part, this should answer the question that, at this stage of the study, we have demonstrated that COM701 immunotherapy and in combination with nivolumab has an acceptable safety and tolerability profile. Additionally, at this stage, we have preliminary evidence of anti-tumor activity. We will continue to test our hypothesis that driving robust immune responses will require a combinatory blockade of PVRID with PD-1, TGT, or all three together, and we're still advancing clinical programs that explore each of these combinations.
For the most part of this will answer the questions at the state of the study we have demonstrated that comfortable on one of therapy on in combination with the roadmap has an acceptable safety and tolerability profile.
Additionally, at the state we have preliminary evidence of anti tumor activity. We will continue to test the hypothesis that driving robust immune responses will reflect copulatory.
Profit of Pvs with PD, one television all three together and we're still advancing clinical programs that explore each of these combinations.
Following the evaluation of quality of assessments based on data of the patient samples collected in our studies expansion corpse. The next steps of May include the selection of target indications for additional studies, including combinations with standard of care of agents.
Henry Adewoye: Following the evaluation of correlative assessments based on data from the patient samples collected in our studies expansion cohorts, the next steps may include the selection of target indications for additional studies, including combinations with standard of care agents. We look forward to continued progress in our triple-combination phase 1 slash 2 open-label study, which is evaluating the safety, tolerability, and preliminary anti-tumor activity of COM701 in combination with nivolumab and bristolomyces quince anti-tumor antibody in selected tumor types, namely ovarian cancer, endometrial cancer, as well as the biomarker-driven arm of tumor types with high expression of PBRL.
We look forward to continue to progress on our triple combination for this one's lasting hopefully the study which is evaluate the with the <unk> tolerability on preliminary and thank you on activity will come some of the one in combination with the both of them up on Bristol might be squeezed unseated antibody is selected suicide mimicking brilliant cancer and the <unk>.
Of cancer as well as the biomarker driven of towards the high expression of the year of June.
Additionally, in order to maintain a leadership position on independence to evaluate the <unk> combination regimens. We also have continued to advance face. One this escalation of trial of 900 June and look forward to advancing the clinic or program for 41 cities blocker also in a combination of stuff.
Henry Adewoye: Additionally, in order to maintain our leadership position and independence to evaluate various combination regimens, we have continued to advance our Phase I dose escalation trial of COMP902, and look forward to advancing the clinical program for our fully-owned FIGIT blocker, also in a combination study with COMP701, thereby evaluating a PD-1 slash PD-L1-free regimen. And finally, before turning the call over to Ari, I would like to express my gratitude to the Compugen team, our investigators, and, of course, our patients and families who are playing integral roles as we advance our clinical programs to expand the reach of immunotherapy. Thank you.
We've come several of the one, thereby evaluating repeating one slash the L. One three regimen.
And finally, if not on in the call over to items I would like to express my gratitude, the the companies and see our.
Our investigators and of course patients and families roughly in particular rules as we advanced are clinical programs to expand the reach of Immunotherapies. Thank you.
Pay for your Henrik.
Good morning, and good afternoon to everyone.
Unknown Executive: Thank you, Henry. Good morning and good afternoon to everyone.
Unknown Executive: Our financial results for the fourth quarter and the full year of 2020, released this morning, reflect the continued expenses associated with our ongoing various clinical programs. Our revenues for the fourth quarter and full year of 2020 were $2 million, representing the first development milestone from our license agreement with AstraZeneca announced during the fourth quarter. Research and development expenses for the full year of 2020 were $22.8 million, an increase of approximately 15% compared with $19.8 million in 2019.
Our philosophy result for the fourth quarter and the for the year of 2028 released this morning reflect the continued expenses associated with our ongoing various clinical for court.
Our revenue for the fourth quarter and the full year of 2020 for $2 million, representing the first day benefit milestone from our license agreement with Astrazeneca anal during the fourth quarter.
The research and development expenses during the full year of 2024 of 22 $8 million and the increase of approximately 15% compared with $98 million 2019 for.
Unknown Executive: For the fourth quarter of 2020, research and development expenses were $8.1 million, an increase of 88% compared with $4.3 million in the prior year period of 2019. The increase in both cases is attributed mostly to higher clinical studies and related expenses, as well as CMC-related activities, specifically manufacturing costs for additional drug supply of both COM701 and COM902 to support the planned expansion of our various clinical trials.
For the fourth quarter of 2020 research and development expensive for eight $1 million, an increase of 88% compared with for $3 million and the prior year period of 2019, the increase in both cases.
Is attributed mostly to hire clinical studies related expenses as well as CMC related activities, specifically manufacturing costs for additional drug supply of both current seven the one and combed items to to support the pledge of expansion of our various clinical trial.
Net loss for the full year of 2020 was 29 $70 million of 37 cents per basic in need of the chair compared with the net loss of 27 $3 million of 43 per basic and the look the chair for the 2019.
Unknown Executive: Net loss for the full year of 2020 was $29.7 million, or $0.37 per basic and diluted share, compared with a net loss of $27.3 million, or $0.43 per basic and diluted share, for 2019. Net loss for the fourth quarter of 2020 was $8.6 million, or $0.10 per basic and digital share, compared with a net loss of $6.5 million, or $0.10 per basic and digital share, for the prior year period. At the end of December 31st, 2020, we had approximately $124 million in cash and cash-related accounts compared with approximately $44 million at the end of the prior year.
Net loss for the fourth quarter of 2020 was eight $6 million of 10 cents per basic and do the chair competitive with a net loss of six $5 million or 10 cents per basic and the look of chair for the prior year period.
As of December 31st 2020, we had the approximately $124 million in cash and cash related accounts compared with approximately $44 million at the end of the prior year, we have note that.
The increase in of cash balances is look at tuba fit to approximately $74 million of net profit received in our public offering last March approximately $80 million received from exercise the fourth and approximately $60 million with Steve from exercises for employee option of.
The fit by operating expenses and working capital of approximately 28 million.
Going into 2021, we expect of growth cash expenditures to be in the range between $40 million to $42 million.
Without taking into consideration any potential cash inflow for the company for existing all new collaboration.
Unknown Executive: We have no debt. The increase in our cash balances is mostly attributed to approximately $74 million of net proceeds received in our public offering last March, approximately $80 million received from the exercise of forints, and approximately $60 million received from exercises of employee options, offset by operating expenses and working capital of approximately $28 million. Going into 2021, we expect our gross cash expenditures to be in the range between $40 to $42 million without taking into consideration any potential cash inflows for the company from existing or new collaborations. Thank you, and with that, we will now open the call to questions.
Thank you and with that we will not open the call for questions.
Unknown Executive: Thank you. Ladies and gentlemen, at this time.
Thank you Lady.
Do you think gentlemen at this time, we will begin the question and answer session.
Unknown Executive: At this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to decline from the polling process, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers.
You have a question please press.
Star one if you wish the kind from the point per heck. Please.
Please press the Star table. If you are you think speaker equipment kind of left the handset for packing the numbers. Please.
Unknown Executive: Please stand by while we poll for your question. The first question is from Chris Howerton of Jeffries. Please go ahead. Hi.
The standby lollipop of your questions.
The first question of from Chris Howerton of Geoffrey's. Please go ahead.
Unknown Executive: Hey, good morning, and thanks for taking the questions. So I guess, first of all, it's obviously great to see another complete response. But I guess I'm curious about the monotherapy arms, you know, which, at least by our eyes, the expansion cohorts seem to have at least flat or slightly less efficacy. So I'm curious to see, Henry or Anat, what your explanations might be in terms of what could explain the differences between those two patient populations or subjects in those two different study arms. So that's one question I have.
Hey, good morning, and thanks for taking the questions.
So I guess.
First of all of you say great to see the.
Another complete response.
But I guess I'm curious about the mono therapies arms, what at least by our eyes the expansion cohorts seemed to have.
Flat or the or slightly less efficacy. So I'm curious to see of Henry Aaron What's your explanations might be in terms of.
What could explain the differences between those two.
The patient populations are subject some of those two different steady items. So that's one of the question. The second question would be uhm with respect to the C. R. It's such a slow at such a low dosage of 0.3 Megs.
Unknown Executive: The second question would be, you know, with respect to the CR, it's such a slow, such a low dosage of 0.3 mg. Um, you know, what do you think's going on there? And I guess that is kind of tackling on to my third question, which is, how could you give us a little more color on kind of the biomarker strategy? And how is it that you're going to try and elucidate? What is it, like, prospectively, what are the types of tumor types, um, or patients that could respond to mono, doublet, or triplet therapies? Thank you.
What do you think's going on there and I guess that is kind of tacking onto my third question, which is how could you give us a little more color on kind of the biomarkers strategy and how is it that you're gonna train earlier today, what is it like prospectively what are the type of tumor types.
Or patience that could respond to mono doubled or tripled therapies. Thank you.
Unknown Executive: Sure. Hi Chris.
Cheryl Hi, Gray and I.
Alright, just stay on a few of not hanging out of the SEC Henry and answer the questions that I can get day in general for the second one of her P. M. We were trying not to compare the two.
Unknown Executive: I'll start by just making just, you know, a few remarks, and then I'll just let Henry answer the questions. But I think that, in general, for monotherapy, you know, we're trying not to compare the two portions of the studies with different patients, et cetera. We look at the totality of the data and the directionality of the data that we generated, the dose escalation as well as the monotherapy expansion. I'll let Henry discuss that and also to the CR, and then we'll get back to the biomarker strategy. Henry
The two a portion of the day.
<unk> patient et cetera.
We nuke against the parity of of the day that in the direction of.
And on the data to regenerate and dose escalation is gladys amount of of happy and kind of like Henry related and also today.
Could the C R and can we get extra day Biomarkers packaging.
<unk>.
Unknown Executive: Yeah, thank you very much. And thank you very much for your questions, Chris.
Yeah. Thank you very much of the.
Thank you very much for your questions on Greece, Yes, we looked at the data also.
Unknown Executive: Yeah, we looked at the data also. But the key takeaway from what I would like to say here is that there are two different ways to look at this data, and you'll come to the same conclusion. And the conclusion you'll come to is that there is preliminary antitumor activity with COM701 immunotherapy and also in combination with nivolumab. And if you were to look at the dose escalation cohorts, the objective of the study was just to establish what the safety and tolerability profile and DLTs of COM701, starting at a very low dose, were.
For the key typically for what I would like to see here is that the two different ways to look at this data on you'll contrabassoon confusion and the conclusion, you'll countries days preliminary end of July activity would come 71, one of the therapy and also in combination with the bill amount of <unk>.
You went to look at the commission cohorts U B objective of that of the of the study was just to establish would be <unk> on to reboot your profile on D O Ts.
Would come 71 stretching the the very lewd those was for the expansion of who wants the primary objective of the scoreboard was simply to establish what the safety on Tolerability of calm 71 of <unk>.
Unknown Executive: For the expansion cohort, the primary objective of this cohort was simply to establish what the safety and tolerability of COM701 are at the recommended dose for expansion, which is 20 milligrams per kilogram body weight, IVQ, for four weeks. So we've been able to demonstrate this from what we've been able to show. And therefore, that's the only assessment one should be able to take from it.
The recommended induced for expansion, which is 20 milligrams per to November the words Ivy queue for weeks, so we'll be able to demonstrate the.
From what was moving to show and therefore, that's the E. Assistant once you do to keep from it.
Unknown Executive: And in addition, remember that in patients who are also on therapy at the COM701 20 milligrams per kilogram body weight dose, we have highlighted that at least a third of those patients, right, six out of the 20, have stable disease during the course of the prepared remarks. So that's the way we will look at it, and it will be very, very difficult to start comparing dose escalation with DLTs as an endpoint with safety and tolerability in the expansion cohort, even though you do still see the same anti-tumor activity for both of them. All right. So, let me go to the second question with the confirmed complete response. Yes,
Remember the in patients who are also on therapies.
On the come several of 120 milligrams per kilogram by the way dos we have highlighted the at least the third of the Speakes's.
600 of the 20.
Have a simple disease during the course of the because of my prepared remarks. So that's the way we look at it and it was very very difficult to start comparing dose escalation of D. O T. As an endpoint with 60 on to the ability and the expansion cohorts, even though you do deduced you'll see the same.
Of the two activity for both of them.
Unknown Executive: So, remember, Chris, that we presented data at SIPC with regard to receptor occupancy for COM701, and in that data, we said that the dose, the absolute bottom at 75% receptor occupancy or greater is about 0.3, and about 1, you have 90% or higher. So, we think that possibly a reason for this is that it takes a while in a patient that has been multiple treated with several prior lines of therapy for COM701 to possibly inhibit the activity of all the cancer cells within the tumor itself.
All right. So let me go to the second question with the.
Confirm the complete response, yes, so remember.
That we presented data of.
IPC with regards to reset the occupancy for come several of the one on in that data, we said that the dos the absolute bottom at 75% receptor occupancy.
Great is about three and about one you have 90% or higher so we think that possibly a reason for this is the it takes a while in the patient let us multiply treated wood silver proud of the lines of therapy for actually too for.
For the for come several of the one to possibly inhibit the activity of all the towns of ourselves within the two of itself. So that's one reason that we possibly care of that proposed for the for like six.
Unknown Executive: So, that's one reason that we possibly can have profound reasons for the—why it takes such a long time in this patient. But the ultimate thing for that patient, remember, Chris, is that the complete response was observed again after relapse while on Voluma. I think you can hear it. We've already presented preliminary data in terms of the cytokines in the blood to see if there is any correlation with some of the anti-tumor activity that we've observed, and you've seen that in my prepared remarks. So, I'll just stop there and see if that answers your question or if you have additional comments.
Six O two nine time in the submission.
But the ultimate thing for the patient to remember is that the complete response was observed a day after relapse while on the Boulevard. He's been here for the biomarker strategy of unsure on the two probably want to contribute to the what what we intend to do is to evaluate.
Patients in the expansion cohort pre samples that were obtained before study treatment and samples of teen during the course of study treatment in terms of the Biomarkers of interest primarily to the <unk> to to be able to see the the coalition we've already presented presumably we've looked at preliminary data in terms of the site two kinds.
And the blood to see if the is Amy.
The correlation with some of the day to activity that we've observed of Houston by the way I prepared remarks. So I'll just the balance is that answers. Your question of idea of additional comments.
Yeah, No. That's that's really helpful and and so I guess with respect to the C. R basically the.
Unknown Executive: Yeah, no, that's really helpful. And so I guess, you know, with respect to the CR, basically, my assumption with respect to the biology is that there was obviously some escape with respect to the nivolumab mechanism of action and that the 75% receptor occupancy you feel is enough to get the blockade of the rest of the pathway, I guess is kind of the message you were saying, Henry.
I mean, my assumption with respect to the biology is there is there was obviously some escape with respect to no volume ads mechanism of action and that the 75% receptor occupancy you feel is enough to get the blockade of the the rest of the.
Pathway I guess is kind of the message you were saying Henry.
Unknown Executive: Yeah, but remember, the receptor occupancy I'm talking about is peripheral; it's not within the tumor.
Yes, but remember the result of occupants I'm talking about these proof room, it's not within the two months.
Unknown Executive: And therefore, yeah, and therefore, Chris, remember again that the reason we went as high as the dose that was selected is because of the patient population that we intend to explore. That's one.
Therefore.
Therefore, creased remember again, the the reason we went as I as.
The Dowsabel selected is because of the patient population that we intend to to explore that's one and the number to one of the patients 20 milligrams per kilogram with the with those that's the patient that has a tumor type of that is typically unresponsive to immune to a point that's sufficient will from the periods when the hell cancer.
Unknown Executive: And then number two, one of the patients at the 20 milligrams per kilogram body weight dose, that's the patient that has a tumor type that is typically unresponsive to immune checkpoint therapy. That's the patient with primary peritoneal cancer. At the very first assessment for that patient, the patient had a partial response. We presented that patient's data and the images that were captured by the investigator at AACR last year. So the partial response is actually different with 20 milligrams per kilogram body weight dose.
At the very first assessments for that person the patient of ours. The partial response were presented at the patient data on the images that were captured by the investigator.
Last year. So the partial response actually different with 200 milligrams per kilogram with the with those on that payment has held onto that response from one of the year now. So it shows that you probably within the tumor cell and especially in patients who have been.
Unknown Executive: And that patient has held on to that response for more than a year now. So it shows that, within the tumor cell, and especially in patients who have been treated previously with maybe immune checkpoints or several lines of chemotherapy, you need to achieve sufficient penetration into the tumor itself. The other patient I would like to bring up that is also pertinent is the patient with microsatellite-positive colorectal cancer.
Treated previously with me, the new checkpoints or several of Elton Brown the lines of chemotherapy.
Need to achieve sufficient.
The nutrition into the into the two more itself. The other patients I would like to bring the also the there's also pertinent is the patient will microsatellites civil colorectal cancer. It's the same.
Unknown Executive: It's the same thing that we observed in that patient. Remember, that was the patient that we presented also at AACR. And for that patient, that patient had had four prior lines of treatment. And they were on COM701, in combination with Nivo, Nivo was 362 milligrams IVQ for three weeks, and COM701 was 0.3 milligrams per kilogram body weight dose. That patient was on steady treatment and confirmed stable disease up until about seven months before they then had a PR, partial response, that then was confirmed several times afterwards. So that's the totality and the interpretation of that data.
And that we observed on that decent remember of those efficient that we presented also.
<unk> and for that piece of the of depression at full prevalence of treatment and the way on come several of the one on the competition on on the table.
Maybe it was 260 milligrams of you do three weeks in terms of new one was portion of milligrams per kilogram body with those the patient was on subject treatment on confirm stable disease up until about several months before the then had APR pleasure response. The then was confirmed several times afterwards, so that's that's the too.
At the end of interpretation of the data.
Okay.
Unknown Executive: All right, that's great. I don't know, Anat, if you wanted to add anything to Henry's comments with respect to the biomarker strategy, but I appreciate the response.
Alright, that's great I I don't know of not if you wanted to add anything to Henry's comments with respect for the bedroom I for your strategy, but I appreciate the the cat sure Yeah, Yeah, I'll just add a lack of like Enron related the pamuk of second you've made out of just he just in terms of looking at the pathetic of an ex would be on.
Unknown Executive: Yeah, I'll just add that I let Eran relate to the biomarker strategy, but I'll just say that just in terms of looking at the totality of the data, and that would be for the monotherapy, and that would be a segue to the biomarker discussion, we also stated that we see immunotivation in our initial correlative assessments in blood samples, and that's in the single agent and also in combination. And I think that when you look at the story of what antitumor activity is, when you look at the totality of the data, as well as the fact that there was immunotherapy, and in different tumor types, and durable antitumor activity. For us, it serves as the basis.
For the amount of happy and echoed the heck weighted about market discussion and we also stated that we see in an activation in our initial of that in the initial correlated of heckman in that came back at.
In that case in the.
I think of the agent and also on combination and I think that when you look at the story of what the antitumor activity. When you look at the totality of the date of as well as the fact that get working on activation any different to Mark type. Thank you for a bedroom and your bill of an extra more activity.
For.
Eight.
Sure.
AC.
Unknown Executive: In order to take it to the next page, we think that the data points to the fact that COM701 is active. We will continue to look at the monotherapy setting. The patients are still on study. We'll continue to do some additional correlation studies, and additional biomarker work. Eran will relate to it, and we'll make the decisions with respect to monotherapy specifically as we have the full data. But now it serves us well in order to move forward into combinations and to expand our strategy for combination treatment. So, Eran, would you like to discuss the biomarkers?
In order to take it for the next page.
We seem to get the date of points for the fact that calm Kevin of wine is acting we will continue to look at the moment of therapy checking the patient's head of patients get on the study will continue to do some additional day correlation of studies additional biomarker work around oil related.
And we'll make it of decisions X amount of therapy.
Lee.
As we have it for the data back now.
Well in.
That came out for it and into the a combination.
Combination tend to kind.
So I could do for a combination treatment so around on with the doctor relate to the bedroom. Okay. Yeah. So.
Unknown Executive: Yes, so as I mentioned, we're looking at pre- and post-campus. We're looking at the expression of the dynamaxis, trying to correlate response with the expression of the axis. We're looking at the immunodulatory activity of COM701. We do that by looking at peripheral blood, and we already stated today that you see that COM701 probably enhances immunity in patients, which is very important to see. And at the end of the day, we're also going to look at the true microenvironment with different sequence methods to try to see a modulation of the true microenvironment in addition to what we already see in peripheral blood by COM701, and with that, we'll try to link all of it with response and indication and patient selection. Okay. And the pre-post biopsy analyses, particularly for the DNAM axis, is that anticipated to be at ASCO this year, Eran?
Mentioned, the we're looking at the pre and post office, we're looking at the the expression of the Dean of Max's for the call. It response was the expression of Texas, We're looking at the at the Missoula immune with due to the the activity of some sort of in the one we do that we're looking for a for a blood in the road. We just take the today, but you see that's considered on the one probably enhance.
Which is very important to see in in any of the day. We're also going to look through my co environment with different sequences methods to try to see a modulation of two of my co environment. In addition to what the already seen per per blood the by cost of in the one but that will try for link all of it with response and an indication of inefficient selection.
Got it okay.
And the uhm the pre post.
M C analyses, particularly for the DNA am actresses that anticipated to be at <unk>. This here on.
Unknown Executive: At this stage, we stated that initial correlative assessment will be presented, and in general, the task force was accepted. We didn't give guidance yet to the DNA axis biomarkers in histochemistry. This is a work in progress, and we'll for sure share the data, but we didn't give guidance yet.
At this day do we and we should take the Deckhead initiative Correlative assessment and will be presented in January will be presented the Catholic for accept and we didn't gave the guidance. He ex today and Dean on <unk> any nice the Kenny Street and working progress and.
For sure share the data, okay, and we didn't get diagnosed yet.
Okay.
Unknown Executive: Okay, well, wonderful to see the progress, and again, thank you very much for taking the questions and your answers.
Okay, well wonderful to see the progress and again, thank you very much for taking the questions on your answers.
Unknown Executive: Thank you.
Thank you.
The next question is from Stephen Willie of Stifel. Please go ahead.
Unknown Executive: The next question is from Stephen Willey of Stiefel; please go ahead. Yeah, good morning. Thanks for taking the question. And I was jumping around a bit.
Hi, good morning, Thanks for taking the question.
I was jumping around of it so forgive me if I ask something that was already discussed but.
Unknown Executive: So forgive me if I asked something that was already discussed, but can you maybe just provide a little bit more color around the kinetics of the CR patient in the doublet cohort? How long was that patient confirmed to have stable disease before they flipped to CR? And I guess I ask the question because I know that there are three other patients who are still in the midst of confirmed stable disease for some pretty long durations, and I'm just trying to get a sense as to whether or not those patients could also become responders at some point based upon the kinetics of the CR that was observed.
Can you meet me just provide a little bit more color around the the kinetics of.
The C R patient and the double cohort.
Court.
How long has that patient confirm to have stable disease before before the flips two of C. R and I guess I guess I ask the question of because I know that there's three other patients.
Who are still in the midst of confirm stable disease for some pretty long durations and I'm just trying to.
Sense as to whether or not those those patients could also become responders at some point based upon the.
Kinetics of of the C R that wasn't it.
And May I get you to take it.
Unknown Executive: Henry, I guess you'll say.
Unknown Executive: Yeah, yeah.
Yes, yes.
Unknown Executive: Thank you.
Like the so the the patients with the confirmed come to pre spoons within the we must of Okaka similar.
Unknown Executive: Hi Steve. So, the patient with the confirmed conflict response with NL squamous cell carcinoma was on study treatment for nine months until we observed the conflict response, and it has been seen that the complete response, like I mentioned, has not been confirmed repeatedly.
Was on the study treatment for nine months on to observe the complete response.
Has been seeing that the the complete response like I mentioned I would not be confirmed repeatedly.
Okay.
And for those remaining patients that are better on.
Unknown Executive: And for those remaining patients that are still on, that are still in the midst of a confirmed stable disease, I guess, for six-plus months, have those patients also been at a 20 mg per kg dose? Have you been able to dose escalate those patients as you cleared at various dose levels? Or have you kept those patients at their pre-specified dose level?
That are still in the midst of of confirm stable disease, I guess for for six months.
<unk>.
Are those patients also out of out of 20 make per cake.
Have you been able to gross escalate those patients as you as you.
Cleared in various those levels or have you kept of those patients at their pre specified dose low.
Unknown Executive: Yeah, so for those patients who were at the dose escalation for both the monotherapy and for the combination dose escalation, with the exception of maybe the first two dose cohorts, there was no intra-subject dose escalation. So they will remain at the doses that they're on if they're still on the study. So for example, the patient that is at the 20 milligrams per kilogram body weight dose of pancreatic cancer, which we have the indication that's ongoing at that dose, in the dose in arm A, that patient will remain at that dose so we can collect safety and tolerability. But the previous data we disclosed, we didn't have any dose, intra-subject dose escalation for one patient, which was at a very, very low dose at that point.
Yeah, so for those patients who were at the dose escalation for both the moving at the.
The and for the combination of his condition with.
With the exception of the the first two of those cohorts. There was no do interest subject escalation. So the women at the doses that they're on.
If they're still on the study so for.
For example, the patients that is the 20 milligrams per kilogram for the Windows, we've contracted cancer, which we have the the do some that's ongoing.
Those in the day.
In the.
The patients will remain on that does so.
So we can collect cisgender on their ability.
For the previous data disclosed we didn't have any deuce interest submit this escalation what for one patient because of a very very low dose at that point.
Okay and then.
Have you mentioned or can you discuss at this point I guess, how many patients.
Unknown Executive: Okay, and then. Have you mentioned or can you discuss at this point how many patients you're intending to enroll within each of the doublet dose expansion cohorts? Should we anticipate that this is going to be kind of like monotherapy dose expansion where you have a small number of patients over kind of a fairly heterogeneous spectrum of tumor types, or should we expect more patients to be represented by each?
You're intending to in the world within each of the.
Double it so six spansion cohorts.
Should we anticipate that this is gonna be kind of like model of therapy. Those expansion, where you had a small number of patients over kind of a fairly heterogeneous spectrum of tumor types or.
Should be expect more patient numbers to be represented by each tumor types.
So.
Unknown Executive: So we did that. Go ahead, Henry.
<unk>.
Go ahead Henry.
Yes, so we.
Unknown Executive: Yes, so if you go to clinicaltrials.gov, we do say there for the expansion cohort, the dual combination, we're going to have more patients. But remember, for the immunotherapy expansion, we only had four patients per tumor type. We had five tumor types, lung, ovarian, breast, endometrial, and colorectal, which is microcycloid stable colorectal. For the expansion cohort for the dual combination, we'll have more patients, up to about 20 patients in each of the tumor types that are of interest to us.
If you go on clinical trials of God, we do see the for the Expunction caught the dwell combination we're going to have more patience. So remember her for the Melissa that the expansion, we only had for patients, but supertax with five two matteis non will be of interest in the neutral on colorectal, which is microsatellites table colorectal for the expansion for for the dwelt.
Combination will have more patients up to about 20 patients each of the tumor types that were the.
Interest to us.
Unknown Executive: Okay, so you'll have up to 20 patients per tumor type.
Okay. So you'll have off the 20 patients on a per tumor type basis is that is correct.
Okay.
And then.
I believe there's plans also to look at.
Unknown Executive: [inaudible]
701 with with the nine O two.
I.
Unknown Executive: I believe there's plans also to look at COM 701 with 902. I guess, is that a correct assumption and, in pursuing that dose escalation, would you? Would you be specifying tumor types of interest to serve as the basis of an initial trial?
I guess is is is that of correct assumption and.
And pursuing that dose escalation would you.
Would you be.
Specifying spitz.
Tumor types of interest to serve as the basis of of.
Initial public initial trial there.
Henry.
Unknown Executive: Henry
Unknown Executive: Yes, Stephen, yes. You can see how compelling that strategy is, because now that we've shown preliminary anti-tumor activity of COM7-1 alone in patients who are refractory to standard of care therapies, including immune checkpoints, and also in combination with NIVL in patients who have relapsed following NIVL therapy, you can see that we will be interested in testing a regimen that is PD-1 or PD-L So we haven't enumerated the tumor types yet, but they will be tumor types that we think will have a high probability of having activity with the inhibition of the two non-redundant parallel pathways.
Yes, yes, you can see how compelling strategies because now that we've shown preliminary on sent to my activity of concert one on the new.
On in patients who are the factory to standard of care therapies, including the new checkpoints and also in combination with the board.
Patients who are the <unk>.
Relapsed following the will therapy, you can see that we will be interested in testing.
The strategy enrichment that is P. B one of <unk> just based on the hypothesis that we have so.
So we haven't enumerated the tumor thanks yet.
To be in tumor types that we think will have the high probability of.
Having activity with the introduction of the two non redundant on other pathways.
And Steve of willingly shake.
Unknown Executive: And Steve Willey will initiate this study. The study is expected to be completed in the second half of this year.
That is expected to be initiated in the second half of this year.
Wonderful.
Thank you for taking the questions and congratulations on the products.
Unknown Executive: Thank you for taking the questions and congratulations on the progress.
Unknown Executive: Thank you.
Okay.
Unknown Executive: The next question is from Mark Breidenbach of Oppenheimer. Please go ahead. Hey, thanks for taking my questions and congratulations on the very encouraging clinical update. This might be a little bit of a rephrasing of one of the questions that was earlier in the queue, but
The next question if for Mark Friday back of Oppenheimer. Please go ahead.
Hey, Thanks for taking my questions of congrats on on the very encouraging clinical update. This this might be a little bit of a rephrasing of one of the questions that we get anything too, but I'm trying to get a sense for if you have any predictions about specific biomarkers.
Unknown Executive: I'm trying to get a sense for if you have any predictions about specific biomarkers that might indicate cases where the doublet combination might be more suitable than the triplet combination. And I'm also wondering if the doublet expansion cohorts will test will include non-tomalcel lung cancer, which I believe is being included in the triplet study.
That might indicate cases, where the doublet combination might be more suitable than the triple a combination and and I'm also wondering if if the doublet expansion cohorts will.
We'll test.
We'll include non small cell of lung cancer, and which I believe is being included in the triplets study.
So I just don't like the bed and then on that day and Iran and he.
Unknown Executive: So I'll start, but then I'll let Eran add something. I'll just say that, in general, and you were looking from the indications perspective, but in general. From our perspective, you know, the triplet study is the ultimate way for us to test our hypothesis. But now, being in the situation that, you know, we're the first to move ahead with PDR-IG, and now with the data that we have and some initial data supporting the hypothesis, for us, now is the time to move ahead and broaden the clinical strategy and test all the different combinations that are relevant.
He is getting in general and you were looking from day of indications for accurate, but in general.
A matter of perspective, you know the <unk>.
Or the <unk> <unk>, what can make way for us to check our hypothesis now.
And the situation.
The first can move ahead with the C. D. R. I G and now with the date of that we have and having me share a date of supporting hypothesis for US now is the time to move ahead and for then the clinic kind of strategy and test all of the different combinations that are relevant.
Unknown Executive: out of these three pathway stories. So we think, based on our data, and Eran will relate to it, that different patient populations with different dominance of these pathways may respond differently. But it is also important for us to have some overlapping indications, and this is in order to be able to do some biomarker work and better understand the biology of the PVRIG axis, the contribution of the components, and how the different patient subsets are responding.
Out of the three pathway story. So we think based on on beta in Iran would related.
Unknown Executive: Transcription by ESO, translation by —
Different patient populations different dominance of these pathways may respond differently back.
It's also important for us to have some overlapping indication.
And this is in order to be able to do some biomarker work and that kind of understand the biology of the P. B R. I G access the contribution of the components of how the different patient subsets are responding so I I think that when you think about the packaging you think about the different combinations.
Unknown Executive: So I think that when you think about the strategy and you think about the different combinations, an array of combinations that we're going to execute and about the different indications, we're also rationally designing how we're going to collect information from these patient populations and make decisions about specific subsets that would fit the different combinations. So we got a letter around this, specifically the doublet first. Translational Data.
A ray of combination if there were thank too.
The cute <unk>.
And about the different indications will also rationally designing how we're going to collect information out of the Asian population and make eventually decisions at the.
Fixed upset and would fit the different combinations. So we get a lack of Iran.
I need the debit card.
Occasional data yes.
Unknown Executive: Yes, basically, all three pathways have a multi-parametric approach to look at them. We have the ligands, we have the receptors, and we have the expression by different cell types for each of those. And at the end of the day, we do identify some indications, and even inside those specific indications, some patients.
Yeah. So basically all three of pathways has the multi problematic of push to look at them with all of the like guns off the accept those of the expression, but different cell types for each of those.
And the of the day, we do identify some indications of even inside of the specific the dictation, some patients which of the different dominance across all types of the different pathways and the if that could be the patients in which the and the the the one and fever two parts of the modem and on the would expect to see more dominant response in the spacious even.
Unknown Executive: Which have different dominance across cell types of the different pathways. And yes, there could be a patient in which the PD-1 and PBRG pathways are more dominant. We expect to see more dominant responses in these patients, even in the absence of digit blockade. So, we're going to look at this in the trial. We're also going to look at biomarkers, the DNA-match test, PD-1, etc., and see again if we see any responses specifically in this patient that we anticipated, even in the absence of digit blockade.
The depth of sufficient okay. So we're going to look at this in the end of the try to the and the local so <unk>. So the <unk>, the one et cetera, and the second the formulate the preceded responses specifically the description of the 25th of the response given the the absence of the biggest book it.
Okay. That's that's helpful. Just the another question related to kinetics of response, maybe maybe for Henry.
Unknown Executive: Okay, that's helpful. Just another question related to kinetics of response, maybe for Henry. Can you remind us what the average time to response has been across the various cohorts, combination or monotherapy cohorts that you've seen responses in, excluding the one complete response that developed at nine months. Thanks.
Just can can you remind us what the average time to response.
Has been across the various cohorts combination of monotherapy cohorts the that you've seen the responses in excluding the one complete response, but that developed the 999 cent. Thanks.
Yes, so a month so the like I said the complete the exposed the piece of wood you know what's.
Unknown Executive: Yes. So, Mark, like I said, the complete response, the patient with NL spermal cell carcinoma was nine months in when we observed the first complete response. The patient with colorectal cancer, microcephalic stable, was seven months in when we saw the first partial response in that patient. Remember, the doses here were 0.3 milligrams per kilogram body weight and 360 milligrams IVQ for three weeks of nivolumab. For the patient with primary peritoneal cancer on a monotherapy arm, a partial response was observed at the very first imaging assessment, which was at eight weeks.
Go on sale kind of similar was the <unk>.
Nine months.
Until we observe the first complete response, the patient with cooler token of the Microsoft like Google with several months E onto the so the first the pressure response and that's on the patients.
Remember the the nurses queue is zero point for two milligrams per kilogram for the wait and the 360 milligrams.
Q3 weeks of the.
The bill amount for.
For the patients with primary pairs and all kinds of on the monitor one of the therapy the.
I shall we spoke with both of the the very first image of my assistants, which is.
Eight weeks, so uhm so the.
Unknown Executive: So, you can see that that's why I mentioned previously that perhaps it takes much longer in a patient population that is multiple treated for there to be penetration into the tumor itself, and that's why we probably observed that partial response at the outset with the patient with primary peritoneal cancer and the deepening of that effect. So those are the ones we've seen. For patients with stable disease, it's obviously at the very first disease assessment. And for those who have confirmed stable disease, that stable disease just shows, if you look at the patients with target lesions, continuous stabilization in most of these patients. And that's all.
You can see the that's why I mentioned previously that perhaps it takes much longer in the patient population that is multiple treated for that to be the nutrition into the tumor itself.
And that's why we probably observed that the pressure response of the visit at the outset with the patient with them.
From the birds cancer and the details of that is that the whole so so.
So those are the ones, we've seen for the patient with stable disease.
Obviously on the very first do the assessments.
And for those.
Firms stable disease, that's the disease just shows if you look at the patient with target missions.
Continue of civilization.
Most of the stations and that's all I can see on this one.
Okay.
Unknown Executive: I'll just add for everyone that the corporate presentation is updated with a few slides describing the clinical data. Okay, terrific. Thanks so much for taking my question. The next question is from Wren Benjamin of JMP Securities. Please go ahead. Hey, good morning, guys. Thanks for taking the questions and comments on the...
The.
And just to add a five O. One of the corporate presentation is updated we few sites from man and describing the the clinical data.
Okay perfect. Thanks, so much for taking my questions.
The next question is from rent Benjamin of JMP Securities. Please go ahead.
Alright, good morning, guys. Thanks for taking the questions on cause that's on the on the update maybe just a couple of questions. On one can you just comment on on what the median duration of responses across maybe the monotherapy in the in the combination of studies or separately.
Unknown Executive: on the update.
Unknown Executive: Um, maybe just a couple of questions. One, can you just comment on what the median duration of response is across, maybe, the monotherapy and the combination studies or separately? Also, is there any way outside of the biomarker data to try to narrow down the indications to focus on? I guess I'm trying to get a sense as to how you might be thinking about a registration strategy going forward. And you mentioned other combinations, outside of, you know, 701 plus on Devo. Wanted to just get your thoughts on what sort of combinations you might be thinking about and when you might start those.
Also is there any way outside of the biomarker day to to try the narrow down.
On the indications to focus on and I guess I'm trying to get a sense of as to how you might be thinking about a right of registration of strategy.
Going forward and you mentioned other combinations outside of 701 for some devo on just get your thoughts on on what sort of combinations you might be thinking about and when you might start those.
And we have to get your take this one.
Unknown Executive: Henry, I guess you'll take this one.
Unknown Executive: Yeah, I'll take the first one. Hi, Renny.
Yeah, I'll take the visit of hide any thank you for your question yes.
I spoke to the media on duration of response, we actually haven't even reached the median for I mean, it's still ongoing because the patient none of the patients.
Unknown Executive: Thank you for your question. Yeah, so with respect to the median duration of response, we actually haven't even reached the median for that yet. I mean, it's still ongoing because the patient, none of the patients, with the exception of the patient with microsatellite cervical rectal cancer that was on for 44 weeks, right, the other two patients are ongoing. So statistically, the only way to interpret that kind of data is just to say that it is still not estimable in terms of what the median will be because we have one patient that's been on study treatment now, with a complete, complete response, with a confirmed complete response that's ongoing for 18 months.
With the exception of the pizza with microsatellite civil colorectal cancer those on the for 44 weeks right. The.
Other two patients ongoing so statistically the only way to interpret that's on a bit of just to say that it is still not estimable in terms of what the media will be because we have one piece of the that's been on the started treatment now.
The complete complete responds with the company with the confirm complete responds that's ongoing for 18 months and then we have the other patients will probably better.
Unknown Executive: And then we have the other patient with primary peritoneal cancer that's ongoing now for 14 months. So you can see that because the data is heavily skewed towards the patients that are ongoing, it is still too early to know what the median duration of that response will be. However, what one can see from this data is it's going to be much longer. It looks like it's going to be much longer than at least a year. So that's just the preliminary way to look at that in terms of the responders, okay, in the study. All right.
Cancer, that's been going on for 14 months so.
You get into that because of the data is heavily skewed towards depictions of the ongoing it is too early too low what the median duration of the of the response will be however, one can see from the day that is it's going to be much longer it looks like it's going to be much longer than actress of the year. So that's just the preliminary way too.
Look at that in terms of the responders on the study.
Unknown Executive: And then the other question you asked was, what is our thinking with regard to biomarkers for the indications? That is something that maybe Anat and I will probably contribute a little to. We will look at the expression of these candidate biomarkers to see if there's any correlation. And that will then guide, based on that, what the tumor types are, whether it's going to be a basket trial or another kind of innovative trial.
Alright, and then the other question was what is the thinking wood against the Biomarkers for the indications that is something that may be and that's on.
And I will probably contribute to.
We will look at what's the expression of this kind of the biomarkers on.
To see if the if there's any correlation and that will guide based on that what's the tumor types, whether it's going to be a basket trial of they're kind of innovative trial would.
Unknown Executive: With respect to my comments on additional testing outside of an immune checkpoint, I think that's a valid way to look at the totality of the safety, the preliminary safety, and tolerability profile of COM701. It's tolerable at the doses that we've gone as high as 20 milligrams per kilogram body weight IVQ for weeks. It is tolerable at that dose with NIVO at standard doses for 18 milligrams IVQ for weeks. I don't foresee any safety findings if we combine it, for example, with standard of care therapies in any of the tumor types that we've enumerated. So it's still an open question with regard to what those combinations will be and what those tumor types will be.
With respect to my comments on additional testing outside of.
The new checkpoint.
That's in valued ways to look at the totality of the <unk>. The preliminary <unk> file of comes to open the one.
Terrible of the dosage that was going on as high as sort.
Towards the bill against the to the grandmother with Ivy queue for weeks for these tolerable at that deals with legal of standard dosing sporting team of the against the queue for a week.
I do I do for see if we combined for example, the standard of care therapies in any of the tumor types that are eliminated.
Illuminated.
Any 15 findings.
So it's still on open question with regards to what boost combinations will be on what this too much of that you'll be and once we get to the information and not to be able to provide back to G.
Right, Yeah, I've seen the just think himself and we're now focusing on on the combinations specific indications of this is why there is some overlap between the indications we want to make sure that we we kind of have you seen vacation that were raised by by our date on Max's hypotheses sent the translation alligator.
Unknown Executive: Right. Yeah, I think that just in terms of the, you know, we're now focusing on combinations in specific indications, and this is why there is some overlap between the indications. We want to make sure that we cover these indications that were raised by our data maxis hypothesis and the translational data. But obviously, focusing on specific indications and taking a path to registration is also something we have in mind. And as Henry said, as we move forward, when we formulate this path forward, we'll share it with the investors.
Lot of.
Obviously, focusing on specific indication of can take and get past the registration all of these also something in on mine and we said as we move forward a when would formulate to this day and.
And at path forward, we share it with the index.
Okay, and just as a as a follow up we tend to do biomarker analyses on quite a bit of analysis on the patient instead of responding any any work that you guys are doing on the patient of that aren't responding at any learnings that you're that your obtaining from those that are in the.
Unknown Executive: Okay, and just as a follow-up, you know, we tend to do biomarker analysis and quite a bit of analysis on the patients that are responding. Any, any work that you guys are doing on the patients that aren't responding and any learnings that you're obtaining from those that are not responding that you might be able to utilize as an exclusion criteria. Yes, so we're looking, obviously, at all the patients.
Responding that you might be able to utilize with an exclusion criteria.
Yeah. So we're looking over street all of the patients actually it's very important that you mentioned political so anonymous blending patients and for letting all parameters for me again from within or the analysis all of the questions and for all of the surface of threw up reinforced and we're gonna correlate the ballpark of two response and of course, we're gonna also identify the non response.
Unknown Executive: Actually, it's very important, as you mentioned, to look also at non-responding patients. And we are correlating all parameters from, again, within all the analyses to all the patients and for all the samples that we have pre and post. And we're going to correlate the biomarkers to response. And, of course, we're also going to identify the non-responding population, try to understand which patients we should not treat. Got it. Thanks for taking the question. The next question is from Asthika Goonewardene of Truist Securities. Please go ahead. Hi, good afternoon, guys. And congrats on the updates that you provided in the call today. It's really exciting to see them.
The population for.
To understand which for sure we should look for it.
Got it thanks for taking the questions.
The next question is from Africa, Ghana walking out of choice. The Securities. Please go ahead.
Hi, good afternoon, guys on and congrats.
Congrats on on the update that you provided the call today I'm really excited to see that.
Unknown Executive: You can see that.
Unknown Executive: And I just want to, maybe just.
I just want the <unk>, maybe the same another V phrasing of the previous question, but maybe on schedule for my here could you just cut the translational date of the gave you the confidence that the doublet comes to have it on one of the people has sufficient activity and breast of Aaron endometrial in CRC of specifically of wondering what what COVID-19.
Unknown Executive: Another rephrasing of the previous question, but maybe I'll ask it a different way here. Could you discuss the translational data that gave you confidence that the doublet COM701-Optivo has sufficient activity in breast, ovarian, endometrial, and CRC? I'm specifically wondering what it was that you saw in the data that made you pull the trigger? And I've got a couple of follow-ups after that.
What is it that you saw on the day that that made you pull the trigger I got a couple of follow ups up the app.
So several of translational data what restart the see is that the comfort of on on his probably inducing enhancing the only thing this regarding the and the proof of blood the can see and for some type of car fix it for the duration of et cetera, indicating activity. The consider the same monotherapy, which is of course very important to relate to the activity.
Unknown Executive: So, in terms of translational data, what we start to see is that COM7-1 is probably inducing enhanced immunity in this regard in the peripheral blood. You can see an increase in cytokines, PCL proliferation, et cetera, indicating activity. You can see this in monotherapy, which is, of course, very important to relate the activity to COM7-1 itself. We also see this in combination therapy. Again, that COM7-1 in combination is a devoting enhanced immune activity, and taking this with the clinical data and the clinical response that we've seen in the doublet specifically, probably all of this together is strongly hinting at a signal in doublet that should further be explored in clinical studies. David, thank you. And then maybe Henry will come in after this.
To come in on itself, but also citizen the and the combination and then the cost of it on the combination of the people can enhance the noon activity and taking this was the clinical that the and the clinical resource that we've seen in the doublet, specifically probably all of this together is strongly hinting for a signal and doublets, that's just for the big Sporting clinical.
The studies.
Alright take care of and then moved to Henry Index.
And the expansion.
Unknown Executive: I know the details are going to be at ASCO, but I was wondering if you could entertain us here. How many of these STs were in PD-L1 low or PD-L1 negative tumors, if you could just maybe give us some sort of a sense of that, and perhaps if any of them were, and if the three non-small cell lung cancer patients were PD-L1 low or negative too.
Fashion of studying the price tumor types.
I know that the the details of gonna be hopefully it I scope of of Wonder if you could entertainment here how many of these ftes.
Oh on low of pizza on negative tumors.
It's interesting to give us some sort of a sense of to that and perhaps the if any of them and.
And if the three north 12th of lung cancer patients for pizza of one low negative too.
Yes, yes, we will provide that day that at.
Unknown Executive: Yes, we will provide that data at ASCO, but I think the key takeaway, so I will not be able to disclose to you now, is what the analysis is in terms of the breakdown by the number of prior therapies, the PD-1, and PD-L1 percentages are, and in terms of patients with refractory disease, and so on. I think what is exciting for us is that, especially in the patient population that we're enrolling in the study in the immunotherapy expansion, these are patients who have exhausted all available standard of care therapies. So it's not like a first line or a second line.
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But I think the key pick the result will not be able to disclose to you know.
What the analyses in terms of the breakdown with the number of prayer therapies. The P. D. One TVO one for.
The centerpiece on in terms of the patients with reflected on so on the district will provide.
Subsequent release, when we update the data.
Unknown Executive: They've exhausted everything in terms of what the eligibility we have in the protocol is. Now, it's also important to note that, like I mentioned, of the 20 patients that we have, six have at least stable disease at the time of doing this presentation. So, the breakdown we'll provide when we update the data.
What is exciting for Ross is that especially in the patient population that we have that.
And move on the study and the one the therapy Expunction. This of patients who have exhausted all available standard of care therapies. So it's on like the first line of second line with the adjusted of everything in terms of what the energy. The meeting we have in the protocol is now it's also important to note that like I mentioned the between the patients that we have six have.
At least stable disease of the time, we'll do this presentation. So the the breakdown you provide when we update the data.
Got it and the last day I was wondering if you could maybe tell us a little bit about when we could see more on your on my life program and maybe other on your applications of the discovery platform.
Unknown Executive: Got it. And then lastly, Anat, I was wondering if you could maybe tell us a little bit about when we could see more of your MyLoid program and maybe other new applications of your discovery platform. Thanks a lot.
Excellent.
Sure and so first I'll just make sure that the everyone that also.
Unknown Executive: Sure. So first, I'll just make sure that everyone has heard the fact that we are anticipating to disclose additional data also beyond ASCO for the triplet dose escalation in [inaudible]. And we would like, these are novel programs; we would like the science to deepen in a way that we can push these programs forward and know that we have a path to the clinic and that we can protect these programs also business-wise.
And had hagdon where are anticipating to discuss addition on the date also beyond the call for the truth of those escalation.
In.
Thank you for an offer for a continental to programming queue for.
And with respect the day, my like programs as well as discovery capabilities.
We didn't get any guidance and the guidance at the following for the for the modeling programs and the and for the other problems in our early stage of that tiny tough on including Maryland.
And we would like these are another program, we would like to have the sign the deepening the way that we can push this program forward no net and we have the past two the clinic and actually.
Protect programs also add businesswise.
Unknown Executive: And that's what's directing our decisions when and what we're going to disclose. So, you know, with this, I know that this is of interest to investors, and we will share data as soon as we get to this point that I just defined. For the computational discovery capabilities, I can only say that we continue to enhance these capabilities. Obviously, there is a huge interest in the computational biology field in the industry.
Let's look at what's the directing the hour efficient when the when and what we're going to just go so we.
I know that to the seeds of interest to invest Eric and day and day.
We will share data as soon as we will get to the point that I'd just be fine for the computational the discovery capabilities I can only say the cat will continue to have the capabilities. Obviously there is an eight you get interesting day complication of lab balance.
<unk> and the.
The industry.
Unknown Executive: We continue to enhance our capabilities in order to continue to feed our own pipeline. And usually, we're not sharing data with respect to new drug targets that we discover at this point in time. So I think that only sharing the type of platforms that we discover, et cetera, but I guess that with respect to new drug targets that we discover, that will need to remain undisclosed and within a corporate structure.
And we continue to enhance our capabilities in order to continue to feed our own pipeline at.
And day, usually we're not sharing good data with respecting you drive the targets that we discover the point in time, So I think.
And only sharing the type of that for him and we discover etcetera, but I guess at K with the sector new drug targets, if we discovered that would need to be and remain on disclosed.
And from the corporate strategy.
Thank you very much guys.
Unknown Executive: Thank you very much, guys. Thank you. The next question is from Tony Butler of Roth Capital. Please go ahead. Thank you very much.
Thank you.
And the next question is from Tony Butler of Roth Capital. Please go ahead.
Thanks, very much just three brief questions if I'm the number one is.
Unknown Executive: Just three brief questions, if I may. Number one is, when you combine 701 and or NEVO with 902, 902, or when you in the future do that, 902, as you laid out, is dosed Q3, and obviously the other two could be dosed Q4, so I'm curious how you think about that, if at all, today. Number two is, you've made comments about some tumor types, including breast cancer, which I assume is HER2 negative breast cancer, but what's interesting, I think, is that 701 has activity, obviously, as has been demonstrated in PD-L1 low, PD-L1 negative, cohorts.
When you combine seven on one <unk> neutral with nine of too.
Nine O two.
You.
In the future do that I know too is the.
Laid out dose cute through.
And obviously the other two could be dosed queue for some curious how you think about that if the if at all today number two is uhm.
Uhm, you've made comments about of some tumor types, including brass, which I assume this for two negative breath spot.
What's interesting I think is the 701 has activity obviously.
As has been demonstrated.
P D O one low P D of one negative.
Unknown Executive: It's interesting to note that certainly in triple negative breast cancer, only PD-1 can be utilized in PD-L1 high patients. So I was just curious if you'd given any thought about TMDC because, in combination, you may have some really nice responses certainly in PD-L1 negative patients. And then finally, when you present data or when data are presented later at ASCO, have you considered having a call or meeting in conjunction with those data to perhaps, you know, expand on the total presentation? Thanks very much.
The cohorts, it's interesting to note that certain triple negative for us the only PD one can be utilized in P. D. L. One high. So I was just curious given any thought about T. M. B C. Because in combination may have some some real nice response of certainly NPD of one negative patients and then.
Finally.
When you present day to.
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When the data are presented later at ESCO have you considered having a call or a meeting in conjunction with those data to perhaps.
Expand on the total presentation, thanks very much.
Unknown Executive: Thank you. With respect to ASCO, obviously, we first need to be accepted, and we'll see how to, you know, how we present data as part of the ASCO. So that still remains to be, we first need to be accepted. And with respect to the breast, a question with respect to breast cancer or triple negative breast cancer, I'll just let Henry address it.
Thank you and with respect to ask the obviously were first need to the except Ed and that cash.
And we'll see how to you know how we present day as part of the Apple So at the table.
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And with the extra day.
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And the question was affect the tobacco trip of negative breast tired of the set Henry attractive.
And we very much on on yes. Thank you so much on that I was on mute, yes patients who are of triple negative breast cancer eligible for enrollment onto the study. So it's open to them and I am aware, we're all aware of the data with the to do on to the other one in theater.
Unknown Executive: Thank you very much, Anat. Yes, thank you so much, Anat. I was on mute.
Unknown Executive: Yes, patients who have triple negative breast cancer are eligible for enrollment in this study. So it's open to them. And I'm aware, we're all aware of the data with the PD-1, PD-L1 inhibitors in this patient population so that patients are eligible for enrollment in this study. The other question had to do with the dosing strategy in terms of the PK, so I'll just take you back a little bit.
In the patient population so that.
The patients eligible.
Illogical for enrollment consequence of the study yeah the.
Other question has to do with inducing strategy in terms of the the P. K.
Unknown Executive: So we have looked at COM701, and this data has already been released at both AACR, most recently last year, looking at Q3 dosing and Q4 dosing for COM701. And we're able to dose COM701 at any of these times, either Q3 weeks or Q4 weeks. For now, the dosing for COM902 is Q3 weeks, but obviously, we will look to see, as we accumulate more data, whether dosing can be spaced out to Q4 or any other dosing strategy, and this result, and what we will do, will be based on what the PK data actually shows, which we will obtain, and then be able to dose.
So just to keep back a little bit. So we have looked at come seven the one on this data is already released.
Both ECR most most recently last year on.
Looking at Q3, Duesing on queue for Duesing for conserving the one and where Phoebe two does.
Comes up on the one on any of these.
Q for two weeks on queue for weeks.
So now the Duesing come 92 is Q3 weeks, but obviously, we will look to see as we accumulate more data where the duesing can be.
Spaced sweet.
The starts on queue for or.
Or any other do some strategy on these results and what we will do will be based on what the PQ do that actually shows which will obtain and then be able to dose, but having said that do recall that evil is the difference.
Unknown Executive: But having said that, do recall that even if there is a difference in terms of dosing, Q3 weeks, Q4, for any of the therapies, you can still do evaluation during dose escalation, even if the dosing doesn't match. You can see many regimens with chemotherapy, or even some with immune checkpoints, where they combine with other agents to employ that strategy.
Difference in terms of do C Q3 weeks queue for for any of the therapies you can still do evaluation for their interest is condition. It will need to reduce do see doesn't doesn't match you can see many regiments with chemotherapy or even with some of new checkpoints, where the combined with on the agents are doing for that strategy, but.
Unknown Executive: Yes, it is a little bit more convenient for patients if they choose the two or more agents that you administer have the same schedule in terms of attitudes.
Yes, it is any of the.
The more convenient for patients is the true too.
Or more of you can say, yes administrative have the soon scheduling in terms of items.
Unknown Executive: Henry, thank you very much, and I appreciate it. This concludes our Q&A session. I will now turn the call back.
Thank you very much and I appreciate it.
This concludes our Q&A session I will now turn the call back to comprehend the president and CEO factor current Diack would you like to make of concluding statement.
Unknown Executive: All back to Compugen's President and CEO, Dr. Colin Dayag.
Unknown Executive: Would you like to make your concluding statement now?
Unknown Executive: Yes, thank you. We are enthusiastic about the steady progress and execution across multiple clinical programs, which we believe solidifies Compugen as the leader in denim axis immunotherapy. We're excited by the COM 701 data we disclosed earlier today, which reinforced our conviction with respect to our clinical development strategy. We look forward to expanding our clinical program to explore additional combination regimens, as well as important data readouts across our ongoing clinical programs evaluating the single, dual, and triple blockade of DNAM axis members.
Okay. Thank you.
We are enthusiastic by the steady progress on execution across multiple clinical program, which we believe solidifies comp again is the leader, Indiana exit immunotherapy.
We're excited by the common Kevin one data would disclose the earlier today, which range for our conviction with respect the clinical development packaging.
We look forward to any of our clinical program fix the additional combination regimen as well as important data readouts across the ongoing clinical programs evaluating the thing get do and treated brocade of denim ex member.
2021 is expected to provide meaningful insight into the underlying Dara D and potentially further substantiate thank the clinical relevance of the etsy.
Unknown Executive: 2021 is expected to provide meaningful insights into the underlying biology and potentially further substantiate the clinical relevance of this, and with our wholly owned PVRIG and TIGIT assets, we're uniquely capable of developing potentially transformative cancer immunotherapy. Thank you for joining us today and your continued support. Stay safe and healthy.
And we got and we can hardly on P. B R. I G N ticket assets.
Well of uniquely capable of developing potentially transformative cancelling of happy.
Thank you for joining us today, and your continued support a safe and healthy.
Thank you. This concludes the cartridge and limited fourth quarter and full year of 2020 financial herself conference call. Thank you for your participation. He may go ahead and disconnect.
Unknown Executive: Thank you. This concludes the Compugen Limited fourth quarter and full year 2020 financial results conference call. Thank you for your participation.
You may go ahead and disconnect.
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