Q4 2020 CytomX Therapeutics Inc Earnings Call
Good afternoon, ladies and gentlemen, thank you for standing by and welcome to the site till next therapeutics fourth quarter and full year 2020 financial results call. Please be advised that today's call is being recorded.
Operator: Ladies and gentlemen, thank you for standing by. Welcome to the CytomX Therapeutics fourth quarter and full year 2020 financial results call. Please be advised that today's call is being recorded. I would now like to hand the conference over to your host for today, Chao Cheng, CytomX's Vice President, Investment Relations and Corporate Communications. Please go ahead.
And I'd like to hand, the conference over to your host for today.
Cheng Telmex's, Vice President Investor Relations and corporate Communications. Please go ahead.
Chao Cheng: Thank you, Victor. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarthy, CytomX's President, Chief Executive Officer, and Chairman; Dr. Amy Peterson, Chief Development Officer; and Carlos Campoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our fourth quarter and full year 2020 financial results and highlights the important progress we have made during the year. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.
Thank you Victor good afternoon, and thank you for joining US with me today are Dr. Sean Mccarthy, Cytol mixes, President and Chief Executive Officer and Chairman.
Amy Peterson, Chief Development Officer, and Carlos Campoy, Chief Financial Officer.
Earlier today, we issued a press released and it includes a summary of our fourth quarter and full year, 'twenty and 'twenty financial results and highlights the important progress we made during the year.
And encourage everyone to read today's press release, and the associated materials, which have been filed with the FCC.
Chao Cheng: Additionally, the press release and a recording of this call can be found under the investors and news section of our website at CytomX.com. During today's call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks, including uncertainty surrounding the COVID-19 pandemic, which are difficult to predict and many of which are outside our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov, including our Form 10-K filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. With that in mind, I'd like to turn...
Additionally, the press release and a recording of this call can be found under the investors and news section of our website that's title makes dot com.
During today's call and we'll be making forward looking statements because forward looking statements relate to the future theyre subject to inherent uncertainties and risks and cuda.
And uncertainty surrounding the COVID-19 pandemic.
Difficult to predict and many of which are outside our control.
Important risks and uncertainties are set forth and our most recent public filings with the S. E. C. S E E Gov.
Including our form 10-K filed today and.
Take no obligation to update any forward looking statements.
And as a result of new information future developments or otherwise with that I would like to turn the call now over to Sean.
Sean A. McCarthy: Thank you, Chao, and good afternoon, everyone.
Thank you Chad and good afternoon, everyone and thanks for joining us today.
Sean A. McCarthy: 2020 was a highly productive year for CytomX in spite of the COVID pandemic, as we continue to execute our strategic plan to deliver on the promise of our technology platform for transforming the lives of people with cancer and building a sustainable oncology-focused commercial organization for the long term. To that end, we are well on our way as we continue to work diligently towards initial readouts in 2021 from ongoing Phase II work on our LEAD conditionally activated antibody drug conjugate. CX2009 or Pralizatamab Ravtanzine, and CX2029.
'twenty 'twenty, one and a highly productive year for <unk> in spite of the Covid pandemic, because we continue to execute our strategic plan to deliver on the promise of our technology platform for transforming the lives of people with cancer and building a sustainable oncology focused commercial organization for the long term.
So that and we are well on our way as we continue to work diligently towards initial readouts in 2021.
Some ongoing phase two work on our lead conditionally activated antibody drug conjugate CX two thirds of our nine or problems that semi ref, tenzing and CX two zero Tonight.
Sean A. McCarthy: Let me begin by reiterating that we are the leader in the emergent field of conditional activation of antibody therapeutics. Our approach, the ProBody platform, is designed to increase the exposure of therapeutic antibodies in cancerous tissue compared to normal tissue by leveraging the protease-rich tumor microenvironment. We believe that disease localization of therapeutic antibodies will be an important therapeutic concept for many years to come, and we're only at the beginning of what this approach will ultimately do.
Let me begin by reiterating that we have the leader and the emerging field of conditional activation of antibody therapeutics.
Our approach the priority platform is designed to increase the exposure of therapeutic antibodies in cancerous tissue compared to normal tissue by leveraging the protease rich tumor microenvironment.
We believe that disease localization of therapeutic antibodies will be an important therapeutics holds out for many years to come and we're in.
And at the beginning of this approach will ultimately do.
Sean A. McCarthy: CytomX is blazing the trail of conditional activation, and we believe this can lead to important advances in oncology, perhaps in other therapeutic areas. CytomX has demonstrated versatility of conditional activation across multiple antibody modalities, including immune checkpoint inhibitors, antibody drug conjugates, and by specific antibodies. Our robust clinical pipeline now comprises five pro-body therapeutic candidates, four of which are in phase two evaluations, across nine cancer types. We have purposefully applied our ProBody technology to two different but complementary therapeutic strategies that we believe offer an appropriate balance of risk.
So the time weighted blazing the trail and conditional activation and we believe we can lead to important advances in oncology and other therapeutic areas.
And so it makes it demonstrated the versatility of conditional activation across multiple antibody modalities, including immune checkpoint inhibitors antibody drug conjugates and by specific antibodies.
Our robust clinical pipeline and that comprises five priority therapeutic candidates four of which are in phase two evaluations across nine cancer types.
We have purposefully applied our profile and technology to two different but complementary therapeutic strategies.
That we believe offer and appropriate balance of risk.
Sean A. McCarthy: Firstly, we've advanced pro-body therapeutics directed against validated immuno-oncology targets such as CTLA-4 and PD-L1 with the goal of developing best-in-class assets and expanding the reach of these foundational anti-cancer therapies. Secondly, and in contrast, we have challenged ourselves to drug the undruggable and, in doing so, create potentially first-in-class cancer therapies for which we all agree there remains enormous unmet medical need.
Firstly, we've advanced property therapeutics directed against validated immuno oncology targets, such as <unk> four PD L. One.
With the goal of developing best in class assets and expanding the reach of these foundational anti cancer therapies.
Secondly, and and contrast, we've challenged ourselves to drug the undruggable and and doing so.
Potentially first in class cancer therapies, but wish we all agree that there remains enormous unmet medical need.
Sean A. McCarthy: This strategy has led us to exciting programs evaluating CX2009 and CX2029, antibody drug conjugates against novel tumor antigens CD166 and CD71, respectively. Moreover, our two therapeutic strategies dovetail into novel combination approaches, such as our ongoing Phase 2 study combining CX2009 with CX072, our proprietary anti-PDL1 inhibitor, in triple negative breast cancer, thus illustrating the potential of our platform to unlock novel and potentially powerful combination strategies I'll now briefly summarize our ProBody Therapeutic Pipeline before handing over to Amy for some additional details.
This strategy has led us and exciting programs evaluating CX, two thirds airline and CX two zero tuna antibody drug conjugates against novel tumor antigens, CD 166, and <unk> 71, respectively.
Moreover, our two therapeutic strategies dovetail into novel combination approaches such as our ongoing phase II study combining CX two thirds are in line with CX <unk>, two our proprietary anti PD, one inhibitor and triple negative breast cancer.
Thus illustrating the potential of our platform to unlock novel and potentially powerful combination strategies.
I'll now briefly summarize our priority therapeutic pipeline before handing over to Amy for some additional detail.
Sean A. McCarthy: CX2009 is a wholly owned conditional antibody drug conjugate targeting CD166 currently in a three-arm Phase II study in HER2 non-amplified breast cancer, which we initiated in the fourth quarter of 2020. Given that breast cancer remains the second leading cause of cancer deaths in women, and about 80% of breast cancer is hereditary non-amplified, we believe the opportunity for CX2009 is significant. The target of CX2009, CD166, is a glycoprotein that, among other functions, plays an important role in the formation and maintenance of tissue architecture.
CX 200 is a wholly owned conditional antibody drug conjugate targeting CD 166.
Currently and a three arm phase two study and hurts <unk> non amplified breast cancer, which we initiated in the fourth quarter of 2020.
Given the breast cancer remains the second leading cause of cancer deaths and women and.
And about 80% of breast cancers hurts, you know and amplified we believe the opportunity for CX. Two thirds are in line is significant.
The target of CX two thirds are in line C. D was 66 is a collective protein that among other functions plays an important role and the formation and makes it and so tissue architecture.
Sean A. McCarthy: While its biological roles are not fully understood, CD166 is an attractive target to us since it's expressed at high levels in many types of tumors, including breast cancer. However, CD166 is also broadly expressed in normal tissues, thereby compromising its potential role as a conventional ADC target.
While the spinal true roles and not fully understood citywide 60 stages and attractive target to US. This is expressed at high levels in many types of tumors, including breast cancer.
However, C. D. 166 has also broadly expressed in normal tissues, thereby compromising its potential role as a conventional ADC target.
Sean A. McCarthy: CX2009 has demonstrated single-aging clinical activity in several cancer types, including breast, ovarian, lung, and head and neck cancers. We anticipate the initial data from our ongoing Phase II breast cancer study towards the end of this year. Turning to CX2029, a conditional antibody drug conjugate that targets CD71, which is also now in Phase 2. KD71 is a transmembrane glycoprotein receptor ubiquitously expressed in most normal tissues that functions in cellular ion uptake through its interaction with transference.
She has two thirds airline has demonstrated single agent clinical activity and several cancer types, including breast ovarian and lung and head and neck cancers and.
Dissipate and initial data from our ongoing phase two breast cancer study towards the end of this year.
Turning to see X two zero to nine.
The conditional antibody drug conjugate target <unk> 71, which is also now and phase II.
<unk> 71 is the trial has been brain glycoprotein receptor ubiquitously expressed and most normal tissues.
And the functions and cellular iron uptake through its interaction with transparent.
Sean A. McCarthy: CD71 is overexpressed in many cancers to allow tumor cells to meet their increased iron requirements for growth, while the high expression on malignant cells and its ability to be readily internalized make CD71 an intensively studied target for the delivery of drugs into malignant cells. However, it's remained an elusive and undruggable target to date due to its broad expression in normalcy.
She did 71 is over expressed on many cancers to allow tumor cells to meet the increased iron requirement for growth.
While the high expression on malignant cells and its ability to be readily internalize make CD 71, and intensively studied target for the delivery of drugs into malignant cells.
And elusive and Undruggable targets day due to its broad expression on normal cells.
Sean A. McCarthy: Using our ProBody platform, we believe we have created a therapeutic window for CD71. And, in partnership with AbbVie, we are now exploring this asset in phase 2 expansions in four different tumor types, with initial data anticipated in the fourth quarter of this year. In addition to our progress with CX2009 and CX2029, we're also very pleased to report that our partner, Bristol-Myers Squibb, continues enrollment in its ongoing, randomized Phase 1-2a study of the anti-CTLA-4 probody, BMS-986249, in patients with previously untreated, unresectable Stage 3-4 melanoma. And BMS has expanded the scope of the Part 2B evaluation to include three new cohorts.
Using a probiotic platform. We believe we have created a therapeutic window for CD 71, and a partnership with Abbvie. We are now exploring this asset and phase two expansions and four different tumor types with initial data anticipated in the fourth quarter of this year.
In addition to our progress with CX, two 009, and CX <unk> two nine and we're also very pleased to report that our partner Bristol Myers Squibb continues enrollment and its ongoing randomized phase <unk> study of the anti <unk> four provolone.
Slide 86249, and patients with previously untreated unresectable stage III for melanoma.
And BMS is expanded the scope of the <unk>.
So you'd be evaluation to include three new cohorts.
Sean A. McCarthy: These new cohorts are enrolling patients with advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple negative breast cancer. BMS also continues enrollment into a Phase I study of a second ATTLA-4 probody, BMS-986288. In addition to this continued clinical progress in our alliance with BMS, we look forward to continuing collaborative discovery and development activities towards the generation of additional pro-body therapeutics in oncology. Turning now to our preclinical pipeline, where we continue to explore and leverage our platform, and specifically to our third investigational antibody drug conjugate, CX2043, which targets EPCAM, also known as CROP1.
These new cohorts are enrolling patients with advanced Paypal cellular carcinoma, castration resistant prostate cancer and triple negative breast cancer.
BMS also continues enrollment into a phase one study of a secondary piece detailed report for anybody BMS nine and eight six to eight.
In addition to this continued clinical progress and our lines with BMS, we look forward to continue and collaborative discovery and development activities towards generation of additional property therapeutics in oncology.
Turning now to our preclinical pipeline, where we continue to explore and leverage our platform and specifically to our third investigational antibody drug conjugate CX two zone, four three which targets and can also noticed one.
Sean A. McCarthy: Epcan has been regarded as a high-potential oncology target for decades, but efforts to generate systemic anti-Epcan therapeutics have not been successful to date. However, locally derived approaches have shown some success, and in fact, a recombinant fusion protein that targets Epcan has recently been submitted to the FDA for approval in bladder cancer, but this agent has to be instilled directly into the bladder. This is because Epcam, or epithelial cell adhesion molecule, as the name suggests, is present in the majority of normal epithelial tissues, and conventional anti-Epcan biologics administered systemically have significant dose-limiting toxicity.
And it kind of has been regarded as hypertension oncology target for decades, but efforts to generate.
And the outcome therapeutics have debate BOP and successful.
However, locally derived approaches have shown some success and in fact, a recombinant fusion protein that targets that can most recently been submitted to the FDA for approval and bladder cancer, but this agent has to be instilled directly into the bladder.
This is because that camera or epithelium and cell adhesion molecule as the name suggests its presence on the majority of mobile epithelial tissues.
And conventional <unk> and biologics administered systemically have significant dose limiting toxicities.
Sean A. McCarthy: In contrast, our anti-EpCAM conditional ADC, GX2043, designed to be delivered systemically, has shown in preclinical studies potent anti-tumor activity across multiple cancer types and superior tolerability in animal models compared to the corresponding unmasked conventional ADCs. GX2043 is currently in IND-enabling studies, and an IND application is anticipated for late 2021. Another preclinical candidate that we continue to advance towards the clinic is CX904, our T cell engaging bispecific probody that we're developing in partnership with Amgen.
And contrast, our anti <unk> and conditional ADC.
CX 2043.
Designed to be delivered systemically the share.
And in preclinical studies potent antitumor activity across multiple cancer types, and superior Tolerability and animal models compared to the corresponding unmask conventional ADC.
She excuse or a four three is currently in IND, enabling studies and then any application is anticipated for late 2021.
Another preclinical candidate, which we continue to advance towards the clinic CX 904, our T cell engaging by specific per body and weight developing in partnership with Amgen.
Sean A. McCarthy: CX904 targets the CD3 receptor on T-cells and the epidermal growth factor receptor, or EGFR, on tumor cells. Now, although both EGFR and CD3 are validated in their own right. We see this combination as undruggable for conventional bi-specific approaches due to the extraordinary potency of both mechanisms when combined. In collaboration with Amgen, we continue our work towards unlocking potential in this target combination with our ProBody platform, with the goal of ID filing this year.
CX 904 targets the <unk> receptor on T cells, and the epidermal growth factor receptor or egfr on tumor cells.
And although both Egfr and <unk> three are validated and their own rights. We see this combination as undruggable for conventional bi specific approaches.
The extraordinary potency of both mechanism when combined.
And collaboration with Amgen, we continue our work towards unlocking potential and this target combination with our <unk> platform with the goal of filing this year.
Staying with the bi specific theme. We're also excited about our recently initiated drug discovery activities under our collaboration with Astellas.
Sean A. McCarthy: Staying with the bi-specific theme, we're also excited about our recently-initiated drug discovery activities in our collaboration with Astellas, also aimed at broadening the therapeutic window of bi-specific T cell engagement. Now, I'd like to hand the call over to Amy for a deeper dive into our lead programs and where we're taking them.
And so aimed at broadening the therapeutic window of bi specific T cell engagements.
Now I'd like to hand, the call over to Amy for a deeper dive into our lead programs and where we're taking them maybe.
Thank you, Sean Hi, everyone.
And I'm going to start with he accused euro nine or Mab, Brad TMT and lay out our strategy per demonstrating the value. We believe is inherent in this asset.
Amy Peterson: Thank you, Sean. Hi everyone.
Amy Peterson: I'm going to start with CX2009, or Prilosec-Mab-Rab-Tanzine, and lay out our strategy for demonstrating the value we believe is inherent in this asset. CX2009 is a potentially first-in-class, conditionally activated ADC with the potential to address two major subsets of breast cancer. At the 2020 San Antonio Breast Cancer Symposium, we provided clinical updates from our phase one work in patients with HER2 non-amplified breast cancer, as well as translational data. These clinical updates reinforced data previously reported at ASCO.
<unk> nine is a potentially first in class conditionally activated ADC with the potential to address two major subsets of breast cancer.
The 2020 at San Antonio Breast cancer Symposium, we provided clinical updates from our phase one work and patient with hurricane and non amplified breast cancer as well as translational data.
Clinical update reinforced data previously reported at <unk> two.
Confirmed responses occurred in patients with hormone receptor positive disease, and compelling, but unconfirmed responses were observed and three patients with triple negative breast cancer, including one patient who had progressed on paclitaxel Pampa and.
Amy Peterson: Two confirmed responses occurred in patients with hormone receptor positive disease, and compelling but unconfirmed responses were observed in three patients with triple negative breast cancer, including one patient who had progressed on paclitaxel pembrolizumab and subsequently progressed on sasituzumab dovetican. Encouragingly, our data to date suggest that CX2009 does not appear to show cross-resistance to other The Clinical Benefit Rate, or CBR, was 41% at 16 weeks and 28% at 24 weeks. These data indicate that responses can occur early on and can be durable.
And subsequently progressed and Saskatoon and Nab therapeutics.
Yeah.
Encouragingly, our data to date suggest that <unk> 009 does not appear to show cross resistance to other approved breast cancer treatment and either hormone receptor positive or triple negative disease.
The clinical benefit rate or CVR was 41% or 16 weeks and 28% at 24 weeks. These data indicate that responses can occur early on and can be terrible.
Furthermore, these data speak to the potential tolerability of this agent and indeed, there are a handful of patients that remained on treatment for nearly a year.
Amy Peterson: Furthermore, these data speak to the potential tolerability of this agent, and indeed, there are a handful of patients that remained on treatment for nearly a year. CX2009 was generally well-tolerated with a manageable adverse event profile at the recommended phase two dose of 7 mg per kg every three weeks. Ocular toxicity was the most frequently observed adverse event.
<unk> was generally well tolerated with manageable adverse event profile at the recommended phase II dose of seven makes per kg every three weeks.
And ocular toxicity wasn't much frequently observed adverse event.
Also at San Antonio we provided data from exploratory translational study and circulation CX. Two 009 was found to be predominantly impact that is it remained.
Amy Peterson: Also at San Antonio, we provided data from exploratory translational studies. In circulation, CX2009 was found to be predominantly intact. That is, it remained stable mass.
Conversely on mask antibody drug conjugate with measurable to an appreciable per song and tumors passion Scotsman Biopsied 40, and following the first infusion.
Furthermore, the concentration of activated intra tumoral CX. Two 009 was found to be significantly correlated with CD 166 expression.
Amy Peterson: Conversely, unmasked antibody drug conjugate was measurable to an appreciable extent in tumor specimens biopsied four days following the first infusion. Furthermore, the concentration of activated intratumoral CX2009 was found to be significantly correlated with CD166 expression. This further supports investigation as to whether CD166 selection could be used to enrich the patient population. We believe that, collectively, these data underscore the potential of targeting CD166 with CX2009 and support its initial Phase II investigation in breast cancer. Let me just provide a quick recap on the design of the Phase 2 study. CX2009 will be investigated in three parallel and rolling arms.
Further supports investigation as to whether <unk> 166 collection could be used to enrich the patient population.
We believe that collectively these data underscore the potential and targeting PD, one and 66, what CX two years, there are nine and support its initial phase two investigation and breast cancer.
Let me just provide a quick recap on the design of the phase III study.
Two there there are nine will be investigated and three parallel enrolling arms arm, a and we'll evaluate monotherapy CX two years euro <unk> and patients with hormone receptor positive Hershey and non amplified breast cancer. This is the largest subset of breast cancer, representing over two thirds of all patients with breast cancer.
Amy Peterson: Arm A will evaluate monotherapy CX2009 in patients with hormone receptor positive HER2 non-amplified breast cancer. This is the largest subset of breast cancer, representing over two-thirds of all patients with breast cancer. Arm B will evaluate monotherapy CX2009 in patients with triple-negative breast cancer. Arm C, also enrolling patients with TNBC, will evaluate CX2009 in combination with pacmilibam or CX072, our conditionally activated anti-PDL1 antibody. Our previously reported preclinical work on CD166 in combination with PD inhibition and that of others provides clear rationale for combining ADCs with checkpoint inhibitors, and we're excited about the first clinical evaluation of a pro-body pro-body combination. Each arm is expected to enroll approximately 40 patients, and ocular prophylaxis is mandatory.
RMB will evaluate monotherapy CX, two 009 and patients with triple negative breast cancer.
Arm C also enrolling patients with T and B C will evaluate CX two 009 in combination with Pac mill about or CX <unk> two.
Conditionally activated anti PDL one antibody.
Our previously reported preclinical work on CD 166 in combination with PD inhibition and that of others provides clear rationale for combining adcs with checkpoint inhibitors and we're excited about this first clinical evaluation of a probiotic pro body combination.
Each arm is expected to enroll approximately 40 evaluable patients and.
Ocular prophylaxis is mandatory.
Mary and point of the study will be objective response rate based on Central Radiology review. Other endpoints include duration of response, CBR, 16, and 24 and progression free and overall survival.
Analysis will be performed separately for each arm and efficacy evaluable patients.
So do you want and 66 is highly expressed by IHT and greater than 80% of hormone receptor positive breast cancer that we will not select for CD 166 expression and arm.
Amy Peterson: The primary endpoint of the study will be objective response rate based on central radiology review. Other endpoints include duration of response, CBR 16 and 24, and progression-free and overall survival. Analysis will be performed separately for each arm in efficacy-evaluable patients. CD166 is highly expressed by IHC in greater than 80% of hormone receptor-positive breast cancer. Thus, we will not select for CD166 expression in Arm A. High CD166 expression has been observed in approximately 50% of triple negative breast cancers.
Hi, CD 166 expression has been observed and approximately 50% of triple negative breast cancer. So we will require that patients tumors Express CD 166 in order to be eligible for arms B or C.
We started the study in December of last year, and anticipate initial data to be available in the fourth quarter of this year.
Moving on to CX two O two nine our anti CD 71, conditionally activated antibody drug conjugate employing the MMA payload and <unk>.
<unk> 2020, we provided the first data ever demonstrating successful targeting of this receptor with and ADC approach.
Amy Peterson: So we will require that patients' tumors express CD166 in order to be eligible for arms B or C. We started the study in December of last year and anticipate initial data to be available in the fourth quarter of this year. Moving on to CX2029, our anti-CD71 conditionally activated antibody drug conjugate employing the MMAE payload. At ASCO 2020, we provided the first data ever demonstrating successful targeting of this receptor with an ADC approach.
We provided an additional update and the fourth quarter focusing on the 12 patients with squamous histology that enrolled into the study.
Including four patients with squamous non small cell lung cancer and.
Patients with head and neck squamous cell carcinoma.
That analysis highlighted that of the four patients enrolled with squamous lung one achieved the best response of stable disease lasting approximately six months and.
Amy Peterson: We provided an additional update in the fourth quarter focusing on the 12 patients with squamous histology that enrolled in the study, including four patients with squamous non-small cell lung cancer and eight patients with head and neck squamous cell carcinoma. That analysis highlighted that of the four patients enrolled with squamous lung, one achieved the best response of stable disease, lasting approximately six months, and two had confirmed partial responses, one with a duration of response approaching six months.
And two had confirmed partial responses one with a duration of response approaching six months.
The fourth patient was enrolled at Onemain per kg. It does not expect it to be clinically active and progressed on study.
For head and neck squamous cell carcinoma, all eight patients received two or three makes cricket we observed a Bachelor response of stable disease or better in seven of the eight patients, including one patient with a confirmed partial response, who remained on treatment for nine months and one patient with stage.
Amy Peterson: The fourth patient was enrolled at 1 mg per kg, a dose not expected to be clinically active, and progressed on steady. For head and neck squamous cell carcinoma, all eight patients received two or three mg per kg. We observed a best response of stable disease or better in seven of the eight patients, including one patient with a confirmed partial response who remained on treatment for nine months and one patient with stable disease who remained on treatment for eight months.
Disease, who remained on treatment for eight months.
Of these 12 patients none discontinued treatment due to an adverse event.
And all patients and most commonly occurring grade three or higher adverse event was anemia, which was predictable and manageable using one of four and your vengeance red blood cell transfusion growth factor support dose delay or dose reduction no patient discontinued CX two O two nine treatment for.
Anemia.
Well anemia is and expected payload toxicity from M&A.
Amy Peterson: Of these 12 patients, none discontinued treatment due to an adverse event. In all patients, the most commonly occurring grade 3 or higher adverse event was anemia, which was predictable and manageable using one of four interventions: red blood cell transfusion, growth factor support, dose delay, or dose reduction. No patient discontinued CX2029 treatment for anemia. While anemia is an expected payload toxicity from MMAE, the rate and severity were higher than what has been reported with other MMAE ADCs.
Rate and severity were higher than what has been reported with other and then maybe ADC and we're continuing to work with experts from the field to investigate the mechanisms contributing to this toxicity, which could include Cds 71, biology, and red blood cell production as well as the effects of various intervention. So that we may better.
Mitigate the side effect and the phase II expansion study taken together.
Exciting results from our phase one dose escalation for CX two O. Two nine had let us and collaboration with our partner Abbvie to launch a phase II multi cohort study evaluating patients with squamous non small cell lung head and neck squamous cell carcinoma, esophageal or GE J cancer or just easily.
Amy Peterson: And we're continuing to work with experts in the field to investigate the mechanisms contributing to this toxicity, which could include CD71 biology and red blood cell production, as well as the effects of various interventions so that we may better mitigate the side effect in the phase two expansion study. Taken together, the exciting results from our phase one dose escalation for CX2029 have led us, in collaboration with our partner AbbVie, to launch a phase two multi-cohort study evaluating patients with squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal or GEJ cancer, or diffuse large B cell lymphoma.
And B cell lymphoma.
As previously announced we dosed the first patient in this trial in November of last year and with sites actively recruiting patients. We anticipate initial data to be available in the fourth quarter of 2021 with that and I would like to turn the call over to Carlos to review our financials.
Thank you Amy we have continued to successfully finance tectonics has operation just last month, we raised approximately $108 million and net proceeds from my follow on public equity offering which added to the $316 million and cash cash equivalents and short term investing.
Amy Peterson: As previously announced, we dosed the first patient in this trial in November of last year, and with sites actively recruiting patients, we anticipate initial data to be available in the fourth quarter of 2021. With that, I would like to turn the call over to Carlos to discuss our financials.
And then we had as of December 31, 2000, and 'twenty, Bethesda, and a strong financial position.
We believe our strengthened balance sheet will allow us to continue to advance our clinical pipeline of conditionally activated antibody to introduce new product candidates from our probiotic platform and technology into human testing and to meet project protect net operating requirements into 'twenty and 'twenty three.
Carlos Campoy: Thank you, Amy. We have continued to successfully finance CytomX's operations. Just last month, we raised approximately $108 million in net proceeds from a follow-on public equity offering, which added to the $360 million in cash, cash equivalents, and short-term investments we had as of December 31, 2020, put us in a strong financial position. We believe our strength and balance sheet will allow us to continue to advance our clinical pipeline of conditionally activated antibodies to introduce new product candidates from our ProBody platform technology into human testing and to meet projected operating requirements into 2023.
Now my line some of the financial results for the quarter and year ended December 31 2020.
Total revenues were $16 million and 100 million per the quarter and full year, respectively, compared to 8 million and 57 million per the corresponding periods in 2019.
Research and development expenses were $22 million and 113 million for the quarter and full year, respectively, compared to $36 million and $132 million and 2019.
Carlos Campoy: Let me now highlight some of the financial results for the quarter and year ended December 31st, 2020. Total revenues were $16 million and $100 million for the quarter and full year, respectively, compared to $8 million and $57 million for the corresponding periods in 2019. Research and development expenses were $22 million and $113 million for the quarter and full year, respectively, compared to $36 million and $132 million in 2019. General and administrative expenses were essentially flat for the quarter and full year compared to 2019, amounting to $9 million for the quarter and $36 million for the year. With that, I'll turn the call back to Sean.
General and administrative expenses were essentially flat for the quarter and full year compared to 2019 amounting to 9 million for the quarter and 36 nine and for the year.
With that I'll turn the call back to Sean.
Great. Thanks Carlos.
So 2020 was a highly productive year for sites, IMAX, and which we saw our clinical stage pipeline advance to now encompass phase II evaluations of four priority therapeutics across line cancer types.
And while contending with the challenges posed by the COVID-19 pandemic.
We have demonstrated that our priority technology has the potential to widen or create therapeutic window first in class and validated oncology targets and we continue to execute on our strategic plan to deliver on the promise of our technology for transforming the lives of people with cancer.
Our leadership and the research discovery and development, that's a conditionally activated antibody candidates and positions us well for future growth as we know drives two important phase II dataset with CX two thirds are in line.
Sean A. McCarthy: Great. Thanks, Carlos.
And CX two there are two nine and also advance our pipeline broadly.
Sean A. McCarthy: So, 2020 was a highly productive year for CytomX in which we saw our clinical stage pipeline advance to now encompass phase two evaluations of four pro-body therapeutics across nine counts of therapy, all while contending with the challenges posed by the COVID-19 pandemic. We have demonstrated that our ProBody technology has the potential to widen or create therapeutic windows for first-in-class and validated oncology targets. We continue to execute on our strategic plan to deliver on the promise of our technology for transforming the lives of people with cancer.
We're pleased with the ongoing progress within our strategic partnerships, especially the recent commitments from BMS to expand their evaluation of BMS nine and six to four nine and three additional tumor types beyond melanoma.
In addition to deepening and broadening and advancing our unique pipeline of <unk> therapeutics throughout 'twenty and 'twenty, we continue to build strength throughout the company, including the appointments of MS. Halley Gilbert and Dr. Mani by hindrance to our board of directors.
Their appointments exemplify our commitment to creating a stronger and more inclusive board and also underscore our strong corporate culture of diversity equity and inclusion across our entire organization and and the community at large.
Sean A. McCarthy: Our leadership in the research, discovery, and development of conditionally activated antibody candidates positions us well for future growth as we now drive to important Phase II datasets for CX2009 and CX2029 and also Advance Our Pipeline Broadly.
I'd like to take a brief moment here to sincerely. Thanks, I told him and his board member Dr. Charles Fuchs for his valuable guidance and friendship over the years.
Active April 1st Charlie will step down from <unk> Board after taking a new role at Genentech and we wish him the very best.
In summary, 2020 was a year like no other but I am proud to say sites home, it's came out stronger and every dimension.
Sean A. McCarthy: We're pleased with the ongoing progress in our strategic partnerships, especially the recent commitments from BMS to expand their evaluation of BMS 986249 in three additional tumor types beyond melanoma. In addition to deepening, broadening, and advancing our unique pipeline of pro-body therapeutics throughout 2020, we continue to build strength throughout the company, including the appointments of Ms. Hallie Gilbert and Dr. Mani Mahindra to our Their appointments exemplify our commitment to creating a stronger and more inclusive board and also underscore our strong corporate culture of diversity, equity, and inclusion across our entire organization and in the community at large.
To convey my gratitude and appreciation to our entire sites IDEXX team for their incredible efforts in 'twenty and 'twenty also to our partners and our investors for their continued support.
We look forward to speaking with you all again soon as this exciting year progresses, we plan to host a virtual analyst and Investor briefing in April with key opinion leaders and to provide you with background on our priority technology are conditional ADC strategies and the outlook for the year ahead.
With that let's open the call up for Q&A, so back to the operator.
To ask a question press star one on your telephone and two.
So enjoy your question price the donkey police and viable we compile the Q&A roster.
And our first question will come from the line of Terence Flynn from Goldman Sachs May begin.
Hi, good afternoon, and thanks for taking the questions.
Sean A. McCarthy: I'd like to take a brief moment here to sincerely thank CytomX board member, Dr. Charles Pukes, for his valuable guidance and friendship over the years. Effective April 1st, Charlie will step down from the CytomX Board after taking a new role at Genentech, and we wish him the very best. In summary, 2020 was a year like no other, but I am proud to say CytomX came out stronger in every dimension. I'd like to convey my gratitude and appreciation to our entire CytomX team for their incredible efforts in 2020, also to our partners and our investors for their continued support.
Maybe two from me was just wondering if you can give us some perspective on the clinical trial environment right now and maybe kind of end of last year and to this year our sites generally back open and enrolling patients and then how does this factor into your enrollment timelines over the course of the year and then the second question I have is relates to <unk>.
009.
Obviously, the treatment paradigm for triple negative breast has been evolving here.
There has been a second entry of a PD, one as well as true Lv and just wondering how you expect two 009 to be positioned there. If it's approved thank you.
Yes, Hi, Terence Thanks for the question, let me make a couple of general comments on.
Our experience at sites and enrollment.
Sean A. McCarthy: We look forward to speaking with you all again soon as this exciting year progresses. We plan to host a virtual analyst and investor briefing in April with key opinion leaders and to provide you with background on our pro-body technology, our conditional ADC strategies, and the outlook for the year ahead. With that, let's open the call up for Q&A.
And then I'll hand over to Amy who may want to add.
And then maybe we'll address the 2009 question as well.
So you know.
And we certainly as you all know last year and factory.
Almost a year ago.
We were all.
And wondering what was going to happen with Covid did impact at that time with our 2009, a phase one expansion.
Operator: To ask a question, you will need to press star 1 on your telephone, and to withdraw your question, press the down key. Please stand by while we compile the Q&A roster. Our first question will come from the line of Terrence Flynn from Goldman Sachs. You may begin.
We did.
Slow that down we paused enrollment and we took advantage of that pose too.
Rewrite the study as a formal phase two study, which is what we've launched at the end of last year.
Terrence Flynn: Hi. Good afternoon. Thanks for taking the question. Maybe two for me.
<unk>.
We have I would say you've seen like others.
Sean A. McCarthy: I was just wondering if you could give us some perspective on the clinical trial environment right now and maybe kind of the end of last year into this year. Are sites generally back open and enrolling patients? And then how does this factor into your enrollment timelines over the course of the year? And then the second question I have relates to 2009. Obviously, the treatment paradigm for triple negative breast cancer has been evolving here. There's been a second entry of PD-1 as well as Tredelvi. And I was just wondering how you expect 2009 to play out?
Enrollments.
Across the pipeline has come back.
Over the course of the.
Towards the back end of 'twenty and 'twenty.
Still not ideal.
Certain and certain ways, mostly limited by one's ability to obviously get into sites.
That said, we remain we feel pretty good about our guidance on data for the 209 and 202 nine programs by the end of this year. So with that let me hand over to Amy to comment, particularly on your question on 2009 and Triple negative.
Sean A. McCarthy: Yeah, hi, Terence. Thanks for the questions. Let me make a couple of general comments on our experience at CITES and enrollment, then I'll hand over to Amy, who may want to add, and then Amy will address the 2009 question as well. So, you know, we certainly, as you all know, last year, in fact, Gosh, almost a year ago.
Yep got it thanks, so regarding that.
And and trade and terms of PD, one and yes, we are aware of that and the frontline.
And what we actually are excited about is that T X and.
Seven two when we look at the data and the phase one study.
We enrolled a cohort of triple negative breast cancer and saw some very compelling signs of activity in this disease.
Sean A. McCarthy: We were all wondering what was going to happen with COVID. We did, in fact, at that time, with our 2009 Phase 1 expansion, we did... slow that down.
Specifically.
So we know checkpoint inhibition works, we know our checkpoint inhibitor works, we know that right now the best partner with checkpoint inhibitor happens to be chemotherapy.
Sean A. McCarthy: We paused enrollment, and we took advantage of that pause to rewrite the study as a formal Phase 2 study, which we launched at the end of last year. We have, I would say, seen, like others, that enrollment across the pipeline has come back over the course of the...towards the back end of 2020. Still not ideal in certain ways, mostly limited by one's ability to obviously get into sites. That said, we feel pretty good about our guidance on data for the 2009 and 2029 programs by the end of this year. So with that, I will hand over to Amy to comment, particularly on your question about 2009 and triple negatives.
D. CS are a sort of modified version of a chemotherapy and we certainly have observed single agent activity with two 009. So we're looking forward to that combination and part C. Now, how we position to zero and zero nine.
And what we have shown and and our.
Corporate presentation is we do have a patient and I mentioned her in our earnings call. We do have a patient with triple negative breast cancer, who had very large.
Large volume disease also reading through the scan and she received $10 and now with Paclitaxel as a frontline therapy and her best response to that line disease progression.
Sean A. McCarthy: Yep. Got it.
Amy Peterson: Thanks. Regarding the recent entrance of PD-1s, yes, we are aware of that on the front line. And what we are really excited about is that CX072, when we looked at the data in the Phase 1 study, we actually enrolled a cohort of triple-negative breast cancer and saw some very compelling signs of activity in this disease specifically. So, we know checkpoint inhibition works. We know our checkpoint inhibitor works, and we know that right now, the best partner with it happens to be chemotherapy. ADCs are a sort of modified version of chemotherapy, and we certainly have observed single-agent activity in 2009.
And she then got back to the map and her best response to that was disease progression on our study she had a early and marked response.
Unfortunately, she developed care tightest needed to come off treatment to have that treated by the time. She resolved her disease had to be re measured she progressed and we couldn't re initial treatment per per resist but she still had a dramatic response, even at that time after 10 cycles really.
I want to say 16 weeks.
Treatment.
As we think about positioning two 009.
And triple negative breast cancer.
Socrates and that we're well aware and has accelerated approval are we understand what you know accelerated approval looks like for them.
Amy Peterson: So, we're looking forward to that combination in Part C. Now, how we position 2009, what we have shown in our corporate presentation, is we do have a patient, and I mentioned her in the earnings call, we do have a patient with triple negative breast cancer who had very large volumes of disease altering through the skin. She received Pembrolizumab with Paclitaxel as her frontline therapy, and her best response to that was disease progression.
We also are aware that as of the date, we have no reason to believe that there's cross resistance to either checkpoint inhibitor or attitudes and now with monotherapy to zero and zero nine and less exemplified it and the response that we saw and the patient I just described.
So for accelerated approval, we would have to go after are approved therapies, which would be a checkpoint based therapy, and the frontline and <unk> and <unk>.
Amy Peterson: She then got Sacituzumab, and her best response to that was disease progression. In our study, she had an early and marked response. Unfortunately, she developed keratitis, and needed to come off treatment to have that treated. By the time she recovered, her disease had to be remeasured. She progressed, and we couldn't reinitiate treatment per resistance, but she still had a dramatic response, even at that time, after two cycles, really, I want to say, 16 weeks on treatment.
<unk> and map potentially thereafter.
And we'll be looking to see how we position that further as we get data and I hope that answers your question.
Great. Thanks, so much.
Yeah.
And our next question will come from the line of Peter Lawson from Barclays. You may begin.
Hi, everyone and this was Mitchell on for Peter Thank you for taking our questions.
First off I have is what is the bar for efficacy for CD 71 therapies and what would be considered positive results from the phase two expansion.
Amy Peterson: So, as we think about positioning 2009..., in Triple Negative Breast Cancer. Sasituzumab, we're well aware, has accelerated approval. We understand what accelerated approval looks like for them. We also are aware that as of this date, we have no reason to believe that there's cross-resistance to either checkpoint inhibitor or Sasituzumab with Monotherapy 2009, and that's exemplified in the response that we saw in the patient I just described. So for accelerated approval, we would have to go after approved therapies, which would be a checkpoint-based therapy in the frontline, and Sasituzumab, potentially, thereafter. And we'll be looking to see how we position it further as we get data. I hope that answers your question.
Support moving forward with the program and then kind of along those lines. What is the scope of data. We can expect from CX 2029, <unk> 21, and how many patients of data about could we expect.
Yeah. Thanks for the question Michel Let me give a couple of general comments.
Obviously, given the scope of the work that we're doing with <unk> 71, and multiple indications and also the novelty of the target.
We're not in a position to really comment on spin.
Specific bars or expectations at this at this point with.
And we're Super excited about these are these studies and in terms of.
Terrence Flynn: Great, thanks so much.
In terms of scope with data.
Operator: And our next question will come from Peter Lawson from Barclays. You may begin. Hi, everyone. This is Mitchell speaking on behalf of Peter. Thank you for taking our question. The first question I have is, what is the bar for efficacy for CD71 therapies, and what would be considered positive results from the Phase II expansion to support moving forward with the program?
So just to recap those four indications are squamous non small cell lung squamous head and neck.
So if the G L T J and DLP CL and we've guided in recent months that were looking to data from the first couple of cohorts by the end of this year. Our goal is to enroll up to 25 patients and each of these arms.
So.
Peter Richard Lawson: And then,
Where will we be exactly by the end of the year not sure, but we're working towards.
Sean A. McCarthy: And then kind of along those lines, what is the scope of data we can expect from CX2029 and 4Q21? And how many patients of data can we expect?
And as I said disclosure of data across those first two.
Cohorts.
Bye bye.
By the end of this year.
Does that help.
Absolutely. Thank you very much.
Sean A. McCarthy: Yeah, thanks for the question, Mitchell. I'll give you a couple of general comments. Obviously, given the scope of the work that we're doing with CD71 in multiple indications and also the novelty of the target, we're not in a position to really comment on specific targets or expectations at this point. But we're super excited about these studies. And in terms of the scope of data, so just to recap, those four indications are squamous cell and DLBCL.
Okay.
Our next question comes from the line.
Boris <unk> from Cowen and maybe.
And again.
Alright, Thanks for taking my questions maybe the first one just a quick one when you assess the CD 166 O level I'm curious is that a fresh biopsy and we're using archival tissue and how does that impact the measurement.
Yes.
Yes, Yes go ahead and you please.
Okay. Thanks, Yeah. It does.
Yeah, and breast cancer patients tend to have archival tissue and of course, we enrolled more than just breast cancer patients.
Sean A. McCarthy: And we've guided in recent months that we're looking to data from the first couple cohorts by the end of this year. Our goal is to enroll up to 25 patients in each of these arms. So, um, where will we be exactly by the end of the year? Not sure, but we're working towards, as I said, disclosure of data across those first two cohorts by the end of this year. Does that help?
So it's a mix of some.
Fresh but for the most part if our cash.
Rival and what we're what we are doing now is really trying to better understand the role that TD $1 66 plays and the biology of cancer.
And how its expression may or may not change over time, I think it's important to remember it is and adhesion molecule.
Sean A. McCarthy: Absolutely. Thank you very much. Our next question will come from the line of Boris Peeker from Calen. You may begin.
And so there may not be specific pressures to up regulate or downregulates as the tumor progresses, but at this point and time.
Boris Peeker: Great, thanks for taking my questions. Maybe the first one, just a quick one. When you assess the CD166 level, I'm curious, is that a fresh biopsy or using archival tissue, and how does that impact the level?
And beginning to investigate and trying to understand the expression levels and then therefore, what's the best timing of the tissue acquisition for our study, but for the studies that we have ongoing we will allow archival tissue.
Operator: [inaudible]
Amy Peterson: Thanks for the question. Do you want me to answer that? Yeah, go ahead, Amy.
Gotcha, that's helpful and also I'm curious on BMS and you mentioned that they started enrollment of a second Cta law for pro body. Just curious can you comment whats the difference between the first one and the second one.
Amy Peterson: Okay, thanks. Yeah, it is a mix. Breast cancer patients tend to have archival tissue. Of course, we enroll more than just breast cancer patients, so it's a mix of some fresh tissue, but for the most part, it's archival.
Yes.
Yeah.
Let me chip and on that one.
So.
Yeah. That's that's been in the works for a while the second one what we call 288 is a property version of a non few cold related version of AP and so the strategy. There that BMS has been taking and of course, they can speak to it much more effectively than the weekend and the strategy is that the non feed Cogs related version.
Amy Peterson: And what we are doing now is really trying to better understand the role that CD166 plays in the biology of cancer and how its expression may or may not change over time. But I think it's important to remember that it is an adhesion molecule. And so there may not be specific pressures to up-regulate or down-regulate as the tumor progresses. But at this point in time, we're beginning to investigate and trying to understand expression levels and then, therefore, what's the best timing of tissue acquisition for our study. But for the studies that we have ongoing, we will allow archival tissue. Gotcha.
And is intended to be a more potent version of BP because it's a more effective depleter of intra tumoral T regs and BMS presented data at ACR last year.
Actually on both the <unk> pro body and the non fee calculated provolone, showing how the property approach can.
Boris Peeker: Also, I'm curious, on BMS, you mentioned that they started enrollment for a second CTLA-4 pro body. Just curious; can you comment on what the difference is between the first one and the second one?
And Hans therapeutic window for Bose so.
So the goal of the second program is to.
Even further broaden the reach of <unk> for therapy in the long run.
Sean A. McCarthy: Yes, go for it. Let me get it. Thank you. Let me chip in on that one. So. Yeah, that's been in the works for a while.
Great. Thank you very much for taking my questions.
Very welcome.
Our next question will come from the line of Mara Goldstein from Mizuho Securities you may begin.
Sean A. McCarthy: The second one, what we call 288, is a pro-body version of a non-fucosylated version of IPI. And so the strategy there that BMS has been taking, and of course they can speak to it much more effectively than we can, the strategy is that the non-fucosylated version is intended to be a more potent version of IPI because it's a more effective depleter of intratumoral Tre And BMS presented data at AACR last year, actually on both the IPI pro-body and the non-fucosylated pro-body, showing how the pro-body approach can enhance the therapeutic window for both. So the goal of this second program is to even further broaden the reach of CTLA-4 therapy in the long run.
I think this is gabriel on behalf of Mara Goldstein and thanks for taking our questions.
A couple of questions here, how should we think about the data readout for two zero to nine in fourth quarter was there a particular reason as to why two of the total tumor.
And what types are prioritizing or was it just that they haven't happened to enroll faster, probably the head and neck and and not spots alone group and then another question here and again.
<unk> expansion into the three different tumor types to.
And to the extent that you can comment.
What do you think what prompted the EMS to choose those specific tumor types.
And if they do it any additional studies to need them, there and Thats I think.
Okay.
Yeah, Great, China, and thanks, a lot of questions Gabriel.
Let me.
Comment on the two O Tonight, and then true.
And we'll be happy to comment on that.
Next question.
Boris Peeker: Great, thank you very much for taking my questions.
Liberty <unk>.
Very pleased about the.
Additional work with BMS is doing and these additional tumor types.
Operator: Thank you. Thank you.
So yeah with regards to the two O two nine it's a pretty straightforward answer really which is that.
Mara Goldstein: Our next question will come from the line of Mara Goldstein from Mizuho Securities. You may begin.
Gabriel: Hi, team. This is Gabriel on behalf of Mara Goldstein, and thanks for taking our questions. Just a couple of questions here. How should we think about the data readout for 2029 in the fourth quarter? Was there a particular reason as to why two of the tumor types were prioritized, or is it just that they happened to enroll faster, probably the head and neck and the non-spots along group? And another question here on, again, the BMS expansion into the three different tumor types. To the extent that you can comment, what do you think would have prompted BMS to choose those specific tumor types, and if they did any additional studies, to leave them That's it. Thank you.
The first two cohorts of lung and head and neck and where we.
We saw such promising activity in the phase one dose escalation and that's the kind of signaled that you look forward and phase one.
We're just kind of making an assumption and I suppose that.
And that will carry the enrollment and so those two.
Horse.
With a little bit of additional of initial momentum.
So that's that's really the thinking it's not really based on anything else.
At this point and time.
So Amy and any comments on.
BMS two format.
Sure I can.
I can't say exactly what the.
Sean A. McCarthy: Yeah, great. Thanks for the questions, Gabriel. Let me comment on 2029, and then I'm sure Amy would be happy to comment on the BMS question. We're really very pleased about the additional work that BMS is doing in these additional tumor types. So, yeah, with regard to 2029, it's a pretty straightforward answer, really, which is that, you know, we The first two cohorts of lung and head and neck where we saw such promising activity in phase one dose escalation, that's the kind of signal that you look for in phase one.
Let them and we'll just I can speculate on the switches.
And certainly they know what signal would look like would need to look like they had the randomized study going on with melanoma right. That's the killer experiment in a way.
And with chip with.
Cellular they know what responses look like given that it be knievel combination that they have accelerated approval on.
And.
And so I think they know what success would need to look like there. So I think it's the and the.
And these are two indications that will give a clear picture of what the combination can bring to the table and I would imagine that cash.
Sean A. McCarthy: So we're just kind of making an assumption, I suppose, that that will carry enrollment into those two cohorts with a little bit of initial momentum. So that's really the thinking. It's not really based on anything else at this point in time. Amy, any comments on... BMS 249?
And resistant prostate cancer, and triple negative breast cancer, and yet other areas to expand and two that have not yet reaped the benefits of Io Io combos.
Great. Thanks for the detail.
Our next question comes from the line of Robert Burns from H C. Wainwright you may begin.
Hi, guys. Thanks for taking my question just two if I may for right now so although I recognize the highly advanced nature of the patient and the HR positive <unk> negative breast cancer, and metastatic breast cancer and phase one considering that the overwhelming majority were CD 166, and why and it's.
Amy Peterson: Sure, but I can't say exactly what led them to this. I can speculate on this, which is certainly they know what a signal would look like, would need to look like. They had the randomized study going on with melanoma, right? That's the killer experiment in a way. And with hepatiocellular, they know what responses look like given the ipinevo combination that they have accelerated approval for. And so I think they know what success would need to look like there.
Monotherapy efficacy of two 009 and this population appears that it may demonstrate a lower response rates of that scene and T. M. D. C are you considering any potential combinatorial strategies to potentially and hand for response rate.
And there is there are nine.
For example in combination with and serve.
And if not how do you view the potential of surge and that relapsed refractory and we sort of setting.
Amy Peterson: So I think these are two indications that will give a clear picture of what the combination can bring to the table. And I would imagine that castrate-resistant prostate cancer and triple-negative breast cancer are other areas to expand into that have not yet reached the benefits of IO-IO combos.
And then I've got one more after that.
Let me, let me ask <unk> to comment on that one great question and Hi, Robert Thanks.
Happy to do so.
So if I got it right the questions where the.
Potentially lower or are in hormone receptor positive that and triple negative.
I wanted to take a step back and just say, having responses and hormone receptor positive disease is actually encouraging period right. When you think about their disease and where it's located the a bone disease and you don't actually always get resist responses and these patients.
Gabriel: Great, thanks for the sweet details.
Operator: Our next question will come from the line of Robert Burns from H.C. Wainwright. You may begin. Hi, guys. Thanks for taking my question.
Robert Burns: Just two, if I may for right now. So, although I recognize the highly advanced nature of the patients in the HR-positive, HER2-negative breast cancer, metastatic breast cancer cohort in phase one, considering that the overwhelming majority were CD166 high and at the monotherapy efficacy of 2009 in this population, it appears that it may demonstrate a lower response rate to that seen in TMBC. Are you considering any potential combinatorial strategies to potentially enhance the response rate of 2009, for example, in combination with SIRDS? And if not, how do you view the potential of SIRDS in that relapse-refractory sort of setting? And I've got one more after that.
So the other surrogates of activity that we look at are things like clinical benefit rate at 24 weeks.
And those are the things that we will be looking at and in the phase two.
And when it comes to.
So we're equally encouraged by the data that we've observed and dose cohorts are and each cohort, let me say it that way.
When it comes to combinations.
And with Serge and being hormonal based typically what will happen is patients will exhaust hormonal therapy how's.
However, it is delivered.
And at the time that they've been refractory or progressed on Q3 and with the CDK four six inhibitor for example, and they're continuing to progressed oftentimes the physician will start to think about more traditional cytotoxic like chemotherapy.
Amy Peterson: Let me ask Amy to comment on that one. Great question. And hi, Robert. Thanks.
Amy Peterson: Happy to do so. So, if I got it right, the questions were the potentially lower ORR in hormone receptor positive than in triple negative. I want to take a step back and just say having responses in hormone receptor positive disease is actually encouraging, period, right? When you think about their disease and where it's located, they have bone disease, and you don't actually always get resistant responses in these patients.
And so they may not and go back two thirds or hormone or <unk> based therapy.
With the the other thing that drives the physician to think more towards chemotherapy is the disease in the patient. So while I said most of the time they have bone disease, that's usually how it will start but once they get aggressive or more aggressive it will.
Amy Peterson: So, the other surrogates of activity that we look at are things like clinical benefit rate at 24 weeks. And those are the things that we will be looking at in the phase two. When it comes to, so we're equally encouraged by the data that we've observed in both cohorts, or in each cohort, let me say it that way. When it comes to combinations, you know, with CERDs being hormonal-based, typically what will happen is patients will exhaust hormonal therapy, however it is delivered, and at the time that they've been refractory or progressed on 2, 3, and with a CDK4, 6 inhibitor, for example, and they're continuing to progress, oftentimes the physician will start to think about more traditional cytotoxics like chemotherapy, and so they may not go back to CERDs or hormonal-based therapy.
Involved the lung and the liver and so visceral involvement and.
Something that physicians will often use as a guide to start more traditional cytotoxic chemotherapy and that's what we would.
Expect where CX two zero.
Line would be positioned initially.
And in combination I think right now we're in the beginning phases I'd love to be able to figure out how to move this into earlier lines of therapy be it horizontal b and in combination with the harm normal agent or other that but right now it's first things first and and look for the monotherapy and the Saturn.
Amy Peterson: The other thing that drives a physician to think more about chemotherapy is the disease in the patient, so while I said most of the time they have bone disease, that's usually how it will start, but once it gets aggressive or more aggressive, it will involve the lung and the liver, and so visceral involvement is something that physicians will often use as a guide to start more traditional cytotoxic-based chemotherapy, and that's what we would expect CX2009 would In combination, you know, I think right now we're in the beginning phases.
Okay. That's completely fair. Thank you Amy.
And my last question for now.
So have you done any additional correlative studies regarding senior and 71 expression and the anti tumor efficacy seen with easier to nine and if so what does that shown to date.
Yes, it really early on that still Robert Great question, and there's certainly an important question.
You know from the data we presented so far.
Yeah. It really is a little early to tell but we're highly interested and understanding more about that.
It's a it's an.
And target and many different tumors.
Amy Peterson: I'd love to be able to figure out how to move this into earlier lines of therapy, be it hormonal, be it in combination with a hormonal agent or others, but right now, it's first things first and look for monotherapy in this setting.
And also are rapidly internalizing target and so the properties of this target.
You know.
And we just need to study more so there's not really a whole lot. We can say right now.
Awesome. Thank you.
Thank you.
Our next question will come from the line of Ed <unk> from Guggenheim You may begin.
Robert Burns: Okay, that's completely fair. Thank you, Amy. I know my last question for now, so have you done any additional...
Hey, this is Paul on for Ed Thanks for taking our questions.
I'm, hoping to get a little more color on what we can expect from the analyst day and April and April and is there potential to see any sort of clinical updates for 2009 or two between now and at that time or at any other conferences ahead of the plan for fourth quarter disclosures.
Operator: https://www.cdc.gov.au
Sean A. McCarthy: expression in the anti-tumor FTP scene with P029, and if so, what has that shown to date?
Sean A. McCarthy: Yeah, really early on that still, Robert. Great question. It's certainly an important question. Yeah, from the data we've presented so far, yeah, it really is a little early to tell, but we're highly interested in understanding more about that. It's an abundant target in many different tumors. It's also a rapidly internalizing protein. And so the properties of this target, you know, we just need to study it more. So there's not really a whole lot we can say right now.
Yeah, Hi, Paul and thanks for the question.
So the goal of the analyst day that we're planning for April will be really more the outlook for the year ahead. So we'll be talking more about the.
And the platform.
Our approach to conditional activation, which I think is of increasing interest to a lot of people given the.
Broad emerging interest in.
Robert Burns: Awesome, thank you. Thank you.
These types of approaches to localize antibody activity.
Operator: Our next question will come from the line of Edzer Darao from Guggenheim. You may begin. Hey, this is Paul on behalf of EdSER. Thanks for taking our question. I'm hoping to get a little more color on what we can expect from Analyst Day in April. Is there the potential to see any sort of clinical updates for 2009 or 2029 at that time, or at any other conferences ahead of the planned fourth quarter disclosures?
We'll be talking about our.
Strategies for conditional Adcs and how to really think about these novel agents and we will talk about.
And in more detail.
The design of our ongoing studies.
And.
And so far as.
So I wouldn't expect any new data.
And it's really more the outlook for the year ahead, we have not yet communicated on.
Edzer Darao: Yeah, hi, Paul. Thanks for the question. Um, no, so the goal of the Analysts' Day that...
Specific timing or venue.
For our Q4 data updates that will be coming a bit later in the year.
Sean A. McCarthy: , and ,. .. .. .. .. .. .. .. .. ...
Paul: Great, thanks, that's really helpful. And then just one more. With your recent raise, I was wondering if you could provide some comments on how you're currently thinking about capital allocation versus pipeline priorities.
Great. Thanks, that's really helpful. And then just one more with your recent raise I'm wondering if you could provide some comments on how you're currently thinking about capital allocation versus pipeline priorities.
Carlos Campoy: Great question for Carlos:
Great question for Carlos.
Sure so and <unk>.
Carlos Campoy: So, as we stated before, this additional raised position does really well to continue to fund our clinical stage pipeline but also allows us to introduce new programs that are currently in the preclinical stage into human testing, and that takes us into 2023. So, that's about the extent of the guidance of where we're investing our money.
As we stated before.
This additional rate positions us really well to continue.
To fund our clinical.
Clinical stage pipeline, but also allows us to introduce new programs that are currently and preclinical stage I enter human testing and that takes us and king <unk> 'twenty and 'twenty price. So that's about the extent of the guidance.
And where outward and investing our money.
Paul: Great, thank you.
Great. Thank you.
Operator: Thank you. And our last question will come from Mohit Ghansal from Citigroup. You may begin.
Thank you and our last question will come from the line of Mohit Bansal from Citigroup you may begin.
Mohit Ghansal: Great, thank you for squeezing me in, and congrats on all the progress. I'm just wondering, Amy, you mentioned that, and Sean, you also mentioned that basically CD166 is a novel target. So, expectations, probably it is hard to understand at this point, but just looking across the board, ADCs as a monotherapy treatment have come a long way, and the kind of responses we are seeing with the likes of Tredelby and other ADCs out there, they are getting in like even late lines of therapy, they are getting in 30% plus kind of responses.
Yeah.
Great. Thank you for squeezing me in and.
Congrats on all the progress I was just wondering so you mentioned that.
And Sean you also mentioned that.
Basically CD, one and six six is a novel target.
So expectations, probably it is hard to book.
Understand at this point, but just across the board.
Adcs as a monotherapy treatment have come a long day and the kind of responses, we are seeing and the lack of <unk> and other agencies out there.
And I'm getting like even late line therapy, they are getting and 30% less kind of responses.
Mohit Ghansal: So, to that extent, do you think that, to that extent, you may have to get back? Can you enrich the patients in some way to make sure that you select the patients who benefit the most from these drugs? Thank you.
To that extent do you think that.
Could be and expectations as immunotherapy and has to get good day kind of mark to make a mark and.
And these kinds of tumors.
And if it does.
The next day, you may have to get that.
Can you enrich for patients.
And some day to make sure that you select the patients will benefit the most from these drugs and thank you.
Sean A. McCarthy: Yeah, thanks for the question, Mohit. And you're right, ADCs have come a long way, and we and others, of course, continue to see an enormous amount of potential if we can continue to unlock novel targets, such as we've been doing at CytomX. Again, just to reiterate some of our earlier comments, we're not in a position to comment on specific expectations for these ongoing studies. We are in this business to make a difference, of course.
Yeah. Thanks for the question Mohit.
And you are dead right agencies have come a long way and we and others of course continue to see an enormous amount of potential.
If we can continue to unlock novel targets such as we've been doing that cytogenetics and again just to reiterate some of already earlier comments.
And a position to comment on specific expectations for these ongoing studies we.
We are and this business to make a difference of course.
Sean A. McCarthy: And so, you know, that is our objective. We want to make the biggest difference we can in the tumor sites we're looking at. And we, of course, will be continuing to look at enrichment strategies over time because we all want to make sure we get the right drugs to the right patients. And as Nadine mentioned, we have ongoing strategies, particularly in the triple negative setting, to be prospectively selecting patients for targets for CD166.
And so.
That is our objective and make the biggest difference we can and the true. Besides we're looking at.
And we of course will be continuing to look.
Enrichment strategies over time, because we all want to make sure we get the right drugs to the right patients and as they and you mentioned, we have our ongoing strategies, particularly in the triple negative setting to be prospectively selecting patients for target from <unk> 66, and we think that's going to help.
Sean A. McCarthy: We think that's going to help, and we don't think that's necessary at this stage in the hormone receptor positive setting because of just how high the target is expressed in that patient population. But enrichment across the board is something that we continue to think about a lot.
And we don't think that's necessary at this stage and the hormone receptor positive setting because of just how high the target is expressed in that patient.
Patient population, but enrichment across the board and something that we continue to think about a lot.
Excellent. Thank you Sean.
Sean A. McCarthy: Thank you, Sean. Thank you.
Thank you.
Chow Chiang: And at this time, I'd like to hand the conference back over to Chow Chiang for his closing remarks.
And at this time and I'd like to hand, the conference back over to Chau Cheng for his closing remarks.
Operator: On behalf of the executive team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.
On behalf of the executive team I would like to thank you all very much.
Much for joining us. This afternoon, we look forward to updating you and the future and the ongoing progress.
Yeah.
Operator: Ladies and gentlemen, this does conclude today's conference call. Thank you all for participating. You may now disconnect. And have a great day.
Ladies and gentlemen, this does conclude today's conference call.
Thank you all for participating you know.
Operator: BF-WATCH TV 2021
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Disconnect and have a great day.
And.
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