Q3 2019 Earnings Call
For today's conference Christopher Kenan, Vice President of Investor Relations. Please you may begin.
Operator: and conference, Christopher Keenan, Vice President of Investor Relations. Please, you may begin. Thank you, Thea.
Thank you see a good afternoon and thank you for joining US earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2019 financial results.
Christopher Keenan: Good afternoon, and thank you for joining us. Earlier today, we issued a press release that included a summary of our recent progress and third quarter 2019 financial results. This press release and a recording of this call can be found in the Investors & News section of our website at CytomX.com. With me today are CytomX President, Chief Executive Officer, and Chairman, Dr. Sean McCarthy, CytomX's newly appointed Chief Development Officer, Dr. Amy Peterson, and CytomX Vice President of Finance, Robin Nifson. During today's call, we will be making forward- They are subject to inherent uncertainties and risks that are difficult to predict, and many of which are outside of 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-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. A webcast of this call will be available on the Investor Relations page of the CytomX website at www.cytomx.com. I will now turn the call over to Sean.
This press release on a recording of this call. It can be found under the investors in news section of our website I'd say telmex dotcom.
With me today or say Thomas President Chief Executive Officer in Chairman Dr., Sharon Mccarthy Cytomx newly appointed Chief Development Officer, Dr., Amy Peterson, and say Thomas Vice President Finance Robin Nixon.
During today's call will be making forward looking statements because forward looking statements relate to the future. They are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control.
Important risks and uncertainties are set forth in our most recent public filings with the FCC Si Si dot Gov, including our Form 10-Q filed today.
We undertake no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise a webcast of this call will be available on the Investor Relations page I told mix website at <unk> Dot Com I'll now turn the call over to shock.
Sean A. McCarthy: Thank you, Chris, and good afternoon, everyone, and thanks very much for joining us. It's a pleasure to be here to provide an update on our progress during the third quarter. I'll begin with an overview and some recent highlights, and then I'll turn the call over to Amy to review our recent clinical advances in our CX-072 program. I'll then review progress with our partner programs before turning the call over to Robin for the third quarter financial update. I'll then come back and provide some closing comments and open up the call for questions.
Thank you, Chris and good afternoon, everyone and thanks very much for joining us it's a pleasure to be here to provide an update on our progress during the third quarter.
I'll begin with an overview in some recent highlights and then I'll turn the call able to Amy to review our recent clinical advances in our Cxo something to program. I'll, then review progress with our partner programs before turning the call favorites Robin for the third quarter financial update I will then come back and provide some closing comments would open up for questions.
Sean A. McCarthy: So let me start by first introducing a new voice on today's call. Recently, we announced the appointment of Dr. Amy Peterson to the new role of Chief Development Officer at CytomX. Amy brings over 20 years of experience in oncology clinical practice and drug development, having held multiple senior roles, including chief medical officer of immuno-oncology at Beijing, where she created and led what is today recognized as a globally relevant oncology development organization. Prior to that, she was Vice President of Clinical Development at Medivation, where she was responsible for developing Xtandi and Talzana in breast cancer. Amy also held a variety of leadership roles at Genentech, where she worked primarily on early-stage oncology assets targeting multiple major pathways. Here at CytomX, Amy is charged with oversight of a multidisciplinary team focused on advancing CytomX clinical development activities and driving value creation and differentiated patient outcomes across the CytomX portfolio. We are delighted to have Amy joining our team at this important time in our evolution.
So let me start by first introducing a new voice on todays call recently, we announced the appointments I've talked to Amy Peterson to the new role of Chief Development Officer outside dynamics.
He brings over 20 years of experience in oncology clinical practice in drug development, having held multiple senior roles, including Chief Medical Officer, immuno oncology Beijing, where she created Atlanta, what is today recognized as a globally relevant oncology development organization.
Prior to that and he was vice president of clinical development that Medivation, where she was responsible for developing xtandi until it's not in breast cancer.
And the also held a variety of leadership roles at Genentech, where she was primarily on early stage oncology assets targeting multiple major pathways.
Here's Cytomx Amy is charged with oversight all day multidisciplinary team focused on advancing cytoflex clinical development activities and driving value creation and differentiated patient outcomes across the slight time its portfolio.
Delighted to have any joining our team at this important time in our evolution.
Sean A. McCarthy: Here at CytomX, we see a major opportunity to more effectively target therapeutic antibodies into disease tissue, generating new classes of differentiated anti-cancer therapy. Our innovative approach to antibody localization into disease tissue is called the ProBody Platform. ProBodies are fully recombinant antibody prodrugs comprised of a therapeutic antibody and a mask designed to block the binding of the antibody to its target until the mask is removed. Mask removal is achieved specifically and selectively within cancer tissue by certain disease-associated proteins called proteases.
Our innovative approach to antibody localization into diseased tissue is called the property classes.
For bodies are fully recombinant antibody prodrugs comprised of a therapeutic antibody other mosque designs to block the binding off the antibody to its target until the mask is removed Moscow removal is achieved specifically and selectively within cast a tissue bipartisan disease associated proteins go proteases.
Sean A. McCarthy: This unique approach offers the potential for new and highly effective anti-cancer therapies as either best-in-class molecules against validated targets or first-in-class molecules against novel targets that are currently deemed undruggable. We are the leader in this emerging field of therapeutic antibody localization with four clinical stage programs, strong partnerships, and we are the first to have shown clinical proof of concept for this novel approach. Our many accomplishments in recent years have brought us to an important inflection point as we transition from a research-focused platform company into an integrated R&D organization with multiple emerging product candidates. We had a productive third quarter marked by the continued advancement of our broad portfolio of wholly-owned and partnered programs.
This unique approach obviously, the potential for new and highly effective anticancer therapies. Because he is the best in class molecules against validated targets with best in class molecules I guess novel targets that are currently deemed on Druggable.
We're the leader in this emerging field as therapeutic antibody localization with four clinical stage programs strong partnerships and we are the first two have shown clinical proof of concept for this novel approach.
Our many accomplishments in recent years approaches to an important inflection point as we transition from a research because platform company into an integrated R&D organization with multiple emerging product candidates.
We had a productive third quarter marked by the continued advancement of our broad portfolio of wholly owned and partner programs. These include our wholly owned anti PDL, one probably what do you see X. I was hoping to.
Sean A. McCarthy: These include our wholly-owned anti-PD-L1 pro-body, Cx072, our wholly owned anti-CD166 pro-body drug conjugate CX2009, The Anti-CTLA-4 Probody, BMS 986249, being developed in partnership with Bristol-Myers, and the CD71 pro-body drug conjugate CX2029 being developed by CytomX in partnership with AbbVie. Let's begin with CX072 is a pro-body therapeutic directed against the validated immuno-oncology target PD-L1. Our vision for CX072 is for this pro-body to become a differentiated foundation for combination anti-cancer therapies by making them safer and more effective. We have shown previously that CX072 is active as a monotherapy in multiple tumor types and that the probody has the activity to be expected from a checkpoint inhibitor, providing the first clinical proof of concept for our unique platform.
Our wholly owned at TCT, 166, probity drug conjugate CX twos or nine.
The at TCT I like for probably body BMS 986 to four nine being developed in partnership with Bristol Myers.
And the Cdseventy, one property drug conjugate CX to zero Tonight being developed by sites and makes in partnership with Abbvie.
Let's begin with our lead clinical assets Cxo seven too.
Six or seven too is a pretty body therapeutic directed against the validates it immuno oncology target PDL one.
Our vision for Cxo seven two as for this probably body to become a differentiated foundation for combination anticancer therapies by making them safer and more effective.
We have shown previously that cxos, having two is active as a monotherapy in multiple tumor types.
The property has the activity to be expected from a checkpoint inhibitor, providing the first clinical proof of concept for our unique platform.
Regarding our Cxos, having to monotherapy program patient enrollments is now complete in the party expansion cohorts studying cxo seven two out of the dose of 10 makes the keurig multiple tumor types.
Our most recent data presentation from these expansions at ASCO 2019 continue to demonstrate the cxo seven two functions as a checkpoint inhibitor with an encouraging efficacy and safety profile.
Clinical activity was seen in multiple tumor types, including triple negative breast cancer anal squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Sean A. McCarthy: Regarding our CX072 monotherapy program, patient enrollment is now complete in the Part D expansion cohorts studying CX072 at the dose of 10 mg per kg in multiple tumor types. Our most recent data presentation from these expansions at ASCO 2019 continued to demonstrate that CX072 functions as a checkpoint inhibitor with an encouraging efficacy and safety profile. Clinical activity was seen in multiple tumor types, including triple negative breast cancer, anal squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Previously presented clinical pharmacokinetic and biopsy data has shown that cxo seven to behave as designed remaining stable in circulation and demonstrating intra tumoral activation at levels achieving target saturation.
Taken together these findings provide a very strong foundation for potential clinical differentiation from other PD inhibitors and for combination of six or seven to with other ATSI Cas agents.
Recently, we announced a major company milestone with the entry of Cxo seven two into phase two clinical studies to further evaluates the activity and Tolerability Oxy actually seven two plus the assay CLA for antibody ipilimumab in patients with relapsed or refractory melanoma.
Sean A. McCarthy: Previously presented clinical pharmacokinetic and biopsy data have shown that CX072 behaves as designed, remaining stable in circulation, and demonstrating intratumoral activation at levels achieving target saturation. Taken together, these findings provide a very strong foundation for potential clinical differentiation from other PD inhibitors and for combination of CX072 with other anti-cancer agents. Recently, we announced a major company milestone with the entry of CX072 into Phase II clinical studies to further evaluate the activity and tolerability of CX072 plus the anti-CTLA-4 antibody ipilimumab in patients with relapsed or refractory melanoma. We believe this combination has the potential to become a best-in-class regimen not only for melanoma but also for several other I'd like to spend a few minutes providing some additional context on this newly launched Phase 2 study. Many of you will know that the approved dose of ipilimumab as monotherapy is three milligrams per kilogram.
We believe this combination has the potential to become a best in class regimen, not only for melanoma, but also set for several other cancer types, where either each agent alone or the combination has already demonstrated activity.
I'd like to spend a few minutes, providing some additional context on this newly launched phase two study.
Many of you will note the approved dose of Ipilimumab as monotherapy is three milligrams per kilogram.
But when given in combination with Nivolumab. The PD one inhibitor, it's essentially limited to one make pickaxe the reasons a poor tolerability.
Let us well established that a dose response exists if we go after anti cancer activity.
In recent years experimental regimens testing the combination of PD inhibition, plus ctr before inhibition of use lower and lower doses of the assay CCRC for agents due to poor tolerability.
Some even lower in fact done the already low dose of one make the keurig every three weeks.
Take for example, the two studies.
By BMS Checkmate, two to seven and Checkmate night L.A.
Both of these studies evaluating chemotherapy. This is the combination of if he plus nivo either alone or in combination with chemotherapy in patients with previously untreated non small cell lung cancer.
Of particular note in both of these studies the dose it blew AMAP was one big ticket, but instead of being administered every three weeks. It was now administered only every six weeks.
Astra Zeneca has also reported some recent success in non small cell lung cancer, maybe in that Poseidon trial.
Demonstrating superiority of the combination of Tremelimumab, there's the it seems california, but there when given in combination with allomap their PD, one inhibitor and chemotherapy. So it's just chemotherapy alone.
Sean A. McCarthy: But when given in combination with nivolumab, the PD-1 inhibitor, it's essentially limited to 1 mg per kg for reasons of poor tolerability. Yet it's well established that a dose response exists for ipilimumab's anticancer activity. In recent years, experimental regimens testing the combination of PD inhibition plus CTLA-4 inhibition have used lower and lower doses of the anti-CTLA-4 agent due to poor tolerability. Some are even lower, in fact, than the already low dose of one mcPig every three weeks. Take, for example, the two studies by BMS Checkmate 227 and Checkmate 9LA. Both of these studies evaluated chemotherapy versus the combination of ipi plus nevo either alone or in combination with chemotherapy in patients with previously untreated non-small cell lung cancer. Of particular note, in both of these studies, the dose of ipilimumab was 1 mg per kig, but instead of being administered every 3 weeks, it was now administered only every 6 weeks.
Notably the dose of Cts before in this study was fixed 75 milligrams or again the equivalent of one make the king.
So each of these studies represent a significant Dan dosing in fact as much as six fold from the dose and schedule.
Oh the seats, California is that what is administered as a monotherapy.
We think there was significant room for improvement here.
Our phase two study proclaims cxo seven to 002, well evaluate cxo seven two plus three milligrams per kilogram of if it ever Matt I will allow us to explore the extends to wish we can push the combination dose of it'd be too is approved for monotherapy dose with the objective of driving meaningful anticancer activity and a population of patients with.
Hi, unmet medical need.
This study also offers additional potential proof of concept for our platform technology, whilst also like a foundation for the passage of this combination into other indications and hopefully into other potential registration studies.
We look forward to providing initial data from this program in 2020.
Moving on now to our second polio drug candidate CX users are nine this is a property drug conjugate targeting a unique to bats, unico CD 166 conjugates it to the microtubule inhibitor DM for.
Sean A. McCarthy: AstraZeneca has also reported some recent success in non-small cell lung cancer, namely in their Poseidon trial, demonstrating superiority of the combination of tremolumab, their CTLA-4 inhibitor, when given in combination with divalumab, their PD-L1 inhibitor, and chemotherapy versus chemotherapy alone. Notably, the dose of CTLA-4 in this study was fixed at 75 mg, or again, the equivalent of So each of these studies represents a significant down-dosing, in fact, as much as sixfold from the dose and schedule of the CTLA-4 inhibitor when administered as monotherapy. We think there is significant room for improvement here.
C. D was 66 is the most advanced of our novel targets as well poised to help us better understand our ability to target the on targets.
CD was 66 as an effective internalized sort of antibodies that has expressed a high levels are most solid tumors, but it's also present almost normal tissues.
Having completed dose escalation and presented encouraging phase one data earlier this year at a CR. We're currently in the dose refinements stage and anticipates an assay next steps with this program towards the end of 2019.
I'd now like turn the call Evets, Amy to give some additional background and context, but our newly launched phase two study of Cxo 70.
Thank you Sean first I, just want to say, how thrilled I am to be here as a member of the say comics team and very pleased to be joining all of you on call today. Thank you for your participation.
Want to start with a review of the dose escalation portion of the phase one study, which evaluated the combination of varying doses CX, Oh, seven too [laughter] aluminum.
Sean A. McCarthy: Our Phase 2 study, PROCLAIM-CX072-002, will evaluate CX072 plus 3 mg per kg of ipilimumab and will allow us to explore the extent to which we can push the combination dose of IPI to its approved monotherapy dose with the objective of driving meaningful anti-cancer activity in a population of patients with high unmet medical needs. This study also offers additional potential proof of concept for our platform technology, whilst also laying a foundation for the advancement of this combination into other indications and, hopefully, into other potential registrational studies. We look forward to providing initial data from this program in 2020.
And which underpins our recently announced phase two study.
Proclaim CX Oh, seven kill Oh, one enrolled a heavily pre treated patient population and one that that is not typically thought to respond to checkpoint inhibition.
This trial evaluated cxos seven to does that 0.3 to 10 Megs per case in combination with Illumina just a three to 10 megs per case.
Updated data other than October 2019, snapshot showed that among 27, a valuable patients who received ipilimumab combined with Cxo seven to the disease control rate defined as stable disease or better with 37%.
Sean A. McCarthy: Moving on now to our second wholly owned drug candidate, CX2009. This is a pro-body drug conjugate targeting a unique tumor antigen called CD166, conjugated to the microtubule-inhibited DM4. CD166 is the most advanced of our novel targets and is well poised to help us better understand our ability to target the untargetable. CD166 is an effective internalizer of antibodies that is expressed at high levels in most solid tumors, but it's also present in most normal tissues. Having completed dose escalation and presented encouraging phase one data earlier this year at AACR, we are currently in the dose refinement stage and anticipate announcing next steps for this program towards the end of 2019. I would now like to turn the call over to Amy to give some additional background and context on our newly launched Phase 2 study of CX072.
Five patients achieved a confirmed objective response, including one patient with a complete response.
This represents an overall response rate of 19%.
The median duration of response was 14.6 months.
Importantly, four of the five responders are still on treatment as of this latest either snapshot.
The combination was generally well tolerated with no new safety signals observed of the 27 patients treated across all doses.
Grade three or four treatment related adverse events were reported in nine patients or 33% and grade three or four immune related adverse events were reported in six patients were 22%.
The recommended combination dose for further investigation was determined to be three makes perking up at the lumen now with 10 makes for Keurig Cxos seven too.
We believe that the achievement of a 19% overall response rate in a late stage.
Are we pre treated population of patients with tumors not necessarily known to respond to checkpoint inhibition is encouraging.
Amy Peterson: Thank you, Sean. First, I just want to say how thrilled I am to be here as a member of the CytomX team and very pleased to be joining all of you on the call today. Thank you for your participation. I want to start with a review of the dose escalation portion of the Phase 1 study, which evaluated the combination of varying doses of CX072 plus ipilimumab and which underpins our recently announced Phase 2 study, proclaim CX072001 enrolled a heavily pre-treated patient population and one that is not typically thought to respond to checkpoint inhibition. This trial evaluated CX072, dosed at 0.3 to 10 mg per kg in combination with ipilimumab dosed at 3 to 10 mg per kg. Updated data as of an October 2019 snapshot showed that among 27 valuable patients who received ipilimumab combined with CX072, the disease control rate defined as stable disease or better was 37%. Five patients achieved a confirmed objective response, including one patient with a complete response. This represents an overall response rate of 19%. The median duration of response was 14.6 months. Importantly, four of the five responders are still on treatment as of this latest data snapshot. The combination was generally well tolerated, with no new safety signals observed.
And combined with the observed safety profile create a strong foundation for this novel molecules entry into phase two clinical testing.
Let's move on to our recently announced phase two study.
Her claim see Oh, seven 202 is an open label non randomized multicenter phase two clinical program.
As Sean mentioned it'd be women that will be dosed at the approved monotherapy dose and schedule of the three makes pricking every three weeks.
This dose of if you in that will be given in combination with our PDL one pro body Cxos seven two at a fixed dose of 800 milligram, which is the dose equivalent of 10 makes protect.
This combination will be administered for four cycles every three weeks after which patients will continue with Cxos 70 monotherapy until disease progression.
The first cohort to be enrolled in this phase two study our patients with advanced melanoma, who have previously progressed on a PD pathway inhibitor, given I, either as monotherapy or in combination with other non checkpoint agents.
Measurement of the overall response rate is the primary objective of the study.
Secondary objectives, being safety and Tolerability and other measurements of activity, including progression free an overall survival as well as the duration of response in those patients achieving partial responses indoor complete responses.
The study follow the Simon two stage design enriched stage, one will enroll approximately 40 patients. We expect initial data from this stage in 2020.
Amy Peterson: Of the 27 patients treated across all doses, grade three or four treatment-related adverse events were reported in nine patients, or 33%, and grade three or four immune-related adverse events were reported in six patients, or 22%. The recommended combination dose for further investigation was determined to be 3 mg of ipilimumab with 10 mg of CX072. We believe that the achievement of a 19% overall response rate in a late-stage, heavily pre-treated population of patients with tumors not necessarily known to respond to checkpoint inhibition is encouraging and, combined with the observed safety profile, creates a strong foundation for this novel molecule's entry into phase two clinical testing. So, let's move on then to our recently announced Phase 2 study. Proclaim CX072002 is an open-label, non-randomized, multi-center, phase 2 clinical program. As Sean mentioned, ipilimumab will be dosed at the approved monotherapy dosing schedule of 3 mg per kg every 3 weeks. This dose of ipilimumab will be given in combination with our PD-L1 ProBody, CX072, at a fixed dose of 800 milligrams, which is the dose equivalent of 10 mg per kg.
Stepping back now our rationale for evaluating the combination in this study is in large part due to the persistent high unmet need.
Well, great advances have been made with checkpoint inhibition in metastatic melanoma, approximately 40% of patients never respond to initial PD inhibition.
On an additional one third earn more will progress. Despite an initial response to checkpoint inhibition.
So you can see when you add these numbers up the majority of patients stopped their checkpoint inhibition therapy for lack of ongoing benefit.
Additionally from studies in melanoma as well as another indication we also understand that over 25% of patients will discontinue their treatment due to a toxicity despite benefit.
And as you've heard from Sean This is exactly where we believe the tumor targeting specificity of our pro body mass platform could be advantageous to patient outcomes.
I either by reducing the systemic toxicities to allow for continued exposure or by actually improving the responses and duration of response.
Finally, there are data demonstrating responses are possible with the combination of CBLI four plus PD inhibition in patients previously treated with PD inhibition.
Amy Peterson: This combination will be administered for four cycles every three weeks, after which patients will continue with CX072 monotherapy until disease progression. The first cohort to be enrolled in this phase two study are patients with advanced melanoma who have previously progressed on a PD pathway inhibitor given either as monotherapy or in combination with other non-checkpoint agents. Measurement of the overall response rate is the primary objective of this study with secondary objectives being safety and tolerability and other measurements of activity, including progression-free and overall survival as well as the duration of response in those patients achieving partial responses and or complete responses. The study follows a Simon two-stage design in which stage one will enroll approximately 40 patients. We expect initial data from this stage in 2020.
We are hopeful that our pro body platform combined with the higher dose of C.T. Ali for agent could further improve outcomes in this unmet need population.
Let me finish by restating, how excited I am to join Sean and say telmex at such a thrilling time and to be a part of this group of passionate and talented people committed to putting the patient first and improving outcomes and difficult to treat settings with that I will turn it back over to Sean.
Thanks, very much Jamie.
So I'd like to turned out to our two most advanced partnered programs Rpms Alliance first which stems from our foundational 2014 worldwide oncology agreement continues to make excellent progress the leading edge of this collaboration is our work on the discovery and development of a property version.
Ipilimumab, which is aimed at increasing the therapeutic window for this important antibody and target.
Sean A. McCarthy: Stepping back now, our rationale for evaluating the combination in this setting is in large part due to the persistent high unmet need. While great advances have been made with checkpoint inhibition in metastatic melanoma, approximately 40% of patients never respond to initial PD inhibition, and an additional one-third or more will progress despite an initial response to checkpoint inhibition. So, when you add these numbers up, the majority of patients stop their checkpoint inhibition therapy for lack of ongoing benefit. Additionally, from studies in melanoma, as well as in other indications, we also understand that over 25% of patients will discontinue their treatment due to toxicity despite benefit. And as you have heard from Sean, this is exactly where we believe the tumor targeting specificity of our ProBody's MAS platform could be advantageous to patient outcomes, either by reducing the systemic toxicities to allow for continued exposure or by actually improving the responses and duration of response.
BMS is preparing to initiate a randomized phase two a expansion cohort is ongoing first in human trial.
With the must version of Italy maps that we have generated within the collaboration. This trial is designed to further evaluate the safety and efficacy of BMS nine at six to four nine.
If he probably body in combination with nivolumab versus hippie plus nivo.
Should this program ultimately reach the market size, having said that Israel to receive additional milestone payments and royalties that reach the double digits.
This BMS study is of particular importance with two principal reasons firstly the advancement of this program into a large randomized study obviously signals their satisfaction with the phase one findings.
We expect the BMS team to present at a future date.
Secondly, this study has the potential to be a powerful proof of concept for our technology platform and demonstrating that property technology can favorably impacts the therapeutic index towards a more effective version of keeping Lima that.
Improved tolerability of the probably has the potential to allow fire or longer treatments exposure, increasing the chances of achieving or sustaining anti tumor responses.
I want to also emphasize here that our work at sites high mix that you just heard about with our Cxo seven to probably body plus skippy.
Sean A. McCarthy: Finally, there are data demonstrating responses are possible with the combination of CPLA-4 plus PD inhibition in patients previously treated with PD inhibition. We are hopeful that our ProBody platform combined with the higher dose of CTLA-4 agent could further improve outcomes in this unmet need population. Let me finish by restating how excited I am to join Sean and CytomX at such a thrilling time and to be a part of this group of passionate and talented people committed to putting the patient first and improving outcomes in difficult-to-treat settings. With that, I will turn it back over to Sean.
This that combination taken together with BMS is advancement of the if he probably body plus nivo into phase two.
Office broad potential to demonstrate the value of our platform and the value. We can bring to this important and still most validated I O combinations.
We have to have more to say about the details of the BMS study initiation in the near future.
Moving now to our partnership with Abbvie. During Q3, we continue to advance CX twos or two nine.
Clinical program for this first in class property drug conjugate targeting Cdseventy one.
Cdseventy one is widely expressed on normal tissues, and therefore is considered to be an undruggable target for conventional antibody drug conjugates.
Sean A. McCarthy: Thanks very much, Amy. So, I'd like to turn now to our two most advanced partner programs. Our BMS Alliance first, which stems from our foundational 2014 worldwide oncology agreement, continues to make excellent progress. The leading edge of this collaboration is our work on the discovery and development of a pro-body version of ipilimumab, which is aimed at increasing the therapeutic window for this important antibody and target. BMS is preparing to initiate a randomized phase 2a expansion cohort of its ongoing first in human trial with the masked version of ipilimumab that we have generated within the collaboration. This trial is designed to further evaluate the safety and efficacy of BMS 986249, the IPI ProBody, in combination with nivolumab versus IPI plus Nevo. Should this program ultimately reach the market, CytomX is eligible to receive additional milestone payments and royalties that reach the double digits. This BMS study is of particular importance for two principal reasons.
So that makes us continued dose escalation in this initial phase of this study in the all kind of setting.
We say somebody's have the responsibility for advancing this program to initial clinical proof of concept where upon if successful the program will transition to Abbvie for Registrational studies, an ultimate commercialization.
So that somebody's pertains co development and certain profit split a co commercialization rights for this asset we look forward sharing additional information on CX user Tonight in due course.
At the also recently selected the second research target under the company's 2016 discovery agreement again, reflecting continued endorsement of our platform and forward momentum in this alliance. This is the second to two research targets available to Abbvie under the discovery agreement at it triggered a $10 million payment to Cytomx a few months back.
So let me know turned the corner with Robin for a brief review of financials.
Sean I would like to review selected financial highlights for the third quarter.
Ended the third quarter with cash cash equivalents and investments totaling 325.7 million.
Compared to 436.1 million as of December 31st 2018, and 349.1 million ended June Thirtyth 2019.
Sean A. McCarthy: Firstly, the advancement of this program into a large randomized study obviously signals their satisfaction with the phase one findings, which we expect the BMS team to present at a future date. Secondly, this study has the potential to be a powerful proof of concept for our technology platform in demonstrating that pro-body technology can favorably impact the therapeutic index towards a more effective version of ipilimumab. I want to also emphasize here that our work at CytomX, which you just heard about, with our CX072 ProBody plus IPI, that combination taken together with BMS's advancement of the IPI ProBody plus Nebo interface, too, offers broad potential to demonstrate the value of our platform and the value it can bring to this important and still most validated I-O-I-O combination. We hope to have more to say about the details of the BMS study initiation in the near future.
Our strong balance sheet allows us to comfortably fund operations into the second half of 2021, assuming no new collaboration and our financing.
Research and development expenses were 28 million for the quarter compared to 27.5 million and the corresponding period in 2018.
The slight increase was attributable to increases in personnel related expenses, primarily due to an increasing headcount consulting expenses, resulting from increased clinical trial activity and the allocation of 18 facilities related expenses driven partly from an increase in headcount.
Offset by decreases in laboratory contract services and supply as a result manufacturing timeline.
General and administrative expenses were 8.5 million compared to 8.1 million and the corresponding period in 2018.
Revenues for the quarter were 10.7 million compared to 12.5 million and a corresponding period in 2018.
Decrease was primarily due to a 1.7 million decreasing revenue under the CD 71 agreement with Abbvie due to ongoing dose escalation.
Sean A. McCarthy: Moving now to our partnership with AbbVie, during Q3, we continued to advance CX2029, the clinical program for this first-in-class pro-body drug conjugate targeting CD71. CD71 is widely expressed in normal tissues and therefore is considered to be an undruggable target for conventional antibody drug conjugates.
With that I will turn the call back over to Sean.
Thank you Robyn.
Thank you again to everyone on the call for joining US today. This is a very exciting time for sites I mean, it's as we see our clinical pipeline advancing and as we continue to explore the full potential of our property platform.
We'll be providing additional pipeline guidance before year end and we look forward to a potentially takes a rich 2020 with that I would like to open the call up for Q when I back over to Chris.
Sean A. McCarthy: CytomX has continued dose escalation in this initial phase of this study in the all-comers setting. We, at CytomX, have the responsibility for advancing this program to initial clinical proof of concept, whereupon, if successful, the program will transition to AbbVie for registrational studies and ultimate commercialization. CytomX retains co-development and certain profit split and co-commercialization rights for this asset, and we look forward to sharing additional information on CX2029 in due course. AbbVie also recently selected a second research target under the company's 2016 discovery agreement, again reflecting continued endorsement of our platform and forward momentum in this alliance. This is the second of two research targets available to AbbVie under the discovery agreement, and it triggered a $10 million payment to CytomX a few months ago. So, let me now turn the call over to Robin for a brief review of the financials.
Please open the call for questions.
At this time I would like to remind everyone that if he would like to asking question superstar one on your telephone keypad now well pause for just a moment to compile documentary roster.
[noise] around your line is open.
Hi, good afternoon, everyone and thanks for taking the questions I'll first on Tuesday does your nine if you kind of remind us on a once a gating factor yeah.
Should we think it's more like managing safety for ocular and deeper talk.
And a related question on that should we expect the threats release sometime and before year end for this program.
Yes, hi, Brian Thanks for the questions. So as you know where we're at with two thirds or nine is continuing to.
Continuing with those refinement with the objective of selecting dose and indications for potential expansions and.
Robin Nifson: Thank you, Sean. I would like to review selected financial highlights for the third quarter. We ended the third quarter with cash, cash equivalents, and investments totaling $325.7 million, compared to $436.1 million as of December 31, 2018, and $349.1 million as of June 30, 2019. Our strong balance sheet allows us to comfortably fund operations into the second half of 2021, assuming no new collaborations or financing.
As we communicated previously the.
Work, we've been doing over the last several months has been a set of particular focus on orkin approval access and looking to understand more about the relationship between dose ocular peripheral axis and.
The duration of time, we can keep patients on drug so that work has been progressing well and we remain on track for a communication between now and you ended the year on our specific next that's where the programs.
I'm not going to guide today on exactly what form that would come in but.
We are on track to provide additional guidance.
Hi, Thanks, Sean and another question on zero seven to PDL, One program I feel if I understand correctly. The current phase two of the idea is to have or maintain the if it does that three make quite a cake, but he has got a.
Sean A. McCarthy: Research and development expenses were $28 million for the quarter, compared to $27.5 million in the corresponding period in 2018. The slight increase was attributable to increases in personnel-related expenses primarily due to an increase in headcount, consulting expenses resulting from increased clinical trial activities, and the allocation of IT and facilities-related expenses driven partly from an increase in headcount, offset by decreases in laboratory contracts, services, and supplies as a result of manufacturing timelines. General and administrative expenses were $8.5 million compared to $8.1 million in the corresponding period in 2018. Revenues for the quarter were $10.7 million compared to $12.5 million in the corresponding period in 2018. The decrease was primarily due to a $1.7 million decrease in revenue under the CD71 agreement with AbbVie due to ongoing dose escalation.
Maybe tell us what the internal or what do you guys are thinking in terms of response rate.
You do expect in that refractory patient in melanoma, which scanning farm or potentially moving into other tumor types.
Yeah as an important question, we're not ready to guide on specific response rates at this point, but I would just point you back to the summary that Amy provided of the phase one dose escalation data, where we saw a 19% response rate in the old kind of setting, which obviously is very encouraging and by the way that was across multiple doses.
As of pro body and it'd be so.
You know were optimistic about the study, but we're not providing specific guidance at this stage on exactly what we're looking for.
Sean A. McCarthy: With that, I will turn the call back over to Sean.
Sean A. McCarthy: Thank you, Robin. So, thank you again to everyone on the call for joining us today. This is a very exciting time for CytomX as we see our clinical pipeline advancing and as we continue to explore the full potential of our ProBody platform.
In terms of target response rate, but obviously, we want to make a significant difference for these patients.
Okay. Thank you very much and maybe I just a last one if I may on you know triple negative breast cancer. That's at least one indication that we have seen activity from bullets.
Christopher Keenan: We'll be providing additional pipeline guidance before year end, and we look forward to a potentially data-rich 2020. With that, I would like to open the call up for Q&A and hand it back over to Chris.
In two program as the last two 009. So I was curious how are you got the painting currently for the syndication.
Operator: At this time, I would like to remind everyone that if you would like to ask a question, press star 1 on your telephone keypad now. We'll pause for just a moment to compile the Q&A roster. Barone, your line is open.
Only there's a lot of unmet need in the syndication and I could see some large pharma being threats that to POC not potentially partner finding combination so any color <expletive> people negative.
Sean A. McCarthy: Hi. Good afternoon, everyone, and thanks for taking the questions. First, for 2009, can you remind us what the gating factor here is? Should we think it's more like, you know, managing safety for ocular and liver toxicity? And a related question on that, should we expect a press release sometime before year-end for this program?
You got a thinking and near term.
I think there a couple of different questions. There. So let me let me also both of them.
As we as we commented and we've consistently comments it our vision for Cxo seven two as for this.
Differentiated CRO body to become a.
Centerpiece of combinations they'd be combination as the first one that we're moving into phase two.
We have always said that we would consider it to be a potential combination partner for other.
Sean A. McCarthy: Hi Varun. Thanks for the questions. So, as you know, where we are with 2009 is continuing to continue with dose refinement with the objective of selecting doses and indications for potential expansions. And as we communicated previously, the work we've been doing over the last several months has had a particular focus on ocular prophylaxis and looking to understand more about the relationship between dose, ocular prophylaxis, and the duration of time we can keep patients on drugs. So that work has been progressing well, and we remain on track for communication between now and the end of the year on our specific next steps for the programs. I am not going to give any guidance today on exactly what form that would come in, but we are on track to provide additional guidance.
Molecules coming from our pipeline and the concept of combining go sevenci with twos or is there a nine.
We think is pretty interesting.
To do that and CNBC, obviously is a possibility no specific guidance at this point regarding partnership we do continue to believe that seven two program.
Would benefit from a partner at the right time.
Again, as we like say, we'll do the right deals at the right time, and but we do think given that the program could become very broad very quickly that's.
A partnership in due course could make a lot of sense.
Thank you very much Sean and welcome Amy Thank you.
Thank you ever Okay, operator lets move onto the next question.
The next question is from a Mohit Bansal with Citi. Please go ahead.
Great. Thanks for taking my question.
Okay, maybe from my side.
Huh.
Uh huh.
Uh huh.
Sure.
Sure.
Sean A. McCarthy: Thank you, Sean. And another question on 07-2, the PD-L1 program. So, if I understand correctly, the current phase 2, the idea there is to have or maintain the epidose at 3 mg per kg. But if you can, you know, maybe tell us what's the internal or what you guys are thinking in terms of response rates to expect in this refractory patient in melanoma, which can inform or potentially move into other phenotypes?
Uh huh.
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From.
Okay.
Thank you.
Great Hi move it thanks for the questions.
So with regards to Amgen partnership we focused our comments today on our clinical assets and the Amgen partnership continues to be preclinical it's doing some very.
It wouldn't surprise foundational.
Research and discovery work in T cell by specific pro bodies in the alliance and that continues to be the case.
So who knows.
No specific update at this stage other than.
Sean A. McCarthy: Yeah, it's an important question. We're not ready to guide on specific response rates at this point, but I would just point you back to the summary that Amy provided of the phase one dose escalation data, where we saw a 19% response rate in the all-comer setting, which is obviously very encouraging. And by the way, that was across multiple doses of ProBody and IPI. So, you know, we're optimistic about this study, but we're not providing specific guidance at this stage on exactly what we're looking for in terms of target response rate. But obviously, we want to make a significant difference for these patients.
The.
We are increasingly convinced the T cell bi specifics are going to be a very important modality, particularly in the pro body.
Setting so we're very enthusiastic about that modality.
Starting out the and twos or two nine no no guidance yet on specific timing of a program update.
And then maybe.
Just going back to the.
Okay.
Expansion plan learning.
Just trying to understand conceptually.
Yeah, Hi, it's still.
Oh, no, but I'm just talking about.
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Thank goodness losses.
Sean A. McCarthy: Okay, thank you very much. And maybe just one last one, if I may.
Yes.
Right.
Sean A. McCarthy: On, you know, triple negative breast cancer, certainly it's one indication where we have seen activity from both the 072 program as well as 2009. So, I was curious how you guys are thinking currently about this indication. Certainly, there is a lot of unmet need in this indication, and I could see some large pharma being interested to partner, potentially partner, for any combination. So, any color for triple negative, what are you guys thinking in the near term?
Hi.
So there have been studies in this patient population of it'd be nivo. It specifically in the relapse refractory setting.
It's pretty clear that adding it'd be on top of.
PD one inhibitor PD inhibitor, if you like.
Kind of elicits, a pretty respectable response rates I mean, the datasets a relatively small but good response rates in the 40% range plus or minus and so so this is a patient population that has a very good chaucer responding to.
Sean A. McCarthy: I think there are a couple of different questions there, so let me answer both of them. As we commented, and we've consistently commented, our vision for CX-072 is this: differentiated. ProBody is to become the centerpiece of combinations. The IPI combination is the first one that we're moving into phase two. We have always said that we would consider it to be a potential combination partner for others. So, we have a couple of molecules coming out of our pipeline, and the concept of combining O72 with 2009, we think, is pretty interesting. To do that in TMBC is obviously a possibility.
Our combination, particularly at the three make the keurig.
Yes.
Which has not been two aren't always tested in this population yet so.
So we're breaking new ground with this particular dose in combination.
Does that help us with the question.
Yes. It does it does thank you very much.
The next question.
The next question from Mara Goldstein with Mizuho.
Sean A. McCarthy: No specific guidance at this point. Regarding partnership, we do continue to believe that the O72 program would benefit from a partner at the right time. Again, as we like to say, we'll do the right deals at the right time, but we do think, given that the program could become very broad very quickly, that a partnership in due course could make a lot of sense.
Great. Thanks very much.
I understand you're limited as to what you might be able to stay on the subject of 70 program [laughter].
You cannot [laughter].
[laughter] clinical success for that program.
What would be going back up there in that you exceed that and then secondarily on that.
Sean A. McCarthy: Thank you very much, Sean, and welcome, Amy.
Nine different cohorts that was previously treated.
Sean A. McCarthy: Thank you very much.
Right.
Operator: Okay, operator, let's move on.
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Operator: move on to the next question. The next question is from Mohit Bansal with Citi. Please go ahead.
You talk about netback for that program.
Hi, Mark on the second question was that two thirds or nine whats user Tonight.
Sorry.
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Yes on Tuesday, or is it two thirds or nine right. Thanks, Yeah again, you know we need to go. This study launched and we don't have any specific guidance on our target response rate, but as I said, we have effectively a 20.
Sean A. McCarthy: Great, thanks for taking my question and welcoming me from my side as well. Maybe you could start by talking a little bit about the status of your Amgen partnership. I don't recall if you mentioned that on this call. And when can we see data from the FBCD71 program? Thank you.
Several response rate in our phase one study in the all kind of setting we know that it'd be nivo at lower doses can be effective in this patient population. So.
We're optimistic that we're gonna see something here, so but no we're not setting specific goals from the Simon one stage just yet.
Sean A. McCarthy: Great. Hi Mohit.
Sean A. McCarthy: Thanks for the questions. So, with regard to Amgen Partnership, we focused our comments today on our clinical assets, and the Amgen Partnership continues to be preclinical. We're doing some very foundational research and discovery work in T-cell bispecific pro-bodies in that alliance, and that continues to be the case. So, no specific update. We're increasingly convinced that T-cell bispecifics are going to be a very important modality, particularly in the pro-body setting. So we're very enthusiastic about that modality. Regarding AbbVie and 2029, there is no guidance yet on specific timing of a program update.
Regarding two 009.
Again up to restate our goal between now and we ended the year is to communicate on.
Dosing indications for moving into the expansion phase and that's really as much as we were able to say at this point okay.
On the tendency program I know, it's a small number condition.
You'd be able to cook ran out of that any differences in responses between like crater condition.
Did not have any initial response checkpoint inhibitors trigger lock response.
I think you're right that the numbers are gonna be small so we'll be looking at that but I don't know that we would be guiding to.
To being able to draw any conclusions from this or Simon one stage alright. Thank you very much.
Sean A. McCarthy: Right. Very helpful. And then maybe a little bit just going back to the Proclaim study and the expansion plan you are planning. Just trying to understand conceptually when you add the highest dose or maybe a little bit higher dose, like 3 mg per kilogram we are talking about. What do you expect to see? Would you expect to see more responses, or do you think the depth of the response is what, what, what, what? based on the prior trials, if patients can be dosed higher.
The next question is from Boris Peaker with Cowen. Please go ahead.
Getting my first question about seven to one I guess, maybe address the Amy just from the regulatory perspective, if you decide to advanced 072 into pivotal Com combo studies with if he will you have to include monotherapy arm or most of into or monotherapy, if if the or some kind of for cash.
Combinatorial reasons.
Hey, Bob This is Sean let me kick that went off and I would say me so.
Sean A. McCarthy: So, there have been studies in this patient population of ipinevo, specifically in the relapsed refractory setting, and it's pretty clear that adding ipi on top of a PD-1 inhibitor, PD inhibitor, if you like, can elicit pretty respectable response rates. I mean, the data sets are relatively small, but, you know, response rates in the 40% range, plus or minus. And, you know, so this is a patient population that has a very good chance of responding to our combination, particularly at the 3 mg per kg dose, which has not, to our knowledge, been tested in this population yet. So, we're breaking new ground with this particular dose and combination. Does that help answer the question? Yes, it does.
Regulatory strategy I would say is in the early stages the being developed for the program. We're highly focused on this first 40 patients to see what this combination could do for us in this area of high unmet medical need at the end of the day. The the regularly part that we follow is gonna be very much a function of the activity that we see if the combination.
So little hard to comment at this stage, let me ask me to add to that yeah. I think the only thing that I would add is given the nature in which the regulatory environment has evolved in the last couple of years I think everybody's hopeful that we don't have to conduct as rigorous.
Evaluation of what monotherapy might be or what a standard of care therapy might be on there's certainly a lot of studies that are attempting to look at real world data.
As they filed for Registrational approval so.
Suffice it to say that we are going to be as creative as we can.
And we will do whatever.
We do in collaboration with the health authorities globally.
Great further on their claim.
Sean A. McCarthy: Yes, it does. It does. Thank you.
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Operator: The next question is from...
What we see monotherapy data and how important.
Sean A. McCarthy: Thank you. Thank you. Thank you.
Tivity.
Operator: The next question is from Mara Goldstein with Mizuho. Good.
So we continue to as I mentioned on the in the prepared comments the enrollment in the part D expansion cohorts is now complete we continue to collect and analyze that data and we will give an update on monotherapy strategy again between now and the ended the year.
Sean A. McCarthy: Thanks very much for taking my questions. So, I understand you're limited as to what you might be able to say about the CX072 program, but I'm curious as to, if you cannot give specific numbers, sort of conceptually, what is considered clinical success for that program, and what would be the next steps, assuming that you achieve that? And secondarily, on the CX2009 patient cohort that was previously treated, will you be able to provide updated data on those patients when you talk about next steps for that program?
Great and lastly on CD won 66 as a target is there any competitive developments that you're aware.
No pleased to say that we continue to blaze the trail.
With that said.
First a clinical stage novel target of ours. So nothing that we're aware of at this point.
Great. Thank you very much for taking my questions.
Thanks Mark.
The next question is from Byron.
Sean A. McCarthy: Hi Mara. The second question: was that 2009 or 2009?
Please go ahead.
Yeah, Hi, guys. Thanks for taking my questions. Sean you know maybe can you talk a little bit about the big picture on Osama to the compound has been in the clinic since end of 2016.
Sean A. McCarthy: Sorry, on the pro-body drug conjugate.
Sean A. McCarthy: Regarding 2009, again, to restate our goal between now and the end of the year is to communicate on these, those are the indications for moving into the expansion phase, and that's really as much as we're able to say at this point.
However, you know I think what we've seen with other companies is that they've been somewhat creative in terms of pivotal single arm studies and other tumor types.
Sean A. McCarthy: Okay, and if I could just follow up on the 072 program, I know it's a small number of patients, but will you be able to glean out of that any differences in responses between, let's say, those patients who did not have any initial response to checkpoint inhibitors and those who lost response?
And have just been you know I think a more aggressive so at what point do we expect that from cytogenetics and Oh seven so.
Well, there's haber and good to hear from you.
As you know yeah, we've we've taken the approach over the last several years of costing a fairly wide met to really.
Sean A. McCarthy: I think you're right that the numbers are going to be small, so we'll be looking at that, but I don't know that we would be able to draw any conclusions from this Simon 1 stage.
Characterize what we described as the efficacy fingerprint of Cxo seven two because as a priority not antibody isn't the first probably what he's got into patients.
Operator: All right, thank you very much. The next question is from Boris Peeker on Cowen. Please go ahead.
It was always intended to teach us a lot about how the platform works and also how this product candidate works.
Operator: Good evening. My first question is on 7-2, and I guess...
We have learned a lot we presented a reasonable about data over the last couple of years starting at the drug clearly is active as a prodrug antibody as effective as effective in combination with it'd be.
Amy Peterson: to Amy. Just from the regulatory perspective, if you decide to advance O7-2 into pivotal combo studies with IPI, will you have to include the monotherapy arm of O7-2 or monotherapy of IPI or some kind of combinational reasons?
And we've now announced a very clear next step.
An area of significant unmet medical need taking they'd be combination into relapse refractory melanoma as we said on the goal. We do believe that there's going to be potential for the apio seven two combination.
Sean A. McCarthy: Hey, Boris. It's Sean. Let me kick that one off and hand it over to Amy.
Got you know in a in a range of different tumor types, where we already know that it'd be nivo is effective has not been advanced due to toxicity issues or not being able to does high enough.
Sean A. McCarthy: So, regulatory strategy, I would say, is in the early stages of being developed for the program. We're highly focused on these first 40 patients to see what this combination can do for us in this area of high medical need. At the end of the day, the regulatory path that we follow is going to be very much a function of the activity that we see from the combination. So, it is a little hard to comment at this stage. Let me ask Amy to add to that.
Well, it's coming I would make is that.
Talks of Peterson here is.
Rather well known I think for.
Abroad, and aggressive clinical development strategies, and we will be looking for to develop those for us as we move forward.
Got it and then I've got a follow up I guess just on the new phase two trial that you've announced why not out of compared or would it be nivo. So we can actually you know delineate the differentiation Novo Senate too and then I guess you know a second part of the question as you know given PD one is for of hotline.
Amy Peterson: Yeah, I think the only thing that I would add is given the nature in which the regulatory environment has evolved in the last couple of years, I think everybody's hopeful that we don't have to conduct as rigorous evaluation of what monotherapy might be or what standard of care therapy might be. There are certainly a lot of studies that are attempting to look at real-world data as they file for registrational approval. So suffice it to say that we are going to be as creative as we can, and we will do whatever we do in collaboration with health authorities worldwide.
Center of care in melanoma.
I'm going to assume that all of these patients will be retreated with PD, one and your study. So why not also evaluate the combo and the frontline setting.
Yes, great question the.
Step wise thing isn't that so at this stage. We think this is the right experiment to do for the pro body and.
Amy Peterson: Great. And then further on in the PROCLAIM-072 study, when will we see monotherapy data, and how important is monotherapy activity?
Given the unmet medical need in this patient population exposing these patients to running running control arms, we didnt seem to be the right thing to do.
Sean A. McCarthy: So we continue to, as I mentioned in the prepared comments, enrollment in the Part D expansion cohorts is now complete. We continue to collect and analyze that data, and we will give an update on the monotherapy strategy again between now and the end of the year.
We also.
See potential in the long run to bring this combination forward in the in the treatment regimens. So it's a it's a stepwise approach burn.
Got it Okay, and then I guess on you mentioned that at some point you would evaluate a partnership for on 72 can you just talk about where are your efforts. Our first CX one eight the PD one pro body I believe you know you were evaluating partnerships for that program as well.
Sean A. McCarthy: And lastly, on CD166 as a target, is there any competitive development that you're aware of?
Sean A. McCarthy: No, I'm pleased to say that we continue to blaze a trail with that first clinical stage novel target of ours, so nothing that we're aware of at this point.
Operator: Great, thank you very much for taking the time.
Operator: Thanks, Barth.
Operator: The next question is from Byron Amin with Jefferies. Please go ahead.
Sean A. McCarthy: Yeah, hi guys. Thanks for taking my questions.
Sean A. McCarthy: Sean, you know, maybe you could talk a little bit about the big picture on O72? The compound has been in the clinic since the end of 2016. However, you know, I think what we've seen with other companies is that they've been somewhat creative in terms of pivotal single-arm studies and other tumor types and have just been, you know, I think, more aggressive. So, at what point can we expect that from CytomX and O7-2?
Well as you know the PD one pro body, we elected earlier this year to not moved into clinical development and we've.
We've always thought a partnership around the program at the right time could make some sense.
Whether the partnership on.
One of those assets and not the other would be doable remains to be seen.
Sean A. McCarthy: Well, hey, Bernd, good to hear from you. As you know, we've taken the approach over the last several years of casting a fairly wide net to really characterize what we describe as the efficacy fingerprint of CX072 because, as a pro-body, not an antibody, and the first pro-body to go into patients, it was always intended to teach us a lot about how the platform works and also how this product candidate works I believe we have learned a lot. We have presented a reasonable amount of data over the last couple of years showing that the drug clearly is active as a pro-drug antibody. It's effective, especially in combination with IPI. We've now announced a very clear next step in an area of significant unmet medical need, taking the IPI combination into relapsed refractory melanoma.
But all I can really says that we continue to be.
Interested at the right time in partnering the PD program.
Got it thank you.
Yes.
The next question is from parents fun with Goldman Sachs. Please go ahead.
Hi, Thanks for taking my question.
Maybe again, just another big picture one.
Yeah, Shaun you referred to some other recent personal data for.
Opdivo Yervoy in frontline long a couple of studies that came out just wondering your thoughts implication of these data maybe for your programs and then I'm not sure. If you can comment on this but what tumor types would you expect Bristol to focus on for the 249, plus Opdivo phase two trial that you're expecting them to advance.
Sean A. McCarthy: As we said on the call, we do believe that there is going to be potential for the IPI072 combination in a range of different tumor types where we already know that IPI-nevo is effective but have not been advanced due to toxicity issues or not being able to dose it high enough. The last comment I would make is that Dr. Peterson here is rather well-known for her... Broad and Aggressive Clinical Development Strategies, and we will be looking for her to develop those for us as we move forward.
Thank you.
Yes.
Second question.
Ladies and gentlemen, please remain on the line.
Ladies and gentlemen, please continue to standby.
Ladies and gentlemen, please continue to standby the conference will resume momentarily.
Sean A. McCarthy: I've got a follow-up question, I guess, just on the new Phase 2 trial that you've announced. Why not add a comparator of ipinevo so we can actually, you know, delineate the differentiation of O7-2? And then I guess, you know, a second part of the question is, you know, given PD-1 as a frontline standard of care in melanoma, I'm going to assume that all of these patients will be retreated with PD-1 in your study, so why not also evaluate the combo in the frontline setting?
Sure.
Hello.
But your reconnected Sir.
Oh, okay.
Go ahead Hello.
Hello.
Okay, well with Robert Burns with H.C. Wainwright.
Hi.
Hi, Thanks for taking my question guys. So just two if I may so as we soften the press release last week across the 27 patients in phase one proclaimed six and 72 dose escalating dose escalation trial.
Sean A. McCarthy: Yeah, great question. Then, it's a stepwise thing, isn't it? So at this stage, we think this is the right experiment to do for the pro body. And given the unmet medical need in this patient population, exposing these patients to running control arms, we didn't think it would be the right thing to do. We also, um, see potential in the long run to bring this combination forward in the treatment regimen. So it's a stepwise approach, Barron.
83% of patients experiencing GE three for treatment related adverse events, which appears to have ticked up from the prior 25 that we saw I was just curious what was the rate in patients who were treated at the recommended phase two dose.
Sean A. McCarthy: You mentioned that at some point you would evaluate a partnership for O72. Can you just talk about where your efforts are for CX188, the PD-1 ProBody? I believe you were evaluating partnerships for that program as well.
Sean A. McCarthy: Well, as you know, the PD-1 ProBody we elected earlier this year not to move into clinical development, and we've always thought that a partnership around the program at the right time could make some sense. Whether a partnership on one of those assets, but not the other, would be doable remains to be seen. But all I can really say is that we continue to be interested at the right time in partnering the PD program.
And then my second question was could you give some color as to what percentage of first line melanoma patients currently receive opdivo, plus yervoy or just an anti PD one monotherapy.
Operator: Got it. Thank you.
Operator: The next question is from Terrence Flynn with Goldman Sachs; please go ahead.
Regimen. Thank you.
Hey, Robert Good there for me.
Operator: Hi, thanks for taking the question. Maybe again, just another big picture one.
So we have 20 patients in the study treated at that three makes the gig.
Sean A. McCarthy: You know, Sean, you referred to some of the recent Bristol data for Opdivo Yervoy in frontline lung cancer, a couple of studies that came out. Just wondering, you know, your thoughts on the implications of these data, maybe for your programs. And then, I'm not sure if you can comment on this, but what tumor types would you expect Bristol to focus on for the 249 plus Opdivo phase two trial that you're expecting them to advance into? Thank you. Yes, hi Terrence, the second question...
All of it the.
And I believe and right in saying that the.
The response rate among those patients is 25% and is this equates to redeploy eases. The same is 25% so.
So you're right that 33% number is a slight uptick what we presented previously but the numbers broadly speaking in the in this study have held up pretty very well since the breadth of thanks.
Sean A. McCarthy: Yeah, so, hi Terrence, second question... Ladies and gentlemen...
Operator: Ladies and gentlemen, please remain on the line. Ladies and gentlemen, please continue to stand by. The conference will resume momentarily. Hello, you're reconnected, sir.
Does that help.
Yeah that helps thank you and then just some color as to overall treatment patterns and prescribing patterns within the first time melanoma would be helpful. If you can.
Operator: Oh, okay. Go ahead. Hello,
Operator: Okay, we'll go with Robert Burns and HC Wainwright. Hi, thanks for taking my question, guys. So, just two, if I may.
Yes.
Let me, let me hand over David's comment on that yes. The we obviously were very thoughtful and how.
Sean A. McCarthy: As we saw from the press release last week across the 27 patients in the Phase 1 Proclaimed CXO72 Dose Escalation Trial, 33% of patients experienced G3-4 treatment-related adverse event rates, which appears to have ticked up from the prior 25 that we saw. I was just curious, what was the rate in patients who were treated at the recommended Phase 2 dose? And then my second question was, could you give some color as to what percentage of first-line melanoma patients currently receive Opdivo plus Yervoy or just an anti-PD-1 monotherapy regimen? Thank you.
Decided on that particular cohort and although.
Treatment or prescription pattern is not one melanoma and you asked and predominantly academic center focuses more on the combination we found that that is not actually necessarily trail. When you go out into the community.
Position that really more focused on minimizing the side effect profile and increasing tolerability.
Sean A. McCarthy: Hey Robert, good to hear from you.
And oftentimes they will recall that.
Sean A. McCarthy: So, we have 20 patients in the study treated at 3 mg per gig of IPA.
Aurizon until the patients has the graph.
Sean A. McCarthy: and I believe I'm right in saying that the...
Sean A. McCarthy: The response rate among those patients is 25%, and the incidence of grade 3-4 AEs is the same; it's 25%. So, um, so...
And or they determine that an additional eight either so there are opportunities new app.
Well certainly in other regions of the World, where the Dublin is not commonly dosing prescription filled or areas, where we take in consideration for our site and have expanded into reserves that to Korea, and Australia New Zealand.
Sean A. McCarthy: You're right. That 33% number is a slight uptick.
Sean A. McCarthy: The numbers, broadly speaking, in this study have held up really, very well since the first presentation.
Amy Peterson: Yeah, that helps. Thank you. And then just some color to show overall treatment patterns and prescribing patterns within first-line melanoma would be helpful, if you can.
Sean A. McCarthy: Yeah, let me, let me...
Okay, great for that.
Amy Peterson: We obviously were very thoughtful in how we decided on this particular cohort, and although Treatment of Prescription Patterns in Frontline Melanoma in
Does that answer your question.
Yes. Thank you so much.
Sure.
And there are no further questions.
Amy Peterson: The U.S. and predominantly academic centers focus more on the combination. However, we found that that is not actually necessarily true when you go out into the community, where physicians are really more focused on minimizing the side effects profile and increasing tolerability, and oftentimes, they will withhold the CCLA-4 agent until the patient has progressed and or they've determined that an additional agent is needed. So there are opportunities in the U.S. and, certainly, in other regions of the world where the doublet is not commonly the go-to prescription. Those are areas where we've taken into consideration for our sites and have expanded into regions such as Korea and Australia and New Zealand specifically for that. Does that answer your question?
All right operator.
Thank you very much Sean yes, great. Thanks, everybody for your time today against an exciting Q3 first night time, it's exciting year and where we're looking forward to.
Continuing through this novel pipeline Board and as I said as we come to the end of 2019 were beginning to get line of sight to what has the potential to the data rich a mouse ambrish 2020. So thank you again field.
Amy Peterson: Yeah, thank you so much. And there are no further questions.
Operator: All right, operator. Thank you very much.
Ladies and gentlemen, thank you for participating in today's conference call you may now disconnect.
Sean A. McCarthy: Yeah, great. Thanks, everybody, for your time today. Again, it's been an exciting Q3, the first CytomX exciting year, and we're
Sean A. McCarthy: I am looking forward to continuing this novel pipeline forward, and as I said, as we come to the end of
Sean A. McCarthy: We're beginning to get the light of sight of what has to become a reality.
Operator: Thank you again for your time. Ladies and gentlemen, thank you for participating in today's conference call. You may now disconnect.
Operator: BF-WATCH TV 2021