Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Compugen Ltd. (CGEN 0.57%)
Q4 2019 Earnings Call
Feb 20, 2020, 8:30 a.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Ladies and gentlemen, thank you for standing by. Welcome to Compugen's Fourth Quarter and Full Year 2019 Results Conference Call. [Operator Instructions] An audio webcast of this call is available in the investors section of Compugen's website www.cgen.com. [Operator Instructions]

I would now like to introduce Elana Holzman, Compugen's Director of Investor Relations and Corporate Communications. Please, go ahead.

Elana Holzman -- Director of Investor Relations and Corporate Communications

Thank you, operator and thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO; Dr. Henry Adewoye, Chief Medical Officer; and Ari Krashin, CFO and COO. Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections and other forward-looking statements regarding future events, or future business outlook, a business model for development and collaboration efforts and their outcome, a discovery platform, anticipated progress and time line for our existing and pipeline programs and financing and accounting related matters, as well as statements regarding our cash position, cash resources and results of operation.

We wish to caution you that such statements reflect only the company's current expectations, and involve known and unknown risks, and uncertainties that may cause actual results, performance or achievements of the company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission, including the company's most recent Annual Report on Form 20-F filed on March 21, 2019. The company undertakes no obligation to update projections or forward-looking statements in the future unless required by law.

I will now turn the call over to Anat. Anat?

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you, Elana. Good morning, and good afternoon, everyone and welcome to our fourth quarter and full year 2019 corporate and financial update. As Elana mentioned, today on the call, I have with me Dr. Henry Adewoye, our Chief Medical Officer, who will provide updates on our clinical progress. We also have Ari Krashin, our CFO and COO, who will review our financial statements and position.

Starting off, I'm very proud to be here today sharing our tremendous accomplishments throughout the past year. We have entered 2020 truly transformed, positioned to realign the potential of our computational predictive target discovery capabilities. These capabilities have enabled us to discover three new drug target for which antibodies have been developed into clinical programs that are being advanced internally by us or by pharma partner. Importantly, we now also have encouraging initial clinical data for COM701, our first internally developed and most advanced asset. These data combined with our overall science-driven clinical strategy and an efficiently executed and extending clinical program proposed as forward to an exciting time in the evolution of Compugen.

Before we go through some of our 2019 accomplishments and preview what's to come, I would like to review how our discoveries on the DNAM immuno-oncology axis laid foundation for where we are today. With our computational discovery capabilities focused on the field of immuno-oncology, our lead program COM701 stems from our discovery of PVRIG at the novel immune checkpoint and newly discovered inhibitory pathway in the DNAM axis. In addition, our data suggest that TIGIT, an additional inhibitory pathway discovered previously by us and others, along with PVRIG are two parallel and complementary inhibitory pathways in the DNAM axis. Our view is that in certain tumor types in patient population where the two pathways are operative, there may be a need to block both PVRIG and TIGIT in order to enhance anti-tumor in young responses in selected patient population.

In addition to the linkage between the PVRIG and TIGIT pathways, molecular intersection between the DNAM axis and the PD-1 pathway have been reported by others and are also supported by our preclinical data. We have shown in preclinical studies that our PVRIG inhibitor may work in synergy with PD-1 inhibitors as the dual drug combination and as a triple combination with both PD-1 and TIGIT inhibitor. Based on our new PVRIG pathway discovery and its suggested intersection with the TIGIT and PD-1 pathways our overarching hypothesis is that various drug combinations may be required to address these three pathways; PVRIG, TIGIT and PD-1 in different cancer patient populations, and cancer indications. While in some of the patients blocking the PD-1 pathway will be sufficient.

In others, the blockade of one or both of the other pathways with or without PD-1 blockade may be required. This hypothesis and our preclinical data served as the underlying basis for our clinical strategy and the assessment of PVRIG pathway expression in cancer patients serves as the basis for our biomarker informed indications selection. In order to clinically evaluate this hypothesis, we have been working to rapidly advance COM701, our lead investigational agent targeting PVRIG.

To the best of our knowledge, COM701 is the only anti-PVRIG inhibitor currently in clinical trials, providing us the opportunity and advantage to deliver first-in-class drug. This opportunity is even more promising at this point in time with our encouraging initial clinical data in the monotherapy dose escalation arm of the study and with a great deal of industry interest in the DNAM axis due to TIGIT inhibitors in clinical testing by other biopharma companies. To remind you, we're also developing our own anti-TIGIT antibody COM902 as a complementary program to COM701 in order to allow us to test the dual blockade of PVRIG and TIGIT in cancer patients with tumors or the PVRIG and TIGIT pathways are likely to be more dominant.

Henry will provide a detailed update on our COM701 Phase I study and COM902 later in the call. But before that, I'd like to highlight the exciting news we shared this morning. That we are expanding our ongoing collaboration with Bristol-Myers Squibb to include a Phase I/II triple combination study testing COM701 with Bristol-Myers Squibb Opdivo and their investigational TIGIT inhibitor. In this study, we will be directly testing our hypothesis that there is an intersection between the PVRIG TIGIT and PD-1 pathways and that the simultaneous blockade of these three pathways has the potential to synergistically enhance anti-tumor in young responses in selected patient population not responsive to PD-1 inhibitors alone.

This amendment to our agreement with Bristol-Myers Squibb allows us to continue leading the clinical development of COM701, and accelerate our ability to test the three pathways in parallel to evaluate the science driven hypothesis underlying our clinical strategy. We're delighted that our partners at Bristol-Myers Squibb share our enthusiasm for the COM701 program and has agreed to supply not only Opdivo, but also their investigational TIGIT inhibitor for us to conduct a triple combination study, which we sponsor. We believe this triple combination approach may advance our vision of transforming patient life by extending the reach of existing immunotherapies. We intend to begin the trial in the second half of 2020 and look forward to providing additional details on timing and trial designs once these are formalized.

Furthermore, we plan to complete the dose escalation arm of the dual combination of COM701 with Opdivo under our ongoing Phase I study. Once we complete this dose escalation, we will select a dose for a dual combination expansion study, so we are ready at any point in time to initiate such expansion studies. At the moment, we plan to focus on the triple combination study and as such we will not proceed with dual combination expansion cohort as originally planned and the initiation of such studies will be assessed as we progress. As previously indicated, we plan to present initial data from our ongoing combination dose escalation study of COM701 with Opdivo in the second half of 2020.

Excitingly, we're poised to begin the biomarker informed mono-therapy expansion cohort as planned. To which, we recently added colorectal cancer based on the encouraging initial clinical data we have seen so far. The other four indications were chosen based on biomarker informed expression level and we believe these cancers are most likely to respond to COM701 treatment.

We were incredibly pleased to see initial sickness of anti-tumor activity with COM701 as monotherapy in a dose escalation all-comers study addressing heavily pertreated patient population. These data suggest that COM701 targeting immune-oncology pathway be discovered may have the potential to improve patient's outcome. We are pleased by our progress and our plans to extend our clinical study.

We have also made considerable progress with COM902, our anti-TIGIT antibody. It is important to note that while others have clinical programs targeting TIGIT. To the best of our knowledge, Compugen is the only company with clinical programs targeting both PVRIG and TIGIT leaving us well-positioned to synergistically target this premium checkpoint pathways in the DNAM axis. We are on track to initiate our COM902 Phase I study soon and anticipate sharing initial clinical data next year.

Although, we are developing COM902 to support our combination strategy for COM701, we will assess in an ongoing manner whether additional combination products opportunity exists for this clinical stage asset outside of the DNAM axis. We're looking forward to an exciting 2020 in which we plan to conduct three parallel clinical studies: COM701 monotherapy, the newly announced triple combination therapy; and COM902 dose escalation. And expect to have various data read-outs during the second half of 2020 and in 2021.

Turning to discuss our achievements on the intellectual property front. Over the past several years, we were granted multiple important patents in the US and Europe, bolstering our IP position and portfolios with new composition of matter and use patent. It is important to note that our ability to discover new drug target empowers us to build a broad IT portfolio. Recently, we were granted new composition of matter and use patent for COM701 is a monotherapy and for use in combination with PD-1 antibodies and other therapies.

We anticipate these new patents may strengthen our position on our path to develop a first-in-class anti-PVRIG asset. While investing tremendous efforts in advancing our clinical programs as I have described, we continue to invest in our early stage pipelines we serve as our growth engine. It consists of multiple programs having various mechanisms of action with the potential to address the immunosuppressive tumor microenvironment. These are very early stage programs, but as they progress some may serve as our next wave of preclinical and clinical program.

Finally, we have also made some incredible additions to our management team, strengthening our computational discovery team, which is now lead by Dr. Yaron Turpaz as a part-time Senior Vice President and Senior Advisor. Yaron is a proven leader in R&D Informatics and data scientists and technology for drug discovery and development applications and brings to Compugen extensive experience in the biotech and pharma space.

In addition Dr. Oliver Froescheis has recently joined us from Roche to head our corporate and business development effort. Oliver brings significant expertise in the development and licensing of pharmaceuticals across a broad range of therapeutic areas, including immuno-oncology and we look forward to leveraging his experience as we expand our innovative immuno-therapy pipeline and pursue additional business opportunities.

Before turning the call over to Henry, a brief comment on the third clinical program originating from a competent discovery. As you know, Bayer is evaluating BAY 1905254 as the first-in-class immuno-oncology therapeutic antibody targeting ILDR2, a novel immune checkpoint we discovered computationally. Their Phase I study was initiated in September 2018 and includes an evaluation of Bay 1905254 as a monotherapy and in combination with Keytruda in various solid tumors, including bladder, cervical, asterisk, and head and neck cancers. Bayer is solely responsible for clinical development of this program. Overall, we have made remarkable progress this year. I would like to thank our employees, who have made this possible. I'm immensely proud of them and appreciate their hard work and commitment. I look forward to providing additional update on our program throughout 2020.

With that, I would now like to turn the call over to Henry for a detailed update on our clinical progress. Henry?

Henry Adewoye -- Chief Medical Officer

Thank you, Anat and good afternoon, and good morning to everyone. As Anat mentioned, we have made significant strides with our ongoing Phase I dose escalation study. The investigators continued to be entering the aspect of other clinical trial and remain encouraged by the initial clinical data disclosures at SITC in November 2019.

As you know, the data presented were from our ongoing Phase I clinical trial designed to assess the safety and tolerability of escalating doses of COM701 monotherapy, as well as in combination with Bristol-Myers Squibb Opdivo in patients with advanced solid tumors who have exhausted all available standard therapies. The data presented are from the 13 patients in Arm A, the first-seven dose cohorts of the monotherapy dose escalation arm of the trial.

From a safety and tolerability standpoint, COM701 was well tolerated with no dose limiting toxicities across all seven dose cohorts with dosing up to 10 milligrams per kilogram every three weeks. The patients treated in an A of this trial were heavily pre-treated with the number of prior anti-cancer treatments for these 13 patients linked in from two to 15 with a median of seven. In addition to evaluating safety and tolerability, we also reported on preliminary anti-tumor activity of COM701 monotherapy.

We and the investigators were encouraged to see initial signals of anti-tumor activity in this heavily pretreated patient population. The overwhelming majority of the patients enrolled nine of the 13 patients, in other words 69% had the best-time point anti-tumor activity of stable disease. As a reminder, based on the certain patients had prior treatment refractory disease leaving the best anti-tumor activity reported with their last therapy prior to enrolment on our study with progressive disease.

On COM701 monotherapy, five of these patients have stable disease of their initial assessment. We're encouraged by this data. Six of the 13 patients enrolled on the study have micro supplied stable colorectal cancer and three of the six patients also had KRAS mutations. We reported a best standpoint anti-tumor activity of stable disease in five out of six patients or 83% with MSS colorectal cancer, where four of this six patients with MSS colorectal cancer had confirmed stable disease out to week 12.

The historical data with Pembrolizumab monotherapy in patients with MSS colorectal cancer published in the New England Journal of Medicine in 2015 reported 11% stable disease at the similar time point that is week 12. Based on this data, we have decided this tumor type deserves further exploration during COM701 monotherapy dose expansion, and will be included in the expansion cohorts. We and the investigators are encouraged by these data; especially in this very challenging to treat patient populations and look forward to advancing the trial's to additional readouts.

I would now like to provide an update on progress for the rest of the trial. As a reminder, we currently have two trial arms enrolling patients. A, the monotherapy dose escalation of COM701 and B, the dual combination with escalating doses of COM701 and a fixed dose of Opdivo. We recently presented a trial in progress poster at the ASCO-SITC Clinical Immuno-Oncology Symposium detailing our progress, which I will now review. In 2019, we completed enrolment of Q3 weekly dosing cohorts in Arm A, the monotherapy dose escalation of COM701. Enrolments in the eight dose cohort at 20 milligrams per kilogram on a Q4 weekly dosing schedule of Arm A is ongoing.

As a reminder, we are now evaluating a Q4 weekly dosing schedule based on our clinical data and the dosing schedule of nivolumab. Importantly, after completion of the dose escalation with the Q4 weekly dosing schedule, we plan to begin enrolling patients for the COM701 monotherapy cohort expansion. We're expected to begin the monotherapy cohort expansion as it utilizes a biomarker informed strategy where we have selected tumor types based on our preclinical PVRIG expression data.

The COM701 monotherapy cohort expansion will enroll up to five patients in each of this tumor types. Advanced non-small cell lung cancer, ovarian, breast and endometrial cancer, who are progressed on standard-of-care treatment. We have now added a fifth expansion cohort for colorectal cancer based on the clinical data we reported at SITC 2019. We believe our approach focusing on indications that have high PVRL2 expression will target the patient population most likely to benefit from COM701 monotherapy alone and in combination with Opdivo. As part of the trial, we will test the level of expression of PVRL2 in biopsies obtained from patient pretreatment and on treatment to conduct disrespecting biomarker analysis to inform on the correlation of anti-tumor activity and PVRL2 expression.

Next move -- next to an update on [Indecipherable] of the trial. Our drug combination study is evaluating escalating doses of COM701 with a six dose of Opdivo. Enrolments in the first dose level patient cohort at Q4 weekly dosing schedule has been completed and I'm pleased to report that as of our trial in progress presentation at ASCO-SITC earlier this month, we reported no dose limiting toxicity. We continue to have strong enrolment and are pleased to share that we remain on track to complete enrollment and present data in the second half of this year.

Another major accomplishment for this year was the FDA clearance of our IND for COM902, our proprietary TIGIT inhibitor. With this R&D, we intend to initiate the Phase 1 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of COM902 in patients with advanced malignancies, who have exhausted currently available standard of care therapies. As Anat mentioned earlier, we believe having the wholly owned anti-PD-1 antibody is important to our overall clinical development plan. Site initiation activities are currently under way for this multi-stage trial and we look forward to updating you when the trial begins.

The third major clinical study into which we will enroll patients during 2020 is of cost the Phase I/II triple combination study of COM701 with Opdivo and BMS-986207, Bristol-Myers' investigational anti-TIGIT drug, which we announced this morning. I would like to whole-heartedly agree with Anat sentiment that we are incredibly excited to have this opportunity to test our hypothesis on the DNAM axis at this stage and delighted to be working with Bristol-Myers in advancing this program.

The plan Phase I/II open label study will evaluate the safety, tolerability and anti-tumor activity of COM701 in combination with Opdivo and BMS-986207 in selected tumor types. Mainly, ovarian cancer, endometrial cancer and a biomarker driven arm of tumor types with high expression of PVRL2. The study will dose escalate COM701 with fixed doses of Opdivo and BMS-986207. The study is expected to commence in the second half of 2020 following the clearance of a new investigation and new drug application by the US Food & Drug Administration.

Before turning the call over to Ari, I would like to give our sincere thanks to the investigators, the clinical site personal, and in particular the patients and their families who have made this clinical trial possible by the participation. At Compugen, we continue to work diligently in developing and advancing novel investigational agents into clinical trials with the potential to address significant unmet medical needs. In other words, advancing the investigational agents from cold to cure.

With that, I will turn the call over to Ari.

Ari Krashin -- Chief Financial Officer and Chief Operating Officer

Thank you, Henry. Good morning, and good afternoon to everyone. Our financial results for the fourth quarter and full year of 2019 released this morning reflect the continued expenses associated with our Phase I study of COM701, as well as the effect of the restructuring process we implemented at the end of the first quarter of 2019. We're pleased with the significant reduction of expenses we were able to achieve and we are with our improved financial position.

Research and development expenses during the full year 2019 decreased by approximately 35% in total $19.8 million, compared with $30.3 million in 2018. For the fourth quarter of 2019, research and development expenses were $4.3 million, compared with $7.5 million in the prior year period of 2018. The decrease in both cases attributed mostly to the restructuring process we announced at the end of the first quarter of 2019, as well as the clinical activities related to COM902 most of which will conclude that in 2018. This reduction was offset by an increase in expenses associated with the clinical related activities of COM701 Phase I trial, which began in the second half of 2018.

Marketing and business development expenses during 2019 decreased by approximately 50% and total $0.7 million, compared with $1.6 million in 2018. The decrease is attributed mainly to the expenses associated with our revenues during 2018 and the temporary reduction in headcount during 2019. Net loss for 2019 was $27.3 million or $0.43 per basic and diluted share, compared with a net loss of $22.6 million or $0.41 per basic and diluted share for 2018. Net loss for the fourth quarter of 2019 was $6.5 million or $0.10 per basic and diluted share, compared with a net loss of $9.4 million of $0.16 per basic and diluted share for the comparable quarter of 2018.

As of December 31, 2019, we had approximately $44 million in cash and cash related accounts, compared with approximately $48 million at the end of the third quarter of 2019 and no debt. The slight decrease in cash during the fourth quarter represents our ongoing expenses offset by proceeds of approximately $2 million with the exercise of employee's stock options, most of which reached their expiration period.

Going into 2020, I would like to note that today's exciting announcement about expanding our collaboration with Bristol-Myers Squibb does not materially change our cash outlook for 2020. Total cash expenditures is expected to be approximately $27 million in 2020 without taking into consideration any potential cash inflows for the company from existing and new collaborations. Based on our expected cash expenditures, which takes into consideration all of the clinical plans described earlier by Anat and Henry, we expect to have sufficient cash at least through mid-2021.

I would like to remind everyone that as a policy, management and the Board of Directors privately evaluate the company's cash status in light of its development plans, business activities, financing opportunities, and market conditions. Each is considered together with the long-term interest of our shareholders.

Strengthening our balance sheet in order to develop our clinical programs was and continues to be a top priority for management and our Board.

Before opening the call for questions, I would like to thank our shareholders for their continued support. I also want to thank my fellow management members and all of Compugen employees for their hard work and belief in our mission that allowed the company to start 2020 with a positive momentum and a clear path forward.

Thank you. And with that, we will now open the call for questions.

Questions and Answers:


Thank you. [Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Mark Breidenbach -- Oppenheimer -- Analyst

Thanks for taking the questions and congrats on the progress. I think the triple combination trial makes a lot of sense and we're excited about this one. Maybe let me start with one or two for Anat, and then one for Henry to follow with. So, Anat, undoubtedly, you're aware of Roche Genentech's investment in its TIGIT program and their announcement about the new SKYSCRAPER-02 trial, which is focusing on small cell lung cancer. I'm curious if Roche's plans around their TIGIT antibody have in any way impacted your development plans for COM701? And is small cell lung cancer something where you would expect PVRL2, PVRIG to play an important role?

Anat Cohen-Dayag -- President and Chief Executive Officer

So, thank you Mark. Yes, we're aware of the announcements by Roche. So, first, I'll just say that with respect to TIGIT and its potential in this axis and together with PVRIG, we're talking about it for quite a long time. We're expecting because Genetic is more advanced there. I think, we're expecting to hear about their data or any hints about the TIGIT pathway being active.

So, we're very happy with this because it is actually reinforcing what we're saying for quite some time and we do believe that in certain patient populations where both the PVRIG and TIGIT pathways are complementary and are active that PVRIG will add to this activity. So, that's our hope and this is what we're focused to do.

In terms of lung cancer, obviously when we were discussing the selected indications for COM701, we were selecting those that we think that the PVRIG pathway is more expressed and therefore patients are more likely to respond. And if you remember, we selected ovarian endometrial breast but also lung cancer and we think that the PVRIG pathway may have a role also in lung cancer and we'll see. You know, we are positioned as the company that -- the only company to the best of our knowledge with a clinical stage asset, we're positioned to test it. So, we'll see.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay. And I also noticed that they are including chemotherapy in combination with their TIGIT and their PD-L1 antibody, is that something you consider down the road in your collaboration with Bristol-Myers Squibb?

Anat Cohen-Dayag -- President and Chief Executive Officer

So, it's -- we're not rolling this out. Remember, that our agreement with BMS allows us to test various type of combination, so it was from the beginning we didn't only focus on COM701 and Opdivo. We will consider. Chemotherapy could be added based on their scientific rationale for some of the indications and for others it could be added just because this is the standard of care and you want to be able to add your treatment to standard of care. And so, everything is open for us.

For now, we're clearly focused on the triple, which is the critical path for us to ultimately prove what we're saying for quite a long time and we're accelerating here with this expansion of the agreement our timelines forward together.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay, perfect. And a quick one for Henry, if I can, with regard to the two-dose escalation arms that are ongoing right now, can you tell us how -- with the 20 mig per kig Q4 weekly dosing arm, is that the last escalation arm for the monotherapy trial? And can you tell us how many more dose escalation cohorts you intend to enrol in the Opdivo-COM701 combination before wrapping up that trial?

Henry Adewoye -- Chief Medical Officer

Well, thank you very much Mark. At this point, it seems the trial is ongoing and enrolling patients. It would be premature to indicate if this will be the last dosing cohort we will have. We will be able to disclose additional information once we're able to get all the data in that we're looking at, so the data I'm referring to would be not just the clinical data, but also the laboratory data also, and most of it not just in the first -- within the DLT window, that's the first cycle, but subsequent cycles also.

So, we'll see as the trial unfolds. Remember, one of the things that we're interested in there in the conduct of this trial is trying to figure out if we will be able to achieve a maximum tolerated dose. For most of the check points that have been developed, it doesn't have PR2 days one.

So, what I can tell you for certain now is, it will be premature to see if this will be the last dosing cohort for the monotherapy dose escalation. And also, in terms of the monotherapy, the combination with Opdivo-COM701 plus Opdivo, also premature to indicate how many dose level cohorts we will test because, as you know, this is a Phase 1 study and we're just interested in determining the safety and tolerability of the combination. And this will be very important for us because it will inform also what the projected toxicities will be for the triplet combination that Anat mentioned earlier during the call.

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes. And I just would like to add, and Henry, thank you very much on this, but I just would like add, Mark, in order to add some additional context on information that we already disclosed. So, we do anticipate to initiate enrolment for the monotherapy dose expansion arm in 2020 and to complete enrolment in 2020 and to release data in the first half of 2021 for the monotherapy expansion cohort.

So, that gives you some timeframe to what we're looking for, and also for the dual dose escalation COM701 plus Opdivo, we already stated as well that we're going to present data in the -- that we aim to present data in the second half of 2020, so that also puts things in perspective while, as Henry said, the study is ongoing.

Mark Breidenbach -- Oppenheimer -- Analyst

Right. And when you present the dual combination dose escalation result later this year, can we also expect may be extended follow-up from the monotherapy dose escalation cohorts as well?

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, it could be, yes. We will present a data that we have available, yes.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay. Well, thank you very much for taking the questions and congrats again.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you.


The next question is from Varun Kumar of Cantor Fitzgerald. Please go ahead.

Varun Kumar -- Cantor Fitzgerald -- Analyst

Hi, good morning everyone, and thanks for taking the questions. First on triplet. You specifically mentioned ovarian and endometrial as expansion cohort which could come in future. So maybe first, what's the rationale of these two cohorts in particular for the triplet regimen, maybe, Anat, if you can answer that?

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, sure. So, as we stated, ovarian and endometrial were selected for us also for the monotherapy on top of the fact that we're going also to test breast and the lung cancer, and also we added recently colorectal based on the monotherapy dose escalation data. On the triplet, we wanted to make sure that we focused on indications that we also have the monotherapy expansion cohort. We selected ovarian and endometrial because of the high expression as in the other indications that we selected like breast and lung.

The high expression of the PVRIG pathway, that's a biomarker informed decision and that's the reason these two indications are part of the triplet.

Varun Kumar -- Cantor Fitzgerald -- Analyst

Thanks for the color. So, wanted to have a follow-up as well on the triplet. Now, given you are having Bristol TIGIT in this study, I was trying to understand how strategically you are thinking about your own TIGIT. I understand you will have Phase I study with 902. But how strategically you will position your TIGIT molecule given you have now Bristol TIGIT in the clinical study?

Anat Cohen-Dayag -- President and Chief Executive Officer

So, first, having Bristol TIGIT in the study is great and its win-win for both companies in terms of accelerating the timelines and making sure that we're on the critical path to go ahead into these axis that also get observed more as focusing recently and just move on quickly.

Our own TIGIT is actually -- it's a separate story. We develop our own TIGIT in order to make sure that we can test, execute on the overall COM701 clinical strategy. In this strategy, we would like to make sure that we can test COM701 plus COM902 in certain patient populations. We, as a small company, we need to make sure that we have access to everything that we need in order to move ahead and we are looking to extend our relationship with BMS, as much as possible and they are a great partner for us, but as a small company, it's a clinical collaboration we need to make sure that COM701 is the key lead asset for Compugen, and we need to make sure that we have the component in order to move quickly forward as needed.

In general, this strategy for COM902, on top of the fact of combination with COM701, obviously that's a clinical stage asset now, and if TIGIT is a validated pathway as we think it should be, then from our perspective, we have a clinical stage asset of a validated pathway and if there are any opportunities that are outside of TIGIT plus PVRIG, obviously we're going to assess it in an ongoing manner and decide whether we want to pursue our own TIGIT antibody in additional -- on additional fronts in additional business and combination opportunity.

Varun Kumar -- Cantor Fitzgerald -- Analyst

That's very helpful, Anat. Maybe last question if I may on 701, now it's really exciting to see that you're driving the monotherapy as well and expansion cohorts looks like the data is still expected in first half next year. I just wanted to understand is a goal there with monotherapy 701, is the idea to have it be more informative study? Or do you think there could be a path forward with single agent in terms of regulatory path as well, if you get some exciting data there in solid tumor?

Anat Cohen-Dayag -- President and Chief Executive Officer

First, obviously, this is a completely new agent. As Henry is saying all the time, we need to know as much as we can on days on the safety profile, the tolerability and everything possible, so that's part of the reason for us to move forward.

But personally I'll tell you, that obviously our data is supportive of tumor growth envisioning preclinical models, up until now, checkpoints that were showing preclinical data other than PD-1 and CTLA4, did not show encouraging -- maybe not all of the checkpoints, but most of them, encouraging clinical data, and hopefully TIGIT is bypassing this barrier now, But for COM701, even in the dose escalation stage where we had heavily pre-treated population, median of treatments of 7 really exhausted patients and we were able to see some encouraging initial signs of possible activity and that's the reason we added colorectal to the monotherapy.

Look, we selected these indications because we think that these are the indications where this pathway should be more active. These patients and these indications are likely to respond and we'll test it.

Hopefully, we will be able to see also monotherapy, but I think that in general, in this space, if you want to hold your breath, I guess its combo, right? So, I'm not ruling out the monotherapy front obviously, but I think that -- and we're pushing forward as quickly as possible, but I think that with our theory about the three pathways, we look forward into getting data of combination study.

Varun Kumar -- Cantor Fitzgerald -- Analyst

That's very helpful. Thank you, Anat and Henry and Ari as well. Congrats on the progress.

Henry Adewoye -- Chief Medical Officer

Thank you.


And the next question is from Colin White of Jefferies. Please go ahead.

Colin White -- Jefferies -- Analyst

Hi, it's Colin White from Jefferies here. So, on the recent Genentech call, they were discussing the possibility of combining an anti-TIGIT and an anti-PD-1 within I-O 15 [Phonetic] to help us in that NK cell expansion. You're obviously testing your triplet, anti-TIGIT, anti-PD-1 and then COM701. So I was just wondering if you could share any thoughts on the possible advantages of your strategy and whether or not you can settle in combinations with cytokines that you can just cell proliferation?

Anat Cohen-Dayag -- President and Chief Executive Officer

I think that maybe just I'll relate -- in order to address your question, I'll relate to the three pathway signs driven any positives that we have. So, we think that in different patient populations, there may be different need for different combinations. So, I'll just elaborate. So, for patients where PD-1 pathway is more dominant, treating them with PD-1 blocker would probably get this patient to respond, but we think that in other patient populations where the PD-1 pathway is maybe less dominant and there are additional pathways or other pathways that are dominant, you would need to treat with additional or other agents and that's our story with respect to this triple pathway, and we're going to test it. That's our clinical strategy.

So, we think that there is room for TIGIT plus PD-1, but there is also obviously a room for TIGIT and PVRIG and that could be in different patient populations, in different cancer indications and even in -- may be in overlapping for the treatment. So, that's our hypothesis and the clinical strategy.

With respect to cytokines, I think that it goes to a more broader question with respect to infiltrated tumors and excluded tumors and desert tumors where T-cells are not injected into the tumor microenvironment and that goes into how you release the immunosuppressive tumor microenvironment in order to be more permissive in order for T cells to infiltrate and then you can treat them with checkpoint inhibitors.

And obviously, there are different modalities that are being tested now that are dealing more with changing the inhibitory profile of the tumor microenvironment. And cytokines could well address this. We'll see how this data is panning out.

Colin White -- Jefferies -- Analyst

If I could just follow-up with one question about the triplet study design? I mean, how will the study show the contribution of COM701? Is that part of the way the study is going to be designed?

Anat Cohen-Dayag -- President and Chief Executive Officer

So, specifically for the design -- and Henry feel free to jump in if you want to, but specifically for the design, we share more data after the study design is formalized, and we need to submit a protocol and equivalent and get clearance for the IND. So, we'll share more data about the study design itself.

Colin White -- Jefferies -- Analyst

Okay, thanks.

Henry Adewoye -- Chief Medical Officer

Yes, I concur, Anat. And it's a very good question Colin, which will start off internally also. But like Anat mentioned in her prepared address, that we're trying to get to the core of this, which is evaluating the axis, the DNAM axis and blocking the various factors in this access.

So, that will answer the question. And then, trying to figure out the contribution of the relative -- of the two or the three molecules then becomes a little bit easier to address versus that seeing the data come in.

Let me segue a little bit back to the question that both Mark and Varun talked about. So, herein lies the reason why the COM701 monotherapy expansion will continue in the selected tumor types with high expression of PVRL2. That data will not just be informative in terms of the anti-tumor activity, but also satisfies regulatory criteria in trying to disentangle what the contribution of COM701 is and will be, so that partially addresses that also.

Colin White -- Jefferies -- Analyst

That's great. Thanks.


This concludes our question-and-answer session. I will now turn the call back to Compugen's President and CEO. Dr. Cohen-Dayag, would you like to make your concluding statement?

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you. During 2019, we made significant progress in our clinical development plans for COM701, our leading immuno-oncology asset. And in 2020, we will be contacting in parallel three clinical studies, COM701 monotherapy, the treatment combination study of COM701 with Bristol's Opdivo and TIGIT inhibitor, and COM902 dose escalation.

Our ongoing clinical studies, with the support of Bristol-Myers Squibb will advance the clinical evaluation of our hypothesis regarding the potential role of the PVRIG pathway within the DNAM axis and PD-1 pathway. This is particularly exciting given the growing industry focus on this axis.

We remain optimistic and with the hope to expand the reach of cancer immunotherapy to new cancer types and patient populations. I'm extremely pleased with the progress we have made during 2019 and enthusiastic going into 2020, well positioned to execute.

We look forward to sharing with you additional data during 2020 and in 2021. Thank you for joining us on the call today.


[Operator Closing Remarks]

Duration: 55 minutes

Call participants:

Elana Holzman -- Director of Investor Relations and Corporate Communications

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry Adewoye -- Chief Medical Officer

Ari Krashin -- Chief Financial Officer and Chief Operating Officer

Mark Breidenbach -- Oppenheimer -- Analyst

Varun Kumar -- Cantor Fitzgerald -- Analyst

Colin White -- Jefferies -- Analyst

More CGEN analysis

All earnings call transcripts

AlphaStreet Logo