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Jounce Therapeutics, inc (NASDAQ:JNCE)
Q3 2021 Earnings Call
Nov 5, 2021, 2:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day ladies and gentlemen, and welcome to Jounce Therapeutics' Third Quarter 2021 Earnings Conference Call. [Operator Instructions]

I will now turn the call over to your host, Eric Laub, with Jounce Therapeutics. Please go ahead.

Eric Laub -- Vice President of Investor Relations, Corporate Communications, and Media Relations

Thank you, operator. This is Eric Laub, Vice President of Investor Relations at Jounce Therapeutics. Good morning, and welcome to the Jounce Therapeutics Third Quarter 2021 Earnings Conference Call. This morning, we issued a press release which outlines the topics that we plan to discuss today. The release is available in the Investors & Media section of our website at www.jouncetx.com. Speaking on today's call will be our CEO and President, Dr. Richard Murray, who will review our pipeline progress and key milestones; followed by our CMO, Dr. Beth Trehu, who will provide an update on our clinical activities. Our CSO, Dr. Dmitri Wiederschain, will then discuss our discovery efforts. And lastly, our CFO, Kim Drapkin, will review our third quarter financial results. We will then open the call for your questions.

Before we begin, I would like to remind everyone that today's discussion will include statements about our future expectations, plans and prospects that constitute forward-looking statements for the purpose of the safe harbor provisions under the Private Securities Litigation and Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the risk factors discussed in our SEC filings. In addition, any forward-looking statements represents our views only as of today, November 4, 2021, and should not be relied upon as representing our views of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

With that, I'll now turn the call over to Rich.

Richard Murray, Ph.D. -- Chief Executive Officer and President

Thanks, Eric. Good morning, and thank you for joining us today. Jounce has had a very productive quarter as we've made significant progress across all areas of the company. We continue to build momentum as we head into the new year with data expected in 2022 from two ongoing clinical studies, new candidates progressing from our active discovery efforts and a cash runway that allows us to reach new inflection points. We are pleased to report that we are now actively recruiting patients in the monotherapy and combination therapy expansion portion of the INNATE study, testing JTX-8064 plus or minus pimivalimab, our own PD-1 inhibitor, in eight distinct cohorts across seven tumor types. We continue to advance patient enrollment in our SELECT study, which employs our stringent patient selection strategy and have continued our commitment to build our discovery pipeline. We're at an exciting time in Jounce's development and remain committed to progressing new mechanisms that target different immune cell types within the tumor microenvironment. This is now evident in our myeloid and macrophage programs and our program licensed to Gilead, which targets T regulatory cells. We also believe Jounce represents the next-generation of immuno-oncology by unlocking a precision medicine approach through the continued execution of our translational and biomarker efforts.

Biomarker selection and targeting key checkpoints on different immune cell types not only differentiates us, but is integral to our mission to bring the right immunotherapy to the right patients. At the beginning of this year, we announced that enrollment had commenced in INNATE, the clinical study of JTX-8064, our highest priority program. JTX-8064, an inhibitor of the macrophage checkpoint, LILRB2, also known as ILT4, is being tested as a monotherapy and combination therapy along with pimivalimab or pimi. We moved quickly through the necessary monotherapy and combination therapy dose escalation for safety in all-comers cancer patients while establishing safety and PK/PD to allow for dose selection. We determined 700 milligrams as the preliminary recommended Phase II dose for the mono and combo expansion cohorts, and we recently announced enrollment for monotherapy and combination therapy expansion in well-defined patient populations in eight cohorts across seven tumor types. We look forward to delivering further milestones with this program and reaffirm our belief that the myeloid and macrophage biology targeted by JTX-8064 via the LILRB2 mechanism provides a new opportunity to bring benefit to patients, especially patients with PD-1 inhibitor resistant tumors.

As we have previously mentioned, these patients tend to have few therapeutic options and represent a growing patient population due to primary or acquired resistance to prior PD-1 inhibitor treatment. We anticipate presenting the first clinical data from this program in 2022. Patient enrollment continues to advance in the SELECT study. Our Phase II randomized proof-of-concept trial of vopratelimab, our ICOS agonist in combination with pimi. The key feature of this study is the biomarker selection of patients utilizing TIS vopra, an 18-gene signature that includes genes relevant to both CD8 and CD4 T cell biology. We believe from our own clinical data and from others that a rigorous patient selection strategy may be critical to optimize the benefit of an ICOS agonist. We look forward to reporting clinical data from the SELECT trial in 2022.

We ended our quarter with a strong financial position and are situated to fund our two wholly owned proof-of-concept studies, INNATE and SELECT, to past their inflection points while continuing our robust novel discovery efforts, identifying and progressing new mechanisms that target a diverse set of immune cell types within the tumor macro environment. With the goal of a new IND every 12 to 18 months, we are on track to nominate another development candidate. In June, Jounce successfully opened the IND for GS-1811, formerly JTX-1811. And in August, the clinical study was initiated by Gilead. We are extremely pleased to now have four internally developed candidates in the clinic in the past five years. We remain fully committed and on track to achieve all the milestones set out for 2021 from the clinic to our discovery efforts.

Before turning the call over to Beth, I'd like to welcome back to Jounce, Jigar Raythatha. In September, we announced that Jigar joined our Board of Directors. His experience and skills are highly relevant and synergistic with the needs of our Board. As a former team member of Jounce, Jigar has an intimate working knowledge of our science as well as an understanding of what we are working to achieve. We look forward to his continued contributions now as a Board member. I'll now turn the call over to Beth to provide a clinical update. Beth?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Thanks, Rich, and good morning. I'm extremely pleased with the progress and continued execution we have made in both our INNATE and SELECT clinical trials. Before getting into detail on our ongoing proof-of-concept studies, I'd like to emphasize a point Rich made about cancer patients in need of better options. Unfortunately, there are far too many patients still not benefiting from improved T cell-based IO therapies. With these patients in mind and our goal of bringing the right immunotherapy to the right patients, we are enthusiastic about the potential for JTX-8064 as a macrophage checkpoint inhibitor to improve clinical outcomes in patients with both tumors that are sensitive and resistant to PD-1 or L1 inhibitors. Both the INNATE and SELECT trials are consistent with our belief that novel mechanisms and biomarker strategies are necessary to bring clinical benefit to patients who do not optimally benefit from T cell checkpoint inhibitors.

Turning first to JTX-8064 and our INNATE study. We believe targeting immune cells such as macrophages has the potential to address the greatest unmet need in immuno-oncology and bring effective treatments to patients with PD-1 inhibitor resistant tumors. By identifying and inhibiting key checkpoints of the innate immune system, new populations of T cells can be primed and directed to the tumor, something T cells alone cannot do. For patients, this might mean a more comprehensive immune response and one that may overcome that significant barrier of treating PD-1 inhibitor resistance or nonresponsiveness. This substantial unmet need is why we consider JTX-8064 to be our highest priority program. JTX-8064 aims to convert immunosuppressive macrophages to an antitumor state and create a bridge between the innate and the T cell arms of the immune system. As a reminder, the INNATE trial is divided into four parts. Part one is JTX-8064 monotherapy dose escalation in all-comer solid tumors.

Part two, JTX-8064 plus pimi dose escalation in all-comer solid tumors. Part three, JTX-8064 monotherapy expansion cohort in PD-1 naive ovarian cancer. Part four is JTX-8064 plus pimi in seven tumor-specific expansion cohorts. As planned, we moved quickly through the dose escalation of the INNATE study, and we are proud of the efforts our team made to accomplish this. With the dose escalation of both mono and combo completed, we are now enrolling patients in the important proof-of-concept portion of the INNATE monotherapy and combination expansion cohorts. The expansion cohorts will study JTX-8064 in three subsets of patients in order to identify the most rapid development paths for JTX-8064 alone or in combination with PD-1 inhibitors.

First, patients who have progressed on PD-1 inhibitors and are now PD-1 inhibitor resistant. These patients have very few treatment options, and repeat immunotherapies have been largely unsuccessful. Indications we have targeted for this patient population include triple-negative breast cancer, cutaneous squamous cell carcinoma, non-small cell lung cancer and clear cell renal cell carcinoma. Second, PD-1 inhibitor naive patients with tumors that don't typically respond to PD-1 inhibitors. This is also an area of high unmet need in which T cell directed immunotherapy has not had a significant impact. Indications we have targeted for this patient population include ovarian cancer and sarcoma. Finally, PD-1 inhibitor naive patients with tumors for which PD-1 inhibitors are approved, but there is still room for improvement.

The indication we have targeted for this patient population is frontline head and neck squamous cell carcinoma. Earlier this year, we shared our translational approach to defining disease areas of interest for JTX-8064 based on analyses of the tumor microenvironment across multiple tumor types. We have taken these disease areas of interest and defined specific indications to include in the expansion stage of INNATE based on biology, unmet need, competitive differentiation and consideration of PD-1 or L1 inhibitor sensitivity and resistance. We believe it is important to investigate this new and exciting mechanism in the three distinct patient populations mentioned previously. Proof-of-concept expansion cohorts in INNATE follow a Simon's two-stage design with the potential to enroll up to 29 patients per combination cohort and up to 47 patients in the monotherapy cohort if prespecified criteria are met. INNATE will also assess pharmacodynamic and potential predictive biomarkers to guide future development, aligning with Jounce's philosophy of developing the right immunotherapies for the right patients.

As data emerges, we will have the opportunity to explore other indications and combinations with JTX-8064 as well. Importantly, the combination expansion cohorts in INNATE allow us to potentially take two Jounce molecules, JTX-8064 and pimi, through to registration. Next year, we will guide on when and how we plan to release the data. Now turning to SELECT where screening and enrollment continue to progress well. SELECT is our Phase II randomized proof-of-concept trial of vopratelimab in combination with our own PD-1 inhibitor, pimi, in approximately 75 immunotherapy naive, non-small cell lung cancer patients who will be selected using the predictive TIS vopra biomarker and randomized to vopra plus pimi versus pimi alone. We expected approximately 20% of these second-line, non-small cell lung cancer patients to be TIS vopra positive, and screening to date continues to validate this projection. The essential feature of this study is a rigorous biomarker selection of patients utilizing TIS vopra, an 18-gene signature that includes genes predictive for both a PD-1 inhibitor response via CD8 cells as well as the unique pharmacodynamic effect of vopra via CD4 cells. We believe this biomarker could represent a precision medicine approach in IO. We are pleased with how enrollment is progressing and are on track to share data in 2022.

I would like to take a moment to thank our team at Jounce, our investigators and the patients who we have the privilege to treat. Now more than ever, I believe it is imperative that we execute on our mission of delivering long-lasting benefit to cancer patients. Our translational science biomarker approach and commitment to new mechanisms targeting different immune cells brings us closer to achieving this target. We look forward to our continued progress this year and next and to delivering on our important upcoming milestones.

With that, I will now turn the call over to Dmitri to discuss our ongoing discovery efforts. Dmitri? Thanks, Beth. We focus on utilization of our translational science platform to address the problems that patients with cancer are facing today, namely resistance to T cell checkpoint inhibitor therapy. We believe that our ability to dissect the tumor microenvironment at the molecular level using immune cell type specific gene signatures will lead us to targets that may be important for overcoming resistance to checkpoint blockade. JTX-8064 serves as an example of our integrated biomarker approach from discovery to development. This approach is key to the value-generating programs we are pursuing. We are confident that the LILRB family represents attractive immuno-oncology targets with the potential to improve upon and restore responsiveness to PD-1 or L1 inhibitors. As disclosed earlier this year, we are rapidly advancing two additional LILRB family of programs through discovery, one targeting LILRB1 and the other targeting LILRB4. We are on track to nominate our next development candidate within the LILRB family. In addition, we are now leveraging highly specific LILRB targeting building blocks to generate multi-targeted biologics that we are exploring preclinically. To date, our discovery efforts have been very successful and value generating. Our scientists and broader research teams are steadfast in their commitment to bring novel therapies to patients in need. We're very proud of their work, and I look forward to sharing updates on our productive discovery engine in the future. I will now turn the call over to Kim for a discussion of our third quarter financial results. Kim?

Kim Drapkin, CPA -- Chief Financial Officer

Thank you, Dmitri. As we reported in this morning's press release, cash, cash equivalents and investments as of September 30, 2021, increased $249 million compared to $213.2 million as of December 31, 2020. The September 30, 2021, cash balance includes the recognition of a $25 million milestone received from Gilead in the third quarter. Turning to the P&L, no revenue was recognized during the third quarter 2021 or 2020. During the third quarter of 2021, we incurred $23.3 million in research and development expenses compared to $18 million for the same period in 2020. The increase in R&D expenses was due to increased clinical and regulatory expenses for INNATE and SELECT, manufacturing activities performed for our development programs and increased payroll and stock-based compensation expenses.

General and administrative expenses were $6.9 million for the third quarter of 2021 compared to $7.1 million for the same period in 2020. The decrease in G&A expenses was primarily a result of decreased professional fees, offset by increases in other administrative costs. Net loss for the third quarter of 2021 was $30.1 million, resulting in a basic and diluted net loss per share of $0.59 as compared to a net loss of $24.9 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.73. The increase in net loss is attributable to increased operating expenses, and the decrease in the net loss per share is attributable to an increased number of shares outstanding as compared to the same period in 2020. We are narrowing our cash burn guidance and expect gross cash burn on operating expenses and capital expenditures for full year 2021 to be approximately $100 million to $110 million, ending 2021 with approximately $220 million. We expect our existing cash, cash equivalents and investments to be sufficient to enable the funding of our operating expenses and capital expenditure requirements through the third quarter of 2023.

I'll now hand it to Rich for some final words.

Richard Murray, Ph.D. -- Chief Executive Officer and President

Thanks, Kim. The combination of our experienced team, innovative science and financial resources puts us in a strong position to move beyond our next set of inflection points and continue to execute our strategic plans. Jounce continues to focus on patients first, and we're proud of the IO pipeline we're building to address the growing unmet medical need faced by cancer patients. Before closing, I'd like to take a moment to recognize the efforts our team makes every day and congratulate them on our fourth IND and all the advances we've made across our pipeline. Additionally, we're fortunate to have such dedicated collaborators and clinical investigators that are true partners in our mission. We have an exciting upcoming year with important clinical data expected, and we look forward to updating you on our programs.

With that, we'd now like to open the call for your questions. Operator?

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Ted Tenthoff with Piper Sandler.

Ted Tenthoff -- Piper Sandler -- Analyst

Great. Thank you very much and I appreciate the update. So much going on and appreciating INNATE data next year. I wanted to ask my question on SELECT and just get a sense for expectations around timing and sort of what you see as the bogey there and what potential next steps could be for ICOS PD-1 combo? Thanks.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Thanks, Ted. This is Beth. So I'll reiterate, as we've said, we'll have data on SELECT next year, and it will be the final study data, the primary endpoint and all the secondary endpoints of the combo with vopra-pimi and the pimi alone arm. And as you may recall, this study was designed to be a proof of concept, but our intention is that the next study to follow this one will be a registration study if the data supports that. We believe the data that we generate from this study will give us all the information we need to design our randomized Phase III trial for registration.

Ted Tenthoff -- Piper Sandler -- Analyst

And do you see opportunities to -- again, obviously, it's early and it will be data dependent, but to pursue this combination beyond loan?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Yes. Our belief, as with IO agents in general, is the data from one tumor type can be very informative for other tumor types. And we believe that this combination of vopra plus pimi plus the biomarker is something that could be applied broadly across tumor types where PD-1 inhibitors are used, but there's room for improvement with better patient selection and the addition of CD4 T cell targeting agents. Remember the -- in SELECT, we found that about 20% of the patients are TIS vopra positive. And we'll be looking across other tumor types. We have some data on the prevalence in those as well. But I think that's exciting that we're really honing in on the percentage of patients who are most likely to benefit as opposed to some other biomarker selection like PD-L1, which kind of eliminates the bottom 20%. We're really targeting the top 20% of patients who are most likely to benefit from this therapy.

Ted Tenthoff -- Piper Sandler -- Analyst

Yes. And then one other one, tried to take so much time and focus on SELECT and this mechanism for a moment. But is there a potential, too, for a triple combination therapy? I know that's kind of moving the ball further down the field. But as you guys evaluate all the data, and this is even before the SELECT data readout, are there other mechanisms that might make sense to add to this already co-stim and checkpoint inhibitor or stim inhibitor?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Yes, that's a great question, Ted. I think the first part of the answer to that question is the safety of the combination of vopra plus pimi is -- has been -- as we've shown with vopra and nivo in the ICONIC trial and even with vopra and ipi in EMERGE, vopra does not add any toxicity to checkpoint inhibitors. So that certainly opens up the possibility for taking those two drugs together and adding additional drugs. As with everything we do, any new combinations would be very, very science-driven. And the same goes for any additional combinations that we may consider with JTX-8064.

Eric Laub -- Vice President of Investor Relations, Corporate Communications, and Media Relations

Rich?

Richard Murray, Ph.D. -- Chief Executive Officer and President

Yes, I'd just make a quick comment. I think part of that question also is very much the -- all the different cell types in the tumor environment that we think really lead to the logical combination. So PD-1 on the T cells, you know we're going up to the macrophages. And we kind of continue to push that cell type specific biology that we think will lead to the best combinations.

Ted Tenthoff -- Piper Sandler -- Analyst

Thanks a lot. Thanks for all the time.

Operator

Our next question comes from the line of Boris Peaker with Cowen.

Boris Peaker -- Cowen -- Analyst

Great. My first question is on 8064. I'm just curious, did you see a dose response? Or how did you establish the recommended Phase II dose?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Sure. So this is a classic inhibitory monoclonal antibody. And so the recommended Phase II dose or the dose that we're using for continued development is based on receptor occupancy and PK. And so using the data from both of those assays, we're able to determine that at 700 milligrams, which is the dose we're taking forward, patients will have full receptor occupancy through the entire three-week dosing cycle. We actually saw full receptor occupancy and the requisite PK data at 300 milligrams every three weeks, but we really wanted to optimize both the percentage of patients who would have full receptor occupancy given potential inter-patient differences and also optimize the amount of receptor occupancy in the tumors, which may be different from what you see in the peripheral blood. So the choice of the dose was not based on any clinical data other than PK and receptor occupancy and, of course, safety.

Boris Peaker -- Cowen -- Analyst

Got it. Okay. And maybe on the SELECT study, can you remind us again how the TIS vopra biomarker works? And specifically, I'm just thinking how it can be scaled up from the clinical scale to a commercial scale market.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Sure. So it's -- currently, it's an 18-gene RNA signature. It's done on the NanoString platform. But you have asked a very important question and something that we're spending a lot of time and effort on is how to make this something that is scalable for commercial use and also make it easier for patients and physicians. So that's in the works, but the NanoString platform is something that's pretty widespread. And so we believe that it's very feasible to take this forward as a companion diagnostic. Do you want to add anything, Rich?

Richard Murray, Ph.D. -- Chief Executive Officer and President

Yes. I think, Boris, that's all kind of gated accordingly and in pace with the clinical data. So the next -- as we're using it now in the clinic, that kind of next step to really take that forward, coordinated with the next step in clinical would then be moving into that more commercial realm of how to use the biomarker.

Boris Peaker -- Cowen -- Analyst

Great. Thank you for taking my question.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Welcome.

Operator

Our next question comes from the line of Steven Seedhouse with Raymond James.

Steven Seedhouse -- Raymond James -- Analyst

Good morning, thank you. As you guys know, the Phase I data from Merck is out before an inhibitor was recently published, but I know you look closely at that paper. But I just wanted to ask if you could share your thoughts on the data in that paper and what either supports or contradicts any of your expansion cohort choices or your hypotheses regarding the mechanism. Thanks.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Sure. Thanks, Steve. I think in general, the Merck data, as published in the recent paper, is completely supportive of our approach. We believe the kind of biology that they're following in terms of the tumor types that they're exploring and the data that they saw really is very similar, if not identical, to the biology that we're following. And I think we were very pleased to see it published. We're really encouraged by the data that they've shared. We remain super excited about this mechanism. And I think, in particular, their data continues to reinforce that this is a mechanism that may reverse PD-1 inhibitor resistance and be able to increase the number of patients who can benefit beyond those who just respond to PD-1 inhibitors. Dmitri, if you want to say something about the biomarker?

Dmitri Wiederschain, Ph.D. -- Chief Scientific Officer

Yes. Thanks, Beth. I think, as Beth mentioned, Merck publication is largely consistent with our hypothesis around LILRB2. As we disclosed and mentioned during our R&D Day a few months ago, CD163 is a marker of immunosuppressive macrophages, and it is a negative prognostic marker in many cancers. I think that's very consistent with the Merck messaging in their manuscript. And we've also shown that the ratio of LILRB2 specifically to the interferon gamma signature, which is the marker of tumor inflammation, could be a negative predictor of response to PD-1 inhibitors. And again, I think that's very consistent with what Merck has shown. We're looking forward to analyzing biomarker data from INNATE where we have many opportunities to assess potential predictive biomarkers. We'll be looking at them individually as well as in relation to each other and correlating that with clinical efficacy.

Elizabeth Trehu, M.D. -- Chief Medical Officer

And maybe I'll just mention that when we do report the data from the expansion cohorts in INNATE, we will have the potential predictive biomarker and the pharmacodynamic biomarker data included with the clinical data.

Steven Seedhouse -- Raymond James -- Analyst

Great. Thank you.

Operator

Our next question comes from the line of Cory Kasimov with JPMorgan.

Tiffany Sun -- JPMorgan -- Analyst

Hi. Thanks for the questions. This is Tiffany on for Cory. Just one on INNATE. How has trial enrollment gone across your eight expansion cohorts? Are certain cohorts enrolling faster than others or pretty similar across the board?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Thanks for the question. Yes, we're very pleased with enrollment. We expected each cohort to have different enrollment rates based on the prevalence of the tumor type, and we built all of those assumptions into our site selection and our program time lines. So as of now, things are going well.

Tiffany Sun -- JPMorgan -- Analyst

Thanks.

Operator

Our next question comes from the line of Colleen Kusy with Baird.

Colleen Kusy -- Baird -- Analyst

Great. Thank you so much for taking my questions. On the dose for the INNATE study, I think you previously said you would be exploring potentially a higher dose of 8064. Any update on that? And what -- why you might be looking at a higher dose beyond 700 mgs?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Thanks, Colleen. Yes, in our dose escalation, we went up to 1,200 milligrams every three weeks, and we've completed that. We've completed dose escalation for both monotherapy and combination. 1,200 was the highest dose we planned to test. We've completed that. It was safe. So the purpose of doing that is really just to give us that information about the safety profile of the drug at a higher dose than the one we've chosen to take forward. But at this time, we're very happy with 700 milligrams. That's the dose that we're taking forward in the expansion cohorts.

Colleen Kusy -- Baird -- Analyst

Got it. That's helpful. Thank you. And then still on the dose for the INNATE study. Remind us what the dose is for pimi that you're using and how that compares to the dose you're using in the SELECT study?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Sure. The dose of pimi is 500 milligrams every three weeks, which was the -- we had two different recommended Phase II doses for pimi, either 500 every three weeks or 1,000 every six weeks. And since JTX-8064 is given every three weeks, we're using the 500-milligram dose.

Colleen Kusy -- Baird -- Analyst

Got it. Thank you. And then last question. For the INNATE update next year, would that -- do you expect that, that would include both dose escalation and early dose expansion data?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Correct. Correct. Our goal is to really have a presentation of this meaningful data as possible. And so that would include the dose escalation data, also preliminary data from the expansion cohorts with at least 18 weeks of data on patients and all of the predictive and pharmacodynamic biomarker data.

Colleen Kusy -- Baird -- Analyst

Great. Thanks for taking the questions.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Welcome.

Operator

[Operator Instructions] Our next question comes from the line of Zegbeh Jallah with ROTH Capital Partners.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Hi. Thanks for taking my questions. I just have two quick ones. The first one is just about the combo owns in the INNATE study. Just wanted to get a sense of the competitiveness of those different arms. And I think the key one that we've been getting questions about is about your PD-1 inhibitor. And I know you've gone through the data on this, but a lot of folks are still curious about the efficacy and safety. So can you just comment on that and how you're thinking about it? Is it competitive than relative to other PD-1s?

Elizabeth Trehu, M.D. -- Chief Medical Officer

So pimi was originally studied in a Phase I dose-escalation trial. We had no dose-limiting toxicities that doses was quite safe, very similar to other PD-1 inhibitors. And importantly, we had a 17% response rate in all-comers tumors that, by definition, could not have approved PD-1 inhibitors because the patients had to be PD-1 inhibitor naive and had to have failed all available therapies. So we were very pleased with both the efficacy and safety of pimi. And as you know, we're using it in the SELECT trial and INNATE trial. And we're very pleased that we're able to use pimi in every one of the expansion cohorts, including frontline head and neck cancer. So it's a big advantage for us to be able to use our own PD-1 inhibitor and both from a cost perspective and flexibility perspective for doing the clinical trial, but it also gives us the potential to actually get two Jounce wholly owned drugs approved at the end.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

And then just the last one here. It's just about SELECT. For our model, you still view it as a call option, but there's still a lot of good signs backing this. And as you mentioned, the biomarker strategy is novel and very exciting. And so for folks that are interested in understanding a bit more about the outlook of this program, can you just comment a little bit on what you're thinking about in terms of the uniqueness of this approach? And if there's anything else that you've seen more recently or that you've done internally more recently to give you a stronger conviction around this program and the data readout.

Richard Murray, Ph.D. -- Chief Executive Officer and President

Yes. I can take that one, Zegbeh. I think the most important thing in describing the biomarker that we're applying, TIS vopra, is that we're learning from clinical data. And so for us, being able to kind of follow and show retrospectively that we can pick up this biomarker, this cutoff point and where clinical benefit was observed, we can kind of identify those patients from the retrospective analysis. So I think that's kind of really the driver for us. It's really following the science, following the clinical data that puts us in a position to really bring that right immunotherapy to the right patients. So for us, it's an example of one of the most and one of the more stringent biomarker selections. We're currently in immunotherapy to date, that really hasn't been the case. There's been cases of removing a small percentage of patients, but a really rigorous selection, we think, is -- follows the lines of the logic of a precision medicine approach in oncology. So that's the path we're taking. It's driven by the science and our clinical data.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thanks, Rich. And sorry, just a quick follow-up. I think key to this would be the threshold has been set. And so I was just wondering if you can just comment again on your conviction around whether or not you did select the right threshold for your biomarker.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Yes. From all the data that, as Rich was talking about, that we generated, retrospectively, this biomarker seemed to have the best sensitivity -- sorry, this threshold seems to have the best sensitivity and specificity. And also from a practical point, finding 20% of patients is a lot better than finding 4% of patients that could be really challenging. So we've been extremely pleased that the screening data from the SELECT trial has continued to really be spot on with 20% of patients being TIS vopra positive, which we think is really -- it gives us that really finding the top group of patients most likely to benefit, but in a way that's actually clinically manageable. Doctors and patients are willing to do the screening, knowing they have a one-in-five chance of being eligible based on the biomarker. So it's worked out very well.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thanks, Beth, really appreciate it. And I think folks -- or congrats, you know that you guys are erred on the side of caution in terms of picking patients most likely to respond as opposed to trying to get a bigger part of the market.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Yes.

Operator

Our last question comes from the line of Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth -- H.C. Wainwright -- Analyst

Thank you. Good morning, Rich and Beth. Most of my questions have been asked, but just want to try to understand how the data releases are going to work in 2022, especially in the combination cohorts, the expansion cohorts that you recently initiated. Among -- with eight different studies going on in seven different indications, would you be releasing data cohort-wise? Or would you want to wait until all of these cohorts -- the data from all the cohorts are available to release?

Elizabeth Trehu, M.D. -- Chief Medical Officer

Yes. Our goal is to present, as I said, a meaningful body of data, and we think that means data across multiple cohorts. So that's what you can expect. It will be data across multiple cohorts and, yes, along with biomarker data.

Swayampakula Ramakanth -- H.C. Wainwright -- Analyst

Fantastic. You're looking at ovarian cancer both as a monotherapy and a combination therapy. I'm just trying to understand, let's say, if the data is good on both fronts, how could you rationalize which way to go? Are you planning to do a late-stage study in -- as both monotherapy and combination therapy? I'm just trying to figure out how you will sequence these things.

Elizabeth Trehu, M.D. -- Chief Medical Officer

Sure. That's a good question. It was important for us to have a cohort of monotherapy. Eventually, we expect this. As with all immunotherapy, it's most likely to be used in combination. The monotherapy is helpful for proof of concept. But also because if there is sufficient data there that could support a registration, that's always the fastest path to market. So we'll look at the data, and we'll do the development in a way that gets us the earliest possible approval for JTX-8064, but also serves the greatest number of patients. So that will -- it will really be determined as we look at the data.

Swayampakula Ramakanth -- H.C. Wainwright -- Analyst

Thank you. Thank you Beth, Thank you, Rich. Talk to you soon.

Operator

[Operator closing remarks]

Duration: 45 minutes

Call participants:

Eric Laub -- Vice President of Investor Relations, Corporate Communications, and Media Relations

Richard Murray, Ph.D. -- Chief Executive Officer and President

Elizabeth Trehu, M.D. -- Chief Medical Officer

Kim Drapkin, CPA -- Chief Financial Officer

Dmitri Wiederschain, Ph.D. -- Chief Scientific Officer

Ted Tenthoff -- Piper Sandler -- Analyst

Boris Peaker -- Cowen -- Analyst

Steven Seedhouse -- Raymond James -- Analyst

Tiffany Sun -- JPMorgan -- Analyst

Colleen Kusy -- Baird -- Analyst

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Swayampakula Ramakanth -- H.C. Wainwright -- Analyst

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