Jounce Therapeutics, Inc.
Q2 2020 Earnings Call Transcript

Published: 7 Aug 2020

[Operator:]

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Second Quarter 2020 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded at the company's request. I'll now turn the call over to your host, Komal Joshi, with Jounce Therapeutics. Please go ahead.

[Komal Joshi:]

Thank you, Operator. Good morning, and welcome to the Jounce Therapeutics second quarter 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. Rich Murray, who will discuss our progress and key milestones; followed by our CMO, Dr. Beth Trehu, who will provide an update on our clinical activities; lastly, our CFO, Kim Drapkin, will review our second 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 purposes of the Safe Harbor provisions under the Private Securities Litigation 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 represent our views only as of today, August 7, 2020, and should not be relied upon as representing our views as 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 will now turn the call over to Rich.

[Rich Murray:]

Thanks, Komal, and good morning, everyone. We continue to build a leading immunooncology company and are pleased by the progress we've made over the last quarter, both clinically and pre-clinically. I'm excited to share that in 2021, we expect to have four wholly-owned Jounce programs in the clinic, while also maintaining our discovery efforts of first-in-class biomarker driven programs. Before I talk about our pipeline, I want to touch on how we think about the immunotherapy landscape and the need for novel approaches. Over the last decade, the approved Checkpoint inhibitors have resulted in game changing treatment advances in oncology. Despite this progress, we still lack a durable solution to treat the majority of patients, including those who fail their first IO therapy, and those who progress on or after an initial response to PD-1 inhibitors. We believe this represents a very critical distinction between patient populations. Our pipeline and translational science approach are tailored to both of these important patient populations by focusing on two main concepts. First, our novel programs target mechanisms across different immune cell types, not just the CDA positive T cells. Second, the same technology is used in a coordinated biomarker effort for each program, which includes both pharmacodynamic as well as predictive biomarkers. Our growing pipeline covers crucial biological aspects of cancer immunology, including novel development programs targeting ICOS and CD4 T cell biology, LILRB2 also known as ILT4 and suppressive macrophage biology, CCR8 and suppressive T regulatory cell biology in addition to our own PD-1 inhibitor. Our sustainable discovery effort is aimed at reversing the effects of tumor microenvironment cell types that are implicated in suppressing the immune response, within the evolving patient population exposed or not exposed to IO therapies. It is important to note that our current pipeline would not be possible without the incredible work of my dedicated colleagues at Jounce. Even through the current challenges of the COVID-19 pandemic, the Jounce team has not lost sight of our important work, focusing on bringing long-lasting benefits to patients. As a result of this commitment, I'm pleased to announce that in July, we completed enrollment for the interim analysis of the EMERGE Phase 2 trial. We remain on track to complete the interim analysis of efficacy and critical biomarker data on more than 40 patients in early 2021. We also remain on track to initiate SELECT, our Phase 2 predictive biomarker trial with vopra and JTX-4014 in 2020. In building an integrated pipeline, this is an example of a wholly-owned combination trial employing a biomarker approach to patient selection. We're also announcing today that we expect to begin enrollment in our Phase 1 dose escalation study of JTX-8064 in 2020. Suppressive macrophage biology has become an intense area of interest in IO. And we believe that LILRB2 or ILT4, the target of JTX-8064 and our lead macrophage program may be relevant in both IO naive as well as IO failure patients. JTX-8064 inhibits the binding of LILRB2 to HLA molecules, importantly, including HLA-G. This is conceptually similar to the checkpoint inhibition of PD-L1 binding to PD-1 on T cells. Thus we believe that LILRB2 may function as an immune checkpoint for macrophages. Supporting preclinical data on JTX-8064 was presented at the 2019 AACR Annual Meeting. Given this exciting biology, we look forward to advancing this program into the clinic this year. Closely behind JTX-8064 is the most recent addition to our development-stage assets, JTX-1811. As a reminder, JTX-1811 is our first novel program directed at T regulatory cells. The antibody is designed to selectively deplete immunosuppressive tumor infiltrating T regulatory cells. The target of JTX-1811 CCR8 is a chemokine receptor enriched on the T regulatory cells in the tumor. By selectively eliminating tumor infiltrating T regulatory cells, we believe, we can remove the suppressive barriers brought on by these cells. Importantly, our preclinical data shown at the June AACR Meeting establishes that this biology is independent of PD-1 and can restore PD-1 inhibitor activity in resistance setting. With that, in 2021, we expect to have four wholly-owned Jounce programs in clinical trials. Shifting now to our discovery engine, let me remind you that we believe IO is not defined by one single point of therapeutic intervention in the immune system. Rather, understanding the importance of the coordinated interaction of all immune cells, and tumor microenvironment cell types will reveal multiple points of potential therapeutic intervention. These may vary from patient to patient, highlighting the importance of biomarker directed studies. To this end, we continue to focus our discovery efforts for different immune cell types and mechanisms at a biomarker driven fashion as Beth will highlight in a moment. Given the growing emergence of PD-1 inhibitor failure patient populations, we've now established efforts on PD-1 inhibitor susceptible versus resistant mechanisms overlaid on to our specific cell type discovery methods. These are all active targeted areas for our discovery engine and we expect to see more novel programs like JTX-8064 and JTX-1811 emerge from our efforts, with the goal of naming a new development candidate every 12 to 18 months. I'll now turn the call over to Beth to discuss our clinical activities in more detail.

[Beth Trehu:]

Thanks, Rich, and good morning, everyone. I am very excited about our progress at Jounce this quarter, and look forward to the milestones to come. First and foremost, we remain on track with both EMERGE and SELECT and we continue to make significant progress on our earlier development programs JTX-8064 and JTX-1811. As a reminder with the EMERGE development path, we focus on the induction of ICOS hi CD4 T cells prior to administration of vopra because our data indicates that vopra needs T cells to be present to work. Based on this biology, we initiated the Phase 2 EMERGE trial of vopra in combination with ipilimumab in June 2019. The EMERGE trial enrolls second and third line non-small cell lung cancer patients who have progressed on both a PD-1 inhibitor and platinum-based therapy, either in combination or sequentially. For these patients, the default standard of care is docetaxel, which I'll address in a moment. As Rich mentioned, I'm very proud of the work our clinical and supporting teams continue to do. We've completed enrollment for the EMERGE interim analysis despite the ongoing challenges of COVID-19 pandemic. This is a testament to the strength of our clinical team and to our investigators belief in the potential of vopra for patients with little to no other treatment options left. We remain on track to complete the interim analysis of efficacy and biomarker data from EMERGE. The interim analysis is designed to include clinical data through at least 18 weeks on all the valuable patients plus important pharmacodynamics and predictive biomarker data. Data will be analyzed for the study as a whole and at different dose levels, which tests differentiated durations of high cost engagement by vopra. With enrollment now complete, our timeline to the interim analysis remains unchanged, and will include data at over 40 evaluable patients. To help put both the EMERGE and SELECT studies in context, I would like to review the outcomes associated with docetaxel and PD-1 inhibitors in second line non-small cell lung cancer patients, focusing on the nature of the benefits that PD-1 inhibitors bring and the large and growing unmet need in patients who have progressed or have not responded to them. Most docetaxel data are in the PD-1 inhibitor naive setting and as you know in EMERGE patients have progressed on PD-1 inhibitors. In second line PD-1 inhibitor naive, non-small cell lung cancer patients, docetaxel provides response rates of approximately 6% to 14% median overall survival of 6 to 9.6 months and significant toxicity. In second and third line, non-small cell lung cancer patients who are PD-1 experienced like the patients in EMERGE; docetaxel has become standard of care by default, making it the most appropriate benchmark. However, KOL feedbacks suggests that clinical benefit from docetaxel especially overall survival in this population is likely no better and potentially works than in the PD-1 inhibitor naive patients. It is also important to remember that in IO naive patients, single-agent PD-1 and PD-L1 inhibitors without biomarker selection produced modest response rates but were approved based on meaningful improvements in overall survival compared to docetaxel. To-date, the greatest contribution of IO therapy has been the durability of clinical benefits compared to chemotherapy, resulting in improved survival. Since response rates may be less predictive of survival with IO therapy, the criteria defined in the EMERGE protocol for a continuing enrollment past the interim analysis includes response rate, or clinically meaningful treatment effect based on thorough evaluation of other measures of efficacy, including tumor target lesion reduction, disease control rate, and duration of response. Data from many IO trials suggest these endpoints may be better predictors of overall survival than response rate. In order to expand EMERGE beyond the interim analysis; these would need to get accompanied by a favorable safety profile in a well-defined patient population. The duration of follow-up goes into our interim analysis will allow us to share data from EMERGE on these critical measures of efficacy for immunotherapies. We also plan to have a coordinated set of data for the whole study and by dose level on pharmacodynamics and potential predictive biomarkers. The former to investigate the ICOS induction hypothesis and its correlation with clinical benefits; and the latter for the potential of future selection of patients more likely to respond. At the June AACR Virtual Annual Meeting, we presented additional translational data on vopra. The ICOS hi phenotype is induced in an antigen specific manner through the stimulation of the T cell receptor, and the ICOS hi CD4 T cell population in the peripheral blood of iconic responders is comprised of Th1, T central memory, anti-follicular helper subsets. We believe that the generation of these functionally specialized subsets of CD4 T cells, which do not occur with CD4 inhibitors may contribute to a more comprehensive immune response, and that the T central memory cells support a role for vopra in durable clinical benefit. Now, I would like to turn to SELECT, our biomarker selection trial of vopra and that we believe is a move towards precision medicine in IO. The trial will employ the predictive biomarker to vopra and our goal is to select the patients more likely to generate ICOS hi CD4 T cells on vopra treatment and the durable clinical benefit. Because TIS was initially developed as a potential predictive biomarker for PD-1 inhibitors, we expect results with JTX-4014 and the TISvopra biomarker to be better than those for PD-1 inhibitors without biomarker selection. Because TISvopra has been designed to optimize the prediction of ICOS hi CD4 T cell emergence in patients treated with vopra and PD-1 inhibitor, we expect the combination to be potentially better than JTX-4014 alone at these selected patients. So the trial is powered to demonstrate the superiority of vopra plus JTX-4014 to JTX-4014 alone. We believe that using a pharmacodynamic biomarker to distinguish the effect of vopra from the combination PD-1 inhibitor, and then selecting a predictive biomarker, that is directly linked to the vopra pharmacodynamic effect is the right approach to finding the right immunotherapy for the right patients. We expect to enroll approximately 75 immunotherapy naive second line non-small cell lung cancer patients who will be selected using the predictive TISvopra biomarker and randomized to vopra plus JTX-4014 versus JTX-4014 alone. We estimate that approximately 20% of second line non-small cell lung cancer patients will be above TISvopra threshold and potentially eligible for the trial. We remain on track to initiate the SELECT trial in 2020 and we expect to report SELECT clinical data in 2021. We continue to believe that developing JTX-4014 was an important strategic decision for Jounce. The Phase 1 trial of JTX-4014 is ongoing as one complete and one partial responder continue to do well on over a year of treatment. In addition to our SELECT trial, we plan to include JTX-4014 in the upcoming JTX-8064 trial to evaluate the benefits of this combination with a PD-1 inhibitor. Our clinical team is well-positioned to execute across the vopra and JTX-4014 trials and the new Phase 1 trials for JTX-8064 and JTX-1811. As we look to 2021, we will have four Jounce candidates in multiple clinical trials in the U.S. and outside the U.S. With JTX-8064 and JTX-1811 preclinical development underway, coupled with the translation of our key learnings from ICONIC into EMERGE and SELECT, we're taking important steps forward as we continue our commitment to developing novel IO programs for patients who are not sufficiently benefiting from today's therapy. Now I would like to turn the call over to Kim.

[Kim Drapkin:]

Thanks, Beth, and good morning everyone. As we reported in this morning’s press release cash, cash equivalents and investments as of June 30, 2020, totaled $127.2 million compared to $170.4 million as of December 31, 2019. The decrease was primarily due to operating costs incurred during the period. Turning to the P&L. During the second quarter of 2020, we incurred $21 million in research and development expenses compared to $18.1 million for the same period in 2019. The increase in R&D expenses was due to external clinical and regulatory costs associated with the EMERGE and SELECT clinical trials and increased employee compensation costs partially offset by lower IND enabling expenses. General and administrative expenses were $7.2 million for the second quarter of 2020 compared to $7.3 million for the same period in 2019. The slight decrease in G&A expenses is primarily the result of lower professional service fees. Net loss for the second quarter of 2020 was $28 million, or a net loss per basic and diluted share of $0.82, as compared to a net loss of $7 million for the same period in 2019 or a net loss per basic and diluted share of $0.21. The increase in net loss was primarily attributable to no license and collaboration revenue in the second quarter 2020 and an increase in operating expenses. We continue to expect gross cash burn on operating expenses and capital expenditures for the full-year 2020 to be approximately $80 million to $95 million. We're reiterating our previous guidance and 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 end of 2021. In closing, we believe the scientific progress that stems from our translational science platform, leading to our wholly-owned innovative immunotherapy pipeline gives us the flexibility to efficiently execute against our strategic plans and goals of four Jounce programs in the clinic in 2021. I will now turn the call back to Rich for final remarks.

[Rich Murray:]

Thanks, Kim. In conclusion, staying true to our core mission of providing benefits to patients with unmet medical needs, Jounce is poised for a robust 2020 and 2021, with critical upcoming milestones. Across our pipeline, we plan to initiate the SELECT Phase 2 trial of vopra and JTX-4014 using our TISvopra biomarker in 2020; initiate the Phase 1 trial of JTX-8064 in 2020; complete the interim analysis of efficacy and biomarker data of EMERGE in early 2021; continue IND enabling activities for JTX-1811 with an expected IND filing in the first half of 2021; and continue to work on advancing multiple new targets from our discovery pipeline. With that, we'd like to now open the call for your questions. Operator?

[Operator:]

[Operator Instructions]. Our first question or comment comes from the line of Debjit Chattopadhyay from H.C. Wainwright. Your line is open.

[Debjit Chattopadhyay:]

Hey, good morning and thank you for taking the questions and I apologize if I missed your comments, I'm on three other calls simultaneously. Just on the SELECT program, could you just walk us through the rationale again, especially the lessons from the ICONIC program in terms of the ability to induce ICOS, the kinetics of the emergence, and the dose of vopra that you plan to use? And also, in terms of the patient enrollment, would you primarily focus on PD-1 low or PD-1 1 to 49 or PD-1 greater than 50%? And where do you expect to see the most benefits? Thank you.

[Beth Trehu:]

Okay. So the SELECT trial is exploring our hypothesis that by well, it's really based on the fact that we know vopra needs ICOS hi CD4 T cells are activated or prime CD4 T cells to work. And so in the ICONIC study, we found those ICOS hi cells in the peripheral blood of the patients who had the best clinical outcome. We then used that to go back to baseline tumor biopsies and identify a gene signature called TISvopra in those baseline tumor biopsies that actually predicted very well for the patients who had the emergence of the ICOS hi CD4 T cells. So basically using our pharmacodynamic biomarker, the ICOS hi CD4 T cells to find a predictive biomarker for those ICOS hi CD4 cells. We then applied that biomarker retrospectively to the clinical data and found that it also predicted for clinical benefit. So we're using TISvopra in this SELECT trial to only treat patients who are above the TISvopra threshold. So that means those patients we believe are more likely to be able to generate ICOS hi CD4 cells because presumably they have activated CD4 T cells in their tumors and so they should be able to respond to vopra. It's a randomized trial of vopra plus JTX-4014, our PD-1 inhibitor, against 4014 alone and because TIS was originally developed as a potential predictive biomarker for PD-1 inhibitors, we expect the outcomes with 4014 to be better than unselected patients with PD-1 inhibitors. So there, is as you pointed out, Debjit, there is data in the second line non-small cell lung cancer settings that we're studying. Remember, these are PD-1 naïve. There is data on unselected patients and also with PD-L1 scores of greater than or equal to one or greater than or equal to 50 for nevo and pembro. And so we'll have a good kind of historic benchmark to see how JTX-4014 with the TISvopra biomarker selection compares to those. We are not prospectively selecting any PD-L1 population, because our data suggests that there's not direct overlap. There may be some overlap, but there's not complete overlap between TISvopra and PD-L1. In fact, in ICONIC, PD-L1 IHC was not at all predictive for ICOS hi CD4 T cells, whereas TISvopra was highly predictive for that. So we will look retrospectively, we'll be collecting the data to look at the PD-L1 scores, but we are not doing any selection prospectively because we believe TISvopra is a better predictive biomarker for what we're looking for. So the trial is powered to demonstrate the superiority of vopra plus 4014 versus 4014 alone. I'll ask Rich to make some additional comments.

[Rich Murray:]

Yes, thanks. And yes, Debjit, thanks for the question. Just to kind of reiterate a bit on Beth's comment, what we expect since TIS itself was developed for PD-1 inhibitors, we expect selection of patients more likely to respond just in the JTX-4014 arm. But since the TIS threshold is really tuned and optimized for also predicting for patients, who are more likely to generate the ICOS hi cells as property of vopra, we expect an even better opportunity to see benefit in the combo. So that's really kind of the -- kind of stacking, if you will of selection of patients, we expect the increase in PD-1 alone and on JTX-4014 and more so in the combo, and that concept benefits nicely with a randomized trial.

[Beth Trehu:]

Yes, and then in the population, we expect about 20% of that lung cancer patients to be above the threshold and eligible for the trial. I think did that answer all of the parts of your question?

[Debjit Chattopadhyay:]

Yes, it did. Thanks very much. And just in terms of timelines, your Data Analysis is going to be based on 75 patients and you said 20% are likely to get -- are likely to have the emergence of the TIS signature. So how long do you think it's going to take to enroll the study? And if you are planning on updating the data in 2021, rationally, how many patients do you think we should expect? I know it's early days, and you haven't released other enrolling?

[Beth Trehu:]

Sure. So we don't intend to analyze the data until the study has completed enrollment. We have a target enrollment of 75 patients and we have selected enough sites, we believe, to be able to enroll that in time to have data by the end of 2021. But when we report data, it will be on the entire study.

[Operator:]

Thank you. Our next question or comment comes from the line of Mike Ulz from Baird. Your line is open.

[Colleen Hanley:]

Hi, this is Colleen Hanley on for Mike. Thanks for taking our questions and congrats on the progress this quarter. I guess, just with the upcoming EMERGE data early 2021, do you have any updated thoughts on if you have a preference for a medical meeting? Or rather that would be more of a top-line result. And then I know you said at least 18 weeks, do you have kind of an idea of what the range might be a follow-up? And then for the biomarker data, would that include the TISvopra?

[Beth Trehu:]

Sure, so great questions, Colleen. Thank you. I know, that's the burning question on everyone's mind. So we just finished enrollment and we're starting to work on getting the data in and planning for the interim analysis. So basically the range will be that the last patient in will wait until their second scan at 18 weeks is done. Now, the studies started enrolling in June of last year. So the range can be up to a year or more of data. So it will be -- it's really the interim analysis triggered on that last patient getting their 18 week scan. And the interim analysis will include the ICOS hi CD4 cells, target engagement, TISvopra, all the biomarkers that are really built into the study, so that we really have a comprehensive data package. And so we will provide more clarity around where and how we'll release the data as we get closer to the interim analysis. But for now, we're still on track to do that in the beginning of next year.

[Operator:]

Thank you. Our next question or comment comes from the line of Jim Birchenough from Wells Fargo Securities. Your line is open.

[Nick Abbott:]

Good morning. It's Nick on for Jim this morning. Just to go back to SELECT and notwithstanding the fact you almost answered a question for Debjit. So if I looked at EMERGE, it took about a year to enroll 40 patients, and then we could await in approximately six months data to -- further data to mature. So can you just walk us through the immediate screening patients prior to enrolling them? And then you're trying to enroll almost twice as many patients I mean how confident are you can do all of this in such compressed timeline?

[Beth Trehu:]

Sure. So when we think about clinical trial enrollments, we always look at metrics in terms of patients per site per month, and that's how we decide how many sites to include in the trial. So we pick the number of sites that we think we need to be able to enroll in the timeframe that we've set for ourselves. So there are a lot of unknowns. You're absolutely right. We'll have to see what the screen failure rate is. But as of now, we and our CRO feel very confident in our timelines.

[Nick Abbott:]

Okay. And then just going back to EMERGE, a couple of questions there -- is there and I apologize, I'm missing the point here. But is there a balance between PD-L1 high tumors and PD-L1 negative tumors? And also one of the challenges in ICONIC, a real big challenge in ICONIC obviously was very rapid patient drop-off, are you able to comment on if that's not being observed in this trial?

[Beth Trehu:]

So in terms of the PD-L1 scores again, we don't perspectively have any restrictions on PD-L1 scores. We certainly will do analysis of efficacy based on baseline PD-L1 scores. But remember, these are all patients who have failed a PD-1 inhibitor. So and what we're looking at is there are archival tumors. So I don't know how informative that will be, but we certainly will look at it. And then your second question. Sorry, I just forgot what your second question was?

[Nick Abbott:]

Beth, second one Beth was, the big problem in ICONIC was early drop-off?

[Beth Trehu:]

The early drop-off, yes.

[Nick Abbott:]

Yes. And so can you make any comment about whether that that you're not seeing that? I guess and EMERGE would be comforting to that?

[Beth Trehu:]

Right. So we don't usually make any comments on enrollments or dropouts or anything like that. It is a second line non-small cell lung cancer patients. But they are PD-1 inhibitor failures. So we obviously will be -- will report that when we finally report the data.

[Operator:]

Thank you. Our next question or comment comes from the line of Cory Kasimov from J.P. Morgan. Your line is open.

[Gavin Weiss:]

Hi, good morning. This is Gavin on for Cory. I just had a clarifying question on the SELECT study. I think you made a comment that 20% of the second line lung cancer patients will be above the TISvopra threshold. Can you just clarify that that's correct? And is this 20% of all second line patients? Or is there -- is it 20% of subgroups within that patient group? Thank you.

[Beth Trehu:]

Sure. No, that that data comes from just analysis of TIS data across multiple different sources. And our expectation is about 20% of the second line non-small cell lung cancer in general, would be above that threshold. So, again, there have been drugs approved that have been very successful in lung cancer that apply to 3%, 4%, 7% of the population. And those trials, kind of getting back to Nick's question can be very, very difficult to enroll. Having 20% of the patients potentially eligible is a lot easier. And we've talked a lot with investigators about the feasibility and the attractiveness of a study where one in five patients will be eligible, and they felt that was absolutely reasonable. And we're very excited about this study. I'll ask Rich to make a comment as well.

[Rich Murray:]

Sure, yes, I think Gavin another side of that question is the population itself. So we think about 20% will make it over the threshold. But as we all appreciate PD-1 inhibitors are just continuing to be just firmly established off of frontline therapy. So as more of those patients are treated, more of those patients are failing and needing -- in dire need really of a next line of therapy. As Beth mentioned, we're benchmarking that to docetaxel, kind of sad to say, that's the alternative patients have in this line of therapy. But importantly, as we look at that market, it's a growing market in terms of the number of patients entering into that line of therapy. Beth?

[Beth Trehu:]

Yes, I think that Rich your comments I think are more directed to the EMERGE trial, the PD-1 failures, but --

[Rich Murray:]

I'm sorry, I'm sorry Beth. Yes, yes, I'm sorry.

[Beth Trehu:]

And for SELECT.

[Rich Murray:]

I am going to apologize for that, Gavin. That was a comment Beth was making on SELECT. I extrapolated that to -- to EMERGE, that was my bad.

[Beth Trehu:]

Yes, but it could apply to the SELECT trial as well. And we are going to be retrospectively looking at TISvopra in the EMERGE trial as well. So we'll be getting a lot of information about TISvopra levels in PD-1 experienced as well as the PD-1 inhibitor naive population in SELECT.

[Gavin Weiss:]

Okay, great. And then just one more in terms of the geographic breakdown with the clinical trial site; is there any commentary you can make on, is this more like East Asia or Eastern Europe or just ex-U.S. broadly?

[Beth Trehu:]

Yes, it's ex-U.S. I mean we'll be once it's posted on clinicaltrials.gov people will be able to see all the sites but it's in primarily in Eastern Europe. And what we've found is there's a tremendous desire on the part of patients to get PD-1 inhibitors, but in most cases their only way of getting them is on clinical trials. So I actually feel really good about the fact that we're making an effective therapy available to patients with a need in those places.

[Operator:]

Thank you. Our next question or comment comes from the line of Boris Peaker from Cowen. Your line is open.

[Unidentified Analyst:]

Hi, this is Vidya [ph] on for Boris. Maybe a quick one for me on JTX-8064. Can you talk about more about your development plans for that candidate? And are there particular tumor types you're thinking of exploring? And I hear on the call that you're thinking of a combo of JTX-4014 for that candidate?

[Rich Murray:]

Sure, sure. I'll take that one. Yes, so as we progress any of our programs or channels, we coordinate that with a biomarker plan and biomarker analysis. So there'll be kind of a broad -- there is ongoing and will continue to be a broad evaluation of the selection of tumor types. And that's based on analogies to how we looked at vopra run the ICOS program, looking for predictive as well as pharmacodynamic biomarkers to kind of couple with the program. So that's kind of a fundamental for all of our programs. What we can't say of course, is there are -- there is data available data to be investigated about macrophage signatures that identify suppressive macrophage biology within tumors and of course, that's a great interest to us. So we haven't stated yet exactly what tumors will go into, we will do that. We do know from competitive intelligence point of view, there is some indication of that, there's a Merck program that's in the clinic in Phase 1. That program what we can observe just through available information has been expanded from 70 patients to 270 patients to 290 patients. And so there's information available about how Merck is taking that forward into particular, particular tumor types. And we'll be watching that program very carefully. We'll be having a presentation at ESMO at the end of September. On the PD-1 side of that, the preclinical data that we have generated as well as a publication that came out on this mechanism showed that there is biology that we think could be independent of PD-1 as well as in combination with PD-1. So there's some biology there that we think is important in kind of directing where we go into patient populations. But more specifically, we'll come out with tumor types as we get closer.

[Operator:]

Thank you. [Operator Instructions]. Our next question or comment comes from the line of Steve Seedhouse from Raymond James. Your line is open.

[Steve Seedhouse:]

Great, congrats on completing enrollment of the interim analysis cohort of EMERGE. I was hoping you could just clarify patients in EMERGE are all second line, as I think you mentioned for the interim analysis, or if there are also any third line patients as well. And then also, is this locally advanced and metastatic patients or are they all metastatic? Thanks.

[Beth Trehu:]

Thanks, Steve, very important questions. First of all, they are all metastatic. So these patients all have to have received a platinum-based regimen and a PD-1 inhibitor for metastatic disease. And so some of them will be second line, if they've received platinum regimen plus PD-1 in frontline, but then they could also have received them in sequence. So they could have gotten chemo frontline, PD-1 inhibitor second line, or rare cases PD-1 inhibitor frontline, chemo second line. So they will be a mix of second -- they are a mix of second and third line patients with non-small cell lung cancer all metastatic.

[Steve Seedhouse:]

Okay, helpful. Thanks. And on SELECT, you mentioned the study is designed for superiority of vopra plus PD-1 versus PD-1 alone. I'm wondering if you can share just the particulars on powering there specifically, I guess the effect size that you're powering for vopra and on which endpoint?

[Beth Trehu:]

Sure. So I think once the study starts enrolling, we will start providing a lot more detail about that. I'd rather do that in a sort of a more formal setting than just in a Q&A. But we do plan to explain on how the study is designed and powered and help people think about how to interpret the results once it starts rolling.

[Steve Seedhouse:]

Okay, sounds good. And then just last question on the use of ipilimumab in EMERGE. Can you just generally speak to maybe did everyone in the interim analysis cohort receive the maximum allowed doses of ipi or were there any patients that dialed back dosing?

[Beth Trehu:]

Yes, I can't comment on that right now. I actually don't even know that data. We're just starting to pull the data together.

[Operator:]

Thank you. Our next question is a follow-up from the line of Debjit Chattopadhyay from H.C. Wainwright. Your line is open.

[Debjit Chattopadhyay:]

Hey, thanks for pulling back in. So for the EMERGE study, how would you define success especially in terms of the lower bound of the conference interval and have you totally ruled out a follow into UC due to PASC, but PASC is not really curative. And so I mean, historically, the data would to get a four has been pretty encouraging in UC, so I'm just wondering if you want to revisit that story again?

[Beth Trehu:]

Sure. So the second one I'll take. As you know, we had originally planned to have urothelial cancer in the study. But when in vopratelimab the dosing got approved, it really was directly overlapping. So once we see the results of the interim analysis, we will follow the data. So if it suggests that there might be other tumor types of interest, I wouldn't rule those out. As of now, we're focusing on the interim analysis in the lung cancer patients. So with respect to your question about what success looks like, so what I've defined in today's earning calls for the first time because we know people are really curious about that is the criteria specifically defined in the original EMERGE protocol. So what we've learned from following the IO space and doing lots of analyses on other trials is that response rate in general appears to be less predictive of survival with IO therapy. The PD-1 inhibitors have gotten approved with fairly modest response rates, but really impressive survival. So when we wrote the EMERGE trial, we defined the criteria for continuing enrollments past the interim analysis to include response rate, or clinically meaningful treatment effect based on a thorough evaluation of other measures of efficacy, including the percentage of patients who have target lesion reduction, the disease control rate, which includes stable disease and the duration of response. And that's because data from many IO trials suggests that these endpoints may actually be better predictors of overall survival than response rates. And since our ultimate goal is a registration trial to demonstrate improve overall survival, that's really important to us as we look at our earlier proof-of-concept trial. So we need to try to figure out, what's the best way to predict a survival benefit in Phase 3. And so those are the things we'll be looking at in addition to response rate. And then in addition, in order to expand, we also obviously need to see a favorable safety profile and a well-defined patient population. So that I think, that sort of helps, I hope you understand the context in which we're looking at the data. And the fact that we're waiting for at least 18 weeks on the last patient enrolled, really underscores that right because those really what we think are critical measures of efficacy for immunotherapy include duration of follow-up. So that's one of the reasons that there's, we need time to let the drugs and their effects play out, so that we can really do the best analysis of the results.

[Debjit Chattopadhyay:]

Just to follow-up on maybe for Kim, given where your cash position is currently and where the stock is trading, how important does your BD efforts become right now for the macrophage program or your anti-PD-1 which has some pretty interesting monotherapy data?

[Kim Drapkin:]

Thanks, Debjit. So obviously, we always try to maintain a strong balance sheet. And one of the things that I think gives us complete flexibility in how we address keeping the strength of our balance sheet is our wholly-owned pipeline. So we're always looking opportunistically at BD opportunities, as you said, we believe, we have very exciting assets and we'll balance when the right time to partner is versus maintaining and keeping some programs to ourselves. But we'll certainly be looking forward towards raising money one way or the other to continue to bolster our balance sheet. But as I said, I feel like we have a lot of flexibility between BD as well as the markets are continuing to be strong even in despite COVID.

[Rich Murray:]

Yes, I think, Debjit, also just to jump in on that, I think having the entirety of our pipeline owned and as we look into 2021, having four clinical stage assets, we think that really gives us a lot of flexibility on that front.

[Operator:]

Thank you. I'm showing no additional questions in the queue at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may now disconnect. Have a wonderful day.