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Jounce Therapeutics, Inc. (JNCE)
Q2Â 2020 Earnings Call
Aug 7, 2020, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics' Second Quarter 2020 Earnings Conference Call. [Operator Instructions]
I will now turn the call over to your host, Komal Joshi with Jounce Therapeutics. Please go ahead.
Komal Joshi -- Head of Investor Relations and Strategic Finance
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 in 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.
Richard Murray -- Chief Executive Officer and President
Thanks, Komal, and good morning, everyone. We continue to build a leading immuno-oncology company and are pleased by the progress we've made over the last quarter, both clinically and preclinically. 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 effort 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 improved 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 there 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 CD8 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 benefit to patients. As a result of this commitment, I am 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 the biomarker approach to patient selection. We are 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 its 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 resistant settings. 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 toward different immune cell types and mechanisms in a biomarker driven fashion as Beth will highlight in a moment.
Given the growing emergence of PD-1 inhibitor failure patient population, we've now established efforts on PD-1 inhibitor susceptible versus resistant mechanisms overlaid onto 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.
Elizabeth Trehu -- Chief Medical Officer
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, for 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 these 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 the PD-1 inhibitor and platinum-based therapy, either in combination or sequentially. For these patients, the default standard of care is it 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 completed enrollment for the EMERGE interim analysis despite the ongoing challenges of the 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 evaluable patients plus important pharmacodynamic and predictive biomarker data. Data will be analyzed for the study as a whole and at different dose levels, which test differentiated durations of ICOS engagement by vopra.
With enrollment now complete, our timeline to the interim analysis remains unchanged and will include data on 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 benefit 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 the 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 six 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 feedback suggests that clinical benefit from docetaxel, especially overall survival in this population is likely no better and potentially worse than 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 benefit compared to chemotherapy, resulting in improved survival. Since response rate may be less predictive of survival with IO therapy, the criteria defined in the EMERGE protocol for continuing enrollment past the interim analysis include 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 that these end points may be better predictors of overall survival than response rate. In order to expand EMERGE beyond the interim analysis, these would need to be accompanied by a favorable safety profile in a well-defined patient population. The duration of follow-up built 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 pharmacodynamic and potential predictive biomarkers. The former to investigate the ICOS induction hypothesis and its correlation with clinical benefit 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 and T follicular helper subsets. We believe that the generation of these functionally specialized subset of CD4 T cells, which do not occur with PD-1 inhibitors, may contribute to a more comprehensive immune response and that the T central memory cells support a role for vopra in durable clinical benefits.
Now, I would like to turn to SELECT, our biomarker selection trial of vopra and what we believe is a move toward precision medicine in IO. The trial will employ the predictive biomarker, TISvopra and our goal is to select the patients more likely to generate ICOS hi CD4 T cells on vopra treatment and achieve 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 the PD-1 inhibitor, we expect the combination to be potentially better than JTX-4014 alone in 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 a right approach to finding the right immunotherapy for the right patient. 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 still 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 continued 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 benefit of this combination with the 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 under way, coupled with the translation of our key learnings from ICONIC into EMERGE and SELECT, we are taking important steps forward as we continue our commitment to developing novel IO programs for patients who are not sufficiently benefiting from today's therapies.
Now, I would like to turn the call over to Kim.
Kim Drapkin -- Chief Financial Officer
Thanks, Beth, and good morning, everyone. As we recorded 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. This -- the decrease was primarily due to operating cost 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 cost associated with the EMERGE and SELECT clinical trial and increased employee compensation cost, 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 are 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 requirement 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.
Richard Murray -- Chief Executive Officer and President
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?
Questions and Answers:
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 -- H.C. Wainwright & Co. -- Analyst
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. The -- 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 benefit? Thank you.
Elizabeth Trehu -- Chief Medical Officer
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 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 outcomes. We then use 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 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's 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 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 setting that we're studying. Remember, these are PD-1-naive, there is data on unselected patients and also with PD-L1 scores of greater than or equal to 1 or greater than or equal to 50 for nivo 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 for any PD-L1 population, because our data suggests that there is not direct overlap. There may be some overlap, but there is 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.
Richard Murray -- Chief Executive Officer and President
Yeah, thanks. And yeah, 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, that's 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 arm JTX-4014 and more so in the combo and that concept then fits nicely with the randomized trial.
Elizabeth Trehu -- Chief Medical Officer
Yeah, and then...
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Got it. Thank you.
Elizabeth Trehu -- Chief Medical Officer
Population. We expect about 20% of that lung cancer patient population to be above the threshold and eligible for the trial. I think, did that answer all of the parts of your question?
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Yeah, 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 really started enrolling.
Elizabeth Trehu -- Chief Medical Officer
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.
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Got it. Thank you so much and good luck.
Elizabeth Trehu -- Chief Medical Officer
Thanks a lot.
Richard Murray -- Chief Executive Officer and President
Thanks.
Operator
Thank you. Our next question or comment comes from the line of Mike Ulz from Baird. Your line is open.
Colleen Hanley -- Robert W. Baird & Co. -- Analyst
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 whether that would be more of a top line result? And then, I know you said that at least 18 weeks, do you have kind of an idea of what the range might be of follow-up? And then, for the biomarker data, would that include the TISvopra?
Elizabeth Trehu -- Chief Medical Officer
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 the -- basically, the range will be -- the last patient in will wait until their second scan at 18 weeks is done. Now, the study 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'll 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.
Colleen Hanley -- Robert W. Baird & Co. -- Analyst
Great. Thank you.
Elizabeth Trehu -- Chief Medical Officer
Thanks.
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 -- Wells Fargo Securities -- Analyst
Good morning. It's Nick on for Jim this morning. Just to go back to SELECT and notwithstanding that sadly you almost answered the question for Debjit, but if I look at -- I don't know if it took about a year to enroll 40 patients and then we're kind of waiting approximately six months for the data to mature. So can you just walk us through -- I mean, you have to screen patients prior to enrolling them and then total enrolled almost twice as many patients and I mean, how confident are you, you can sort of do all of this in such a compressed timeline?
Elizabeth Trehu -- Chief Medical Officer
Sure. So when we think about clinical trial enrollment, 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've picked the number of sites that we think we need to be able to enroll in the time-frame 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 -- Wells Fargo Securities -- Analyst
Okay. And then just going back to EMERGE, a couple of questions there. Is there -- and I apologize, if I am missing the point here but is there a balance between PD-L1 hi tumors and PD-L1 negative tumours? And also one of the challenges with that tug on, real big challenge with ICONIC proxy was very rapid patient drop off. Are you able to comment on if that's not being observed in this trial?
Elizabeth Trehu -- Chief Medical Officer
So in terms of the PD-L1 scores, again we don't prospectively kept any restrictions on PD-L1 scores. We certainly will in -- 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 their 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 -- Wells Fargo Securities -- Analyst
Second question Beth was, the big problem in ICONIC was early drop off.
Elizabeth Trehu -- Chief Medical Officer
The early drop off, yeah.
Nick Abbott -- Wells Fargo Securities -- Analyst
Yeah, and so can you make any comment about whether that -- you not seeing that, I guess in EMERGE would be comforting to know.
Elizabeth Trehu -- Chief Medical Officer
Right, so we don't usually make any comments on enrollment or drop outs 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 -- we'll report that when we finally report the data.
Nick Abbott -- Wells Fargo Securities -- Analyst
Okay, great. Thanks.
Operator
Thank you. Our next question or comment comes from the line of Cory Kasimov from J.P. Morgan. Your line is open.
Gavin Scott -- J.P. Morgan -- Analyst
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 if that's correct and is this 20% of all second line patients or is there -- is it 20% of subgroup within that patient group? Thank you.
Elizabeth Trehu -- Chief Medical Officer
Sure. 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 the study, where one in five patients will be eligible and they felt that was absolutely reasonable and we're very excited about the study. I'll ask Rich to make a comment as well.
Richard Murray -- Chief Executive Officer and President
Sure, yeah I think, Gavin another 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, so just continuing to be just firmly established off of front-line therapy. So as more of those patients are treated, more of those patients who are failing in meeting in -- 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.
Elizabeth Trehu -- Chief Medical Officer
Yeah, I think that's his -- yeah. Rich, your comments, I think are more directed to the EMERGE trial, the PD-1 failures. But...
Richard Murray -- Chief Executive Officer and President
I'm sorry, I'm sorry, Beth. Yeah, yeah, I'm sorry. Yeah, yeah, I apologize for that, Gavin. I -- that was a comment Beth was making on SELECT. I extrapolated that to EMERGE. That was my bad.
Elizabeth Trehu -- Chief Medical Officer
Yeah, the -- 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 Scott -- J.P. Morgan -- Analyst
Okay, great. And then just one more, in terms of the geographic breakdown of 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?
Elizabeth Trehu -- Chief Medical Officer
Yeah, it's ex-U.S., I mean we will 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 found is there is 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 trial. 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.
Gavin Scott -- J.P. Morgan -- Analyst
Great, thank you.
Operator
Thank you. Our next question or comment comes from the line of Boris Peaker from Cowen. Your line is open.
Cynthia Chen -- Cowen & Co. -- Analyst
Hi. This is Cynthia on for Boris. Maybe a quick one from 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 did I hear on the call that you're thinking of a combo of JTX-4014 for that candidate?
Richard Murray -- Chief Executive Officer and President
Sure, sure. I'll take that one. Yeah, so as we progress any of our programs at Jounce, we coordinate that with the 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've looked at vopra and 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 say, of course, is there is data available, data to be investigated about macrophage signatures that identify suppressive macrophage biology within tumors and of course, that's of great interest to us. So we haven't stated yet exactly what tumors we will go into. We will do that. We do know from a competitive intelligence point of view, there is some indication of that. There is 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 is information available about how Merck's taking that forward into particular tumor types. We'll be watching that program very carefully. They'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 the 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 is some biology there that we think is important in kind of directing where we go into patient populations. But more specifically, we will come out with tumor types as we get closer.
Cynthia Chen -- Cowen & Co. -- Analyst
All right, great. Thank you for taking my questions.
Operator
Thank you. [Operator Instructions] Our next question or comment comes from the line of Steve Seedhouse from Raymond James, your line is open.
Steven Seedhouse -- Raymond James -- Analyst
Great. Congrats on completing enrollment of the interim analysis cohort of EMERGE. I was hoping you could just clarify if 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.
Elizabeth Trehu -- Chief Medical Officer
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 the PD-1 inhibitor for metastatic disease. And so some of them will be second line if they have received platinum regimen plus PD-1 in front-line, but then they could also have received them in sequence. So they could have gotten chemo front-line PD-1 inhibitor, second line for rare cases PD-1 inhibitor front-line, chemo second line. So they will be a mix of -- or they are a mix of second and third line patients with non-small cell lung cancer, all metastatic.
Steven Seedhouse -- Raymond James -- Analyst
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 about the powering there specifically, I guess the effect size that you're powering for vopra and on which end points?
Elizabeth Trehu -- Chief Medical Officer
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 the -- how the study is designed and powered and help people think about how to interpret the results once it starts enrolling.
Steven Seedhouse -- Raymond James -- Analyst
Okay, sounds good. And then just last question on the use of Ipilimumab in EMERGE, can you just generally speak maybe, did everyone in the interim analysis cohort receive the maximum allowed doses of Ipi or were there any patients that are down back-dosing?
Elizabeth Trehu -- Chief Medical Officer
Yeah, I can't comment on that right now. I actually don't even know that data analysis. We're just starting to pull the data together.
Steven Seedhouse -- Raymond James -- Analyst
Okay, no problem. Thanks for the questions.
Elizabeth Trehu -- Chief Medical Officer
You're welcome.
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 -- H.C. Wainwright & Co. -- Analyst
Hey, thanks for letting me back in. So for the EMERGE study, how would you define success, especially in terms of the lower bond of the conference interval? And have you totally ruled out a foray into UC due to Padcev, but Padcev is not really curative. And so I mean, historically the data with CTLA-4 has been pretty encouraging in UC. So I'm just wondering if you want to revisit that story again.
Elizabeth Trehu -- Chief Medical Officer
Sure. So the second one, I'll take. As you know, we had originally planned to have urothelial cancer in the study, but when Enfortumab Vedotin 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 suggest 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 have defined in today's earning call 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 analysis 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 enrollment 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 suggest that these endpoints may actually be better predictors of overall survival than response rate.
And since our ultimate goal is a registration trial to demonstrate improved overall survival, that's really important to us as we look at our more 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 are 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 is -- we need time to let the drugs and their effect play out, so that we can really do the best analysis of the results.
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Just to follow-up and maybe for Kim, given where your cash position is currently and where the stock's 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 -- Chief Financial Officer
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 are 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 toward 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.
Richard Murray -- Chief Executive Officer and President
Yeah, and 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.
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Got it. Thank you so much.
Kim Drapkin -- Chief Financial Officer
Thank you.
Operator
[Operator Closing Remarks]
Duration: 49 minutes
Call participants:
Komal Joshi -- Head of Investor Relations and Strategic Finance
Richard Murray -- Chief Executive Officer and President
Elizabeth Trehu -- Chief Medical Officer
Kim Drapkin -- Chief Financial Officer
Debjit Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Colleen Hanley -- Robert W. Baird & Co. -- Analyst
Nick Abbott -- Wells Fargo Securities -- Analyst
Gavin Scott -- J.P. Morgan -- Analyst
Cynthia Chen -- Cowen & Co. -- Analyst
Steven Seedhouse -- Raymond James -- Analyst
