Jounce Therapeutics, inc (JNCE) Q2 2021 Earnings Call Transcript

Image source: The Motley Fool.

Jounce Therapeutics, inc (JNCE)
Q2 2021 Earnings Call
Aug 5, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to Jounce Therapeutics Second Quarter 2021 Earnings Conference Call. [Operator Instructions]

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

Mark Yore -- Director of Corporate Development

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 review our pipeline progress and key milestones; followed by our CMO, Dr. Beth Trehu, who will provide an update on our clinical activities. Our CFO, Dr. Dmitri Wiederschain, will then discuss our discovery efforts.

And 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 once 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 5, 2021, and 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'll now turn the call over to Rich.

Richard Murray -- Chief Executive Officer and President

Thanks, Mark, and good morning, everyone. Jounce had a very productive second quarter as we made important progress across all areas of the company. In parallel with our ongoing pipeline efforts, the IO sector as a whole recently seen exciting new advances for PD-1 or PD-L1 inhibitors and I-O IO combinations. While this is great news for some patients, most of the added benefit primarily occurs in the PD-1 inhibitor naive patient settings. Still sorely lacking are the desired advances for the PD-1 inhibitor resistant patients, a growing and unmet need as more and more patients do not respond to the wide and growing adoption of PD-1 inhibitor therapy as a first IO-based treatment.

We believe that our approach is aimed at innate immune system cells such as macrophages have the potential to address this challenging gap of effective treatment for 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 cell checkpoints alone cannot do. For patients, this might mean a recharge in 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, our LILRB2 or ILT4 inhibitor to be our highest priority program. JTX-8064 aims to convert immunosuppressive macrophages to an antitumor state and can create a bridge between the innate and the T cell arm of the immune system. As a reminder, INNATE, our Phase I clinical trial studying JTX-8064 has moved quickly through the necessary monotherapy dose escalation portion of the trial. Beth will share some of that progress with you in a few moments. More broadly, we've made significant progress this quarter across our pipeline.

One of these accomplishments was the FDA clearance of our fourth internally generated IND, resulting in our first milestone under the Gilead license agreement of JTX-1811. That $25 million milestone allows us to extend our cash runway through the third quarter of 2023, further solidifying the strength of our balance sheet. With runway through this period, we are well positioned to fund our two wholly owned POC studies, INNATE and SELECT, past their inflection points, while continuing our robust first-in-class discovery efforts that now include additional targets of the LILRB family.

During the quarter, we presented two trials in progress or TIPs posters at ASCO and continue to enroll patients in INNATE and SELECT. Enrollment in both trials is on track. We also made key employee hires, most notably, our Chief Scientific Officer, Dr. Dmitri Wiederschain. Together, under Dimitry's leadership, we continue to focus on identifying and progressing new mechanisms that target a diverse set of immune cell types in the tumor microenvironment. We were pleased to be able to share these exciting advancements at our first virtual R&D Day in June. Now turning to SELECT.

Enrollment also continues to progress in our Phase II randomized proof-of-concept trial of vopratelimab in combination with our own PD-1 inhibitor in IO naive non-small cell lung cancer patients. The key feature of this study is a rigorous biomarker selection of patients, utilizing TIS vopra, an 18 gene signature that includes genes predictor 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 selection is more stringent than the typical PD-L1 IHC scores. And we look forward to sharing data in 2022. Beyond our development programs, we continue to make progress advancing our early stage pipeline. Our discovery engine and approach has been both productive and value generating, and we expect to see more novel programs like JTX-8064 and JTX-1811 emerge from our efforts. Looking ahead, we remain committed to achieving the milestones we laid out for the remainder of this year and beyond. As I mentioned earlier, we achieved our JTX-1811 goal for the year when the FDA cleared our IND.

This CCR8 program, now referred to as GS-1811 is now in Gilead's hands, and we look forward to following its progress through development. Looking ahead, we plan to evaluate safety and determine the recommended Phase II dose for JTX-8064 and open tumor-specific expansion cohorts in the second half of 2021, now expected in Q3 2021. Continue enrollment to enable reporting of efficacy and related biomarker data for from the SELECT study in 2022 and continue to advance our discovery pipeline of potential first-in-class programs with the goal of a new IND every 12 to 18 months.

I'll now turn the call over to Beth to provide a clinical update. Beth?

Elizabeth Trehu -- Chief Medical Officer

Thanks, Rich, and good morning, everyone. I am pleased to announce this morning that we have completed enrollment in the monotherapy dose escalation portion of the INNATE trial, and we have selected our target dose for JTX-8064. Before getting into more 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 approved 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 tumors that are both sensitive and resistant to PD-1 or L1 inhibitors. Both the INNATE and SELECT trials are key to 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 to INNATE. This study includes dose escalation of both JTX-8064 monotherapy and combination therapy with as well as indication-specific expansion cohorts for both monotherapy and combination therapy, which are designed to demonstrate proof of concept. This trial was initiated in January 2021 with the monotherapy dose escalation in all comers, meaning no specific indications were prespecified in these patients with relapsed or refractory cancers that have failed all available therapy. The monotherapy dose escalation cohorts enrolled quickly, and we are pleased with the strong enthusiasm from the investigators participating in the study.

In the monotherapy dose escalation, we have completed the evaluation of seven dose levels across 22 patients. The target dose was selected based on a combination of safety, PK and receptor occupancy data in the first 3-week cycle and will be used in the monotherapy expansion cohort and the first dose escalation cohort with pimi. Efficacy assessments are performed every nine weeks. So evaluation of confirmed response is available only after 18 weeks of therapy. Importantly, to date, JTX-8064 has been well tolerated with no dose-limiting toxicities.

The monotherapy dose escalation included doses from 50 milligrams to the highest planned dose of 1,200 milligrams. We have observed full receptor occupancy throughout the 3-week dosing interval at doses of 300 milligrams and above and we will be moving forward with a dose of 700 milligrams. Having identified our target dose, we are now poised to move into the next stages of the INNATE study, specifically the monotherapy expansion in ovarian cancer and in parallel, the combination dose escalation of JTX-8064 plus in all comers with relapsed or refractory solid tumors and no therapeutic options.

The combination dose escalation is designed to confirm the safety of the target dose of JTX-8064 plus pimi, leading to the initiation of seven indication-specific combination expansion cohorts. Combination dose escalation is designed to explore just two doses, 700 milligrams and 1,200 milligrams with four patients per dose level. Once the 700-milligram combination cohort has been cleared from a safety perspective, we plan to open the indication-specific combination expansion cohorts in parallel with the 1,200-milligram combination dose escalation cohort.

We remain on track for all three of the next stages of the study, monotherapy expansion combination dose escalation and combination expansion to open for enrollment in this quarter. At our R&D Day, we shared with you our translational approach to defining disease areas of interest for JTX-8064 based on analysis of the tumor microenvironment across tumor types. We have taken these disease areas of interest and define specific indications to include in the expansion stage of innate based on biology, unmet need, differentiation from other LILRB2 inhibitors and consideration of PD-1 or L1 inhibitor sensitivity and resistance. We believe it is important to investigate this new and exciting mechanism in three different types of patients.

First, patients whose tumors have progressed on or after PD-1 or L1 inhibitors and are resistant; second, patients with tumors for which PD-1 or L1 inhibitors are not approved; and third, patients with more typically PD-1 or L1 inhibitor responsive tumors for which PD-1 or L1 inhibitors are approved but where there is still much opportunity for improvement. In the first group, PD-1 or L1 inhibitor experienced patients whose tumors are resistant, we will be evaluating JTX-8064 plus pimi in triple-negative breast cancer, non-small cell lung cancer, cutaneous squamous cell carcinoma and clear cell renal cell cancer. In the second group, PD-1 or L1 inhibitor naive patients with tumors that are historically resistant to and, therefore, have no approved PD-1 or L1 inhibitor.

We will be evaluating both JTX-8064 monotherapy and combination with pimi in ovarian cancer and the combination in undifferentiated pleomorphic sarcoma and liposarcoma. In the third group, to assess the potential for JTX-8064 in a more PD-1 or L1 inhibitor-sensitive tumor, we will evaluate JTX-8064 plus pimi in PD-L1 positive front-line head and neck cancer. As data emerges, we will have the opportunity to explore other indications and combinations with JTX-8064 as well.

Importantly, every indication in the expansion cohorts provides the opportunity for us to potentially take two Jounce molecules, JTX-8064 and pimi, through to registration. I would now like to turn to an update on vopratelimab and our first biomarker patient selection trial, SELECT. Screening and enrollment are on track to report data from the SELECT trial in 2022. As a reminder, we plan to enroll approximately 75 immunotherapy-naive, second-line non-small cell lung cancer patients who will be selected using the predictive biomarker and randomized to vopra plus pimi versus pimi alone.

We believe the TIS vopra biomarker will select for more appropriate patients for both the CD8 mediated benefit of a PD-1 inhibitor as well as for the potential CD4-related benefit of vopra. We expected approximately 20% on of second-line non-small cell lung cancer patients to be TIS vopra positive, and we are pleased that screening to date has validated this projection.

With that, I will now turn the call over to Dmitri to discuss our ongoing discovery efforts. Dmitri?

Dmitri Wiederschain -- Chief Scientific Officer

Thanks, Beth. As Rich said, it's been an exciting quarter, and I'm thrilled to now be a fully integrated member of the Jounce team. At our R&D Day in late June, I was pleased to share more about the signs behind our pipeline, translational work and particularly the opportunities around the myeloid cell focus as exemplified by the LILRB family. We hope you found it beneficial to hear from our scientific team directly at this event. Our scientists and broader research teams are steadfast in their commitment to bring novel therapies to patients in need, and we are very proud of their work.

In addition to our scientists, we were honored to be joined by one of our notable founders, Dr. Bob Schreiber. Bob spoke about the scientific rationale for targeting myeloid cells and the therapeutic potential of reprogramming macrophages for inhibition of LILRB2, which we consider to be a macrophage checkpoint analysis to the PD-1 checkpoint on T cells. We believe the biology of the LILRB2 pathway highlights its potential to reverse resistance to PD-1 or L1 inhibitors. We continue to believe 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 such, we announced at our R&D Day that we are rapidly advancing two additional LILRB family programs through discovery, one targeting LILRB1 and the other targeting LILRB4. With our goal of a new IND every 12 to 18 months, we expect at least one of our next development candidates to target the LILRB family of receptors. In addition to disclosing these discovery programs during our R&D Day, we also focus on the 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. We also use JTX-8064 as an example to demonstrate our integrated biomarker approach from discovery through development. We believe this approach is key to the value-generating programs we are pursuing.

I will now turn the call over to Kim for a discussion of our second quarter financial results. Kim?

Kim Drapkin -- Chief Financial Officer

Thanks, Dmitri, and good morning, everyone. As we reported in this morning's press release, cash, cash equivalents and investments as of June 30, 2021, increased to $246.1 million compared to $213.2 million as of December 31, 2020. This increase was primarily due to the $90.9 million in aggregate net proceeds from sales under our follow-on public offering and our ATM offset by operating costs incurred during the period. The June 30, 2021 cash balance excludes the $25 million milestone earned in the second quarter as it was received in July 2021. Turning to the P&L.

We recognized $25.4 million in license revenue during the second quarter of 2021, which was comprised of revenue related to milestone achievement and noncash revenue related to research and transition services performed under our license agreement with Gilead. No revenue was recognized during the same period in 2020. During the second quarter of 2021, we incurred $22.1 million in research and development expenses compared to $21 million for the same period in 2020.

The increase in R&D expenses was due to increased expenses for manufacturing activities performed for our development programs and increased clinical and regulatory spend on JTX-8064, offset by decreased spend on vopra. General and administrative expenses were $7.3 million for the second quarter of 2021 compared to $7.2 million for the same period in 2020. The increase in G&A expenses was primarily the result of increased insurance expense. Net loss for the second quarter of 2021 was $4 million, resulting in a basic and diluted net loss per share of $0.08 as compared to a net loss of $28 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.82.

The decrease in net loss and net loss per share was attributable to revenue recognized under the license agreement with Gilead during the second quarter of 2021. We are reiterating our cash burn guidance and continue to expect gross cash burn on operating expenses and capital expenditures for the full year 2021 to be approximately $95 million to $110 million. We are, however, updating our cash runway guidance in light of the $25 million Gilead milestone earned. We now 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.

Jounce continues to focus on patients first, and we are proud of the IO pipeline we are 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 the advances we have made across our pipeline. We look forward to updating you on our programs as the year progresses.

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

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question coming from the line of Ted Tenthoff with Piper Sandler. Your line is open.

Ted Tenthoff -- Piper Sandler -- Analyst

Great. Thank you very much. And thank you for the update. I was wondering if we could get maybe a sense at least, I know it's so early, for kind of cadence of enrollment and initiation of these expansion cohorts. Obviously, you're casting to that broadly here. But are there any that either make more sense or are kind of a higher priority or there's greater interest for it? Thank you so much.

Elizabeth Trehu -- Chief Medical Officer

Thanks, Ted. This is Beth. So that's an interesting question. We actually are really excited about all of the expansion cohorts. I don't think I would say that any are higher priority than others. We've selected our sites to be able to enroll across all of the expansion cohorts. So some are rare tumors than others, such as the sarcomas, the cutaneous squamous cell carcinoma, but we've tried to balance the sites to try hopefully have fairly similar enrollment in all of them. So yes, there may be a little bit of difference, but we expect it to be pretty minor. So we expect all of the cohorts to be enrolling in parallel.

Ted Tenthoff -- Piper Sandler -- Analyst

Fair enough. And I apologize if I missed this, but did you disclose what the go-forward dose was balancing between a couple of things. Thanks.

Elizabeth Trehu -- Chief Medical Officer

Yes, we did, yes. So the target dose, which is both for the monotherapy expansion cohort and also the first combo dose escalation cohort is 700 milligrams every three weeks.

Ted Tenthoff -- Piper Sandler -- Analyst

Awesome. Great. Thank you very much. Congrats on the progress.

Elizabeth Trehu -- Chief Medical Officer

Thank you.

Operator

Our next question coming from the line of Colleen Kusy with Baird. Your line is open.

Colleen Kusy -- Baird -- Analyst

Great. Thanks, good morning. Thanks for taking our question. Thanks for the updates today. Could you provide a little color on the receptor occupancy you saw at the 700-milligram go-forward dose versus what you saw at 300 milligrams when you started seeing complete receptor occupancy? And then can you comment specifically on what you saw potentially both in terms of efficacy and safety at the higher doses that you tested beyond 700 mg?

Elizabeth Trehu -- Chief Medical Officer

Sure. So with respect to receptor occupancy, once you max out, it's kind of hard to go any higher. So we saw continuous complete receptor occupancy throughout the entire 3-week dosing cycle at 300 milligrams every three weeks and all doses above that. So really, once you hit that, you can't really go any higher.

So we just have complete receptor occupancy, which is exactly what you want for an inhibitory molecule since our goal is to prevent LILRB2 from binding to any of its ligands. So we've achieved that at 300 milligrams and all doses above that. And then for your other question, so as we've reported, it's been well tolerated. We did not have any dose-limiting toxicities with monotherapy, but we aren't reporting efficacy at this time.

Colleen Kusy -- Baird -- Analyst

Makes sense. Thank you. And I guess do you have a sense of the relative dosing for JTX-8064 for the go-forward dose versus LILRB2?

Elizabeth Trehu -- Chief Medical Officer

They reported that they saw a full receptor occupancy doses above 350 milligrams, I believe, their dose going forward is 800 milligrams every three weeks. So I think we're probably in similar ranges.

Colleen Kusy -- Baird -- Analyst

Okay. Great. Thank you. And then just one on the earlier stage pipeline, I guess. Just kind of how you're prioritizing the development of other LILRB2 or LILRB family members in your development?

Dmitri Wiederschain -- Chief Scientific Officer

This is Dmitri. Thanks for the question. I think as missed during R&D Day and today, we find the whole family quite intriguing. Their biology may be complementary, and we really view those as complementary opportunities to target different immunosuppressive cells than the two micro environment. So we're obviously very pleased with the progress of the LILRB2 inhibitor and JTX-8064 in the clinic. And rapidly advancing our molecules targeting LILRB1 and LILRB4 toward development candidate and would be very happy to provide further updates in the future.

Colleen Kusy -- Baird -- Analyst

Great. Thanks for taking our question.

Operator

Our next question coming from the line of Boris Peaker with Cowen. Your line is open.

Boris Peaker -- Cowen -- Analyst

Good morning. Maybe let me just start with the SELECT trial. Can you provide some additional color on the timing of the data update beyond just 2022, whether first half or second half or any kind of specific medical meetings where you think be reasonable to have the data.

Kim Drapkin -- Chief Financial Officer

Thanks for the question. So as enrollment continues and we get closer, then we'll provide a narrower window for guidance, but for now, just 2022.

Boris Peaker -- Cowen -- Analyst

Got it. And maybe on 1811, I understand that Gilead controls this molecule now. Is there any time line or when we do anticipate kind of an update on that.

Richard Murray -- Chief Executive Officer and President

Yes. Hey, Boris, this is Rich. I'll take that one. Yes. So we've got a very engaged partnership with Gilead. They're extremely excited about the program, and we fully expect them to move that forward as quickly as possible. So we're pleased with that. We don't want to speak to their time lines, that would have to be a question for them. But it's been extremely productive, and we think they're are on the go.

Boris Peaker -- Cowen -- Analyst

Great. Thank you very much. Thanks for taking my question.

Operator

And our next question coming from the line of Steve Seedhouse with Raymond James. Your line is open.

Steve Seedhouse -- Raymond James -- Analyst

Good morning. Thanks very much. 700-milligram the dose that you selected for 8064 was between two doses in your dose escalation monotherapy portion. I'm still a bit unclear on the rationale for that specific dose given the full receptor occupancy down to 300 mgs and no DLTs up to 1,200 mg or 900 mg. So I was hoping you could just comment on what factors were driving that dose selection. Thank you.

Elizabeth Trehu -- Chief Medical Officer

Sure. Thanks for the question, Steve. So we chose the dose of 700 milligrams to ensure that all patients would have complete blood receptor occupancy and also to increase the likelihood of full receptor occupancy in the tumor. So as you know, dose selection in the Phase I trial is made based on a small number of patients and PK and receptor occupancy can vary between patients. So in addition, the amount of drugs that actually gets into the tumor may vary by the type of tumor.

So since JTX-8064 has been well tolerated up to 1,200 milligrams, we had the luxury of selecting a dose that optimizes receptor occupancy for all patients. Now to the point that it wasn't one of the doses we tested, what we do is we take all of the data and we plug it into a population PK model that helps us to figure out where we get to that flat part of the curve for receptor occupancy for almost for all patients. And so 700 milligrams proved to be the right dose for that.

Steve Seedhouse -- Raymond James -- Analyst

Very helpful, thank you.

Operator

[Operator Instructions] Our next question is coming from the line of Swayampakula Ramakanth with H.C. Wainwright. Your line is open.

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

Good morning. This is RK from H.C. Wainwright. Congratulations on all the progress. And obviously, you folks are entering into some exciting times here. In terms of the data, the data that you collected so far in the dose escalation phase, would you be presenting them at any conference this year? Or is that -- would that be for next year with additional data from the studies that you're starting now?

Elizabeth Trehu -- Chief Medical Officer

Sure. I know everybody is excited about the data as are we. We're really pleased by the rate of progress. Given the timing of the data and the abstract submission deadlines, we don't expect to present data this year. As you know, our presence present at a medical leading, and we also want to present a meaningful body of data that includes dose escalation and expansion for both mono and combo. And also, as I mentioned on the call, we can't really assess efficacy unless we have 18-week data. So we want to wait until we have 18-week data on all the patients that we present. So again, we share your excitement. And we really believe this program and this drug has the potential to be paradigm shifting, but we're going to wait until we have a meaningful body of data.

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

Thanks for that, Beth. One other question on the monotherapy expansion into the ovarian cancer. Can you remind us what's the rationale there and why ovarian?

Elizabeth Trehu -- Chief Medical Officer

Sure. So as you may recall, and as we shared at the R&D Day, we had a very strong biological rationale for all of the tumor types that we're selecting and started with biomarkers that could be potential predictive biomarkers for the program. And then we looked in large data sets for tumors that had high expression are high proportion of patients are tumors that had expression of those biomarkers. So we start with the biology. We then look at through the window of unmet need opportunity for differentiation and whether tumors are in PD-1 PD-1 inhibitor sensitive or resistant.

So for monotherapy, ovarian really checked all the buses for a strong biological rationale. It's a PD-1 inhibitor naive tumor, we thought it was important for monotherapy to be going into PD-1 inhibitor-naive patients since the PD-1 inhibitor experienced and resistant patients have been such a challenge. We wanted a PD-1 inhibitor naive tumor where PD-1 inhibitors typically don't work that well, and we're hoping that a different mechanism of actions may also give us some benefit there and obviously, an area of high unmet need. Rich, do you want to add anything to that?

Richard Murray -- Chief Executive Officer and President

Yes, sure. Thanks, Beth. Yes, I think RK, it's also as we think about the science behind the mechanisms, we want to take advantage of any monotherapy past that week that we could find. But if you think about an innate system checkpoint kind of releasing and priming new populations of T cells you may need that PD-1 inhibitor on that kind of back end with those T cells. So we think, hence, the focus on seven combination studies that we'll be putting up starting this quarter. But we certainly don't want to miss the opportunity for monotherapy. And so we took what we thought could be the best choice for monotherapy.

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

Thank you. [Indecipherable.]

Operator

Our next question coming from the line of Zegbeh Jallah with ROTH Capital Partners. Your line is open.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Good morning. Thanks for taking my question.Just kind of wanted to follow up on 8064. I was just kind of wondering what is quite common following treatment around some of the decision-making to go with that dose?

Elizabeth Trehu -- Chief Medical Officer

I'm sorry, Zeg, but can you repeat? I didn't quite get the question.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Apologies, my reception is a little bad, but I was just wondering on some of the common AEs that we're seeing within that range because you didn't really touch 700 but within that range.

Elizabeth Trehu -- Chief Medical Officer

Sure. So we haven't reported on the full safety profile. All we're saying at this point. It's been well tolerated. We've had no dose-limiting toxicities. But I think I would say we're fairly comfortable in terms of safety to what with their program.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thanks, Beth. And then just to follow up as well. We just also wondering if the plan is to explore an accelerated approval path for monotherapy use since the patients that are being treated are pretty late.

Elizabeth Trehu -- Chief Medical Officer

Sure. That's a great question, Zegbeh. And as Rich mentioned, for us pursuing monotherapy is really important because as you're alluding to, that certainly would be the fast in path to approval, specifically a single-arm monotherapy trial. So that would be wonderful if you will wait and see where the data takes us, but that's certainly one of our considerations in opening a monotherapy cohort.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thanks. And is the plan to also use the time dose for monotherapy and combo treatment? And then the follow-up to that is also any expectations as to when we might begin to see responses? I think you said 19 weeks or 18 weeks after the depreciation of treatment. How quickly do you think we might be able to see some responses?

Elizabeth Trehu -- Chief Medical Officer

Sure. So regarding the dose, yes, we were really pleased that we're able to start combo dose escalation at the target dose. And so basically, if that clears safety, then we will start the expansion cohort at that target dose in combination. We'll still, as I mentioned, we'll do one higher dose, 1,200 milligrams, but we'll run that in parallel with opening the tumor-specific expansion cohorts.

Then in terms of data, as I mentioned, when we present data, we really want it to be a robust data package with meaningful data on a substantial number of patients. So just given the timing of when we'll start getting that 18-week data and abstract deadlines, we won't have we don't expect to present data this year, but we will continue to guide as we see how enrollment goes.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thank you. And then the last one for me is on the SELECT. I don't think I've asked this in the past, but I was actually curious as to what you think hurdle is or the response might be for alone in the SELECT study just because you're doing a better job of preselecting patients. So what do you think in the hurdle is to kind of move this forward? Or what are you thinking you might get from that pimi alone arm?

Elizabeth Trehu -- Chief Medical Officer

Sure. So the benchmarks are available from the data on which nivo, pembro and atezolizumab were approved in second-line PD-1 inhibitor-naive non-small cell lung cancer, and those response rates ranged from 14% to 20%. So of course, they weren't approved based on response rates. They were approved based on overall survival, which is a much more important endpoint well, for any drug, but also for immunotherapy since that's where immunotherapy really makes the biggest difference.

So something that compares favorably to those would be a good start. But remember, the primary endpoint of the study is one that we believe is a better predictor for overall survival and a better reflection of the benefits of IO therapy, and that's the tumor reduction averaged over nine and 18 weeks to the percent change from baseline in the tumors. So we'll be looking at that. We'll also be looking at response rates. But again, something that compares favorably to 14% to 20% response rate would be a starting point.

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Thank you.

Operator

I'm not showing any further questions at this time. [Operator Closing Remarks]

Duration: 42 minutes

Call participants:

Mark Yore -- Director of Corporate Development

Richard Murray -- Chief Executive Officer and President

Elizabeth Trehu -- Chief Medical Officer

Dmitri Wiederschain -- Chief Scientific Officer

Kim Drapkin -- Chief Financial Officer

Ted Tenthoff -- Piper Sandler -- Analyst

Colleen Kusy -- Baird -- Analyst

Boris Peaker -- Cowen -- Analyst

Steve Seedhouse -- Raymond James -- Analyst

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

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

More JNCE analysis

All earnings call transcripts