Q2 2020 Jounce Therapeutics Inc Earnings Call
Good morning, ladies and gentlemen.
You bet Johnson Therapeutics second quarter 2000, <unk> earnings Conference call.
All participants are in listen only mode.
Later, we will conduct a question answer session and instructions will follow.
As a reminder, this conference call is being recorded at the doctors. Your question I'll now turn the call over to your host small Joshi just therapeutics. Please go ahead.
Thank you operator, good morning, and welcome to the Jones Therapeutics second quarter Conference call. This.
This morning, we issued a press release, which outlines the topics that we plan to discuss today.
There will be says available in the investors immediate section of our website at Www Dot Jounce T X dot com.
Speaking on today's call will be our CEO, and President Dr., which Murray, who will discuss our progress in key milestones followed by our CMO Dr. bets trade, who will provide an update on our clinical activities Lastly, our CFO Kim Drapkin will review, our second quarter financial results.
He 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, various important factors, including the risk factors discussed in our SBC filings.
In addition, any forward looking statements represent our views only as of today August 720, 20, 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.
Thanks, scalable 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 own jobs programs in the clinic, while also maintaining our discovery efforts a first in class biomarker driven programs.
Before I talk about our pipeline I wanted to touch on how we think about the immunotherapy landscape and the need for novel approaches.
Over the last decade, you approve 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.
Putting those who failed their first Io therapy, and those who progress on or after an initial response to PD one 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.
Okay, saying on two main concepts.
First our novel programs targeting mechanisms across different immune cell types.
Not just the C D a positive T cells.
Second.
The same technology is used in a coordinated biomarker effort for each program.
Which includes both pharmaco dynamic as well as predictive biomarkers.
Our growing pipeline covers crucial biological aspects of cancer immunology.
Including novel development programs targeting I costs, and Cdfour T cell biology.
Larvae to also known as I also before and suppressive macrophage biology.
She CR rate and suppressive T regulatory cell biology in addition to our own PD one inhibitor.
Our sustainable discovery effort is aimed at reversing the effects of tumor microenvironment cell types that are implicated in suppressing immune response.
Within the evolving patient population exposed or not exposed to I O therapies.
It is important to note that our current pipeline would not be possible without the incredible work, but my dedicated colleagues jobs.
Even through the current challenges at the covert 19 pandemic. The jobs team has not lost sight of our important work.
Focusing on bringing long lasting benefits 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 two trial.
We remain on track to complete the interim analysis of efficacy and critical biomarker data on more than 40 patients. It early 2021.
We also remain on track to initiate so what.
Our phase two predictive biomarker trial with Barbara and Gtx 44 team in 2020.
And building an integrated pipeline. This is an example of a wholly own combination trial employing a biomarker approach to patient selection.
We're also announcing today that we expect to begin enrollment in our phase one dose escalation study of Gtx 80, 64 in 2020.
Suppressive macrophage biology has become an intense area of interest in Ohio.
We believe that little RB too or I LT for the target of Gtx 80, 64, and our lead macrophage program.
Maybe irrelevant in both Io naive as well as I O failure patients.
Gtx 80, 64 inhibits the binding of little RB too to HR lay molecules importantly, including easily G.
This is conceptually similar to the checkpoint inhibition, a PD L. One binding to PD, one or T cells.
Thus, we believe that will RV to me function as an immune checkpoint for macrophages.
Supporting preclinical data our Gtx 86 before was presented at the 2019 AC our annual meeting.
Given this exciting biology, we look forward to advancing this program into the clinic this year.
Closely behind Gtx 80, 64 is the most recent addition to our development stage assets.
Gtx 18 11.
As a reminder, Gtx 18 11 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 Gtx 18, 11, CCR eight is it came in kind receptor enriched on the T regulatory cells in the tumor.
By selectively eliminating tumor infiltrating T regulatory cells. We believe we can are removed the suppressive barriers brought on buddy cells.
Importantly, our preclinical data.
Shown at the June AC our meeting.
Stab wishes that this biology is independent of PD one.
And can restore our PD one inhibitor activity in resistant settings.
With that and 2021, we expect to have four wholly own jobs programs in clinical trials.
Shifting now to our discovery engine.
Let me remind you that we believe I O 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 micro environment 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 and we continue to focus our discovery efforts toward different immune cell types and mechanisms in a biomarker driven fashion as best will highlight in a moment.
Given the growing them emergence of PD, one inhibitor failure patient population. We've now established efforts on PD, one 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 Gtx 80, 64, and Gtx 18, 11 emerged 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 best to discuss our clinical activities in more detail.
Thanks, Rich and good morning, everyone.
I'm very excited about our progress a chance this quarter and look forward to the milestones to come.
First and foremost we remain on track with both emerge and solar and we continued to make significant progress on our earlier development programs Gtx 80, 64, and TTX 18 11.
As a reminder for the emerged development path, we focus on the induction I caught hi, TV for T cells prior to administration of Oprah because our data indicates that oprah needs. These cells to be present to work.
Based on this biology, we initiated assays to emerge pile of both in combination with it. So let me Matt in June 2019.
Emerged trial enrolls second and third line non small cell lung cancer patients who have progressed on both a PD one 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 at the work our clinical and supporting teams continue to do.
We completed enrollment for the emerged interim analysis, despite the ongoing challenges.
19 pandemic.
This is a testament to the strength of our clinical team and to our investigators believe and the potential to both for patients with little to no other treatment options left.
We remain on track to complete the interim analysis.
Okay and biomarker data from the merge.
The interim analysis is designed to include clinical data through at least 18 weeks on all of valuable patients plus importance pharmaco dynamic and predictive or data.
It will be analyzed for the study as a whole at a different dose levels, which test differentiated durations of I costs engagement by <unk>.
Enrollment now complete our timeline to the interim analysis remains unchanged and will include data over 40, a valuable patrons.
To help.
Emerge and select studies in context, I would like to review the outcomes associated with the Texas and PD one inhibitors in second line non small cell lung cancer patients.
Focusing on the nature of the benefit that PD one inhibitor spring.
And to large and growing unmet need in patients who have progressed well have not responded to them.
Most of the technical data or in the PD, one inhibitor naive setting and that's you know and emerge patients have progressed, a TV money theaters in second line PD, one inhibitor naive non small cell lung cancer patients Ddos attacks or provides response rate of approximately 6% to 14%.
Median overall survival of six to 9.6 month and significant toxicity.
In second and third line non small cell lung cancer patients, where PD one experience like the patience in emerge.
Most of Paxil has become standard of care by default, making it the most appropriate benchmark.
However, kao L. feedback suggests that clinical benefit from actual especially overall survival. In this population is likely know that no better and potentially worse dozens of PD one inhibitor naive patients.
If it's also important to remember that in Idaho naive patients single agent PD, one PDL one inhibitors without biomarker selection produced modest response rate, but were approved based on meaningful improvements in overall survival compared to ddos attacks.
To date, the greatest contribution of iron therapy, that's been the durability of clinical benefit compared to chemotherapy, resulting in improved survival.
Since response rate, maybe less predictive of survival with Io therapy.
Criteria to find kidney emerged protocol for in continuing enrollment half. The interim analysis include response rate or clinically meaningful treatment effect based on through evaluation of other measures of efficacy, including tumor target lesion reduction disease control rate.
Okay and duration of response.
Data from many Io trial suggest these end points, maybe better predictors of overall survival then response rate.
In order to expand emerge be onto the interim analysis. These wouldn't need to be accompanied by a favorable safety profile in a well defined patient population.
The duration follow up built into our interim analysis will allow us to shared data from emerge on these critical missions of efficacy for immuno therapies.
We also plan to have a coordinated set of data for the whole study and by dose level on pharmacodynamic and potential predictive biomarkers former to investigate the I costs induction hypothesis and its correlation with clinical benefit.
The letter for the potential of future selection of patients more likely to respond.
At the June I see our virtual annual meeting we presented additional translational data on both Brett <unk>.
I could hi, phenotype is induced in an antigen specific manner through the stimulation of the T cell receptor and the <unk> Hi, CD for T cell population in the peripheral blood of iconic responders.
Price of P.H. one.
He's central memory.
Listen to their help or subset.
We believe that the generation of these functionally specialist subsets Cdfour T cells, which do not occur with PD one inhibitors. They contribute to a more comprehensive immune response, and that's a t. central memory cells support role for Oprah and durable clinical benefit.
I would like to parent to select a biomarker selection trial of Oprah and but we believe this move towards precision medicine and Io.
The trial will deploy the predictive biomarkers to soap opera and our goal is to select the patients more likely to generate I cut was type C. Before T cells on both men and the G durable clinical benefit.
Because this was initially developed as a potential predictive biomarker for PD. One inhibitors, we expect results with Gtx 44 team and the two spoke for biomarker to be better than those for PD, one inhibitors with a biomarker selection.
Because its footprint has been designed to optimize the prediction I coast, Hi, see before T cell emergence in patients treated with Oprah and the PD. One inhibitor, we expect the combination to be potentially better than gtx, 44% alone. These selected patients. So the trial is powered to demonstrate this.
Purity of Oprah plus Stratex 40, 14 to Jay TX, one or two alone.
We believe that using a pharmacodynamic biomarker to distinguish the effect of Oprah from the combination PD one inhibitor and then selecting a predictive biomarker. It is directly linked to the vote for Pharmacodynamic effect, It's a brand 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 predicted to scope for biomarker and randomized Oprah, Let's say takes 40 14 versus Gtx 40 14 alone.
We estimate that approximately 20% of second line non small cell lung cancer patients will be above to soper threshold and potentially eligible for the trial.
We remain on track to initiate the select trial and 2020.
We'll expect to report select clinical data in 2021.
We continue to believe that developing Gtx 40, 40 was an important strategic decision for Joe.
Phase one trial of Gtx 40, 14 is ongoing as one complete and one partial responder continued to do well and over a year of treatment.
In addition to work so that trial you plan to include Gtx 40, 14 in the upcoming TTX 80 before trial to evaluate the benefit of this combination with a PD one inhibitor.
Our clinical team is well positioned to execute across the Oprah and Gtx 40, 14 trial and the new phase one trials for P.T.F.C.D. 64, and Gtx 18 11.
As we look to 2021, we will have four Jones candidates in multiple clinical trials in the U.S. and outside the U.S.
With Gtx any 64, and Gtx 18, 11 preclinical development underway, coupled with the translation of our key learnings for my chronic into emergent select we're taking important steps forward as we continue our commitment to developing novel I O programs for patients who are not sufficiently Ben.
Fitting from today's therapy, now I would like to turn the call over to Kim.
Thanks, fast and good morning, everyone.
As we recorded in this mornings press release cash cash equivalents and investments as of June Thirtyth 2020 totaled 127.2 million compared to 170.4 million as of December 31st 2019.
It's the decrease was primarily due to operating costs incurred during the period.
Turning to the piano 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 in select clinical trials and increased employee compensation costs.
Actually offset by lower I, Andy enabling expensive.
General and administrative expenses were 7.2 million for the second quarter of 2020 compared to 7.3 million for the same period and 29 team.
The slight decrease in DNA expenses is primarily the result of lower professional service fees.
Net loss for the second quarter of 2020, with 28 million or a net loss per basic and diluted share of 82 cents as compared to a net loss of 7 million for the same period in 2019 or a net loss per basic and diluted share up 21 cents.
The increase in net loss was primarily attributable to know license and collaboration revenue in the second quarter 2020.
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.
The flexibility to efficiently execute against our strategic plans and goals afford programs in the clinic in 2021.
I'll now turn the call back to rich.
Thanks Kim.
In conclusion, staying true to our core mission of providing benefits to patients with unmet medical needs jobs is poised for a robust 2020 and 2021 with critical upcoming milestones.
Costs, our pipeline, we plan to initiate the select phase two trial of Oprah and Gtx 40 14.
Using artists vote for a biomarker in 2020.
Initiate the phase one trial of Gtx 80, 64 in 2020.
Complete the interim analysis of efficacy and biomarker data of emerge in early 2021.
Continue I, India, enabling activities for Gtx 18, 11, with an expected I Indy filing and the first half of 2021, Yeah 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.
Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one I get telephone keypad.
If your question has been answered all your worst or move yourself from acute simply press the pound cake.
Again, if you ever question or comment at this time. Please press Star then one or your telephone keypad.
Our first question or comment comes from the line of Debjit Chardonnay from H.C. Wainwright Wainwright. Your line is open.
Hey, good morning, and thank you for taking the questions and I apologize if I missed your comments I'm on the other calls I'm against you.
He just on the select program could you just walk us through the rationale again, especially the lessons from that clinic program in terms of the ability to induce heico's.
The kinetic solve the on margins and the.
Doors are open that you plan to use and also in terms of the patient enrollment would you primarily focused on PD, one no or PD. One wanted to 49 of PD, one greater than 50% and where do you expect to see the most that's it. Thank you.
Okay. So the select trial is exploring our hypothesis that by well, it's really based on the fact that we know vote for needs I can tie city for cells are activated or prime CD for T cells to work and so in the iconic study we found those.
I coasts high 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 pissed vote brought in those baseline tumor biopsies that actually predicted very well for the patients who had the emergence of the I coast high Cdfour T cells, So basically using our pharmacodynamic biomarker, yeah, 'cause type C before cells to find a predictive.
Yeah on marker for those I close I see before cells. We then applied that biomarker retrospectively to the clinical data.
Found that it also predicted for clinical benefit so we're using to smoke era.
In the select trial to only treat patients who were above the test Oprah threshold. So that means those patients. We believe are more likely to be able to generate I close I see before cells, because presumably they have activated T before T cells in their tumors.
And so they should be able to respond to though for us.
It's a randomized trial of both BREP plus Gtx 40, 14, our PD one inhibitor against 40 14 alone.
And because TS was originally developed as a potential predictive biomarker for PD. One inhibitors, we expect the outcomes with 40 14 to be better than unselected patients with PD one 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 one naive there is data.
Unselected patients and also with PDL, one scores of greater than or equal to one or greater than or equal to 54, Nivo and pembro.
And so we'll have a good kind of historic benchmark to see how Gtx 40, 14 with the pit spoke for biomarker selection compares to those we are not prospectively selecting for any PDL, one population because our data suggest that.
There's not direct overlap there maybe some overlap, but there's not complete overlap between pissed Oprah and PDL one in fact in iconic.
PDL one I see was not at all predictive for I Cosac Cdfour T cells, whereas just spoke for was highly predictive for that so we will look retrospectively will be collecting the data to look at the PDL one scores, but we're not doing any selection prospectively, because we believe test.
Oprah is a better predictive biomarker for what we're looking for so the trial is powered to demonstrate the superiority of Oprah plus 40, 14 versus 40 14 alone.
Yes, rich to make some additional comments.
Yeah, Thanks, and a yeah. The GE. Thanks for the question just to just.
Got it.
Reiterate a bit on Ah that's common [noise].
What we expect since test itself was developed for PD. One inhibitors, we expect selection of patients more likely reason to respond just in the Gtx 40 14 are.
But since the terrorist threshold is really tuned and optimized for also predicting for patients who are more likely to generate the icon hi.
Cells, that's property of Oprah, we expect you know and even better opportunity to see benefit and in the combo. So that's really kind of the kind of stacking. If you will have a selection of patients. We expect the increase in PD, one alone and I'm joined here for 14 and more so in a in the.
Combo and that that concept and fits nicely with the randomized trial.
Yeah and then.
[laughter] population, we expect about 20% of that lung cancer patient, Pat and to be above the threshold and eligible for the trial I think did that answer all of the parts of your question.
Yeah. It did thanks very much and just in terms of timelines you know your data analysis is gonna be based on 75 patients and you said, 20% to like you did get I like you do have the emergence of.
The fiscal <unk> the signature so how long do you think it's going to take to end little the study and if you are planning on a beating the data in 2021.
Rationally, how many patients do you think we should expect a I know it's early days and you haven't really started enrolling.
Sure. So we don't intend to to analyze the data until the study has completed enrollment.
We we have a target enrollment of 75 patients and we have you know 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.
Got it. Thank you so much and good luck.
Thanks, a lot.
[music].
Thank you our next question or comment collection line of Mike Old from Baird. Your line is open.
Hi, This is Colleen Hanley on for Mike. Thanks for taking your questions and congrats on on the progress this quarter I guess I'm just at the upcoming emerged data early 2021 give any updated thoughts on if you have a preference for a medical meeting or whether that would be part of the topline results and then I know you said at least 18 weeks 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 to celebrate.
Sure so great questions Colleen. Thank you I know that's the burning questions on everyone's mind. So so we just finished enrollment and you know where we're starting to work on on getting that data in <unk> and planning for the interim analysis. So the.
Basically the range will be the last patient and you know we'll wait until their second scan at 18 week is done at the study started enrolling in June of last year. So the range can be up to a year or more of data. So.
You know it will be it's really that the interim analysis triggered on that last patient getting there 18 weeks scan.
And see interim analysis will include the I coast high CD for cell target engagement, just Oprah you know all the Biomarkers that are really built into the study. So that we really have a comprehensive data package and so will provide.
Slide more.
Already around where and how will 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.
Great. Thank you.
Thanks.
Thank you. Our next question or comment comes from the line of Jim Birchenough from Wells Fargo Securities. Your line is open.
This morning, just to go back to select and [noise].
Notwithstanding the something you almost sounds my question.
Yeah.
Pretty much is concerned about it you just.
Right away.
Yes.
They tend to.
<unk> presentation materials. So can you just walk us through the New York screening patients prior to enroll in them.
And then I'll try to involve almost twice as many patients.
Okay. That's all you can.
Do all of this and such compressed timeline.
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.
We've picked the number of sites that we think we need to be able to enroll in the timeframe that we've set for ourselves so.
You know 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 end RCR ROE feel very confident in our timelines.
And then.
Just going back to.
Uh huh.
A couple of questions or is there.
It is fun missing the point.
Is there a balance between.
No PDL, while I'm quite unionism PDL one negative.
And also one of the challenges like Tony will be challenged electronically.
Hey, rapid patient trial.
The label to comment on.
No.
<unk>.
So in terms of the PDL one scores again, we don't prospectively.
Have any restrictions on PDL one scores, we certainly will it will do analysis of efficacy based on baseline PDL one scores, but remember these are all patients who have failed to PD one inhibitor, so and what we're looking at is there archival tumor. So you know I don't know how in form but with that.
We'll be but we certainly will look at it.
And then and then your second question sorry, I just forgot what your second question was that.
Second question, but the.
They can take problem and I thought it was.
I don't really drop off yeah. Yeah. So can you can you make any comment about with that.
You're not seeing that I guess.
The comforting to know.
Right. So we don't usually make any comments on you know enrollment or dropouts or anything like that it is a second line non small cell lung cancer patients, but you know they are PD one inhibitor failures. So we obviously will be well report that when we finally reports the data.
Okay, great. Thanks.
Thank you. Our next question or comment comes from a line of Cory Kasimov from JP Morgan Your line is open.
Hi, good morning wasn't gathered on for Corey I, just got a clarifying question on almost like study I think you made a comment that.
20% of the second line lung cancer patients will be above the tis beaupre threshold.
Can you just color or clarify if that's that's correct and as this 20% of all second line patients or.
Is there is that 20% of subgroup within that patient group. Thank you.
Sure no that that data comes from you know just analysis of test data.
<unk>.
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, you know there have been drugs approved that had been very successful in lung cancer that apply to you know three.
Or 7% of the population and those trials kind of getting back 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 you know 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.
Sure Yeah, I think you know given another another side of that question is the population itself. So we think about 20% will make it over the threshold, but but as we all appreciate PD. One inhibitors. So just continuing to be just firmly established off of a frontline therapy. So as more of those patients are treated more of those patients.
It's are failing and meeting you know and in dire need really over the next line of therapy.
As Beth mentioned, you know we were benchmarking that to Docetaxel and you know kind of sad to say that's the that's the alternative patients out in this line of therapy, but importantly, as we look at that market. It it's a.
It's a you know to it to a growing market in terms of the number of patients entering into that line of therapy.
Yeah, I think that's his yeah rich your comments I think are more directed to the emerge trial. The PD, one failures, but oh, I'm, sorry, I'm, sorry, yeah, Yeah, I'm, sorry, I got yeah.
Paul just for that got an eye that was a comment that was making on select I extrapolated that to actual remarks that was that that was my bad.
Yeah, the but it could apply to the select trial as well and we are going to be retrospectively looking at just spoke breadth in the in this in the emerged trial as well so we'll be getting a lot of information about just spoke for levels in PD, one experience as well as the PD, one inhibitor naive population and select.
Okay, Great and then just one more in terms of the geographic breakdown on the clinical trial sites. It is there any commentary you can make on yeah. It's just more like east Asia, or eastern Europe, or or just ex U.S.
Broadly.
Yeah, it's its ex U.S. mean will be you know once its posted on clinical trials dot Gov people will be able to see all the sites, but it's it's in a primarily in eastern Europe and and what we found is there's a tremendous desire on the part of patients to get PD, one inhibitors, but in most cases.
They're only way of getting them is on clinical trials. So I actually feel really good about the fact that we're making you know an effective therapy available to patients with a with a need in those places.
Great. Thank you.
Thank you. Our next question or comment comes from a line of Boris Peaker from Cowen Your line is open.
Hi, This is cynthiana or Boris maybe a quick one for me on TTX on April six for can you talk a lot more about your development plans for that Canada and are there particular tumor types, you're thinking of exploring on did I hear on the call that you're thinking of a combo GTS on 44 teams that I can't do it.
Sure sure I'll take that one yes, so as we progress any of our programs. The jobs, we coordinate that with a with a biomarker plan a biomarker analysis, so they'll be they'll be kind of a broad you know there is ongoing and well continue to be abroad evaluation of the.
Selection of of tumor types and that's based on you know [laughter] analogies to how we've looked at both Brian you know run the run the I guess program looking for predictive as well as a pharmacokinetic biomarkers to kind of coupled with the program. So that's kind of a fundamental for all of our programs, what we can't say of core.
This is there are there is no data available data to be investigated about macrophage signatures that identify ER suppressive macrophage biology within tumors and of course, that's a great interest to us. So are you know we haven't stated yet exactly what tumors.
We'll go into we will do that we do know from a competitive intelligence point of view there is.
You know some indication of that there's a Merck program. That's in the clinic in phase one that program. What we can observe just through a available information has been expanded from 70 patients to 270 patients 290 patients and so there is you know information available about how it works taking.
At forward into a particular particular tumor types.
We'll be watching that program very carefully they'll be having a presentation at ESMO or at the end of a at the end of September you know on the PD one side of that the preclinical data that we have generated as well as a publication that came out in this mechanism showed that.
There is a biology that we think couldn't be independent PD, one as well as in combination with PD. One so there's some biology there that we think it's important in kind of you know directing where we go into patient populations, but more specifically will come out with tumor types, a as we get closer.
Alright, great. Thank you for taking my question.
Thank you again, ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad. Our next question or comment comes from a line of steel sheet House from Raymond James Your line is open.
Great. Congrats on completing enrollment of the in Permian L. scored of a merger I was hoping you could just clarify patients in a merger all second line as I think you mentioned for the interim analysis or if there are also a third line patients as well and that also is this locally advanced and metastatic patients or all the whole mother.
Got it thanks.
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 of PD, one inhibitor for metastatic disease and so some of them we'll be second line, if they've received platinum regimen.
Plus PD one in front line.
But then they could also have received them in sequence. So they could have gotten chemo front line PD, one inhibitor second line or rare cases, PD one inhibitor frontline chemo second line. So they will be a mix upset or they are a mix of second and third line patience with non small cell lung cancer all.
At a static.
Okay helpful. Thanks, and on select you mentioned the studies designed for superiority of Oprah plus PD, one versus maybe what alone wondering if im sure I'm just the particulars powering their specifically I guess the effect size that your power for tougher volpara and on which endpoint.
Sure. So I think you know wants to study start enrolling we will start providing a lot more detail about that I'd, rather do that in a sort of a more formal setting then just in the acuity, but we do plan to explain the how the study is designed and.
Howard and you know how people think about how to interpret the results once it starts rolling.
Okay sounds good and then just last question.
On the use of it will ever had been emerge.
Just generally speaking maybe did that everyone in the interim analysis cohort receive the maximum allowed doses of it be or were there any patients that.
A dial back dosing.
Yeah, I can't comment on that right now I.
I actually don't even know that date [laughter], we're just starting to up to full debate it together.
Okay No problem. Thanks for the question.
You're welcome.
Thank you. Our next question as a follow up from the line of Debjit top tier from H.C. Wainwright. Your line is open.
Hey, Thanks, something back in so it's probably a much study how would you define success, especially in terms of than they were bond that the confidence interval and how do you totally lose out afford and do you see due to about Steve.
But he was not any curative and so I mean there.
Basically the date of it.
So you get a for has been pretty.
Encouraging and you see so I'm just wondering if you know you want to revisit that story again.
Sure. So the second one I'll take you know 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 you know once we see the results of the interim analysis, we will follow the data so with it you know.
Jeff that there might be other tumor types of interest you know I wouldn't rule those out.
As of now we're focusing on the interim analysis and the lung cancer patients.
So with respect to your question about what success looks like so what ive defined in today's earnings call for the first time, because we know people are really curious about that is the criteria specifically defined in the original emerged protocol. So.
What we've learned from following the IPO 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, you know the PD one inhibitors have gotten approved with you know fairly modest response rates, but really impressive survive.
Well.
So when we wrote the emerged trial, we just signed the criteria for continuing enrollment has 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 include staple 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, then response rate and since our ultimate goal. You know is a registration trial to demonstrate improved overall.
Survival, that's really important to us as we look at our you know are 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 three.
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 you know 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 or you know at least 18 weeks on the last patient enrolled really underscores that right because those really but we think are critical measures of efficacy for immunotherapy include duration of follow up. So that's one of the reasons that there's you know we need time to let the drugs.
And their effect play out so that we can really do the best analysis of the a of the results.
Just a follow up on maybe for Kim given where your cash position is currently and where the stock screening how important does your media for its become right now.
For the microphone program or Youre anti PD, one which has some pretty interesting monotherapy data.
So obviously you know 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 you know we believe we have varied.
Exciting assets and we'll balance when the right time to partner is versus you know maintaining and keeping some programs to ourselves.
You know well certainly be looking for towards raising money, one way or the other two continue to bolster our balance sheet, but as I said I feel like we have a lot of flexibility between BD as well as you know the markets are continuing to be strong even in the cycle.
Yeah, I think that he 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.
Got it. Thank you good luck.
Thank you.
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.
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