Q1 2021 Jounce Therapeutics Inc Earnings Call
[music].
Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics first quarter 2021 earnings conference call.
At this time all participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
As a reminder, this conference call is being recorded at the company's request.
I will now turn the call over to your host that went beyond the Jounce Therapeutics. Please go ahead.
Thank you operator, good morning, and welcome to the Jounce Therapeutics first 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 and media section of our website at Www Dot Jounce, TX Dot com.
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 CSO, Dr. Dimitri Vitor Schein, who will discuss our discovery efforts our CMO Dr. Beth <unk>, who will then provide an update on our clinical activities and lastly, our CFO Kim dropped.
Ed will review, our first 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 provision.
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 May force 2021 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, Marilyn and good morning, everyone.
Jos has made meaningful progress at the start from 2021 as we continue to advance our two proof of concept studies grow our discovery and development pipeline.
And add to our strong balance sheet.
We're at an exciting point in Johnson's development and remain committed to progressing new mechanisms that target different immune cell types in the tumor microenvironment.
Our translational science platform and biomarker approach are integral to our commitment to bring the right therapy to the right patients.
I'd like to take a few minutes to provide updates from the quarter.
At the start of the year, we announced that enrollment commence and then eight our phase one clinical trial of our highest priority program <unk>.
<unk> to $8 64.
A little RB two <unk> also known as <unk> four inhibitor.
And he is moving quickly through the necessary dose escalation portion of the trial towards the opening of eight tumor specific expansion cohorts.
We plan to include Gtx, 80, 64, monotherapy as well as combination with our own PD, one inhibitor <unk> thousand 14.
We're an approved PD one inhibitor.
J T X 40, <unk> 14 will now be known as Tim of Allomap for PV.
We continue to believe that the myeloid and macrophage biology.
Artist by the potential effect of Gtx 80, 64 via the Wil Rbq mechanism.
Provides a new opportunity to bring benefits to patients.
Enrollment also continues in select.
Our phase two randomized proof of concept trial of Volcker telematics in combination with our PD one inhibitor.
The key feature of this study is the biomarker selection of patients.
Utilizing tests both from an.
And 18 gene signature that includes genes relevant to both <unk> and CD four T cell biology.
We believe it's clear from our own clinical data as well as that of competitors that are rigorous patient selection strategy may be critical to optimize the benefits of an <unk> agonist and a PD one inhibitor.
We look forward to reporting clinical data from the select trial in 2022.
As Beth will mention in more detail. We're also pleased to present two trials in progress posters on both innate and select at the upcoming <unk> meeting in June.
We continue to progress Gtx 18, 11, our potential first in class antibody designed to selectively deplete immuno suppressive tumor infiltrating T regulatory cells.
We licensed the program to Gilead in 2020 and remain on track for the IND filing in the first half of this year.
We are not development programs, we continue to make progress advancing our earlier stage pipeline.
Our broad discovery pipeline includes multiple programs targeting diverse immune cell types and PD, one or PDL, one inhibitor resistance mechanisms.
These are all active targeted areas for our discovery engine and we expect to see more valuable novel programs like J T X 86, before and Gtx 18, 11 emerge from our efforts.
Additionally, during the first quarter, we added more than $90 million to our balance sheet through a follow on offering and through the use of our now completed ATM program.
This capital infusion strengthens our balance sheet and gives us the runway to complete our key proof of concept studies, while also driving new discovery programs forward.
We remain excited for what lies ahead for Jounce with critical milestones laid out for the remainder of this year and beyond.
To reiterate we plan to evaluate safety and determined recommended phase two dose for Gtx 80 64.
Open tumor specific expansion cohorts in the second half of 2021.
Continue enrollment to enable reporting of efficacy and related biomarker data for volt brought in from me from the select trial in 2022.
Continue R&D, enabling activities for <unk>, 18, 11, and anticipate an indie clearance in 2021.
And continued to advance our discovery pipeline of potential first in class programs with the goal of the new IND every 12 to 18 months.
I would like to take a moment now to welcome the newest member of our management team.
Dr. Dimitri <unk>, who was appointed as Chief Scientific Officer in April.
Dmitry has more than 15 years of pharmaceutical industry experience as a scientific leader and drug developer and brings a broad knowledge of contemporary immuno oncology approaches.
Tumor immunology and cancer biology.
His expertise with preclinical target discovery and first in human research will provide invaluable contributions and our work to deliver the right immunotherapies to the right patients.
We're excited to have dmitry on the Jounce team.
With that I'll turn the call over to Dmitry to say a few words.
Thanks Rich.
I'm thrilled to join Jounce at such a pivotal moment in our company's journey to discover develop and commercialize important new immunotherapies.
After many years of building the oncology I O pipeline incentive fee.
My goal was to join a vibrant science oriented and fast based organization that understands what it takes to succeed in IL has resources to do so and is ready and able to forward integrate the company.
Coming from a large pharmaceutical company setting and seeing many biotech companies through business development activities I believe jounce is that place.
With J T. F 80, 64, and <unk> 18, 11 is good examples we hope to continue to create new important options for patients and value to jounce shareholders.
At our upcoming R&D day in late June I look forward to sharing more about the exciting science behind our pipeline translational work and particularly the opportunities around the myeloid cell focus as exemplified by little our family.
With that I'll turn it over to Beth to discuss our clinical programs in more detail.
Thanks, Dmitry and good morning, everyone.
<unk> 2021 is a year of clinical execution for Jounce and we remain focused on our two ongoing proof of concept studies innate and select.
These 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.
I would now like to provide more detail on both ongoing trials beginning with J P. Ex 80, 64, a little RB two inhibitor.
J T X 80, 64 is designed to reprogram immunosuppressive R. M. Two macrophages to immune stimulatory or M. One macrophages to enhance or restore anti tumor immune activity.
We view J T X 80, 64, as a macrophage checkpoint inhibitor with the potential to reverse PD, one or PD L. One inhibitor resistance as well as to further improve outcomes in PD, one inhibitor sensitive tumors.
Thereby having the potential to provide clinical benefit to a wide range of cancer patients.
We are very pleased with the pace of enrollment in the innate trial.
Our trial is designed to progress quickly through dose escalation and demonstrate proof of concept and expansion cohorts that will enroll patients with specifics the tumor types.
These tumor types were selected based on a variety of factors, including macrophage biology, potentially predictive RNA signatures.
The opportunity for differentiated development pathways.
An important part of our tumor selection process involved an examination of the unmet need and opportunities in both PD, one inhibitor experienced and naive patients as we explore the best opportunity for J T X 80, 64 to make a difference for patients with cancer.
At last month's ACR conference, we presented data describing how expression profiles of Lille RB two mrna.
Our proprietary tumor associated macrophage or Tam signature and interferon gamma signature we are used to identify tumor types that may benefit most from J P. Ex 80, 64 treatment alone or in combination with PD one inhibitors.
This data was used to inform the tumor types and expansion cohorts of the <unk> trial.
We remain on track for the opening of eight expansion cohorts, one with J T X 80, 64, monotherapy and seven in combination with PD one inhibitors.
These planned expansion cohorts will studied J T X 80, 64, and three subsets of patients in order to identify the best and most rapid development paths for J T X 80, 64 alone or in combination with PD one inhibitors.
These patients have very few treatment options and repeat immunotherapies have been largely unsuccessful.
We believe that J T X 80, 64 has the potential to restore responsiveness to PD, one inhibitors and bring the durable benefits of immuno therapy to these patients.
Second PD, one inhibitor naive patients with tumors that don't typically respond to PD one inhibitors.
This is also an area of high unmet need in which T cell directed immunotherapy has not had a significant impact and we believe that J T X 80, 64 alone or with a PD one inhibitor may make immunotherapy a viable option for these patients.
Finally, PD, one inhibitor naive patients with tumors for which PD. One inhibitors are approved but there is still much room for improvement.
By combining our macrophage targeting agent with a T cell directed therapy, we hope to improve clinical outcomes beyond what is achievable with PD one inhibitors alone.
We will provide the details on tumor types and scientific rationale for the expansion cohorts in a trials in progress poster at <unk>.
Once we have selected the dose and opened these expansion cohorts, we will provide guidance on the timing of data readouts.
I would now like to turn to an update on Volcker telematics and our first biomarker patient selection trial select screw.
Screening and enrollment is 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 piss flow for biomarker and randomized to vote from plus our PD one inhibitor pin me vs.
<unk> alone.
We believe the tis flow for biomarker will select more appropriate patients for both the C. D. Eight mediated benefit of a PD one inhibitor as well as the preferred the potential C. D four related benefit of Oprah.
We expected approximately 20% of second line non small cell lung cancer patients to beat his folk are positive and we are pleased that screening to date has validated this projection.
Details of the select trial will be provided in a trials in progress poster at ESCO.
Before closing I would like to take a moment to thank our team our investigators and the patients, whom we have the privilege to treat <unk>.
Now more than ever it is imperative to execute on our mission of delivering long lasting benefits to cancer patients.
We believe that our translational science biomarker approach and commitment to new mechanisms targeting different immune cells brings us closer to achieving this target.
We look forward to our continued progress in 2021 and to delivering on our important upcoming milestones I will now turn the call over to Kim for a discussion of our first quarter financial results.
Thanks, Beth and good morning, everyone.
As we reported in this morning's press release cash cash equivalents and investments as of March 31, 2021 increased to $271 3 million compared to $213 2 million as of December 31st 2020.
This increase was primarily due to the $90 8 million in aggregate net proceeds from sales under our follow on public offering and our ATM offset by operating cost incurred during the period.
Turning to the P&L, we recognize one 5 million in license revenue during the first quarter of 2021 which was comprised of 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 first quarter of 2021, we incurred $20 5 million in research and development expenses compared to $19 6 million for the same period in 2020.
The increase in R&D expenses was due to increased expenses from manufacturing and IND, enabling activities performed for our development program.
Offset by decreased clinical and regulatory costs attributable to reduced spending on both fronts.
General and administrative expenses were $7 6 million for the first quarter of 2021 compared to $7 5 million for the same period in 2020.
The increase in G&A expenses was primarily the result of increased stock based compensation expense.
Net loss for the first quarter of 2021 was $26 5 million, resulting in a basic and diluted net loss per share of 58 cents as compared to a net loss of $26 4 million for the same period in 2020, resulting in a basic and diluted net loss per share of <unk> 78.
Seth.
We are reiterating our financial 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 have always maintained a strong balance sheet and expect our existing cash cash equivalents and investments to be sufficient to enable the funding of our operating expenses and capital expenditure requirements through the second quarter of 2023.
The combination of our experienced team financial resources and innovative science puts us in a strong position to move beyond our next set of inflection point and continue to execute against our strategic plans and goals.
GAAP 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.
We look forward to updating you on our progress as the year progresses.
With that we would now like to open the call for your questions operator.
Operator.
Thank you, ladies and gentlemen to ask a question you will need to press. The Star then the one key on your Touchtone telephone to withdraw your question West the pound key.
Please stand by while we compile the Q&A roster.
And my first question coming from the line of Steve seen House with Raymond James Your line is open.
Good morning, This is Ryan Deschner on for Steve.
Wanted to ask are.
You guys seeing any surprises so far and by L. T. Four treated patients with respect to the pharmacology of the molecule or is it excuse me translate in humans as expected.
Thanks for the question, we don't usually report on data from ongoing clinical trials and all I can tell you is as I said enrollment is going very well.
And I think you know as we've said we think our molecule is more similar than different to merck's molecule. So we would expect something similar to what they saw in their phase one study.
Okay, and maybe real quick.
Can you talk about the stopping criteria for selecting when the interim analysis is expected.
They're yeah, there isn't an interim analysis and select.
Our expectation is to complete the.
To complete the study and report data in 2022.
Okay. Thank you very much.
And our next question coming from the line of.
Sway them.
From a time with H C. Wainwright your line is open.
Thank you this is RK from H C Wainwright.
<unk>.
Uh huh.
I have a couple of questions.
You know regarding the in its studies.
Rich is going to have about seven different combinations.
Between it is 64.
And on the PD one inhibitor.
Hum.
In the press release, and you hope that it could be either reported 14 14 or an approved.
<unk> one inhibitor.
How would you what are the criteria and in deciding.
Rich expansion cohort will get what PD one inhibitor.
Sure. That's a great question, what we've as I mentioned, we'll have the trials in progress poster at ESCO.
Where we will introduce that tumor specific tumor types.
That we're including in the study and then later in June we expect to have an R&D day to day and that's when we'll get into a little bit more detail will describe which PD, one inhibitor and which cohort the scientific rationale for each cohort more detail about the lines of therapy and that kind of thing for each cohort so stay tuned.
And we'll be providing detail on all of that very soon.
Sure and then just a follow up within the trial itself. You know you were talking about the three subgroups of patients that you're going to be investigating.
My question is more on the PD, one naive subsets and also the PD one naive but.
Minimal to poor response.
Group.
Within those subgroups I don't know if it is too early in the in the expansion cohorts.
Would you think about.
How to sequence the combination.
<unk> are that is from.
Another question now you'll just wanted to go ahead and just do a straight combination and then think about sequencing the drug's later.
Yeah, and we believe giving them on the same day. It makes sense Merck certainly saw very encouraging data in their study where they where the drugs were given on the same day. So we obviously as you know we collect a lot of Pharmacodynamic biomarkers in our study as well as the potential predictive biomarkers. So.
We certainly will be analyzing our PK and a receptor occupancy data and the PK of the companion molecules throughout the study.
To see if there's any suggestion that we would need to do sequencing them, but maybe I'll ask rich to comment on that as well.
Rich I think you're on mute.
Yes, Thanks Spencer.
Okay. Thanks for that question just to follow up on Thats, a little bit I think as we continue to study the mechanism.
We really believe that there is kind of the simultaneous action of these antibodies that of course there'll be onboard in terms of dosing. The route throughout the dosing cycle. So we'll still to pursue the mechanistic kind of underpinnings of what we what we see but I think all of that work really translates into.
Dosing molecules on the same day.
But that being said if they're both inhibitors so yeah.
Once you achieve that concentration that maintains inhibition of binding to the ligand at that point I don't know that sequencing really becomes that that relevant.
True Cellulosic.
Yeah, One last question from me before they step in.
To step back into the queue.
Beyond these 64 and $4 14, and obviously at 11, and we'll be moving onto and into their hands from Gilead.
Second half.
And I'm thinking about early stage pipeline.
I understand you'll talk more in due in June and your R&D day, but you.
Not with Mr. Jones.
Experience of bringing novel molecules to them to the forefront in or what sort of molecules should we expect that you could be unveiling.
Later in the year.
Yeah sure I think.
What will what will give us dmitry alluded to.
In late June.
As you know the kind of direction of where we anticipate new new programs to come from.
Been stating, we're very interested in the myeloid related cell biology.
RB two <unk> and 864 as our first example, but there are other low family members other mechanisms associated with.
Overall myeloid cell function that we think are.
Very important areas to pursue so we will provide a bit of depth on that dmitry has hit the ground running here and we'll provide that update in late June and then we'll stick to our kind of pattern of how we identify specific molecules. Once we're at the stage of the development candidate.
Then we will kind of announce that kind of progression as things move into the IND, enabling stages. So stay.
Stay tuned a lot of focus on the myeloid cell biology, we're very excited about that and again stay tuned for for late June on that one.
Thank you rich and the team. Thank you.
Sure. Thanks.
And our next question coming from the line of Colin Christie with Baird. Your line is open.
Hi, good morning. Thanks, so much for taking our questions is there any update you can provide on how many escalate.
Escalation dosing cohorts, you've cleared and then for the <unk> update can we expect any safety data from the <unk> study. It will that just be focused most on the trial design.
Yeah, Hi, Kelly and its Beth.
In terms of the dose escalation cohorts I think whats.
Important is we are still on track to open expansion cohorts, both monotherapy and combination in the second half of the year.
So other than that I'm not going to go into detail on those but we're doing really well on track we will be opening expansion cohorts in the second half of the year.
And regarding the trials in progress poster.
S. So just not allow inclusion of any data in the east coast. It really has to be strictly a description of the scientific rationale of a study design that.
Kind of thing.
Great that makes sense and helpful. Thank you.
And in light of the interesting data that you guys presented at ACR can you comment on how youre thinking of incorporating potential biomarkers into the expansion cohorts of the study I guess could some of those expansion cohorts potentially use biomarkers as a screening criteria or will that still be more exploratory.
Sure. That's a great question. So at this point all day in all of the expansion cohorts, we're collecting both archival tumor tissue and a fresh biopsies pre treatment and we will be screening those for a whole.
Panel.
Of potential predictive biomarkers that include both RNA signatures some of which we've.
Commented on in our prior posters and also some IH C. So we have.
I think we're in a great position because we have a number of these biomarkers that we've already identified so we're gonna be testing them.
Retrospectively looking back at the samples and doing analysis to see if they correlate with clinical outcomes. If we see something that looks like it's correlates. The next step would be to either enrich for select so I would say what you could look at these expansion cohorts now as the hype.
Potthast is generating.
And then the next stage would be something where would we would either enrich or select with whichever one of those biomarkers looks the most promising rich did you want to add anything.
Yes, yes, just as a reminder that.
Biomarkers that are is.
Speaking to that really is a kind of a collective set of what we think are the appropriate either PD or potentially predictive biomarkers that have come directly from our mechanistic and tumor related work.
Within jobs, so we kind of serve up assets that we think are worthy of being tested coordinated to the trial as Beth mentioned it should we find those correlations with clinical data then we move to the next stage.
Great that's really helpful and if I can just add one more quick one.
Are there any other potential combination regimens that you think could be interesting with 80 64 beyond PD one.
Sure and you know.
That's something that I think you know choline even after we're in the clinic. Our research teams are still very very active on the same program. So that's an active area of investigation.
Thank you for that question.
Great. Thank you.
And our next question coming from the line of Boris <unk> with Cowen Your line is open.
Great. Thanks for taking my question.
My first one is on $80 64, or you mentioned that your drug is relatively similar to merck's drug I'm. Just wondering if you could also maybe compare in terms of the patients you're enrolling in the studies how that may different front of patients that Merck is enrolling in their initial studies.
Sure Boris I got so in the dose escalation phase like Merck, we're enrolling all comers no specific tumor types, no kind of enrichment or selection. So I would say the dose escalation parts of the study are probably very similar.
Then we are doing these expansion cohorts in specific tumor types.
We're being very specific there is down to the line of therapy. The type of prior therapies allowed for each of those Merck is also doing expansion cohorts in their study them. They opened nine expansion cohorts are in January of 2020, and we don't know as much about those is.
We know about the dose escalation patients.
What I can say is in the dose escalation, we will have far fewer patients than Merck did because we were able to leverage some of their data and reduce the amount of dose escalation cohorts. However.
Once we get into the expansion cohorts those are really dictated by the specific eligibility for each cohort Merck has theirs, we have ours. So there unless we do cohorts that are at exactly the same patient population I would expect them to be potentially different and I'll finish just by saying.
Since the molecules do appear to be quite similar we believe that the way that we can differentiate is through the tumor types that we're exploring as well as our biomarker strategy.
Gotcha and maybe.
Speaking of a biomarker or switching to vote for the tissue Oprah biomarker.
Clinical development would you have to do in order to get the diagnostic tests for the biomarker approved.
Sure when you when you develop a drug that set with a companion diagnostic the companion diagnostic is actually developed by a company that makes the biomarker them, but it's a very collaborative process. This is done on the non of strength platforms, such a well recognized process and.
You know, we we know what the development takes there's a whole paths through a different part of the F. D. A.
You know well mapped out so if that's what we do going forward.
There's no no particular extra complications there we know what we need to do to take that forward Rich did you want to add anything.
Yeah, Yeah, and maybe just maybe just add to kind of on the business side of that.
It kind of different stages of investment that one would that one would take in the kind of journey to get to the companion diagnostic. So clearly we're at the clinical stage weird.
Running the assay.
Banner, that's consistent and appropriate with that but we will be able to seed stage gate our investment on that.
Kind of passed which would then go to the next stage should the data warrant.
Kind of readiness score.
Starting on the route to readiness for commercialization of that of that biomarker in assets.
Great. Thank you very much for taking my questions.
Welcome.
And our next question coming from the liner Nic average with Wells Fargo Securities. Your line is open.
Good morning, Thanks for taking my questions and Dmitry welcome to the T line literally it could mean to you virtually.
<unk> ended the year.
A couple of questions from me.
So lei.
So can you remind us if there's a correlation between makers.
Bakers signature any oncogenic drivers of long term and just sort of thinking or maybe that control. Obviously, you have one variable which is.
Basically the patients for which we don't know.
PD one inhibitor would do in net subset of patients, but then on top of that I'm wondering what spectrum of different oncogenic driver as you might expect to see.
Yes, I think I cannot I can take that one Nick.
We don't have a physical oprah.
Related kind of correlation to <unk>.
Specific oncogenic drivers. However, we know of course that.
There are oncogenic drivers in these patients and they will.
Follow that route to a specific therapy should they have the right kind of kind of the <unk>.
Kind of driver mutation as such but as we look at that kind of potential overlap with <unk>. His volta is really telling us much more kind of the state of activation of the CD eight cells and we believe the CD four cells. So thats really kind of the uniqueness about this biomarker, we're kind of getting both anger.
Rules on that C H.
84, and then.
Whether that kind of overlaps with mutate.
Mutations.
Or not.
The <unk> bokor score makes the patients more likely to be benefiting from this combo combo therapy. So we don't don't have that kind of direct correlation to the oncogenic drivers of course, if those patients have those drivers they will be going down the route of a particular, a particular line of therapy for that particular.
Their drug.
Yeah, that's right. So they're in addition, yeah. In addition, Nick we actually we exclude patients with Egfr mutations.
That being the biggest class of oncogenic drivers.
That generally patients with those mutations don't do as well with PD one inhibitors. So we're excluding them and then as rich mentioned the patients with other drivers would be likely to go down a different path of therapy.
Targeting the mutations.
Yes, I think we will also learn Nick as we get these larger datasets from all the patients enrolled how all these things kind of overlap or not with each other.
That kind of data, we'll we'll emerge as these as the dataset fills out.
Okay. Thanks.
And then 80 60 pool for that.
PD lone experience.
Net of tumors.
Do you think there's a difference in the role.
Total itself in the setting for primary required.
Moving to PD, one inhibitor and <unk> and how do you think about studying both those populations potentially.
And the expansion cohorts at midnight.
Yeah.
Yeah, I think that's a great question I'm not sure there's enough data right now to know the difference between which cell types are playing a primary role in primary and acquired resistance and that's why we're planning to study those two groups of patients. So you could the PD one resistant patients who have failed.
The PD one inhibitor you could say some of them might be primaries, some of them might be secondary and we'll certainly be collecting that data and then the tumor types that are PD, one naive that where PD. One inhibitors aren't approved you could think of those as kind of primary PD. One resistant. So we think it's important to look at both and we'll be analyzing the data based on.
And what kind of assistance they have.
Terrific. Thank you very much.
Youre welcome.
Our next question coming from the line of that bad childhood with Roth Capital. Your line is open.
Good morning, guys. Thanks for taking my question. The first one here is just on.
On the enrolment Bristow last I know you can't say much but I was just wondering if you're finding second line Io naive patients as easily as you thought you would buy going ex U S and then another.
Another follow up to that is that I mean, I know that there's not too much that can be done, but I was just wondering if you could perhaps while we wait for the data looked at our cloud low tissues from tissue Bank line, a little bit more about that kids love by signature because I believe must have the original analysis was done based on tissue from day.
Connick study.
Yeah, that's a great question sake, but we also worked with non a strength to get some additional tests data, but to your point.
First of all the we did have some setbacks related to COVID-19 I really think the COVID-19 impact it's really the only negative impact on the study in terms of the screening rate.
We're quite happy with that and also we've been very pleased that as we predicted 20% of these patients artist fault for positive. So that was our prediction based on prior analyses and that's what we're seeing in the study.
So that the patients are definitely there there are a lot of places where patients don't have access to PD one inhibitors, we have to screen.
Five day to find one.
But that's actually not too bad when you think about the the the rates of some of the other target you know that biomarkers for targeted therapies, which are in the single digits.
Thank you.
Uh huh.
Yes, sorry to say, but maybe to the other part of your question. There is just data available and thus we can kind of dial in the <unk>.
Specific cutoff point in other types of tumors as well so kind of you know more to come on that in terms of the science, but it's not not unlike the sense you get certain tumor types from more highly infiltrated have more activated immune cells. Other tumor types down the other end of the spectrum and may not.
Have that so that's kind of the way to think about disciplined growth.
Thank you very helpful. And then just one follow up here.
Alrighty your comment about you know multiple range.
Just curious because I got excited when you said multiple cohorts I'm thinking multiple shots on goal here, but in terms of you know that the cohorts I know you can't say too much now because you have to tell them pack I close it back from a risk perspective, just curious how.
How much are you pushing the envelope with some of the cohorts in terms of you know.
How much you know you really think you have data to support it versus the others, where it's just like one of the melting that people typically do I'll of course expansion.
Oh sure. So I think actually all of the cohorts are really grounded in the science. So I think they all have an equal potential to to show. Good results and then what we've done is you know as we've described.
Of those seven combination cohorts.
Some of them are in the PD one.
Experienced some of them are PD, one naive and you know some of them are in tumor types that respond to PD one summer in tumor types that typically don't so I think we've got a really good distribution and.
And the.
And the goal is to really cast a wide net but all based on the science. All of these are absolutely rooted in the science and then they're just exploring different settings in which that mechanism might work.
Thank you and I think this has been related to a follow up question as well you know just regarded as you know just trying to understand at what sells my where you know it and things like that with myself my dry eye resistance and things like that so I think sometimes you do have to go where we have large books just wondering if you.
But I'd be doing such large studies in the future because you're just trying to like yours that cast a wide net is that what we're going to expect from your other programs.
Really huge studies and then just so I can hop off follow up here you guys seem to still be the only one that's focused on you know really going after novel Biomarkers. So I'll follow up Cabarrus as cash then it's just.
How complex is the biomarker strategy from a development and what you anticipate from a commercialized day from prospective because I'm. Just wondering why you know I'm not a lot of people are still actively pursuing novel Biomarkers beyond the ones that we typically know like PD ones.
Sure. So I think PD one is a good example, PD L. One is a good example of where a biomarker made a huge difference that truly what catapulted from a timber listen map of Keytruda forward.
If the data is strong enough without a biomarker that's fine I mean, if a large percentage of your patients respond and do well then you don't need a biomarker. We just think it's really important to incorporate it early on in case, you really do need it to find the patients that benefit and obviously you don't want to treat.
People with something that's not going to provide benefit to them. So you want to find the right patients the right therapy for the right patients Rich did you want to add to that.
Yes, maybe segment another another way to think about this is the the biomarkers that we now take for as being relatively common where all directed at PD, one inhibitors CDA T cell biology, T cell activation and such and as you know many of our discovery programs appointed a different immune cell types.
So there is a set of biomarkers that may be become more established for the myeloid cells and for the macrophages and perhaps other cell types. So I think thats, perhaps the way to see this kind of you know.
Cascade of Biomarkers, they linked to certain cell types and behaviours in biology.
The difference of the different cell types.
And then in terms of the clinical development program sake, but for a molecule like this it is possible that it could be active.
Active in multiple different tumor types. If you look at the PD one inhibitors. So this could <unk>.
Develop into a very large development program, yes, I mean, what we're planting the seeds in you know in all of these different cohorts now there are additional things that we might want to look at in the future. We could expand these within the study we could do additional studies in these tumor types I think where we're planting the seeds for a.
Very large development program.
Thanks, guys and congrats again on the progress.
Thank you.
And as a reminder, ladies and gentlemen to ask a question. Please press star one non next question coming from the line up to.
Ted Hoff with Piper Sandler Your line is open.
Great. Thank you very much so question from environments with reports of the poster at <unk>.
EPS includes can be a great update.
Is the plan with respect to the.
806, four or in the expansion studies to do critical partnering with those cohorts be able to be expanded on success from potentially in the form registrational curves.
Great question Ted.
Yes. These are initially for signal finding but each expansion cohort is actually designed as a Simon two stage design. So we have particular triggers that would lead to further expansions and.
You know if we see encouraging data.
Then the next step.
To see if they could potentially become registration trials would obviously be discussion with FDA, but we do think some of them may have that potential.
If the data is strong enough.
Great.
Like the new day.
Did you have another question.
No I was just saying I like the new name for the PD one.
Kimi.
Yes.
Thanks, guys.
Alright, thank you.
That's all the time, we have for a question and answer session today, ladies and gentlemen, thank you for participating in today's conference.
This does conclude the program you may now disconnect have a good day.
Thanks.
Yeah.
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