Corvus Pharmaceuticals Q4 2024 Earnings Call Transcript

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March 25, 2025

There are 8 speakers on the call.

Operator

Good afternoon, everyone. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Fourth Quarter and Full Year twenty twenty four Business Update and Financial Results 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. It is now my pleasure to turn

Speaker 1

the call over to Mr. Zack Kubo of PL Chemistry. Thank you. Please go ahead, sir.

Speaker 2

Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals fourth quarter and full year twenty twenty four business update and financial results conference call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer Leif Li, Chief Financial Officer Jeff Arquera, Chief Business Officer and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences. The executive team will open the call with some prepared remarks followed by a question and answer period. I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements.

Speaker 2

Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements, including the risks and uncertainties described in Corbus' annual report on Form 10 K for the year ended 12/31/2024, that was filed today and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law. With that, I'd like to turn the call over to Laith Leith. Laith?

Speaker 1

Thank you, Zack. I will begin with a quick overview of our fourth quarter and full year 2024 financials and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter twenty twenty four totaled $6,000,000 compared to $4,000,000 for the same period in 2023. The $2,000,000 increase was primarily due to an increase in socolitinib clinical trial expenses. R and D expenses for the full year 2024 totaled $19,400,000 compared to $16,500,000 for the full year 2023.

Speaker 1

For the full year 2024, the increase of approximately $2,900,000 was primarily due to higher clinical trial costs associated with the development of socolitinib. The net loss for the fourth quarter twenty twenty four was $12,100,000 including a non cash loss of $2,200,000 related to Angel Pharmaceuticals, our partner in China. In addition, we recorded a non cash loss of $2,300,000 from the change in fair value of Corbus' warrant liability during the fourth quarter twenty twenty four. This compares to a net loss of $6,700,000 for the same period in 2023, which included a $1,400,000 noncash loss related to Angel Pharmaceuticals. The net loss for the full year 2024 was $63,300,000 including a $3,200,000 noncash loss related to Angel and a noncash loss of $33,400,000 from the change in fair value of Corvus' warrant liability during the year.

Speaker 1

This compares to a net loss of $27,000,000 including a $5,300,000 non cash loss related to Angel for the full year 2023. Total stock compensation expense for the fourth quarter and full year 2024 was $800,000 and $3,000,000 respectively compared to $600,000 and $2,100,000 for the same periods in 2023. As of 12/31/2024, Corvus had cash, cash equivalents and marketable securities totaling $52,000,000 as compared to $27,100,000 at 12/31/2023. Of note, associated with our financing in May 2024, we also sold common stock warrants that have an exercise price of $3.5 and expire on 06/30/2025. Two investors early exercised their warrants during the fourth quarter of twenty twenty four, resulting in $18,600,000 in cash to the company.

Speaker 1

If all the remaining warrants are exercised, we will receive approximately $41,000,000 in additional cash. Based on our current plans, we anticipate our cash provides runway into the first quarter of twenty twenty six. I will now turn the call over to Richard who will discuss our clinical progress and elaborate on our strategy and plans.

Speaker 3

Thanks, Leif, and good afternoon, everyone. Thank you for joining us today for our business update call. As we look into 2025, we remain optimistic on the potential for sokolitinib to provide a powerful new approach for the treatment of a broad range of immune diseases and cancer. Sokolitinib is well positioned as a first in class oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system. Our confidence is backed by a strong and growing body of evidence, both from our clinical efforts and preclinical research conducted by us and others.

Speaker 3

First, we have reported a thirty nine percent objective response rate from our Phase one trial of socolitinib in patients with relapsed T cell lymphoma. This included a twenty six percent complete response rate, which is more than double the rate seen with standard chemotherapies. Based on this data, we are enrolling a registrational Phase three trial of socolitinib in patients with relapsed peripheral T cell lymphoma and we have gained a significant amount of experience that we are applying to our other socolitinib programs. Second, we observed a favorable safety and efficacy profile from interim data from our Phase one trial of socolitinib in patients with moderate to severe atopic dermatitis. This includes significant responses in the socolitinib treatment groups compared to placebo or the clinically significant endpoints of investigator global assessment or IGA001 and eczema area and severity index or EASI 75.

Speaker 3

Third, preclinical data supports the potential of ITK inhibition in a broad range of indications, including solid tumors, immune conditions such as autoimmune lymphoproliferative syndrome or ALPS, systemic sclerosis, pulmonary fibrosis and graft versus host disease and inflammatory conditions such as asthma, psoriasis and inflammatory bowel disease. The data also highlights its mechanism of action skewing differentiation to Th1 cells, reducing Th2 and Th17 cells and their downstream cytokines and promoting a switch to T regulatory cells that suppress inflammation. Given the broad applicability of its mechanism of action, we view the potential of ITK inhibition as analogous to BTK inhibition, a category that members of the Corvus team, including myself helped to develop. BTK inhibitors were first approved for B cell malignancies and then expanded into autoimmune conditions. Today, I will recap our previously reported data in atopic dermatitis and next steps for the trial, share some detail on the recently initiated NIH trial in ALPS and highlight the upcoming milestones for sokolitinib.

Speaker 3

In January, we reported interim data from the Phase one trial of socolitinib in patients with moderate to severe atopic dermatitis. The trial includes four cohorts that are enrolling 16 subjects each at a three:one ratio of active to placebo, 12 active for placebo. The trial is double blind, meaning the patient and the doctor do not know what they're taking. The active medicine and placebo are indistinguishable tablets. The company and the data review committee are not blinded.

Speaker 3

The treatment period is twenty eight days and then we follow patients off therapy for another thirty days. The twenty eight day treatment period is relatively short compared to later stage atopic dermatitis studies with other agents, which typically treat up to sixteen weeks or longer. The primary endpoint is safety and tolerability, secondary endpoints measure based on IGA and EASI scores along with patient reported measures of itch and biomarkers. The first two cohorts received socolitinib doses of one hundred milligrams twice a day and two hundred milligrams once per day. The same total dose of drug was used in the first two cohorts.

Speaker 3

Based on our lymphoma studies, we know that one hundred milligrams will provide 50% to 80% occupancy of the target and two hundred milligrams will provide about 80% to 100% occupancy. In January, we reported data from sixteen patients in Cohort one and ten patients in Cohort two for which twenty eight days of treatment had been completed. In total from the combined cohort one and two, this included nineteen patients treated with sopolitinib and seven patients treated with placebo. In the sopolitinib group, twenty six percent achieved IGA zero or one and thirty seven percent achieved EASI 75. Recall, these have been accepted as measures of clinical benefit and have been used as the basis for regulatory approval for several approved treatments for atopic dermatitis.

Speaker 3

In the placebo group, no patients achieved IGA0 or one or EASI75. No significant safety issues were observed and no clinically significant laboratory abnormalities were seen. Cohort three of the trial, which administers a dose of two hundred milligrams twice a day, that is twice the total daily dose we used in the earlier cohorts is nearing completion of enrollment and some patients have already reached the twenty eight day follow-up period. The efficacy results so far in the trial, including full cohort one and two and the initial experience in cohort three have been positive and consistent with what we have reported to date. No patients in the active treatment groups received concomitant topical steroids or required rescue medications.

Speaker 3

One patient in the placebo group did receive concomitant topical corticosteroids. In cohorts one and two, two placebos experienced flares in their disease during the twenty eight day treatment period, whereas no disease flares were seen in the patients receiving active drug during the twenty eight day treatment period, as well as the follow-up period off treatment. Sogolitinib has been very safe to date as well with no patients requiring interruption of therapy. We now have experience in over one hundred patients with lymphoma and atopic dermatitis representing more than nine thousand patient days of treatment, including patients with lymphoma on therapy for up to two years. We continue to believe that sokolitinib is an active medicine for atopic dermatitis with several advantages, oral route of administration, attractive safety profile, a novel mechanism of action with an opportunity for unique positioning, including the potential to bridge between topical therapies and systemic injectables.

Speaker 3

We plan to report data covering the first three cohorts at the Society of Investigative Dermatology meeting taking place May '10 in San Diego. Our abstract has already been accepted for an oral and poster presentation at this meeting. Outside of atopic dermatitis, we continue to enroll patients in our registrational Phase three trial of sokolitinib in patients with relapsed PTCL. Recently, we presented updated data from our Phase one trial at the T cell lymphoma forum with longer follow-up showing that the median progression free survival is 6.2 and the eighteen month progression free survival is thirty percent. The median duration of response was seventeen point two months.

Speaker 3

PFS or progression free survival is the primary endpoint of our Phase three trial, which is comparing sopolitinib to either belinostat or pralitrexate, the standard of care agents with reported median PFSs of about three months and eighteen month PFSs of under twenty percent. We also have recently announced the initiation of enrollment in a Phase two trial of socolitinib in patients with ALPS, autoimmune lymphoproliferative syndrome. This study not only addresses a disease with unmet need, but will also provide additional information on the activity of selective ITK inhibition in a serious autoimmune disease. ALPS patients are born with a genetic mutation in fast signaling that results in lympho proliferation and a myriad of autoimmune problems such as anemia, neutropenia, thrombocytopenia and others. Some of these patients go on to also develop malignant lymphomas.

Speaker 3

The ALPS trial is being conducted under a clinical research and development agreement with the National Institutes of Allergy and Infectious Diseases at NIH. It will enroll up to 30 patients aged 16 years or older with confirmed ALPS based on genetic testing. There will be two dosing cohorts, two hundred milligrams or four hundred milligrams of sokolitinib twice per day for a period of up to three sixty days. The primary endpoint of the trial is efficacy determined by reductions in spleen and lymph node volumes as measured by CT scans. In addition, improvements in cytopenias or lower blood cell levels will be assessed by complete blood counts.

Speaker 3

Improvements in cytopenias can improve quality of life and overall health and serve as a biomarker associated with ALPS disease activity, including auto antibody levels that are reactive with red cells, white cells and or platelets. Secondary endpoints include safety and tolerability. We are also planning a single agent socolitinib solid tumor trial in relapsed renal cell cancer or RCC representing a new approach to immunotherapy of this disease. We plan to initiate this trial during the third quarter of twenty twenty five. Outside of sopolitinib, we also continue to advance our other clinical stage development programs.

Speaker 3

We have been one of the leaders in the development of adenosine A2A receptor antagonist for the treatment of cancer with ciforadenant. This includes our Phase 1b2 clinical trial that is being conducted in collaboration with the Kidney Cancer Research Consortium. The trial was evaluating cifiradenant or cifiradenant as a potential first line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab. The study has reached full enrollment of 60 patients at sites including MD Anderson, Vanderbilt Duke and the University of Pennsylvania. The patients are being followed and we anticipate our partners at the Kidney Cancer Research Consortium will present data from the trial sometime later in 2025.

Speaker 3

Finally, I should mention that we are advancing several second and third generation ITK selective inhibitors designed to preferentially affect particular ITK signaling pathways. Summarizing the outlook for the remainder of 2025, we remain focused on advancing the broad opportunity for sopolitinib, which has several potential upcoming catalysts. This includes number one, additional data from the Phase one trial in atopic dermatitis in May at the Society for Investigative Dermatology meeting number two, full data from the Phase one trial in atopic dermatitis in the third quarter. Number three, initiating a Phase two clinical trial with sokolitinib in solid tumors in the third quarter of twenty twenty five with initial data anticipated in the first half of twenty twenty six. Number four, initiating a Phase II atopic dermatitis trial in late twenty twenty five.

Speaker 3

Number five, continuing to activate sites and drive enrollment in the registrational Phase III trial of sokolitinib and PTCL driving towards interim data in late twenty twenty six. And depending on enrollment trends, it's possible we could see initial data from the Phase two ALPS study in late twenty twenty five or early twenty twenty six. Our current cash gives us runway into the first quarter of twenty twenty six, allowing us to execute on these important milestones and further demonstrate the value of our programs and in particular the significant opportunity for ITK inhibition in immunology and cancer. We look forward to providing updates on our programs in the coming quarters. I will now turn the call over to the operator for a questions and answer period.

Speaker 3

Operator?

Operator

Thank you. Thank you. And your first question comes from the line of Jeff Jones from Oppenheimer. Please go ahead.

Speaker 4

Good afternoon guys and thanks for taking the question. Lots of data updates to come, so really exciting time for you guys. I guess starting out on the AD front and the update in May, will the should we expect full data on Cohort three as well as additional patients on Cohort two? And then as you think about the efficacy hurdle there, what do you guys have in your head to move this ahead into the Phase 2a that you just mentioned?

Speaker 2

Or

Speaker 4

in just competitiveness in the field?

Speaker 3

Okay. So Jeff, the meeting in May, the Society of Investigative Dermatology, we intend to report the full data set on Cohort one, the full data set on Cohort two. We've already completed enrollment and follow-up in those two cohorts. Cohort three is almost completed enrollment, twenty eight day follow-up was coming in on patients now. We're also going to have additional one month follow-up beyond that.

Speaker 3

So we'll have the full data for cohort one, two and three. I also expect to have biomarker data for those first three cohorts as well.

Speaker 4

Okay, great. And then just in terms of the success hurdles and efficacy bar that you guys are looking at?

Speaker 3

Well, first of all, we're pretty pleased with the efficacy we saw in cohort one and two. Let me remind you, that's twenty eight days of treatment. We see what a thirty percent difference in some of these 25%, thirty five % difference between placebo, which was zero in cohort one and two and our actives. That's a pretty good number. And that number sustained or improved would be very good in our opinion.

Speaker 3

Now, of course, many people are asking about what would happen if we increase the duration of therapy and that's something that we're thinking about and will come in time. So we're pretty pleased with the efficacy results we have to date. In terms of competitive landscape, of course, we're oral, we have different mechanism of action. Safety looks really good so far, convenience. The study, the design of our study was really intended to determine whether or not selective inhibition of ITK had some role in immune diseases.

Speaker 3

There are some signals, some indication of efficacy in an autoimmune disease. And I think we've got that. Now of course, as we think about Phase two trials and beyond, we'll begin to think about what's required for registration etcetera. But I think from a competitive standpoint, to my knowledge, we're the only selective ITK inhibitor. I know there are some other companies that have ITK inhibitors and are talking about it now, but they're not selective and we view that as critical in the biology.

Speaker 3

And so I think we're in pretty good shape on this.

Speaker 4

Great. Thanks, Richard. I'll hop back in queue.

Operator

Thank you. And your next question comes from the line of Aden Jose Noff from Ladenburg Thiemann. Please go ahead.

Speaker 4

Hi, good afternoon, everyone. Richard, congratulations with the progress this quarter. I've got a couple of questions here. So regarding the potential Cohort four, so could you clarify your plans for Cohort four, whether you still would like to enroll in 400? And just if you could give us like a general idea what is the difference in terms of the doses?

Speaker 4

I mean, why would you like four hundred milligram dose as compared to the oncologic trial where you maximum what's where were your optimal dose is just two hundred milligram?

Speaker 3

Thank you, Aidan. Good question. So just for the benefit of everyone else cohort one was one hundred milligrams BID, cohort two was same total dose two hundred milligrams once a day, cohort three two hundred milligrams twice a day and cohort four as you indicate would be four hundred milligrams at the same total dose one time. So before deciding whether we're going to do cohort four, that is the plan, but we want to look at the full data set from cohort three. We already have cohort one and two.

Speaker 3

We'll look at the data from cohort three and then we'll decide whether we would do that or not. Right now the plan is to do that, although we are thinking about other possibilities like extending duration of therapy. Each of the doses one hundred, two hundred, four hundred give very good occupancy of the receptor. And of course, as I've indicated in previous calls, we don't really know what it takes to get a clinical effect or biologic effect in atopic dermatitis, whether you really need a 100% occupancy. But even at our starting dose of one hundred, there's pretty good occupancy.

Speaker 3

So right now the plan is to do cohort four, but before we decide definitively on that, we want to look at our data.

Speaker 4

That makes sense. And regarding the prior therapies, I know that many of those patients previously failed Dupixent, first two cohorts. How about the Cohort three? Did you see the patients? Sorry, they're Dupixent naive, sorry, the first cohort.

Speaker 4

So is the cohort three also sort of mostly Dupixent naive patients?

Speaker 3

We have deliberately searched for sicker patients in Cohort three. So we do have more Dupixent and systemic treatment failures in cohort three. We also have so far, I mean, we're not done with the cohort. We do appear to have higher baseline EZ scores. So we'll have to look at that and we'll see how that turns out, whether there's a particularly good or effect in the 2P failures, we don't know yet.

Speaker 3

We don't really know how that variable fits in yet.

Speaker 4

Okay, understood. And the last one is the biomarker question. I think you mentioned that you will be talking about biomarkers in May. So could you elaborate a little bit on that? What kind of biomarkers are out there for atopic dermatitis?

Speaker 3

Well, I would say that some of the work that we presented back in January on biomarkers are in December is being confirmed in our ongoing studies. In addition, we've picked up a couple of other things that I think are quite interesting. I've been talking about we've been talking and studying these T regulatory suppressor cells and other cells. And I think those are turning out to be extremely interesting. We continue to see a very durable effect of our treatment in patients who receive the drug.

Speaker 3

And I mean it's a small data set, it's very early, but it's also very provocative at this point.

Speaker 4

Okay, understood. Thanks so much.

Operator

Thank you. And your next question comes from the line of Greg Souvenabe from Zoho Securities. Please go ahead.

Speaker 4

Hi, this is Sam on for Greg. Thanks for taking our questions. Maybe one on ALPS, just given that it's a new indication. Can you just tell us in terms of like the addressable patient population that you guys kind of due diligence? And also what if there is a subset of patients that would be ideal candidates for soclatinib among people with ALPS?

Speaker 4

Thank you.

Speaker 3

Okay. So in The United so ALPS or ALPS, autoimmune lymphoproliferative syndrome is a genetic disease, you're born with it. I'll give you a little background on the disease. Babies are born with it. They at around age two, they start to develop anemia and big spleens and lymphadenopathy infections and they get a diagnosis made of course.

Speaker 3

And then they're on lifelong immunosuppressive therapies, cyclophosphamide, steroids, mTOR inhibitors, things like that. And they can be on that a long time, disease not curable. And they'll have waxing and waning adenopathy and cytopenias, anemia, neutropenia, thrombocytopenia. They can live thirty, forty, fifty years old now, but they suffer a lot of the complications. They have massive splenomegaly as another problem they have with sometimes can rupture.

Speaker 3

A subset of these patients maybe ten percent, twenty percent go on to develop malignant lymphomas, usually they're B cell lymphomas. But the abnormal cell in ALPS is a T cell. It's an abnormal T cell called the double negative T cell that does not have CD8 or CD4. I won't go into the biology of it, but it has a lot of ITK expression. And in our work looking at the effect of sokolitinib in various murine autoimmune models, we found that the same there's a strain of mouse called the MRL LPR negative negative mouse that has the very same mutation that you see in these patients, same disease basically, genetically.

Speaker 3

And when we treated animals with our drug, it was dramatically effective, really dramatically effective. Cytopenia is go reverse and become normal, splenomegaly, lymphadenopathy, all that thing, basically these animals become normal. And so that prompted us to say, hey, let's go treat the human genetic identical genetic disease in humans. And that led us to the NIAID that has a very big collection of these patients. Now most pediatric hospitals have patients like this.

Speaker 3

And you asked about the market. There are about two thousand five hundred patients with this disease in The United States currently. They live a long time. They live to be age 40, 50 as I said, some die sooner, but that in general is their lifespan. I don't think there's any particular subset that would be not to our knowledge now that would be more or less amenable to this therapy.

Speaker 3

So I just we just don't know. Sometimes there are slightly different mutations in patients. But the main problem in the mouse and in the human beings is that their cells, their lymphocytes do not undergo apoptosis. Now there's a very strong connection between T cell receptor signaling and apoptosis. Think about it when there's antigen or you have an infection, you want your T cells to proliferate, kill off the infection, but then you want those T cells to go away when the infection is eliminated.

Speaker 3

That requires apoptosis that is regulated by ITK. ITK has many rules in various signaling pathways. And when you block ITK, you restore apoptosis to these cells. And so that's the rationale for this. So basically, this is a treatment that I think you would take for a long time.

Speaker 3

And given the safety we've seen so far, we think this could be very important. Now also from a regulatory standpoint, this is not a disease I don't think where you're going to be asked to do big randomized clinical trials. So that's something else to think about. We're very excited and interested in this disease. You can tell by my long winded answer.

Speaker 3

And then finally, what this does is, I mean, this is really an opportunity to look at the effect of our drug on all sorts of autoimmune manifestations, anti red cell antibodies, antiplatelet antibodies, all that sort of stuff, which we think will have important relevance to other autoimmune diseases. Does that answer your question? Probably.

Speaker 4

Definitely very insightful. Thanks so much Richard for taking our question.

Operator

Thank you. And your next question comes from the line of Roger Tsong from Jefferies. Please go ahead.

Speaker 5

Hi. This is Chacha Yang on for Roger. I'm looking towards your Phase two for AD and I'm wondering if you can give some color on what subpopulations within the disease you're hoping to target. More specifically, if you could talk about aspects like prior medication use, baseline EZI scores and then any geography and demographics insights that would be great?

Speaker 3

Well, that's a pretty tough question considering we haven't finished Phase one yet, but moderate to severe atopic dermatitis failed topical corticosteroids or a systemic therapy, very similar to the criteria we're using now. I don't know if I would require I mean baseline EASI scores to be moderate or 16 or greater. So I don't think we would have any requirements beyond that. I think a typical study would be look at two different dose levels, plus a placebo. So probably a three arm study, maybe around 200 patients total.

Speaker 3

But that's kind of an approximate answer at this point. But that's all pretty standard.

Operator

Okay. Sounds good.

Speaker 3

And the endpoint would be either EZ 75 those who achieve EZ 75 or IGA01. That's pretty standard endpoint now.

Speaker 5

Great. Thank you for that.

Operator

Thank you. And your next question comes from the line of Lee Watsack from Cantor. Please go ahead.

Speaker 6

Hi, team. This is Daniel Brander on for Lee. I have a question about the prioritizing of opportunities for Sogol in oncology versus inflammatory disease and how you look at it as you move into later stage trials?

Speaker 3

Okay. Well, right now we have sokolitinib in a Phase three registration trial that could produce data in less than two years. And so we're pushing on all fronts as aggressively as we can. So the idea the strategy is try to get an approval in lymphoma, try to get an approval or in an immune disease. Now we are aware of the some of the issues with having a similar same drug for autoimmune and can't autoimmune disease and cancer.

Speaker 3

We have very aggressive program in second and third generation compounds. We also think that the dosing and duration of therapy are going to be very different in oncology versus immunology. Very good example would be Rituxan, for example, which came out of my lab at IDEC. Rituxan is approved for lymphomas as you know, it's also approved for rheumatoid arthritis, pemphigus, ITP and probably a few more autoimmune diseases. And there is really no issue with pricing because the treatment regimens are such that on a per milligram basis, it turns out to be pretty similar.

Speaker 3

So our strategy now is push forward on all these fronts and get deeper and deeper into the pipeline. And at some point, of course, we recognize that autoimmune diseases is a vast undertaking. There's many different diseases and competitive areas. And of course, we would at the right time consider some sort of a collaboration or partnership.

Speaker 6

Okay, cool. Thank you so much for that detailed answer. And the other question we were wondering about is you alluded to earlier a little bit, the delay in the presentation of Cohort four, is that more driven by your waiting and seeing of Cohort three results or has there been a delay in enrollment more generally?

Speaker 3

No delay in enrollment. We're waiting to see the data from Cohort three and we'll make a decision about proceeding with Cohort four or maybe expand one of the other cohorts.

Speaker 6

Okay, cool. Thank you so much.

Operator

Thank you. And your next question comes from the line of Shan Li from H. C. Wainwright. Please go ahead.

Speaker 7

Hi, good afternoon and thanks for taking my question. I just have one on the upcoming solid tumor study that's been planned. I was wondering whether there are specific indications that you feel are most suitable for succulitinib or will it be just a general basket study? And also would you need to do a dose escalation again or would you start with the PDCL dose? Thanks.

Speaker 3

So the first part of the question, which tumors? I would start with the we will start with the immune responsive tumors. So what are those? Those are renal cell cancer, lung cancer would be good. Those would be probably the top choices to start.

Speaker 3

Because you want tumors where you think there's some evidence for immunotherapeutic effects. Melanoma might be another one, although that's a much less common disease and is somewhat adequately treated by other treatments. So I would say renal lung, I don't think we need to do a dose escalation, but certainly you would want to do different doses. You'd want to look at different doses. It wouldn't be a dose escalation in the usual sense that you're thinking of like a Phase one oncology study.

Speaker 3

But you would probably want to look at different doses. But we have a pretty good handle now on the dose and we have a very good pharmacodynamic marker, which is we know what it takes to saturate the ITK target. So one hundred, two hundred, three hundred or four hundred, we're all in the same ballpark. They're all going to be giving pretty much same similar findings.

Speaker 7

Great. Thanks for that.

Operator

Thank you. There are no further questions at this time. I would now hand the call back to Mr. Richard Miller for any closing remarks.

Speaker 3

Okay. I want to thank everyone for participating in the call and we look forward to additional updates in the future. Thank you very much.

Operator

Thank you. And this concludes today's call. Thank you for participating. You may all disconnect.

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