Immunocore Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 15 speakers on the call.

Operator

Greetings. Welcome to the Immunacor Second Quarter 2023 Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

At this time, I would like to hand the call over to Clayton Robertson, Head of Investor Relations. Thank you. You may begin.

Speaker 1

Thank you. During today's call, we will be making certain forward looking statements, including about financial projections, Development activities, business strategy and the timing and impact of future events. Actual results could differ materially from those projected by these statements, which are based on management's views as of today and separate to risks and uncertainties, including those noted in our most recent Form 20 F In any 6ks we filed with the SEC and the earnings press release we issued this morning, you're cautioned not to place undue reliance on these statements and Immunifer disclaims any obligation to update them. We will also disclose certain non IFRS measures on today's call, which are reconciled to comparable IFRS measures in today's slides.

Speaker 2

I will now hand over

Speaker 1

the call to our CEO, Doctor. Bahija Kilar.

Speaker 3

Thank you, Clay. Good morning and good afternoon. Welcome, everyone. I am here today with Brian DiDonato, our CFO Ralph Torbay, Head of Commercial David Berman, our Head of R and D and Mohammad Darr, our CMO. During this call, we will share an overview of our second quarter and first Half of the year performance as we continue to deliver our mission to radically improve outcomes for patients with cancer, infectious disease And autoimmune diseases.

Speaker 3

I am proud to report that we have delivered another excellent quarter of performance, both commercially and in terms of progress with our pipeline. In the first half of the year, KimTrak revenue was 111,000,000 That growth reflects robust commercial execution and the recognized benefit that KinTrak provides to patients. Now approved in over 35 countries, Cimtrack has recently launched in 4 additional countries. Ralph will share some insights on the Q2 commercial execution and the growth drivers for the second half of the year. Disciplined expansion expense management and our strong cash position allow us to continue to advance and invest in the pipeline And we are thrilled to announce that we will start the 1st Phase 3 randomized trial with our PRAME targeted IMTAC.

Speaker 3

David will walk you through the trial design today and provide an update on the durability from the melanoma patients we presented at ESMO last And we have continued to treat patients in the PRAME Phase 1 monotherapy and combination cohorts with plans to present data in the first half of next year. We are also randomizing patients in the Phase twothree late line cutaneous melanoma trial with chemTrak. The expansion of our oncology pipeline continues as our teams are working on IND or CTA application for 3 new products with people on track for IND by year's end. And finally, trials with our infectious disease candidates investigating the I will now hand over to Brian.

Speaker 4

Thank you, Bahija. Good morning, everyone. Earlier today, we released our financial results for the 2nd Quarter ending June 30. I invite you to review the release and our SEC filings for more details. I'll share some of the key highlights.

Speaker 4

On Slide 7, you'll see the summary of our financial results. I'm delighted to report that our teams have delivered another impressive quarter of KimTrak sales. Net KimTrak revenue grew to $57,800,000 In Q2 from $52,000,000 in Q1, primarily driven by growth in the United States. We have now launched with reimbursement in 7 countries, including Italy. I am pleased to announce that we have reached a reimbursement agreement with Germany, which is slightly improved from our accounting assumptions.

Speaker 4

We expect Germany to publish the price in September. Ralph will take you through the launch details. Both R and D and SG and A expenses for the quarter were broadly flat with Q1, with a net loss for the period of approximately $18,000,000 Year to date, SG and A expense includes approximately $12,000,000 of currency mark to market and $14,000,000 of non cash share based payment expenses, So in total, dollars 26,000,000 for a net cash year to date SG and A expense of roughly $60,000,000 Looking ahead, we expect R and D expense to increase gradually over time as we expand our PRAME investment, including the new Phase 3 Mel, on the trial announced today. Our cash position of $435,000,000 has continued to increase over the past 3 quarters, Driven by KimTrak revenue, U. K.

Speaker 4

Tax credits and disciplined expense management. With that, I'd like to congratulate the teams on another great quarter. I will turn the call over to Ralph, who will review the KimTrak commercial performance.

Speaker 5

Thank you, Brian, and hello, everyone. Kim Truck is approved in over 35 countries, and we have launched in 4 additional markets this year, including Italy, Austria, Finland and Israel. With U. S, Germany and France, we estimate these 7 markets represent 3 quarters of KimTrax global potential sales. In Q2, we had our strongest revenue quarter to date with $57,800,000 in net sales, Up 11% quarter over quarter.

Speaker 5

Importantly, this represents the 5th quarter of growth.

Speaker 3

Next slide, please. There are

Speaker 5

3 factors underpinning our growth this quarter. First, we saw 14% demand growth in the U. S, Where we increased our first line market share from around 50% in Q1 to 60% in Q2. The second driver of growth is that patients are appropriately remaining on therapy. This is a result of our focus on educating healthcare professionals Around the importance of continuing treatment in the presence of clinical benefit.

Speaker 5

Lastly, in Europe, Nearly all first line patients in Germany and France received KimTrak. We have seen incremental growth driven by our new launches, including Italy, Looking ahead, in the second half of the year, we see 2 significant revenue drivers for KimTrak. In the U. S, we expect further growth from our continued educational push into the community while supporting patients on therapy. KymTrak's 3 year overall survival data expected later this year will be instrumental in achieving this goal.

Speaker 5

We also expect to grow Italy and continue to launch in several additional European countries by the end of the year. Let's move on to reimbursement updates. As we shared with you in the July 6 ks, the CMS in its draft rule Named KimTrak as meeting a unique circumstance for an increased exemption threshold. If this language is maintained in the final rule Expected in Q4, it would functionally exempt KimTrak from a refund. In Germany, we successfully completed price negotiations And the agreed price will be published in September.

Speaker 5

We're pleased with the outcome, which is no materially higher than our accruals to date. The price remains confidential until publication. In the U. K, we expect reimbursement discussions will continue well into 2024. It has become unfortunately more common for innovative products to receive a negative funding decision from NICE and the process to be extended.

Speaker 5

In France, we're confident going into reimbursement negotiations with KimTrak, having had a strong ASMR III rating from the Commission Le Transperance and plan to have an updated agreement in place in 2024. So to sum up, I'm delighted with our continued progress in the Q2 and we remain Firmly committed to our mission of making chemtrak available to over 1,000 patients per year by 2025. I'd now like to pass the call to David to walk you through our exciting R and D plans.

Speaker 2

Thank you very much, Ralph. We continue to make good progress in our oncology and infectious disease clinical pipeline. And today, I'm going to focus on 2 programs. First, I'm going to share recently published ChemTraq data, which we believe provide insights for how we will develop PRAME. And second, I'm going to update you on PRAME, including the original 18 melanoma patients from ESMO, and I'm very proud to also introduce Our new Phase 3 study in first line cutaneous melanoma.

Speaker 2

We presented the Phase 3 first line ctDNA data for KimTrak result at AACR earlier this year. And there are two points that I take from these data. First, a majority of patients are benefiting from Kimtrac since most patients are having ctDNA reduction. And second, KimTrak has higher activity in first line compared to second line based on the 3 fold higher rate This informs for our platform, including PRAME, that where possible, we should strive to move to earlier lines of therapy. Also at AACR, we presented that KymTRAK At 3 years has long term survival benefit in second line uveal melanoma compared to historical controls.

Speaker 2

We have been following these patients to look for a long term survival tale since this is the hallmark of other IO therapies such as checkpoints. These data are very encouraging, and we will share the 3 year survival updates from the first line Phase 3 study later this year. The emergence of the long term survival benefit, however, increases our confidence that this platform can be transformative to patients, and we hope to extend with PRAME to other tumors. Turning to cutaneous melanoma. We recently published the final results for a KimTrak plus checkpoint combinations.

Speaker 2

Most of the data has previously been shared. However, there are several insights I would like to emphasize. 1st, the durability of partial responses and disease control for this Combination is remarkable, with some ongoing for over 2 years. This increases our interest to study PRAME plus checkpoints. 2nd, the safety profile was consistent with each therapy alone, providing confidence for combining PRAME safely with checkpoints.

Speaker 2

And finally, we have historically dosed Imtech's monotherapy on a weekly basis. However, we had hypothesized that we can switch to less frequent dosing when impacts are combined on a backbone of an active therapy and after initial disease control. In this study, we successfully piloted switching from weekly to monthly chemtrak at 1 year, With most of these patients maintaining their disease control, this provides confidence for doing similar with PRAME. These are some of the many insights we are applying to the PRAME program. At ESMO-twenty two, We shared the initial PRAME monotherapy Phase 1 data that led to the expansions in melanoma, lung, endometrial and ovarian carcinoma as a monotherapy in heavily pre created patients and in combination with standards of care since this will allow us to move We always anticipated to see signals earlier in some tumors that would provide confidence And today, I am very pleased to announce our first Phase 3 registrational trial, PRISM-three zero one in first line cutaneous melanoma.

Speaker 2

Here is the ESMO melanoma data we shared last year, which included 18 melanoma patients, 7 cutaneous melanoma, all had prior ipilimumab and either nivolumab or pembrolizumab and 11 uveal melanoma patients, Roughly half of which were tibenifus naive and half had prior tibenifus. Here is an update on those original 18 melanoma patients. We continue to see strong durability, including partial Partial responses ranging from 6 to 17 months. Even in some patients whose Tumor shrinkage did not meet the criteria for a resist partial response, we see durable disease control. Some of these patients are still on therapy.

Speaker 2

The cutaneous melanoma activity is remarkable to me given these patients are heavily pretreated and the fact that F-one hundred and six C is being administered as a monotherapy. As a monotherapy, The durable responses and disease control from F106E in melanoma were clearly compelling. This, coupled with the well tolerated safety profile, our belief in combinability with checkpoints And the insights that our platform will work best in a first line setting led us to consider opening a Phase 3 1st line melanoma trial with a primary endpoint of progression free survival. In addition to the original 18 patients, The emerging data from the newly enrolled cutaneous melanoma patients, which although has less follow-up, Increases our conviction to start the Phase 3 trial now. Finally, the platform insights And to how we can design a more patient friendly and less frequent dosing regimen in first line solidified our decision To move forward, we had a successful Type B meeting with the FDA, who agreed to the Phase 3 design and for us to start the study now.

Speaker 2

And I will walk you through that study design. PRISM MEL-three zero one was designed with help from global melanoma experts and input from the FDA. We will randomize previously untreated metastatic cutaneous melanoma patients who are HLA-two zero one positive in 2 arms. The experimental arm, nivolumab plus F106 seed versus a control arm of either nivolumab The selection of therapy within the control arm will be country specific and will not be investigator choice. This is the 1st Phase 3 trial we are aware of to randomize to a control arm That includes checkpoint doublet.

Speaker 2

The primary endpoint is progression free survival and the secondary endpoint Our survival and response rate. The F106C regimen shown on the slide reflect Growing confidence on how to dose Intaxx when in combination with an active backbone. Because we had multiple doses that were clinically active and well tolerated, we agreed with the FDA To include an initial randomization to 2 F106C doses, 40 micrograms And 160 micrograms. This approach is consistent with FDA's Project OPTIMIS. We will drop 1 of the 2 F-one hundred and six C doses after an initial interim analysis.

Speaker 2

But importantly, There is no pause in their recruitment and all patients in the go forward dose are included in the intent to treat analysis. This is a really exciting time for us at ImmunoCor. The PRISM MEL-three zero one study represents the 1st Phase 3 study for the PRAME target and for a TCR therapeutic In first line cutaneous melanoma, which is one of the largest melanoma indications, an opportunity of over 10,000 patients per year. The Phase onetwo Study 101 is still enrolling the 4 monotherapy expansions at the 160 microgram dose. And we continue to look at the other tumors, lung, ovarian and endometrial for the next tumor for development.

Speaker 2

Per the Project Optimus FDA discussions, we will also enroll some more patients with the same tumor types In the 40 microgram cohort, which will serve to help confirm the dose. The combinations with standard of care are also progressing, And these will provide safety that will allow us to move into the early lines, where we believe our platform will be most active. Finally, based on our excitement for PRAME, we are building a franchise around this target with our half life extension And our PRAME A24 programs on track for regulatory submissions next year. I'm now going to hand it back to Bahia.

Speaker 3

Thank you, David. Thank you, Brian and Ralph. As you can see, the team is not letting up, and I'm grateful for everything they do. So looking ahead to the second half of twenty twenty three And into next year, the commercial and medical teams will be focused on maintaining the momentum to reach patients who could benefit from KimTrak globally. By the end of this year, we expect to launch in additional European countries and to achieve reimbursement agreements in France in 2024.

Speaker 3

As you have heard, our commitment to people living with cancer is expanding as we embark on our first Phase 3 trial with our CRAME targeted therapy with the aim to randomize the first advanced cutaneous melanoma patient By Q1 2024. We will also continue enrolling more patients in the monotherapy and combination Cohorts of the Phase 1 CRAME trial as we investigate the potential and further indications and will share updated data at Congresses during the first half Finally, in oncology, we plan to submit 3 INDs or CTAs over the next 18 months, starting with the PWEL targeted candidates in Q4 this year. In infectious diseases, We intend to present data next year in our multiple ascending dose trial in HIV, and we continue enrolling patient with HBV as well as with To conclude, immunocore continues to execute on our And we remain really excited by the potential to reach even more patients with our Intax platform. We will now open the call for questions.

Operator

Thank you. We will now be conducting a question and answer session. We ask that you please limit yourself to one question. One moment please while we poll for your question. Our first question comes from the line of Michael Yee with Jefferies.

Operator

Please proceed with your question.

Speaker 6

Good morning. Thanks and congrats on all the progress and congrats on the Phase 3 PRAME program. I guess I'll I'll take my one question to Prem. David, can you just talk a little bit about your plan to start the Phase 3 in melanoma? I know you gave an update on the ESMO data and the duration.

Speaker 6

I think I just saw the curves. And how much of the ongoing expansion cohort data Played a role in that. Are you seeing similar response rates? I think you had 33%. Are you seeing same number of patients?

Speaker 6

Just talk a little bit about The totality of that, particularly in the expansion that you are seeing going on now? And then as a follow-up to that, you did comment that you're thinking about the next tumor type. Can you just talk a little bit about what you're looking at and what you're seeing in front of you in ovarian and maybe lung cancer for Prank? Thank you.

Speaker 3

Thank you, Michael. David?

Speaker 2

Yes, sure. So two questions. So number 1, Michael, again, We looked at the ESMO data, which we showed a very promising update in terms of durability. We were enrolling the expansion, although it's still early. We looked at this data and from a general drug development point of view, I won't speak specifically to the data, which we'll share next year, but general drug development point of view, Michael, we ask 2 questions.

Speaker 2

What are the percent of patients that are benefiting? And can the treatment effect in that Population support the primary endpoint we're interested in, in this case PFS. For us, it was clearly yes based on that data plus the original ESMA. We took that to the FDA who agreed with us when they reviewed the data. We shared that data with global KOLs.

Speaker 2

And so I think it became clear to us And everyone who sought to move forward in the with the Phase 3 study. With regard to the other tumor types, we saw the activity In ovarian, which triggered us to do that expansion, that's still ongoing. We're very interested, of course, in lung and endometrial as well. So those expansions are still ongoing. I think more to come on that, as we review the data.

Operator

Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen. Please proceed with your question.

Speaker 7

Hey, guys. Good morning. Congrats on the strong ChemTraq quarter and it's exciting to see all the new updates. Just to follow-up on Trane and the cutaneous durability update. So clearly, the initial response rate is higher than ChemTraq.

Speaker 7

But Again, just to follow-up on durability, how confident are you that the durability you are seeing with PRAME, even though it's early, is what you saw with KimTrak? And I guess the same question just asked another way. Based on the PRAME construct and design relative to ChemTraq when you consider TCR and CD3 potency, Is there any reason why you wouldn't see similar durability?

Speaker 2

Tyler, so the only direct Comparison we can do and it's limited is in the uveal melanoma, because that's where chemtrax monotherapy has been mostly dosed and where we have PRAME data. And we have the 3 PRs with durations of 12 months, 16 plus 17 months on PRAME. In the Phase 3 PIMTrak study, the median duration of response was 11 months. So that's Phase 3 and this is Phase 1. But I think the data for PRAME is very promising in terms of Tolerability.

Speaker 2

In terms of differences between the molecules, I think that was your second question. The TCR end has the same picomolar potency. The CD3 end is the same. The peptide density for PRAME is higher than it is for GP100, but that's essentially what we know right now.

Operator

Thank you. Our next question comes from the line of Justin Zelman with BTIG. Please proceed with your question.

Speaker 7

Hi. Thanks for taking the question. Maybe for David, can you just walk us through, obviously, you're moving forward Frame here in the first line versus KimTrak and second and third in cutaneous melanoma. Can you just walk us through Just the numbers for the accessible market for GP100 versus PRAME and cutaneous?

Speaker 2

Yes, Justin, so the current Phase twothree study, HEBio AM, KIMTRAC, we estimate to be 2,000 to 4000 patients per year, And that's patients who have progressed on ipilimumab and BRAF targeted therapy and anti PD-1s. For PRAME in first line, part of the reason we're so excited about this, the opportunity is greater than 10,000 patients per year. That's the difference in terms of size.

Operator

Thank you. Our next question comes from the line of Greg Savage with Mizuho. Please proceed with your question.

Speaker 8

Thank you and good morning. Congrats on the progress from me as well. A lot of questions on PRAM, but I would just want to focus on ChemTraq and the cutaneous melanoma opportunity, Well, actually, Yuviel, I know that there's been developments on the competitive landscape, and I know that there are thoughts around Combining Chemtrac with PRAME. So can you just give us your overall strategy there in uveal melanoma? Thanks so much.

Speaker 2

Yes, I'm happy to take that and invite anyone else to join also. So, KimTrak had a great survival benefit There's a lot of patients who benefit. We are really excited about our combination of chemtrax plus PRAME. It's We're currently doing the dose escalation optimization. They're both very active drugs.

Speaker 2

And the idea there would be to study chemtrax plus PRAME in the first line setting. So once we have that data available and we can have a good regimen, we'll be able to share that data.

Operator

Thank you. Our next question comes from the line of Justin Kim with Oppenheimer. Please proceed with your question.

Speaker 9

Hi, good morning and thanks for taking the questions. Maybe just to pivot a little bit to the HIV program, we're hearing a lot more interest And sort of the program as we see potential data near term, can you just frame for us How we should expect the initial data cut to look and what exactly is the expectation for patients who withdraw ART over a 12 week timeframe.

Speaker 3

Great. David, you can.

Speaker 2

Yes, I'm happy to take that. So, in terms of the data, we are doing Full ascending dose where we treat patients for 12 weeks with intra patient escalation and then at a target dose. We expect to have multiple cohorts completed, multiple dose escalations completed when we share the data. The data will include, of course, Safety and biomarkers during the initial 12 week run-in. After 12 weeks, we will interrupt both our bispecific as well as the antiretroviral therapy and there we'll look for a rebound of the virus.

Speaker 2

Historically, I think the virus will rebound usually within a few weeks. I think most of the patients usually rebound within 4 weeks. We have a 12 week Planned interruption. And so in terms of what we're looking for there, it's a new field. I mean, no one has ever really Had a functional cure in HIV.

Speaker 2

So we're really excited to see where this data leads us.

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Please proceed with your question.

Speaker 10

Hey, guys. Good morning and thanks for taking my question. I had a question going back to the planned Phase 3 Got it for Prame and Melanoma. So it sounds like the decision to go into first line was driven partially by The Kintrak ctDNA data. And so I was just wondering about that The concept why the activity on ctDNA was higher in first line patients and whether that is something that Would be the case for other tumor types as well.

Speaker 3

Yes, David or Mohammad, you can

Speaker 2

Yes, I'm happy to start. So The data was based on the ctDNA, but also based on the survival in first line is better. I think we have 2 hypotheses. The first is that perhaps newly diagnosed first line patients have a better immune fitness. And the second hypothesis is that Patients' tumors might not have been edited as much, in contrast to after anti PD-one.

Speaker 2

So that's a pretty Standard phenomenon by the way for all immunotherapies. And so we do expect, I mean, we haven't treated First line patients, but we do expect that the activity will be larger in first line for cutaneous as well.

Operator

Thank you. Our next question comes from the line of Patrick Trucchio with H. C. Wainwright. Please proceed with your question.

Speaker 11

Thanks. Good morning and good afternoon and congrats on all the progress here. Just a follow-up question on the Phase 2, 3 trial with chemtrac in second line or later cutaneous melanoma with the randomization of Phase 3 portion to commence immediately following completion of the accrual into Phase 2 portion. I'm wondering if you can discuss how efficacy from the Phase 2 portion might inform changes to the Phase 3 design. What changes could you implement?

Speaker 11

Would there be potentially accelerated pathway depending on what you see in that Phase 2 portion of the study?

Speaker 2

Yes, Patrick, that's a great question. And we specifically spent a lot of time designing this seamless Phase twothree. So what we'll look at And the Phase 2 is number 1, we have a KimTrak monotherapy, we have a KimTrak plus pembrolizumab. Do we need to have the pembrolizumab on board, yes or no? So we can decide to discontinue one of those arms.

Speaker 2

Number 2, we'll be looking at the treatment effect relative to the control arm because we may need It may be clear that we can decrease the size of the trial if the treatment effect is larger.

Operator

Thank you. Our next question comes from the line of Ahu Demir with Ladenburg Thalmann. Please proceed with your question.

Speaker 12

Good morning. Congratulations on the progress and thanks for taking my questions. 2 on our side. First one is on the cutaneous melanoma. Could you elaborate more on the less What led you to take that leap?

Speaker 12

And is it only driven by KingTruk or is it driven by the Phase 2 data you Got it from the PRAIN program.

Speaker 3

Go ahead, David.

Speaker 2

Yes. I'm happy to do that. So there's a couple of things that led us To the dosing, number 1 was we talked about the chemtraq experience. Number 2 is if you look at the Kaplan Meier curves for first line PD-1s including the volume You see that most of the progressions, in fact, the majority, 2 thirds of progressions occurred during the 1st 12 weeks. So that's where we plan to have the weekly dosing That's where the trial PFS is won and lost.

Speaker 2

After 12 weeks, the Kaplan Meier curves really plateau out. And so we didn't think you need to have A weekly dosing regimen, after 12 weeks. And then of course, by 1 year, it moves to a once monthly regimen. And then I think just finally one other point, when we look at the PRAME data, but also ChemTraq, we see the majority of the tumor shrinkage occurs in the 1st 12 weeks. So that's the time to have the weekly dosing.

Operator

Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.

Speaker 13

Hi, good morning. This is Shay on for Peter. Thanks for taking our questions. I just wanted to get a little more color around the organic growth for the Q2 for ChemTraq. And if you could maybe talk to the volume of volume growth versus price growth and any one timers we should

Speaker 5

Thank you for that question. So Most of the growth was driven from the U. S. With the 14% quarter over quarter growth. That was pure demand growth.

Speaker 5

We did not see any difference in patterns of stocking per se. And you have to consider that we took a price increase

Operator

Thank you. Our next question comes from the line of Nick Hallead with Goldman Sachs. Please proceed with your question.

Speaker 14

Hi, there. It's Nick on for Rajan. And thanks for taking my questions. If we could just come back to the PRISM trial and the design there. We're just wondering what the rationale was for the selection of the 2 doses.

Speaker 14

They seem to or at least optically, they look quite far apart. Why was there not a dose in between? Is that something that you've agreed with the FDA? And then Looking further ahead, could you just give us an idea of what you see as the bar for efficacy and what good data would look like to you? Thank you.

Speaker 3

David?

Speaker 2

Yes. So, with the selection of the 2 doses, we had multiple doses that were Active and well tolerated in Phase 1. In fact, we had a 7 fold dose range. We had 20 micrograms all the way up to 160 micrograms. And we chose the 160 Originally based on modeling and simulation, although we had fewer patients at the lower doses, and I think that was the reason for the need to explore a lower dose.

Speaker 2

When it came to the selection of the lower dose, we had 2 choices, 20 or 40. 20 was the threshold dose, and we felt just in general Good drug development never to choose the lowest dose because of variability in PK, you'll end up with some patients having too low of exposure. And so that really set us on the choice of 40. With regard to the bar for efficacy, The nivolumab median PFS has really ranged, I think, between 4.7 months to, I think, 8 months. The most recent Relativity 47 was 4.7 months from a median perspective.

Speaker 2

We're going to have a blended median TFS Because we'll have some patients who are on Opdulag, some patients who are on nivo. But I think that the median PFS blended is probably still going to be Less than 8 months. This will depend on how many patients are randomized to the Opdivo lag.

Operator

Thank you. Our next question comes from the line of Jeff Funk with Morgan Stanley. Please proceed with your question.

Speaker 8

Thanks for taking my question. How is enrollment going for the PRIME A Tier 2 trial and what should we expect to see in the first half twenty twenty four data? Thanks.

Speaker 3

Okay. Mohammad, do you want to take that? Sure.

Speaker 7

As we had said earlier, we have moved from a Phase 1 footing to a Phase 2 footing. So we continue to Open additional sites and continue to accrue to our multiple priority expansion courts as well as the standard of care combination. So all of That continues to go according to plan. And as we've said, we plan to share, the data as it matures in the first half of next year.

Operator

Thank you. Our next question comes from the line of Gil Blum with Needham and Co. Please proceed with your question.

Speaker 7

Good morning, everyone, and thanks for taking our question. So this is a bit of a hypothetical at this point, but it'd be interesting to see kind of what you expect the interplay would be between the PRAME agent and the When you did previously frame post chemtra active data I suggest that there wasn't a ton of activity, but what happens the other way around? Thank you.

Speaker 2

Yes. So in cutaneous milk so The PRAME after Kyntjeck was in uveal and although we didn't see resist partial response, it was really remarkable the disease stabilization That we saw there. Now why was it disease stabilization and not resist partial responses like we saw in first line? We don't know that. We can speculate, but we don't know.

Speaker 2

I think we really are excited to study PRAME plus ChemTraq to understand how our platform works when you do multiple combinations. It makes sense to study it initially in uveal melanoma because we have a lot of contract experience there, but I think clearly cutaneous melanoma would be the next step. I think there are 2 ways to think about it, Gil. One is because both PRAME and G400 are broadly expressed, we could Target more cells within the tumor and you could also think for cells that co express both,

Operator

Thank you. There are no further questions at this time. I would now like to turn the floor back over to Bahija Jallal for any closing comments.

Speaker 3

Yes. Thank you, operator. I just want to thank everyone for taking the time and today and listening to the progress that we've made. So thank you very much.

Operator

Thank you. This does conclude today's

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