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On Thursday, 05 June 2025, Immunocore Holdings PLC (NASDAQ:IMCR) presented at the Jefferies Global Healthcare Conference 2025. The company showcased significant commercial success with its leading product, Kimtrak, and detailed its robust pipeline of trials. While the conference highlighted strong growth and strategic advancements, challenges from potential competition were also addressed.
Key Takeaways
- Kimtrak achieved a 33% year-over-year increase in net revenues, reaching $94 million in Q1.
- Immunocore’s pipeline includes a Phase 3 trial for Kimtrak in cutaneous melanoma and the PRAME program.
- The company is focusing on expanding Kimtrak’s market penetration internationally.
- New trials and developments in bispecific antibodies and HBV data are anticipated.
- Immunocore is addressing competition in uveal melanoma with established long-term survival data.
Financial Results
- Kimtrak’s Q1 net revenues were $94 million, marking a 33% increase from the previous year.
- This growth represents the twelfth consecutive quarter of revenue increase.
- A one-time $6 million positive revenue adjustment was recognized from pricing agreements in France and Germany.
Operational Updates
- Kimtrak’s market penetration in the U.S. is approximately 65%, with efforts to deepen engagement within community settings.
- Recent international launches include the UK, Poland, and the Netherlands, with further expansion planned.
- The average duration of Kimtrak therapy is around 12 months, surpassing clinical trial expectations.
- Immunocore is optimistic about upcoming TEBY AM and ATOM trials.
Future Outlook
- The Phase 3 trial for Kimtrak in cutaneous melanoma aims to assess overall survival benefits, with results expected in the latter half of next year.
- The PRAME program is in Phase 3 trials, focusing on progression-free survival in first-line melanoma.
- A new TCR bispecific antibody targeting PWELL is in Phase 1 trials for various solid tumors.
- Upcoming HBV data is anticipated later this year.
Q&A Highlights
- Immunocore is prepared to address competition in uveal melanoma by emphasizing Kimtrak’s long-term survival data.
- The cutaneous melanoma trial’s three-arm design aims to demonstrate the added benefit of PD-1 inhibition.
- The PRAME program’s Phase 3 trial decision was influenced by favorable monotherapy data and improved T cell fitness.
For a detailed account of the conference call, please refer to the full transcript below.
Full transcript - Jefferies Global Healthcare Conference 2025:
Michael Yee, Senior Biotechnology Analyst, Jefferies: Welcome everyone to the next session. I’m Michael Yee, Senior Biotechnology Analyst at Jefferies and I’m
Michael Yee, Senior Biotechnology Analyst, Jefferies: very pleased to have members of the Immunocor team up here with us. David Berman, Chief Scientific Officer and Ralph Torbay, the Chief Commercial Officer. Fantastic duo bunch because we’re going to talk about revenues and sales and an approved drug in the commercial side. And, we’re also going to
Michael Yee, Senior Biotechnology Analyst, Jefferies: talk with David about the pipeline. So, that is fantastic. Maybe I would just have Ralph open up first because one of the
Michael Yee, Senior Biotechnology Analyst, Jefferies: great things about Immunocor is Kim Track, which is on pace to do well north of
Michael Yee, Senior Biotechnology Analyst, Jefferies: $300,000,000 right? You’ve got a great orphan antibody that continues to grow in uveal melanoma around the world.
Michael Yee, Senior Biotechnology Analyst, Jefferies: And I would love to maybe just hear a
Michael Yee, Senior Biotechnology Analyst, Jefferies: little bit about your comments about the growth trajectory of Chemtrac and the durability of where that’s going and the growth outlook for that this year. And then we can also get into some questions for David too. David, I got plenty of questions for you.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Don’t worry. Great.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So tell us about ChemTrak, Ralph.
Ralph Torbay, Chief Commercial Officer, Immunocor: Thank you, Michael. And thank you very much for having us today. So we’ve been doing very well with ChemTrak. As you could see from the first quarter results, we had 94,000,000 in net revenues. That’s a 33% year over year increase.
It’s actually our twelfth consecutive quarter of growth for Chemtrek, which speaks obviously to how great the launch and execution and especially the medicine has been doing for patients. We recognized a one time revenue adjustment of 6,000,000, which came actually from very good news because we finalized pricing agreements with France and Germany. And, you know, in the near term, we’re very much focused on maximizing the growth in metastatic uveal melanoma, and that means going a little bit deeper into the community in The U. S. This is an area where, you know, penetration is of uveal melanoma is not as dense, therefore, you have to go in a very methodical way.
And then we still expect new launches. We launch in 26 countries worldwide, and we expect a few more launches, and we’re prosecuting on these launches, which are also helping to drive incrementally the growth. And obviously, in the near term, we have TEBY AM and the ATOM trials that we’re very excited about.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So, in terms of
Michael Yee, Senior Biotechnology Analyst, Jefferies: The U. S, the growth outlook there, how what percent penetrated do you think you are in that market? And where is the drivers of that? I think it’s community,
Michael Yee, Senior Biotechnology Analyst, Jefferies: but like overall, in terms of how many uveal melanoma patients
Michael Yee, Senior Biotechnology Analyst, Jefferies: there are per year and what you are treating per year, what percent penetration do you think you are and how can you get to those other patients?
Ralph Torbay, Chief Commercial Officer, Immunocor: Sure. So we’re roughly at sixty five percent penetrated. There are roughly around five hundred patients with metastatic melanoma who are HLAO two zero one positive. HLA-two zero positivity is around fifty percent of the patient population.
David Berman, Chief Scientific Officer, Immunocor: Okay.
Ralph Torbay, Chief Commercial Officer, Immunocor: And you know, I think the effort now is really going a little bit deeper into that community. A lot of these physicians actually treat cutaneous melanoma and they’re used to that and they see one uveal melanoma patient perhaps a year or every other year. So it’s about doing that just in time. And that’s a lot of the work that we’re actually committed to doing today.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So just to be very specific, SG and A and sales force going out to the community, educating them, because while they may only treat a couple per year, they need to be aware of the drug
Michael Yee, Senior Biotechnology Analyst, Jefferies: in order to get about sixty percent penetrated. That’s right. 65 then, but yeah, steady growth every And then, OUS, yeah, that was
Michael Yee, Senior Biotechnology Analyst, Jefferies: a big thing last quarter. You actually had
Michael Yee, Senior Biotechnology Analyst, Jefferies: a positive adjustment because the price in France and
Michael Yee, Senior Biotechnology Analyst, Jefferies: Germany were
Michael Yee, Senior Biotechnology Analyst, Jefferies: agreed upon. And then actually ended up being slightly higher, more value versus what your accountants had had. So there was a positive adjustment versus what you’re booking. So how is the growth there? What were you doing this quarter?
And then you expect steady growth because there’s new launches in some countries?
Ralph Torbay, Chief Commercial Officer, Immunocor: Yes. So we have new launches in The UK and Poland. Actually UK and Poland were both launched in Q4, Netherlands in Q1. So there we’re right in the middle of launching. And Germany and France actually interestingly, we’re still seeing growth and that growth is coming through marginal penetration.
We’re above 80% in both of those countries. That being said, still see duration of therapy growing there. We’re now working a lot on finding patients earlier because if you find patients earlier they will do better and obviously stay longer on the medicine as well.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Where is duration of therapy now on this drug on average, either in The US or outside The US?
Ralph Torbay, Chief Commercial Officer, Immunocor: It’s around twelve months, which is actually very impressive when you consider the clinical trial data. For me, I mean I’ve launched many drugs in oncology. This is the first time I see a drug doing this well in the market, especially doing better than what we’ve seen in clinical trials.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, clinical trials it was, remind me what the number was?
Ralph Torbay, Chief Commercial Officer, Immunocor: So, it depends on the follow-up of course, but we saw around this time, we saw around ten months.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So, it’s ten months
Michael Yee, Senior Biotechnology Analyst, Jefferies: and actually the duration of therapy is twelve months And that’s because people are continuing on the drug even past radiologic progression or what’s going on there and why are docs continuing to keep them on?
Ralph Torbay, Chief Commercial Officer, Immunocor: That’s right. That’s exactly what’s happening. So in the clinical trial we actually had to at some point call the progression and that’s after two scans that showed more than 20% increase using RECIST. That’s when we called progression, so you had to do it per protocol. But what we’re seeing in the real world is actually physicians are keeping the patient on, potentially using radiation therapy, surgery in some instances, to help with some of the growing lesions.
But really, they’re seeing patients do very well and benefit long term hence why we’re seeing I think a better duration of treatment in the real world.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Where do you think that could go? Twelve months in their treating past radiologic progression? Where can that go?
Ralph Torbay, Chief Commercial Officer, Immunocor: So, you know, we’re hoping it will continue to grow because that means good news for the patients, right? They’re benefiting from it. That being said, are seeing it moderate in certain countries, like in The U. S. And some of the more mature markets as we enter our fourth year of launch, we’re seeing that duration of therapy.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, let’s put it this way. There’s not like another approved drug or another option for people technically speaking on this show. I’m not saying that they’re taking it all the way to average overall survival, but I guess I’m just trying
Michael Yee, Senior Biotechnology Analyst, Jefferies: to figure out why would people usually they don’t treat past that progression.
Michael Yee, Senior Biotechnology Analyst, Jefferies: This has been a key part as to why you’re continuing to see
Michael Yee, Senior Biotechnology Analyst, Jefferies: other than more patients, but people are keeping them on drug longer because doctors see value in the drug.
Ralph Torbay, Chief Commercial Officer, Immunocor: Yeah, mean they’re seeing value in the drug, they’re seeing the patients, and at least what we hear is that the patients are doing well. They have lesions, right? The lesion is still there, but the patient is doing exceptionally well. They’re living their lives, so really that’s one of the reasons they’re
David Berman, Chief Scientific Officer, Immunocor: keeping them on Okay, there also may be an element, Michael, of earlier screening now that there’s a therapy for the metastatic setting whereas before there wasn’t. Some countries have more robust screening to detect earlier metastatic.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male That’s usually so you think that they’re getting on earlier in their first line.
Michael Yee, Senior Biotechnology Analyst, Jefferies: This is first line.
David Berman, Chief Scientific Officer, Immunocor: I think in some countries that could be an explanation.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Interesting. Okay. All right. So that continues to be strong and steady growth. And that’s been one of the key factors to demonstrate success for Chemtrac.
And then, there is some potential perceived competition in uveal melanoma. Another company, Idea, was here. And they’re talking about how they will have phase three data for their oral therapy in first line melanoma, HLA2 negative. But also that they plan to do positives, and also that they’ve been treating people in HLA negative and positive, and they’re going have survival data in phase two at a conference. So, a new therapy is coming, potentially.
How do you help investors walk through the differences between those, and appreciate that it’s definitely possible that another drug could be approved in uveal melanoma?
Ralph Torbay, Chief Commercial Officer, Immunocor: So, Michael, as you said, the other medicines are in HLA-twenty one negative, where they’re being studied. That being said, you know, we take competition very seriously and obviously make plans around it constantly, whether this one or any other competition. I think the important piece to keep in mind, especially when thinking about chemtrike, is really this is an unprecedented this is the first approved medicine for HLA-two-one patients in over forty years in uveal melanoma. We’ve established long term survival three years in fact, was published in the New England Journal of Medicine. We saw two very interesting aspects of this.
One is unprecedented survival at three years, but also the fact that in the long term we see adverse events actually improving. So we see, you know, the safety profile with CRS is predictable at the beginning, and then over time the adverse event
Michael Yee, Senior Biotechnology Analyst, Jefferies: agree, extremely well tolerated drug. I thought that the overall survival
Michael Yee, Senior Biotechnology Analyst, Jefferies: that people quote for your drug is twenty something months that’s in the label. Are you referring to a different overall?
Ralph Torbay, Chief Commercial Officer, Immunocor: There’s a twenty two months which is the median overall survival.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Amazing.
Ralph Torbay, Chief Commercial Officer, Immunocor: And that went from 12, right? So almost doubling of the median overall survival. In fact, the hazard ratio was 0.51.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yep, so twenty two months.
Ralph Torbay, Chief Commercial Officer, Immunocor: To twenty two months. And then at three years, twenty seven percent of patients are alive, which is unprecedented for this Landmark analysis.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Landmark analysis. Years are still one quarter of the people are still on.
Ralph Torbay, Chief Commercial Officer, Immunocor: Yep. That’s right.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay.
Ralph Torbay, Chief Commercial Officer, Immunocor: Beyond that, when you think about the fact that this is not only standard of care but it’s also the most prescribed medicine across major markets, I think between the patient component, they care mostly about overall survival and the fact that this is practice. It’s going take a lot to displace Camp Tracker. Okay.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yeah, I mean, we’re prepared for some of these updates from the competitor. So, again, different HLA subtype and also you have a super long demonstrated survival, been on the market, good standard of care. Now, you’re also trying to, here’s what we could talk about and bring in David as well, because there’s the opportunity for Chemtrak to, in our analyst estimates, more than double sales opportunity because you’re also in a pivotal phase two, three for cutaneous melanoma with KimTrack. This is in combination. So, can you talk about the design of the study and your confidence that this randomized controlled study could work?
I believe the data is coming second half of next year. But again, this could be positive. And this could more than double or triple, because cutaneous melanoma is definitely double or triple the UV melanoma. So what do you think about that, David? That could work?
David Berman, Chief Scientific Officer, Immunocor: Yeah, I just as a reminder, we started it as a phase twothree. Last year we converted it into a standard phase three. The three arms patients who are previously treated on anti PD one, CTLA four and BRAF targeted therapy BRAF mutant, so nothing really available, are randomized to Kymtrak versus Kymtrak plus pembrolizumab versus a control arm. The key thing here is that the primary endpoint is overall survival. So this is the gonna be the first phase three trial if it’s positive to have an overall survival readout in late line melanoma, and it plays to the Kimtrek strength.
I mean, it’s a GP 100 positive tumor like uveal melanoma. In the phase one and the phase one b trial in checkpoint combination with chemtrac in cutaneous melanoma, we saw the same metrics that we saw in uveal melanoma, which is, you know, a modest response rate, but very promising overall survival. And in fact, the survival we saw in late line cutaneous melanoma, the one year survival was seventy five percent, the historical one year survival being fifty five percent. So that’s what gave us confidence to run this trial. We’re asking really two questions, does PD-one add to Chemtrac?
And then the other question of course is and the most important one is, is Chemtrac better than whatever else is available out here with overall survival? And that trial is accruing well. It’s still accruing well and the target is to have that completely randomized in the first half of next year. And then the readouts, which of course is event dependent, could be in the second half.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Can I ask you a
Michael Yee, Senior Biotechnology Analyst, Jefferies: question on
Michael Yee, Senior Biotechnology Analyst, Jefferies: I recall the three arm design?
Michael Yee, Senior Biotechnology Analyst, Jefferies: And at one point, we believed that because there’s two ChemTrak arms one is ChemTrak monotherapy.
David Berman, Chief Scientific Officer, Immunocor: One
Michael Yee, Senior Biotechnology Analyst, Jefferies: is ChemTrak plus PD-one. And then one is a dealer’s choice.
David Berman, Chief Scientific Officer, Immunocor: Essentially. I can go into it, but it’s essentially dealer’s choice.
Michael Yee, Senior Biotechnology Analyst, Jefferies: And in dealer’s choice, there’s not a lot. I mean, there’s old chemos. There is iovance. There is what else? So is this a relevant study?
Because in your combination, PD-one, didn’t people get PD-one in the first line?
David Berman, Chief Scientific Officer, Immunocor: Yeah. So in this setting, there’s nothing really available. I mean, Iovance was Victils was recently approved only in The US. Interestingly, most of our approval is outside The US.
Michael Yee, Senior Biotechnology Analyst, Jefferies: The point of here, just to
Michael Yee, Senior Biotechnology Analyst, Jefferies: be clear, is that that’s early in the adoption. That’s not really going to be a big part
David Berman, Chief Scientific Officer, Immunocor: of the control.
Michael Yee, Senior Biotechnology Analyst, Jefferies: It’s the point of this trial.
David Berman, Chief Scientific Officer, Immunocor: Exactly. So typically, what doctors will do in this setting is they will retreat with PD-1s, they will retreat with BRAF even though they don’t expect much benefit. They’ll give chemotherapy because nothing else is available and they’ll put them on clinical phase one or phase two clinical trials. That’s really all that’s available.
Michael Yee, Senior Biotechnology Analyst, Jefferies: And those are allowed in the control arm?
David Berman, Chief Scientific Officer, Immunocor: They are allowed in the control arm. And the reason is this is why it’s novel is because we have a survival endpoint. So as long as you follow them for survival, they can leave our treatment arm on the study and go into subsequent studies.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male Okay. So what do you expect? Are you going to so again, there’s two chemtrac, I’m sorry. Have you merged that into one? Have you dropped an arm?
What is have you moved to a one versus one now?
David Berman, Chief Scientific Officer, Immunocor: Yeah. No. So, it’s still three arms. The original design of the phase two was to pick one of those arms to continue
Michael Yee, Senior Biotechnology Analyst, Jefferies: Right.
David Berman, Chief Scientific Officer, Immunocor: And then to only have two arms in the phase three part, the control and a chemtrac arm. Yeah. Because of the accrual patterns, the survival wouldn’t have matured to allow us to choose one of the arms, So we just converted the entire study into Phase III and decided to run out both Chemtrac arms in parallel. So we’ll have a Chemtrac plus PD-one, a Chemtrac monotherapy, and then the control arm. So essentially two chemtrac arms and one control arm.
Michael Yee, Senior Biotechnology Analyst, Jefferies: That’s interesting. Okay. And so all of this is based on the phase onetwo open label data where there was a combination and you basically saw a what seventy five percent survival at twelve months?
David Berman, Chief Scientific Officer, Immunocor: Correct.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. Have you followed those patients out for median survival?
David Berman, Chief Scientific Officer, Immunocor: No. The study ended a couple of years ago and you know, there weren’t there weren’t that many patients on to go beyond that, you know, to go with the continued follow-up. The reason I landmark to one year seventy five percent we we did follow-up to two years, by the way, but the reason I landmark to one year is because if you look at all of the other historical trials that are out there, they typically are only robust up to one year. There are very few follow-up patients beyond one year because there haven’t really been phase three trials in this setting. They’re typically smaller trials.
So I felt one year is a still robust endpoint to compare to historical trials.
Michael Yee, Senior Biotechnology Analyst, Jefferies: That’s
David Berman, Chief Scientific Officer, Immunocor: the reason I anchored one year.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So again, next milestone is completion of enrollment
Michael Yee, Senior Biotechnology Analyst, Jefferies: by first half ’twenty six. Obviously, we’re currently in the middle of ’25, so we have some time to go. But you feel it’s been enrolling well? And this is like mostly outside The United States or what?
David Berman, Chief Scientific Officer, Immunocor: It’s mostly outside The United States. We do have some good US participation. But like all melanoma trials to date, it’s mostly enrolled outside The U. S.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay.
David Berman, Chief Scientific Officer, Immunocor: Europe, Australia. Okay.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yeah, this is obviously for HLA two positive.
David Berman, Chief Scientific Officer, Immunocor: Correct.
Michael Yee, Senior Biotechnology Analyst, Jefferies: And then this is second line cutaneous melanoma. There’s not a lot of options.
David Berman, Chief Scientific Officer, Immunocor: Correct, yes.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. All right, so we’ll look to that. But again, that could be
Michael Yee, Senior Biotechnology Analyst, Jefferies: a huge upside opportunity because cutaneous melanoma is two to three times the size. What about obviously PRAME? Right, PRAME, this is a bit of a slightly sore spot for us because while you’re continuing to execute, Wall Street is definitely scratching their heads about the overall probability of success of this. And you’ve presented data at last ESMO and ASCO. And the point about it is you have pushed forward to a phase three randomized controlled study of PRAME plus PD-one in first line melanoma.
Talk about the design of this study and what gives you confidence that this study will be positive.
David Berman, Chief Scientific Officer, Immunocor: Sure. Before I talk about the design, I just wanted to mention we also have the adjuvant chemtrac trial, which I’m pretty excited about. But we can talk about that also.
Michael Yee, Senior Biotechnology Analyst, Jefferies: In uveal? In uveal melanoma too, you’re going earlier. Male Exactly.
David Berman, Chief Scientific Officer, Immunocor: I wanted to round out the chem track before we move to
Michael Yee, Senior Biotechnology Analyst, Jefferies: the Okay, great.
David Berman, Chief Scientific Officer, Immunocor: So with brunetifest, I think there were several factors which led us to move to the phase three trial. Platform works in melanoma. Number two, the brinettifest monotherapy data that you’re referring to that we shared at ASCO last year, we benchmarked that to what we consider a very relevant population, which was nivo plus LAG-three in relativity 20. And there we felt that the monotherapy brunetephus beta was superior cross trial comparison to the nivo plus LAG three. The disease control rate was higher.
Number two, if you look at the spider plots, we’ve talked about this interesting phenotype of a closed umbrella spider plot where most of the patients have disease stabilization that looks like a closed umbrella. And if you compare that to the relativity 20 spider plot, is more of an open umbrella, which is typical in phase one, have some DPRs, but then most of the patients tend to progress. So it does appear to us that as a monotherapy, brinadipas in a similar line was superior to nivo plus LAG-three.
Michael Yee, Senior Biotechnology Analyst, Jefferies: That’s interesting.
David Berman, Chief Scientific Officer, Immunocor: The second was that we showed that T cell fitness improves as you move into earlier lines, and in fact, the median PFS was six months in patients who had a good T cell fitness, and we know T cell fitness improves as you move to earlier lines. And then the third point was in the first line trial, we are now combining brinetephus, which has definite monotherapy activity, a different mechanism with nivolumab Yes. Which, of course, also is an active drug. So So it’s nivo plus brunetifest versus nivo. So the nivo cancels out and then you’re asking is brunetifest going to add anything on top of that?
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yes, so think about that.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So I think Wall Street typically loves to see response rates, huge tumor reductions, spider plots that all go down. And you did have some risk criteria overall response. Correct.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Percent. Yeah. Were some in sick patients and cutaneous melanoma, metastatic melanoma. And you had a lot of stable disease. So you think overall that that’s obviously had, I’d say, biologic activity?
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yeah. So that’s point one.
David Berman, Chief Scientific Officer, Immunocor: Yeah. And I’ll say actually two points, Michael. The first is, yeah, we did have about eleven percent resist PRs. Interestingly, we had an additional, I think, fifteen, sixteen percent of patients had tumor reduction that was still called SD, but had the same durability as a PR. And we saw that exact same phenomena in Chemtrac.
We’re now talking about twenty eight percent of patients are having definite evidence of drug effect. The other point I just wanted to remind everyone is although Chemtrac is a survival drug and had a great survival benefit at the point five one hour, it also met statistical significance for PFS. The PFS hazard ratio, I think, was about point seven two of Kymtrek versus essentially pembrolizumab in first line uveal melanoma. So this is still a platform that can deliver a PFS benefit. Right.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Even if you go to Kimtrek, which everyone agrees is low response rate, you already saw a positive PFS because you’re stabilizing the And that was 0.77 hazard ratio versus Keytruda.
David Berman, Chief Scientific Officer, Immunocor: That was 0.73.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Zero point seven three.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So people on Keytruda are still progressing. The tumors are getting larger even in a drug that has modest stabilization.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So going back to PRAME, on PRAME you’re saying there’s great stabilization of disease and that’s point number one. Point number two is that you’re
David Berman, Chief Scientific Officer, Immunocor: going earlier. Exactly.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. And then point number three
Michael Yee, Senior Biotechnology Analyst, Jefferies: is you’re in combination. If you’re going earlier and then you’re adding on top
David Berman, Chief Scientific Officer, Immunocor: With a different mechanism. Yeah,
Michael Yee, Senior Biotechnology Analyst, Jefferies: you believe with PRAME that that would drive a PFS benefit? What’s the primary endpoint?
David Berman, Chief Scientific Officer, Immunocor: It’s PFS. So I do believe it will drive a PFS benefit. And I do think there’s the potential also to have a higher resist response rate. We haven’t shown that, of course. But I think there’s the potential because we are getting twenty eight percent of patients are having tumor reduction.
Michael Yee, Senior Biotechnology Analyst, Jefferies: You’re in healthier patients too, it’s first thing. Well now, overall response rate won’t be the primary we’re going have to
Michael Yee, Senior Biotechnology Analyst, Jefferies: deliver Do you need to deliver overall survival in melanoma?
David Berman, Chief Scientific Officer, Immunocor: So in first line, we would like to see a trend and we’ll have to follow the patients longer. It’s just that survival is very long in first line. For regulatory approvals right now PFS is accepted, but of course you follow it as a secondary endpoint for overall survival. Okay.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Tell us where that is because we’re going to have to wait a little bit, but that is enrolling. Tell us about
David Berman, Chief Scientific Officer, Immunocor: where that So that’s randomizing nivolumab plus brinadifest versus either nivolumab monotherapy in some countries or nivolumab plus LAG-three, Abdulaleg.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yes. Let me clarify that. Yeah. That’s important.
David Berman, Chief Scientific Officer, Immunocor: So we started that trial last year. And as I’ve seen in all my phase three trials, there’s an initial slow ramp up phase while you get countries activated and sites activated, and then there’s an inflection point. And I think we are at now that inflection point. We have a couple of hundred or between 102 sites already open And we’re on track this year to have the IDMC complete their efficacy and safety review of the ninety patients or of the first sixty patients treated with brinadifest to choose the dose to continue. If you remember, was a dose selection by the IVMC who will review the first sixty patients treated with brunetifest plus nibolumab at dose one and brunetifest plus nivolumab at dose two.
There were two doses.
Michael Yee, Senior Biotechnology Analyst, Jefferies: When is that? I mean, I appreciate is that a Project Optimus thing?
David Berman, Chief Scientific Officer, Immunocor: Yes. It was Project Optimus.
Michael Yee, Senior Biotechnology Analyst, Jefferies: So there is an interim on the first sixty?
David Berman, Chief Scientific Officer, Immunocor: It’s the first ninety patients.
Michael Yee, Senior Biotechnology Analyst, Jefferies: First ninety.
David Berman, Chief Scientific Officer, Immunocor: It’s sixty of Brinadifas.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male I have another company that just kind of
Michael Yee, Senior Biotechnology Analyst, Jefferies: had that run-in period and they picked the lower dose. And when does that occur?
David Berman, Chief Scientific Officer, Immunocor: Male So that will be in the second half of this year. So we’re on track for that.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Speaker: Is there any futility analysis or this is, or what? What are they looking This
David Berman, Chief Scientific Officer, Immunocor: analysis is strictly looking at the brunetifus arms because we agreed with the FDA no alpha would be spent.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male Okay. So they will pick it based on looking at, it’s sort of interesting they look at safety.
Michael Yee, Senior Biotechnology Analyst, Jefferies: What are they looking at
David Berman, Chief Scientific Officer, Immunocor: to pick? Yes, they’ll look at efficacy of course. So they’ll be looking at resist based efficacy.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Resist, correct.
David Berman, Chief Scientific Officer, Immunocor: Because at the end of the day this is a PFS endpoint. So they’ll be looking at resist efficacy, they’ll be looking at safety, which is essentially CRS for the most part.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. So that’s coming later this year we’ll look for that. There shouldn’t be any futility. It is high dose versus low dose?
David Berman, Chief Scientific Officer, Immunocor: Correct.
Michael Yee, Senior Biotechnology Analyst, Jefferies: What do you think? What do you think? Based on the data, can’t remember the data between high dose and low dose. Do you think that the high dose would go forward?
David Berman, Chief Scientific Officer, Immunocor: So we’re open to whatever is the best data. But I think in our phase one dose escalation, we didn’t really see much dose response. We saw a step, which is no activity and then at twenty micrograms activity, we didn’t really see a strong dose response about Okay.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Then we march forward. Now, how many patients are in this study or going be enrolled?
David Berman, Chief Scientific Officer, Immunocor: Sorry?
Michael Yee, Senior Biotechnology Analyst, Jefferies: What’s the target?
David Berman, Chief Scientific Officer, Immunocor: It’s about six fifty patients, three twenty
Michael Yee, Senior Biotechnology Analyst, Jefferies: Three on average per site, that’s not how it works. But that’s, you have 200 sites open, so you feel pretty
David Berman, Chief Scientific Officer, Immunocor: Male no, we have between 102. One hundred and two
Michael Yee, Senior Biotechnology Analyst, Jefferies: hundred sites, okay.
Michael Yee, Senior Biotechnology Analyst, Jefferies: All right. So when does that complete enrollment and then when is data?
David Berman, Chief Scientific Officer, Immunocor: Speaker: Yeah. So currently we put in when we started a three year trial just because that was the benchmark out there. I think later this year, we have in steady state randomization and we get a better sense of event rates, we can project that. But right now we’re penciling in a three year trial, so maybe end of ’twenty seven. Okay.
So
Michael Yee, Senior Biotechnology Analyst, Jefferies: that is interesting. Again, I’ll repeat that it’s interesting also because the control arm is KEYTRUDA in most countries outside The United States. But here in The US, they will be getting lag.
David Berman, Chief Scientific Officer, Immunocor: Yeah, so it’s actually Opdivo.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Opdivo. And here it’s not KEYTRUDA, will be Opdivo.
David Berman, Chief Scientific Officer, Immunocor: Yes, Opdivo. That’s interesting. Right, so it’s Opdivo monotherapy or Opdivo plus lag free. Thank you,
Michael Yee, Senior Biotechnology Analyst, Jefferies: thank you. No KEYTRUDA, thank you. That’s the other company that’s running the phase three. Okay. So that’s great.
And you also believe, obviously, The US that you believe, while a little bit harder to handicap, at least in The United States and certainly with this FDA, they’re going to look at that you believe you’ll beat LAG combo as well?
David Berman, Chief Scientific Officer, Immunocor: Yeah. So we expect to, based on what I call the apples to apples comparison. But yes, and I think commercially we need to show at least a point estimate showing that we’re better than nivo plus LAG-three.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Right, at least a trend. Yeah. Exactly. And then hitting on the overall. Okay.
We will continue to follow the execution on that. That’s super important. Maybe in the last two minutes I’d love to ask a little bit about the additional pipeline things. I’m actually going to skip over the other PRIME indications, if I may. Sure.
Because we have a new target, PWIL. I don’t did that file an IND?
David Berman, Chief Scientific Officer, Immunocor: Yeah. So PWIL filed actually a CTA, so it started
Michael Yee, Senior Biotechnology Analyst, Jefferies: Is a new TCR bispecific? Yeah. So this
David Berman, Chief Scientific Officer, Immunocor: is a TCR bispecific targeting PWELL, which is a novel target essentially expressed in colorectal cancer, gastric, and pancreatic. It’s not really expressed in normal adult tissues except for the testes. So this is already in dose escalation. It’s moving well. Of course, CRC is a huge unmet need.
Michael Yee, Senior Biotechnology Analyst, Jefferies: When can we get data?
David Berman, Chief Scientific Officer, Immunocor: So potentially next year, I would say. Of course, it’ll be data dependent when we have a complete data.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, you know what’s good about ImmunoCorps is
Michael Yee, Senior Biotechnology Analyst, Jefferies: you guys do not do piecemeal, piece drop phase ones. You guys always put out a whole slew of amount of data, and therefore multiple cohorts. Yes. You know, just like the first cohort. And I would think ASCO of next year is probably reasonable.
Potentially.
David Berman, Chief Scientific Officer, Immunocor: Yeah. Potentially.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. And
Michael Yee, Senior Biotechnology Analyst, Jefferies: this is single agent, and you’d expect responses and that type of stuff with this type of mechanism? Yeah,
David Berman, Chief Scientific Officer, Immunocor: mean, an open question. Is this going to be more like a chemtrac?
Michael Yee, Senior Biotechnology Analyst, Jefferies: Colorectal’s tough.
David Berman, Chief Scientific Officer, Immunocor: Late line colorectal, know, it’s essentially single, chemotherapy has single digit response rates.
Michael Yee, Senior Biotechnology Analyst, Jefferies: It’s a cold tumor.
Michael Yee, Senior Biotechnology Analyst, Jefferies: It’s hard to, overall
Michael Yee, Senior Biotechnology Analyst, Jefferies: it’s a tough tumor.
Michael Yee, Senior Biotechnology Analyst, Jefferies: I’m just saying response rates, we’ll look at the totality of the data, obviously. And then obviously you have a second program. I’m going to say infectious disease HIV is one that would matter, but do you think that that’s the one we should highlight here in the last thirty seconds, and when’s the next data? Because that was interesting.
David Berman, Chief Scientific Officer, Immunocor: Yeah, HIV was exciting for us because it told us at least that you can that this platform can touch the disease. Mhmm. And, you know, we’re not yet at the target product profile that we want, but we’re showing that we can actually have an effect on the virus. We have HBV data that will be coming out later this year, single ascending dose data, so not multiple but single. And I think when you put that data together with this data, we’ll begin to ask, can this platform reach the reservoirs?
Michael Yee, Senior Biotechnology Analyst, Jefferies: When’s the next HIV data?
David Berman, Chief Scientific Officer, Immunocor: So the HIV is continuing dose escalation.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Yes.
David Berman, Chief Scientific Officer, Immunocor: Male And then we’ll do an expansion.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male Okay.
David Berman, Chief Scientific Officer, Immunocor: Male When that data is complete, we’ll show it. I would say potentially next year also.
Michael Yee, Senior Biotechnology Analyst, Jefferies: Male Okay. Look, we looked at the
Michael Yee, Senior Biotechnology Analyst, Jefferies: first data. It definitely has biologic activity. There’s promise there. You were seeing all the biomarkers. And also a number of people were able to stay off antiretroviral So more N would be needed, but you’re continuing to dose forward.
All right guys, thank you very much. Appreciate the update and thank you very much.
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