Kura Oncology at TD Cowen Summit: Strategic Innovations in Menin Inhibitors

On Tuesday, 27 May 2025, Kura Oncology (NASDAQ:KURA) presented at TD Cowen’s 6th Annual Oncology Innovation Summit, outlining its strategic focus on menin inhibitors and combination therapies. The company showcased its strong financial position, with over $700 million in capital, and highlighted its plans for NDA submission for Zifdomenib. While optimistic about their clinical data, Kura also acknowledged challenges in the competitive landscape and the need for effective physician education.

Key Takeaways

• Kura Oncology is financially robust with over $700 million and up to $375 million in near-term milestones.
• The company is advancing its menin inhibitor program, focusing on Zifdomenib, with significant trial results expected at ASCO and EHA.
• Strategic plans include expanding into solid tumors and pursuing combination therapies.
• Kura is addressing potential challenges such as differentiation syndrome and market competition.
• Manufacturing and IP strategies are designed to minimize tariff impacts.

Financial Results

• Kura has a strong cash position with over $700 million as of the last quarterly update.
• The company anticipates up to $375 million in near-term milestones.

Operational Updates

• Zifdomenib’s pivotal trial results in NPM one mutant AML will be presented at ASCO.
• Updates on intensive chemotherapy trials and farnesyltransferase inhibitor programs are expected later this year.
• Kura has begun dosing in the COMET 15 study, combining Zifdomenib with imatinib in advanced GIST.

Future Outlook

• Kura plans to pursue menin inhibitors in solid tumors and evaluate combinations with FLT three inhibitors.
• The company aims to expand trials into maintenance settings, focusing on data-driven decisions.
• Aiming for NDA submission for Zifdomenib, Kura targets a significant market opportunity in the frontline population.

Q&A Highlights

• Kura’s competitive strategy includes leveraging combination data and novel endpoints.
• The regulatory approach will focus on both phase two and phase one b data, emphasizing MRD negativity.
• Manufacturing and IP are strategically located to avoid significant tariff impacts.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - TD Cowen’s 6th Annual Oncology Innovation Summit:

Phil Nadeau, Biotech Analyst, TD Cowen: Good morning, and welcome to T. D. Cowen’s sixth annual oncology innovation summit, insights for ASCO and EHA. This year’s conference includes 27 virtual fireside chats with many of the companies that will have notable presentations at ASCO and this year. We hope you find the sessions useful as you prepare for the meetings.

This is Phil Nadeau, one of TD Cowen’s biotech analysts, and I’m happy to host the first session with CURA Oncology’s president and CEO Troy Wilson and CMO Molly Leone. CURA will have very notable presentations at both ASCO and EHA, including the results from Zifdomenib’s pivotal trial in NPM one mutant AML. With that, Troy, I I thought I’d hand it to you. Can you give us a a brief state of the company overview, biggest strengths, biggest challenges, and and what does Cura need to do to create shareholder value over the next year?

Troy Wilson, President and CEO, CURA Oncology: Yeah. Phil, thanks to you and TD Cowen for the invitation to participate. There’s a lot come going on, at ASCO and EHA both with CURA and and, the oncology segment generally. For us, we have, sort of three three buckets for the menin inhibitor program. You’ve already mentioned, we’re looking forward to sharing our top line data, or I should say our full data for the COMMENT zero zero one registrational study at ASCO.

Turning to EHA, we’ll give an update on the COMMENT zero zero seven, intensive chemotherapy phase one a one b. That’s relevant because that’s a direct lead into the comet o 17 study, which is a two parallel phase three studies in both intensive and non intensive. So we’ll cover all of that. We’ve also, as you know, a month or so ago, began dosing patients in COMET 15, which is our, phase one study combining ziftamenib with imatinib in patients with advanced GIST. Beyond those menin inhibitor programs, Phil, we have an update on our farnesyltransferase inhibitor programs, both tipifarnib and twenty eight zero six.

They’re in the second half of the year, hopefully at at ESMO. And then we’ll give another update with additional data for the ceftobenib combinations likely in both the relapsed refractory and the frontline setting rounding out the year at ASH. We’re in a strong position. These are tough markets, Phil, but Kura is well capitalized. We have just over $700,000,000 as of the last quarterly update.

We have 3 up to 375,000,000 in near term milestones coming in. So, you know, we can stay focused, put our heads down, and and keep generating, value. I think the the thing one has to do is just keep a steady hand, and just try to push through these these very difficult markets for the biotech sector. But I think we’ve got good programs, good data, great team, great partnership. I think we’re well positioned.

Phil Nadeau, Biotech Analyst, TD Cowen: Maybe turning to ASCO first. As you noted, the full data from the COMMENT zero zero one trial will be at the meeting. Some of the top line results were actually in the abstract that was released last week. Can you provide the highlights of the data in the abstract and which measures are most important in defining Zifdominib’s efficacy and safety?

Troy Wilson, President and CEO, CURA Oncology: Yeah. So the the the headline number, of course, still is the CRCRH rate, which is twenty three percent. We provided a median duration of response. And as as we look forward to the ASCO and I’m I’m sure Molly can speak more to this, you’ll get additional granularity on that data around things like MRD negativity, survival, all the attributes. We’re we’re really pleased.

We think this is an approvable product. We think it’s very competitive from both a clinical activity and a safety and tolerability perspective with the competition and, look forward to sharing that data.

Phil Nadeau, Biotech Analyst, TD Cowen: I I think a key concern among investors of just about the Meninem class is the competition in the space. Like, how would you position Xifdomainid’s pivotal data compared to what we’ve seen from other pivotal trials as well as the earlier stage data from J and J and and Sumitomo?

Troy Wilson, President and CEO, CURA Oncology: Yeah. It’s a it’s a good question. I think, you know, it’s important to sort of run your own race here, and don’t don’t worry too much about the competition. But we now have two successful, monotherapy registrational studies still, one for us and one for our competitor Syndax. I think what that says is this is a real drug class.

Right? This is likely to make a difference for patients with AML. But the reality is the way in which these drugs are going to be used is in combination and in earlier lines of therapy. So we really view these initial registrations as getting out there into the market, familiarizing both physicians and patients. What I would point people to is increasingly look at that combination data, whether it’s in the relapse refractory setting or in the frontline setting, because that’s where I think you’re going to begin to see programs distinguish from one another.

And importantly, as I think you’ll see, the the challenges of ZIFTO as a monotherapy, Phil, the the biggest challenge actually is is just educating physicians to be patient and keep patients on the drug. Give the drug time to work. As you go into combinations, that problem melts away because, of course, you have the combinations helping to keep the counts under control. So that’s we’re gonna give you a couple of meaningful updates, actually several meaningful updates this year. The first at EHA in the intensive setting, the second, hopefully, around ASH in the non intensive setting, and then as I mentioned, some additional updates in the relapsed refractory setting.

If our our number, Phil, is in in that frontline population, this is a 5 to $10,000,000,000 market. You take 10,000 patients times the price point times, you know, eighteen to twenty four months of therapy. If that’s true, there’s room for two or even three competitors. And we are charging ahead to try to get there as quickly as we possibly can.

Phil Nadeau, Biotech Analyst, TD Cowen: You mentioned the NDA, for for zifdomenib. Which results will be central to the filing? Is it the pivotal phase two data, or is is the combination of the phase one, two data what’s gonna be reviewed by the FDA?

Troy Wilson, President and CEO, CURA Oncology: Yeah. Let me ask Molly, if she can answer that for you, Phil. It’s a good question.

Molly Leone, CMO, CURA Oncology: Sure. Really, the FDA has the ability to review any and all data that they would like to. They have been provided with both the phase two and the phase one b two, combined. Obviously, the phase two will be the pivotal, data reviewed, but the phase one b will probably could be combined in a label. And then the big things that they’re gonna be looking at are, of course, response rate and really evidence of safety.

So lack of myelosuppression, lack of, big risks that would outweigh the benefits of monotherapy. And then as well, one of the factors to look at is transfusion independence and maintenance of transfusion independence. And that’s why we think that’s an important topic to cover.

Phil Nadeau, Biotech Analyst, TD Cowen: And on the safety profile, it seemed like in the pivotal phase two data, the rate of differentiation syndrome was was very manageable, was was quite low. Do you think that’s because physicians have become, better at managing, managing the the risk given that, we’ve seen it from multiple members in the class?

Molly Leone, CMO, CURA Oncology: I think the differentiation syndrome guidance we put in place, I like to say it’s no longer just manageable. It’s managed. These physicians have learned how to identify it early. They know when to be looking for certain signs and symptoms, and then they’re able to intervene at the appropriate time. So I think it’s it’s been a learning about about ZIFTAMENNA because I think each of the menin inhibitors that shows differentiation syndrome at different points and in different ways.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. Maybe turning to EHA. You referenced the data from COMIN-seven. Can you briefly summarize the data that were in the EHA abstract?

Troy Wilson, President and CEO, CURA Oncology: Phelan, would you like to do it?

Molly Leone, CMO, CURA Oncology: So we were presenting the data. This is our frontline, intensive chemotherapy trial with seven plus three, with the addition of zyptomenib in both the MPM one mutants and the KMT two a rearranged patients. We’ve gone through the dose escalation portion, and we have decided on with the FDA’s input, of course, the recommended phase two dose of zyptomenib, which is six hundred milligrams. So what we’ll be showing at EHA is the six hundred milligram treated patients. We will take them both from the escalation and from the expansion phase that we’ve done so that you get a nice large patient pool separately showing the NPM one and the KMT two a.

You’re gonna see response rates. You’re going to see that, you know, the the durability is is really quite the the it’s it’s impressive for these patients, especially the KMT two a patients. You’ll see, you know, how the duration of response is progressing. I wouldn’t say that you should expect to see a median yet, thank goodness, which is a good sign for patients, similarly with survival. But you’ll get to see, overall how these patients’ courses are evolving.

Phil Nadeau, Biotech Analyst, TD Cowen: Can you remind us what you’d expect for intensive chemotherapy on its own in this patient population? What’s sort of the benchmark for CRC as well as duration of response?

Molly Leone, CMO, CURA Oncology: Yeah. So it it varies for either of the types, it’s varied depending on what sources you use. But you’d expect anywhere from a fifty to seventy five percent CR rate in this patient population in general. And when you break it down by subtypes, in the MPM1 mutant, you probably expect higher within the seventy to eighty five percent rate. Within the KMT2A is probably more, you know, that they respond well, but then they relapse quickly.

So probably, you know, closer to the seventy percent range and then a quick relapse. By the first year that patients have been on therapy for MPM1 mutants, even the the quote unquote good AML to have, you know, more than half will have either been relapsed or refractory by that point. So you wanna look and see if these patients are actually able to maintain their responses prolonged periods of time. It’s still early in the study relatively for these patients in their courses, so it’ll just be giving you a general trend in that direction. KMT two a’s, you expect to be relapsedrefractory by six months, seven months.

So, again, watching their their course as they’ve evolved over, time will be will be important for folks.

Troy Wilson, President and CEO, CURA Oncology: Yeah. Bill, it’s not about response rate. It’s about durability. Right? You you expect the backbone to drive high response rates.

As you look across the competitors in the class, you should be looking at the swim lanes and looking for durability, as Molly said.

Phil Nadeau, Biotech Analyst, TD Cowen: And and, I guess, what would you consider to be good durability versus versus disappointing in your mind? Where do you need to be?

Molly Leone, CMO, CURA Oncology: I’m hoping that we barely even know the answer to that question by the time we hit EHA because we’re just still going and going and going. But I’d really like to have it so that, you know, we we beat that one year mark of the fifty percent relapse refractory rate and and have these patients still in a response and and seeking the treatment they want, be it transplant or avoiding transplant.

Phil Nadeau, Biotech Analyst, TD Cowen: Obviously, a key question for any combination regimen is where there’s overlapping techno toxicities. Have you seen anything concerning in the in the initial data?

Molly Leone, CMO, CURA Oncology: The easy answer is is no. We have not. And we actually we one of the biggest things that I think every combination is concerned with is count recoveries, how quickly because these backbones are they’re tough, and they really wipe out a patient’s bone marrow. So we wanted to make sure FDA wanted to make sure, investigators wanted to make sure that ziftamenib wasn’t prolonging any of those time to count recoveries. And so that’s also a very important point to look at, but also the biggest source that that of overlapping talks that you could have.

I I am satisfied that we are not seeing it. And so it’s been it’s been a very good journey to be part of.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. Maybe, moving on to the other part of comment o seven in combination with with Venaza. There was some data reported at ASH twenty twenty four. Can you summarize that that data? And and what does that initial data suggest about the combine ability of ZIFTO and the standard of care in the in, unfit population?

Molly Leone, CMO, CURA Oncology: So the what we presented last year was from the dose escalation portion of the trial, the phase one a, in both the MPM one and the KMT two a. That was in the relapsed refractory patient population as well. Once we reached six hundred milligram dose and confirmed both internally and with the FDA that six hundred milligrams does appear to be the proper dose, we opened up an expansion phase in this frontline patient population, continued the relapse refractory, but also open the frontline population. So this will be people’s first glimpses at that that frontline data. Relapse refractory data tends to be hard to interpret because these patients have had so many different things in their past, and and they’re such different points in their their treatment journey.

So this frontline data is what we’re very excited to be able to share with you guys finally now, so you can see how the combination of ZYFTDA plus VENESA, really could potentially transform the field.

Phil Nadeau, Biotech Analyst, TD Cowen: So so what will differ from the ASH presentation, in the update we get in the second half of the year? Is it is it specifically we’ll get the the frontline data, or are there other elements that we’ll see as well?

Molly Leone, CMO, CURA Oncology: You’ll get the frontline data. It’ll be your first peek at the frontline data. You should also be getting an update on the relapse refractory data.

Troy Wilson, President and CEO, CURA Oncology: Okay. And there and and sorry, Phil, just to jump in. They are obviously these are unfit patients. So the goal is not always to get them to transplant. So you’re looking at, can you keep them on a menin inhibitor as monotherapy?

And essentially, Molly said in the intensive setting, can you keep them in a durable response? Right? That’s what you’re going to be looking for. And and recall, our focus in the frontline is really around the NPM one because in our experience, most of the KMT two a frontline patients go to the intensive chemotherapy because that’s their best chance for cure. So the the frontline focus will be around NPM one, as Molly said.

We’ll also give you an update. Now we have experience at six hundred milligrams in the relapsed refractory setting, and you’ll like to get an update on that as well.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. Maybe moving on to the the pivotal study. In December, you announced the design of the o one seven trial. Can you describe the the, highlights of that design?

Troy Wilson, President and CEO, CURA Oncology: Go ahead, Molly.

Molly Leone, CMO, CURA Oncology: Sure. Under the, umbrella of a single trial, we are actually performing two, pivotal trials, one in the intensive setting with seven plus three and one in the non intensive setting with VENESA. In the intensive setting, we’ll be enrolling both KMT2A and NPM1 mutant patients, and we’ll be doing it in a fashion that allows the the physician and then and whoever’s reviewing the data to understand if where Ziftametin makes the biggest impact. So we’ll be looking at it in induction. We’ll be looking at a consolidation, and we’ll be looking at it in post consolidation, whatever that consolidation may have been, whether it be chemo or whether it be transplant.

Transplant. So it’ll be a three arm study in order to really isolate the effects of ziftamenib. Randomized, blinded, placebo controlled, all the works. Similarly with the Venesa, as Troy mentioned, we, have seen that the KMT-two eighty patients do not enroll in Venesa in the frontline with any any fervor. They it’s very rare that they are part of the frontline Venesa.

They’re younger, they’re seeking different outcomes. So that we’re gonna focus on the NPM one mutant patients. And, again, it will be double blind randomized. These both studies were designed with the potential for accelerated approval in mind. So the seven plus three has an accelerated approval endpoint of MRD negative CR that hopefully we would be able to get a readout of that in 2028 we’ve previously shared.

And for Venesa, similarly, the accelerated endpoint would be the CR rate, and we haven’t really discussed exactly when we should be seeing that. But as this study gets underway and we see the operational characteristics, we’ll be able to give some more color.

Phil Nadeau, Biotech Analyst, TD Cowen: The use of CR and MRD negative CRs regulatory endpoints is is novel. It seems very likely to accelerate development. Can you discuss the key discussion points with regulatory agencies that enabled using those endpoints as as primary for accelerated approval?

Molly Leone, CMO, CURA Oncology: Yeah. Thankfully, the the, the regulators, they they’re scientists. They’re physicians. They see the data. They’ve read the papers.

They see all the trends towards CR MRD negativity really being more predictive of a more durable response. So they become more open to it. So when we take additional data to them showing them, you know, our interpretation of MRD negativity in our data, as well as those those additional resources that have already been published, they’re open to discussing what points they need to see in order to to really believe that they can correlate MRD negativity with overall survival. So they do have a checklist that’s been developed through all the data points they want to see at the time of submission, that’ll really help validate. And they were satisfied that we were able to, provide those based upon the plans that we have in place, and, they they you know, I think they’re rooting for this to work because they really would like to make development, you know, less than the the timelines that it it currently operates under with many, many years to time devoted to getting to the right answer.

Phil Nadeau, Biotech Analyst, TD Cowen: I don’t think you’ve disclosed the powering of this study for either the, primary and part of the accelerated approval endpoints. You disclose those if if you have and or remind us what they are if you have disclosed them? And if not, when do you think we will, be able to know know the powering?

Troy Wilson, President and CEO, CURA Oncology: We’ll we’ll probably disclose that, Phil, as Molly said a little later, in this year as we get closer to those trials actually, initiating. They’ll they’ll go live on clintrials.gov, and and we’ll be able to speak to them. So, not quite yet.

Phil Nadeau, Biotech Analyst, TD Cowen: You’ve guided to the MRD negative CR data available, in 2028. That seems like an aggressive timeline. What what gives you confidence that you can hit it?

Molly Leone, CMO, CURA Oncology: Well, the robust enrollment we’ve been experiencing throughout the the trials

Troy Wilson, President and CEO, CURA Oncology: Uh-oh. Well, Molly first. I’ll I’ll pick it up. Bill, the robust enrollment, that we’ve been experiencing in the o o intensive chemotherapy trial Sight

Molly Leone, CMO, CURA Oncology: excitement. Sorry. Good. As well as the site excitement because, you know, you can’t really conduct the trial part of it and want to part of it globally for something this large. So we we know how many sites will likely participate.

We know the enrollment we expect. So we do think twenty twenty eight is a very reasonable guesstimate. And also, again, it’s an accelerated endpoint. So we’ve timed it so that it’s something that is reliably easily measured in these patients at an earlier time point rather than a survival endpoint.

Phil Nadeau, Biotech Analyst, TD Cowen: What other additional registrational trials are being considered? Are there perhaps trials in the maintenance setting or in combination with foot threes?

Troy Wilson, President and CEO, CURA Oncology: Both. Short answer, Phil. Both. We have to be data driven. I think, again, you you’ll see you’ll see as you see the EHA data and then hopefully the the data if if we’re able to present it at ASH, one needs to consider carefully what a what a maintenance trial looks like.

The one of the takeaways from EHA may may be the large number of patients who are just remaining on ZIFTO as monotherapy without going to transplant. And and as you mentioned, there’s clearly an unmet need among FLT three mutant patients. We have a combination with gilteritinib underway in the zero zero eight trial in the relapsed refractory setting. We intend to, evaluate the combination with quasartanib in the frontline setting. And then depending on the outcome of of those, we can make a data driven decision on how best to to prosecute the frontline FLT three mutant population.

Phil Nadeau, Biotech Analyst, TD Cowen: When could we see additional data from the o o eight trial? Is is that, like, in the second half of this year?

Troy Wilson, President and CEO, CURA Oncology: It’s not gonna be the second half of this year. I think the second half will focus on o o seven. O o eight, you know, not everything can be a priority at the same time. The o o eight cohorts still, which are Flagida, LDAC, and gilteritinib are all still moving methodically through dose escalation. So let’s give those a little bit of time, before we before we share that data with you.

The none of those still are likely to be registrational. Molly’s, Molly’s strategy has been to do, combinations of ziptimenib with all the appropriate standards of care, get that data out there, reassure physicians of the safety, tolerability, combinability. So there isn’t as much of a rush, to really, you know, get those into a registrational setting. The focus is, as you correctly put, zero zero seven and zero seventeen.

Phil Nadeau, Biotech Analyst, TD Cowen: And, maybe last question on MEN inhibitors before we moving to the FTIs briefly in the end. You’ve announced the intention to pursue a MEN inhibitor in solid tumors. What’s the status of that that program, and and, when could we see the initial data?

Troy Wilson, President and CEO, CURA Oncology: So the so I I think we can split that into two pieces, Phil. The first opportunity is ziftamenib plus imatinib in GIST. So that’s the COMMOD o 15 study. That study is now enrolling in dose escalation. We haven’t guided yet on timing for data.

It’s enrolling well, but but let’s, you know, let let’s let’s get some experience with it before we guide on data. Beyond that, there are additional opportunities in other solid tumors. We think it’s likely we would use a different menin inhibitor, beyond ceftobenib, for those opportunities. And and, one of them, you know, you can see is the, the cat six a plus menin combination. That looks that looks interesting, there are other opportunities as well.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. Maybe moving on to the FTIs. Can you give a brief, summary of the of the status of the FTI programs and and when we could see data next?

Troy Wilson, President and CEO, CURA Oncology: Yeah. So the the the the thing that people should be looking for is and this, you know, this has been a this has been quite a quite a journey for us. I think the killer application for FTIs is in combination with other targeted therapies. As as it turns out, whether it’s a a a TKI in renal cell, you know, a KRAS g twelve c inhibitor, a p I three kinase self inhibitor, when you treat tumors with those molecules, the tumors, you either get innate or adaptive resistance, and that resistance runs through a common mechanism that involves a farnesylated target called REB, RAS homolog expressed in brain. So what you’re looking for from this update, Phil, is, again, safety, safety, safety.

Can you safely combine with these different classes? And then can we show you data that says the combination of an FTI plus that targeted therapy is meaningfully better than the targeted therapy alone? That’s that’s the bar that we’re setting. We’re going to provide updates on the fit the excuse me. The current trial, which is TIPI plus alpilicib, as well as the FIT trial, which is the monotherapy escalation for twenty eight zero six, as well as the combination with cabozantinib in renal cell carcinoma.

And look for that in the second half of the year potentially at ESMO.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. Maybe last question to wrap it up. Question we’re getting about all companies. Can you remind us where Zipto’s manufacturing its IP is domiciled and any potential impact on on pharmaceutical tariffs?

Troy Wilson, President and CEO, CURA Oncology: IP is based in The US, domiciled in The US. The the tariff impact, Phil, is de minimis. It’s a small molecule, fortunately. And we’ve actually strengthened the supply chain, so we can we do have certain segments that are in China. We also have segments that are in India and then some of the final productions done in Canada and The US.

So we we think we’re well well protected from any of this, you know, ex ex extra, extra turbulence.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. With that, I think we’re out of time. So thanks so much for a very interesting update, and, congratulations on the data. ASCO and EHA. We look forward to the full presentations.

Troy Wilson, President and CEO, CURA Oncology: Thank you.

Molly Leone, CMO, CURA Oncology: Thank you.

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