Kura Oncology at TD Cowen Conference: Strategic Developments in Cancer Therapies

On Tuesday, March 4, 2025, Kura Oncology (NASDAQ: KURA) presented at the TD Cowen 45th Annual Healthcare Conference, outlining its strategic initiatives in targeted cancer therapies. The company emphasized its robust financial status and innovative clinical trial designs, while acknowledging the challenges ahead in a competitive market landscape.

Key Takeaways

- Kura Oncology’s menin inhibitor, ziftomenib, is a focal point, with plans for an NDA submission in Q2.

- The company secured a $330 million upfront collaboration with Kyowa Kirin, with potential milestone payments of $240 million this year.

- Kura has $750 million in cash, providing strong financial backing for its pipeline expansion.

- The COMET-017 trial aims for accelerated approval, with MRD-negative CR as a potential endpoint.

- Initial clinical data from the Farnesyltransferase (FTI) program is expected in the second half of the year.

Financial Results

- Funding and Collaboration:

- Kura Oncology received $330 million upfront from Kyowa Kirin in December.

- Anticipated milestone payments of $240 million this year could lead to breakeven.

- The collaboration covers half of the commercial expenses.

- Approximately $750 million in cash was reported a week prior to the quarterly call.

- Market Opportunity (SO:FTCE11B):

- The relapsed/refractory market for menin inhibitors is valued at a few hundred million dollars.

- Peak sales for the menin class in AML could reach $7 billion, assuming 18-24 months of use.

Operational Updates

- Ziftomenib Development:

- NDA submission is targeted for Q2.

- Top-line data for ziftomenib in NPM1 acute leukemia indicates a CR/CRH rate between 20% and 30%.

- COMET-017 Trial:

- Consists of two Phase 3 trials within a single protocol for intensive and non-intensive chemotherapy.

- Aims for accelerated approval endpoints in the U.S. and survival-based endpoints in Europe.

- MRD-negative CR is a potential accelerated endpoint in intensive chemotherapy.

- Pipeline Expansion:

- A Phase 1 study combining ziftomenib and quasartinib in frontline FLT3-mutant AML is planned.

- Dosing of patients with ziftomenib and amatinib in GIST is expected in the first half of the year.

- Initial clinical data from the FTI program is anticipated in the second half of the year.

Future Outlook

- Ziftomenib Launch:

- Strategic functions are being built out in preparation for the launch.

- Sales force recruitment will occur closer to the potential PDUFA date.

- Expansion Opportunities:

- Potential for ziftomenib in diabetes and solid tumors.

- Focus on post-transplant maintenance as a potential value driver.

- Clinical Data:

- Meaningful clinical data is expected at major medical meetings (ASCO, EHA, ESMO, ASH) throughout the year.

Q&A Highlights

- Regulatory Discussions:

- Alignment with FDA and EMA on accelerated approval pathways for the COMET-017 trial.

- MRD-negative CR accepted as a surrogate endpoint for survival based on IMPACT Consortium data.

- Trial Design:

- COMET-017 trial includes both intensive and non-intensive chemotherapy arms.

- Bone marrow assessment is used for CR versus plasma markers to demonstrate a clinically meaningful benefit.

- Enrollment and Timelines:

- The COMET-017 study is expected to start in the second half of the year.

- MRD-negative CR top-line results are anticipated in 2028.

In conclusion, readers are encouraged to refer to the full transcript for a detailed understanding of Kura Oncology’s strategic plans and clinical advancements.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Phil Nadeau, Biotech Analyst, TD Cowan: Good afternoon, and welcome once again to TD Cowan’s forty fifth Annual Healthcare Conference. I’m Phil Nadeau, a biotech analyst here at Cowan. And it’s my pleasure to moderate a fireside chat with Troy Wilson, the President and CEO of Kera Oncology. Troy, I’ll hand it to you to start. Can you give us a brief state of the company overview, biggest strengths, biggest challenges and what does Kera need to do to create shareholder value over the next year?

Troy Wilson, President and CEO, Kura Oncology: Sure. Thank you for the invitation to participate in the conference and for the fireside chat. So, you know, Kura is building I think a leading pipeline of targeted therapies to treat cancer. There is obviously a lot of investor and analyst focus on the menin inhibitors. We’ll talk about that.

We’re going to be pursuing opportunities in the relapsedrefractory setting, in the frontline setting, as well as other indications including solid tumors and diabetes. We’ll also later this year show some early clinical data from two of our farnesyltransferase programs which are targeting big solid tumor indications. That has potential to create a lot of value for patients. As far as strengths, you know, I think we’re be building an incredible integrated research development and commercial organization. We are extremely well funded in these which is important in these trying times.

Anybody who’s watching the tape, it’s good to be able to put your head down. You know, we’ve got, I think, really potentially life saving medications and we can advance them forward, stay focused, because eventually everything normalizes. We’re really looking forward to our NDA submission, to sharing top line data, to hopefully a successful NDA approval and a launch of ziptumeneb. And it’s just going to be one thing after another for the next couple of years. Some comment, Phil, that I made on one of our recent calls, I think was our earnings call last week.

We hope to have meaningful clinical data at every major medical meeting this year, ASCO, EHA, ESMO, ASH. So there’s gonna be a lot to pay attention to across the pipeline. And, for those who can stay with it, you know, in these markets, I’m hoping we create a

Phil Nadeau, Biotech Analyst, TD Cowan: lot of value for people. So let’s start with ASCO and the pivotal data from ziptoMenib in NPM1 acute leukemia. Can you summarize what you have disclosed about the data so far?

Troy Wilson, President and CEO, Kura Oncology: Yeah. So we have so the trial is obviously a Phase two single arm trial for registrational intent. We have guided that the top line data, which is the rate of CRCRH, is between twenty percent and thirty percent. That’s what the trial was designed to deliver. That’s in fact what it has delivered.

That means two things. One is, hopefully that that data set is comfortably above the null hypothesis, such that you can rule out chance. That’s obviously important from an approvability perspective. But also the benefit risk as far as safety, tolerability and clinical activity, we think is going to be compelling relative to other competitors in the class and of which there are several. Again, I think we’ll be well positioned not only to compete initially in the relapsedrefractory population as you indicated, but ultimately to be able to drive interest initially in trial enrollment and then ultimately into the frontline population.

And we’re going to try to do both, Phil. You know, we sometimes people focus on one or the other. In the near term, you need to execute in the relapsedrefractory market. Our best guess is that’s a few hundred million dollars. The frontline population, if we assume eighteen to twenty four months of use, which is, what we’ve now guided to a couple of times, that the peak sales for the men in class just in AML, could be as much as $7,000,000,000 or perhaps even more.

So you’ll see our focus is really on how do you build on that initial enthusiasm in the relapsed refractory market and ideally get to these patients as early as you can in their treatment journey so that we give them the best chance of a long term durable remission or potentially even a cure.

Phil Nadeau, Biotech Analyst, TD Cowan: We will dive into the front line market in a lot of detail given your, novel trial designs. But before we get there, just knock off a few more questions, relapsed refractory. Sure. So you’ve disclosed that the results have been submitted to ASCO and will be disclosed, in the at disclosed in the abstract. So can you give us some sense of what measures will be in the abstract versus the presentation?

Will the presentation be the same data cut as the abstract? Will there be a new one?

Troy Wilson, President and CEO, Kura Oncology: Yes. So the principal data points in the abstract will be the CRCRA rate, the duration of response, the safety and tolerability, obviously, sort of the headlines from that. The presentation and we’re targeting ASCO, obviously, there are no guarantees, but it’s a positive pivotal study. So we’re hopeful that we’ll have more data and will obviously sort of cut the data in different ways as people can imagine. In terms of that data versus the data that is going into the NDA submission, that data is roughly contemporaneous.

Our goal is we’ve now, I think largely closed the gap in NPM one and from a timing perspective. There was not that long ago that we were perceived as two years behind. We may even be ahead at this point. I don’t know. We’re guiding to an NDA submission in Q2.

You’ll see the data between what’s gone into the NDA and what you’ll see ultimately, hopefully at ASCO, will be very consistent. Those are as essentially a contemporaneous data cut.

Phil Nadeau, Biotech Analyst, TD Cowan: Got it. And what has to be completed before the NDA can be submitted? Any key rate limiting factors?

Troy Wilson, President and CEO, Kura Oncology: No. Just people are finishing the clinical module. A number of the other modules are complete or very nearly to complete. You know, there’s a whole sort of QA QC process that you step through. We’re targeting Q2.

We know we are in a footrace. And so we’re going as quickly as we can, but not sacrificing quality. Quality has to be the most important thing.

Phil Nadeau, Biotech Analyst, TD Cowan: And what are you doing today to prepare for the launch?

Troy Wilson, President and CEO, Kura Oncology: Yes. So we’ve hired we’ve continued the theme of I mean, I think we’ve just hired this is in these markets, you can actually be a buyer’s a buyer, right, of talent. And we’ve recruited an outstanding commercial team to stand alongside our development and our research teams. We are building out a lot of the strategic functions, marketing, market access, medical affairs, beginning to build out the organization underneath those functions, everything from pricing to competitive intelligence, insights and analytics. There’s a lot that goes into it.

We haven’t yet recruited a sales force and we’ll wait to do that until we get closer to when we have line of sight on a potential PDUFA date. But we, as Kura and then in collaboration with our partners, Kyowa Kirin, intend to be formidable competitors in the market against the one established competitive player out there. We may have a bigger footprint. We may be able to reach more docs. That’ll be this is still a specialty market, but I think our goal is to get out there and promote where we can within the label, but also educate physicians as we continue to see data on this menin inhibitor class evolve over the next year to several years.

Phil Nadeau, Biotech Analyst, TD Cowan: And can you mind is under the collaborative agreement who is in charge of the sales force? Is it a joint steering committee? Is it Keyur? Is it Cura?

Troy Wilson, President and CEO, Kura Oncology: So Cura leads commercial strategy. There is a joint commercialization committee reporting to a joint steering committee. We’re really working, I think, well together. There is a recognition I mean, there’s a recognition between the two companies. Let’s not be duplicative.

Let’s try to if there’s something Cure Kirin already does or does better, let’s go with that, right? But, Kura is leading global development. We’re leading commercial strategy. We’re booking U. S.

Sales. So it’s important that we sort of set the tone. But they’ve our teams are working very, very closely and I think so far very well together. Perfect. It’s a new relationship, so the honeymoon.

Phil Nadeau, Biotech Analyst, TD Cowan: With that, we’ll transition to first line. Yeah. The Comet o one seven design was recently disclosed, has some novel elements in it. Can you, outline the design of the the Comet o one seven trial?

Troy Wilson, President and CEO, Kura Oncology: Sure. So for the for the for the audience, the COMET zero one seven trial is actually it’s a single protocol that encompasses two independent randomized placebo controlled phase three trials. One trial that is evaluating zifediminib in what we call the intensive chemotherapy setting, that’s in combination with seven plus three. A second independent trial that is NIC for non intensive chemotherapy that’s combining ziftomedib with venetoclax and azacitidine. We now have alignment from both FDA and EMA that I will tell you exceeded my expectations before we went into it.

And the alignment pertains to the potential for pathways to accelerated approval in each setting as well as full of, you know, survival based endpoints in each setting. So in the case of non intensive chemotherapy, the endpoints will be complete response or CR rate as a potential endpoint for accelerated approval, overall survival as the full approval endpoint. In the intensive chemotherapy setting now with seven plus three, you have a novel endpoint of MRD negative or measurable residual disease negative CR as the accelerated endpoint and event free survival as the full approval endpoint. The advantage of those accelerated endpoints is they can shave at least a year, potentially more, off of the timelines to get to data and ultimately to market. I will say we have we’ve now engaged with both FDA and EMA.

The feedback we received from both of them was or from each of them was consistent. You’ll notice that the intensive chemotherapy design is actually a three armed study, and that’s intended to support a label of zifediminib with seven plus three for induction, consolidation and then continuation therapy. So that’s obviously a big value driver for patients as well as potentially commercially. The in the non intensive setting, it’s less frequent that those patients go to transplant. So they’ll stay on Venza, you know, They’ll stay on zifediminib with or without Venaza really until progression.

So that’s how that’s intended to proceed. The statistical analysis plans, there are separate ones for The U. S. And Europe. We will pursue the survival based endpoints in Europe.

But, for those who are familiar, our view is if you’re going to argue for reimbursement with the European payers, you want to put your best foot forward with a survival based endpoint. So the trial is designed to deliver accelerated endpoints in The U. S. As well as full endpoints eventually. And really, it’s overpowered to deliver full endpoints in Europe, but that should support a cohesive global development strategy.

One final thing I’ll mention and, you know, this is this is a little bit in the weeds, but it’s important as as people think about, you know, how how companies work. We’re standing up a global randomized Phase three. The reason we did two trials in one is twofold. The first is we can accept any patient, nearly any patient with the exception of FLT3 mutant fit patients. Those patients have to go to a FLT3 inhibitor first, but any other patient is eligible to come on o 17.

So when you go to a site, that site, essentially, any patient who walks in the door, if that patient is NPM one mutant or KMT two a rearranged, that patient is eligible to come on to o seventeen. That’s a that’s a real attraction. Right? It’s like one stop shopping for the for the clinical sites. The other is from the standpoint of the sponsors, you’re standing up only one trial.

So everything from site selection to contracting and budgeting to site activation to monitoring to data cleaning, that’s all happening one time, but you’re getting sort of two phase three shots on goal through it. It’s what gives us the advantage to compete with one of our other competitors. You know a large U. S. Based pharmaceutical company who you know who’s who’s who’s I like to say their landscaping department is bigger than my entire company.

So you have to be smart and you have to you have to be, do things that are a little unusual and and fight to win, fight to get patients.

Phil Nadeau, Biotech Analyst, TD Cowan: To drill down on a few more of the novel aspects of the trial, you mentioned CR and MRD negative CR as the endpoints for accelerated approval. Many companies have hoped to use those endpoints in the past, but you’re the first one to successfully secure them. Can you talk about the regulatory discussions that enabled you to get those into the trial design?

Troy Wilson, President and CEO, Kura Oncology: Sure. Yes. I mean, kudos to Molly Leone, who’s our chief medical officer and her whole team. So to understand this, go back a few years. We at Kura are members of something called the Impact Consortium.

Impact includes Janssen, BMS, Celgene was a member, Kronos was a member. And the Impact Consortium has been working to make the argument with data that MRD negative CR is an is an appropriate surrogate for survival in acute leukemia. It’s now accepted in multiple myeloma. It’s accepted in other contexts to your point, hasn’t ever been been used, although Kronos did did, I believe, have alignment from the FDA on its trial. But we worked with the IMPACT consortium using both public and non public data, a meta analysis looking across a number of trials to help substantiate the association between MRD negative CR and survival.

It was that effort, Phil, that really, I think, excuse me, was really essential to providing the FDA with the data it needed to say, we’re willing to consider this as an accelerated endpoint. Then we went in and like anything, it’s a discussion with the regulators and they were, you know, there’s a recognition, I think. I can’t say enough good things about the FDA, particularly right now. There’s a willingness to be creative to design these trials where you can do a single seamless trial that gets you both an accelerated endpoint and a confirmatory trial all in one. It recognize if there’s a good argument to be made, why make patients wait for a survival based endpoint?

You want survival to go as long as you can. So I think they were ready. They were primed. I was thrilled. I was not my and I think I made the comment to analysts and investors alike.

That was not my base case. My base case was we were going to be looking at survival based endpoints. Molly and our team were able to secure accelerated PALS in both settings. Just a huge accomplishment. And one other thing that’s maybe a little less less visible, we also got alignment from both health authorities on the usage of venetoclax and as a sighted in that is mirrors real world usage.

So one of the challenges with venetoclax and as a sighted in is it’s mild suppressive. Physicians often try to taper patients off of it to help their counts to recover. Previously there’s been a sort of a reluctance to use anything other than twenty eight day venetoclax dosing. You’ll see the alignment that we got really mirrors what happens in the real world. And there again, I think is it’s a golden age in AML.

It allows these frontline trials to go much faster, hopefully much better benefits for patients. So kudos to our team, to the KK team, which participated in the discussions and our partners at the FDA and EMI.

Phil Nadeau, Biotech Analyst, TD Cowan: And what’s the significance of using the bone marrow to assess CR versus plasma markers?

Troy Wilson, President and CEO, Kura Oncology: Yeah. Most importantly, our best estimate, Phil, is the rate of MRD negativity with intensive chemo in as measured in bone marrow is about forty five percent. So if your goal is to demonstrate a clinically meaningful benefit over standard of care, that’s a much lower hurdle rate. To date, what everyone has shown, from all the different sponsors are is MRD negativity, typically as measured by sites typically measured in blood. That’s going to be much higher.

That’s not necessarily the best predictor of long term survival. Bone marrow is a better measure. And this was not something the FDA or EMA mandated. It was what we proposed to them. But it also gives you a better margin of safety in terms of being able to demonstrate a clinically meaningful benefit over the standard of care.

It’s assessed at the same time a physician would make the determination about is a patient in response. But importantly, it runs alongside, you know, the physicians will be making treatment decisions based upon their local testing. So they’ll decide, do I take a patient to transplant or whatnot? We’ll be running this in parallel to support the companion diagnostic and ultimately the accelerated approval endpoint in the study. So that’s why it works well for patients, it works well for the sites.

We handle all of the we sort of do it all on the back end. And there were some questions, if you’ll give me like one more sec, there’s some questions about did we really have FDA alignment, etcetera, etcetera, after we announced it. I can tell you, like, we don’t have to go back to the FDA on anything related to MRD negativity. On any accelerated endpoint, the FDA is always going to say, look, it’s a review issue, right? Bring us the data.

But what they’re saying is we have a willingness to review your data. And if you, if you generate that data consistent with what we’ve discussed, like we’re happy to take that into consideration. That’s as much as you’re going to get. Now it’s on us as sponsor to do the right study and we know exactly what we need to do.

Phil Nadeau, Biotech Analyst, TD Cowan: Can you discuss the powering of the 17 Trump?

Troy Wilson, President and CEO, Kura Oncology: Not yet. No.

Phil Nadeau, Biotech Analyst, TD Cowan: That’s what I thought you were going to say. When do you think you will be in a position?

Troy Wilson, President and CEO, Kura Oncology: I think when the trials go live on clintrials.gov, right around there, we’re we have a responsibility to bring you other analysts and our investors along. We’re also in a competitive dynamic. And, already I get questions as to whether other sponsors can change their endpoints. There’s no point in like having the Khan Academy to AML while we’re running it. Let’s keep it to ourselves.

So we’ve guided we’ll start this study in the second half, look for a lot more detail on endpoints powering timelines to data. We’ve mentioned that one could have MRD negative CR top line results in 2028. I wanted to put that stake in the ground because we were getting questions. Is it 02/1932? Is it 02/1930?

It’s 2028 is, we’ll be honest before we know it. So we put that stake in the ground. We’ll be more forthcoming and more specific probably in the second half of the year.

Phil Nadeau, Biotech Analyst, TD Cowan: 2028 does seem like an aggressive timeline. How confident are you can hit that?

Troy Wilson, President and CEO, Kura Oncology: I wouldn’t put it out if we didn’t think we can hit it. One thing we’ve said and I don’t want that to sound like hubris. We have been consistently getting better and better on enrollment. And if you look at the pace of enrollment in COMET seven, which is the Phase one trial that informs the design of 2017, like we had and we are just enrolling those studies like gangbusters. So we’re using real world data from 2017 to inform 2017.

I will tell you like we’ve set a high bar internally, but as a shareholder that that’s what our shareholders should want is let’s push ourselves to, you know, to get out there and do it. It’s, it’s reasonable. It’s achievable.

Phil Nadeau, Biotech Analyst, TD Cowan: What other registrational trials are you considering?

Troy Wilson, President and CEO, Kura Oncology: So there is a clear and present opportunity with FLT3 inhibitors. FLT3 is 2530% of AML. It’s overlapping with NPM1. We have been doing studies in the relapsedrefractory setting with gilta ritinib. We’ve gotten good safety data.

That was a question, right, is can you combine two novel mechanisms? We know that. You should see us moving into the frontline setting, in a Phase one study combining zifedimentib and quasartinib. And our goal will be to go straight into the front line if FDA will allow us to do that. We’ll generate data.

It’s an interesting question, and I’ll just leave it as a question for now. How big do you open that aperture? Do you go for all of FLT3? Do you go for all patients? Like how do you think about doing it?

But but if you step back and you say half of all frontline AML patients are eligible for men in therapy, the way I get there as I say, it’s NPM1, it’s KMT2 rearranged and then it’s other mutations including FLT3. If you include all FLT3, it gets you above fifty percent. I think that’s a reasonable assumption. With that, if you assume eighteen to twenty four months depending on intensive or non intensive duration of therapy, That’s what’s driving our estimates that the frontline opportunity for the men in class could be $7,000,000,000 peak sales. Again, you look at myeloma as an analog, you look at other, heme malignancies.

If you’ve got good durability, that’s the kind of commercial opportunity that one can drive.

Phil Nadeau, Biotech Analyst, TD Cowan: Another piece of your guidance for this year is that we’ll get updated data from ZIFTO six hundred milligrams plus Venza during the second half of the year.

Troy Wilson, President and CEO, Kura Oncology: Seven plus three.

Phil Nadeau, Biotech Analyst, TD Cowan: Sorry. Seven plus three.

Troy Wilson, President and CEO, Kura Oncology: Seven plus three in the mid year Venza

Phil Nadeau, Biotech Analyst, TD Cowan: in the

Troy Wilson, President and CEO, Kura Oncology: second half. Right? I’m sorry. I stepped on your

Phil Nadeau, Biotech Analyst, TD Cowan: question. Maybe set the table for that by outlining what was presented at ASH and will be incremental in these new updates.

Troy Wilson, President and CEO, Kura Oncology: Yes. So at ASH, we did two dose escalation studies. We did seven plus three plus ZIFTO in frontline adverse risk patients. That study has now turned the corner and is enrolling at six hundred milligrams in all frontline intensive patients. So you’ll see an update on the six hundred milligram dose data with seven plus three.

With the non intensive chemotherapy, the VENAZA, we showed data. We did a safety escalation in relapsed refractory patients. And that was just to ensure there’s no drug drug interactions, you know, additive toxicity. We will show you probably in the second half of the year data now at six hundred milligrams with zifthaminib, Venaza in frontline, newly diagnosed patients. And so those two populations, the significance of that fill, of course, is those two populations reflect the patient population you’re going to see in the o 17 trials.

So you’re looking for, of course, you’re going to get high response rates because it’s newly diagnosed. But what are we seeing in terms of depth of response, durability? Are we seeing an improvement in CR rate, overall clinical benefit? Clearly, we and Cure Kirin feel sufficiently confident that we’re launching these Phase three studies. I think we’ll fill that picture out throughout this year, hopefully at EHA and then again in the second half of the year potentially at ASH.

Phil Nadeau, Biotech Analyst, TD Cowan: Perfect. Actually speaking of Kira Kiran, you recently signed that global strategic collaboration. Can you talk about the rationale for the collaboration and maybe a bit more about the structure?

Troy Wilson, President and CEO, Kura Oncology: Yeah. So the rationale was your the goal here is to maximize value for patients and ideally for shareholders. We’ve talked about it now. To maximize the value just in AML in the front line, one needs to run three independent Phase III trials, fit, unfit and FLT3. We didn’t touch on post transplant maintenance.

Let’s put a pin in that and come back to that next time. That’s potentially a fourth that could drive value. That’s a big lift for a company at current stage while you’re trying to commercialize your first drug while you’re trying to advance your pipeline. The alternative was, you know, we could have done royalty financing or perhaps equity financing, in these markets. That deal looks like a godsend.

You know, it’s you have a very committed partner. We got $330,000,000 upfront which we received in December. We believe we’re on track if all goes well to receive another $240,000,000 this year in milestones. That should put us at roughly breakeven. Given our projected operating expense it leaves us in a very strong cash position.

There are other things we want to do, right? So you want to be you want to we’ve also we get half of the commercial expenses paid for through that collaboration. And that allows us to we’re going to start dosing patients with zifedomenum and amatinib and just if that works, that’s a billion dollar opportunity. Look at IDRX. Look at, you know, decipher us some of the other players in that space.

You’re going to see us go into diabetes. We’ve talked about that. You’re also going to see our Furnacell Transferase program. Had we not done the partnership, Phil, I think the company would look very different. We wouldn’t be able to take on our competitors and play to win.

And so I am extremely grateful to KK. They’ve been a great partner to this point. It caught some people. It was a little out of the box. But importantly, we retain development control.

We retain U. S. Commercial control, we book sales. So from a strategic optionality perspective, if we can deliver on what we’re doing, there’s a lot of value to be created. And we are in a very strong cash position.

We had approximately $750,000,000 in cash a week ago on our quarterly call. And as I’ve said you know we should end this year in a qualitatively in a similar position. Good place to be for companies you know in these markets.

Phil Nadeau, Biotech Analyst, TD Cowan: It does seem like CURE is getting more and more enthusiastic about ZIFTA in GIST. Can you talk about the scientific rationale for that the combination?

Troy Wilson, President and CEO, Kura Oncology: Yeah. Happy to. So very simply all the all the kit inhibitors in GIST work by blocking the catalytic activity of of of kit, which is essential to ninety plus percent of GIST tumors. Kit is kit expression is under the control of menin MLL. So when you combine a menin inhibitor and a kit inhibitor, think about going at the oncogene or the oncoprotein from two different directions.

As a result, you get very potent synergy. And, for these, you know, the reality and gist is most of the time you’ll see stable disease, perhaps PRs. In preclinical models, you see CRs. Why? I think because you so completely turn off kit signaling that the cell has no choice but to undergo program cell death.

Are we going to see that in patients? I don’t know. But given that we’re starting in effectively, just after the front line, so patients who are progressing on imatinib, we’ll know relatively quickly if we’re seeing a signal because you’re looking to restore sensitivity. If that works, you would go straight into the front line on top of imatinib. Imatinib is used for a couple of years.

It’s generic, so you don’t have financial toxicity. Same pricing paradigm is what we’re doing in AML. And you’ve got four thousand to 6,000 patients a year who could be on ZIFTO for a year or two or more if we see synergy. You’d basically push all the kit inhibitors sort of downstream. So it’s a pretty interesting near term opportunity.

We’ll start dosing patients here in the first half of the year. So look for an announcement in the coming months.

Phil Nadeau, Biotech Analyst, TD Cowan: Great. Maybe last question is on the FTI program, a brief update on the status.

Troy Wilson, President and CEO, Kura Oncology: Yes. Just in the time we have, so the goal there is an FTI is the preferred companion therapeutic for targeted therapies. We’ve said we have two drugs, tipifarnib and two thousand eight hundred and six. We’re going to show you data from the 02/1400 mono escalation, from the 02/1400 plus cabozantinib and RCC. A lot of interest in casdatafan and that whole sort of IF2 alpha space.

RCC is very rich and you’ll see data of tipifarnib plus alpellasib and PIK3C and mutant. I think in a best case scenario, Phil, you end up with this is what people have been trying to do with SHIP2, with SARS1, you end up with a companion target that makes each of those targeted therapies, TKIs, PI3 kinase inhibitors, KRAS inhibitors that much better. Look for the initial clinical data in the second half potentially at ESMO.

Phil Nadeau, Biotech Analyst, TD Cowan: Perfect. Well, thank you for making the trip to Cowen’s forty fifth Annual Healthcare Conference. Our pleasure.

Troy Wilson, President and CEO, Kura Oncology: Thanks for having

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