The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jonathan Chang - Leerink Partners LLC - Analyst
: So hi, guys. Thanks for taking my questions. First question on Ziftomenib. Can you discuss your thoughts on the combinability with ven/aza and
your thoughts on whether you need to adjust the dose of ven due to drug, drug interactions and potential CYP3A4 inhibition?
Question: Jonathan Chang - Leerink Partners LLC - Analyst
: Got it. Thanks for clarifying. And then just second question with the KOMET-008 study started. Can you discuss the opportunity for Ziftomenib in
combination with FLT3 inhibitor? And what are your reasons for confidence in the combinability of these drugs? Thank you.
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FEBRUARY 27, 2024 / 9:30PM, KURA.OQ - Q4 2023 Kura Oncology Inc Earnings Call
Question: Jonathan Chang - Leerink Partners LLC - Analyst
: Understood. Thanks for taking the questions.
Question: Jason Zemansky - BofA Securities - Analyst
: Perfect. Good afternoon and thank you for taking our questions. I I'm curious about 007 as the patients continue to hopefully do well on therapy
and potentially approach hematological recovery with longer duration of therapy. What are your expectations in terms of moving them off of
therapy? Is the idea maybe to keep them on Zifto and maybe pull back on ven/aza which usually happens? Or would you necessarily discontinue
the Menin inhibitor at some point? And then a follow-up, if I may.
Question: Jason Zemansky - BofA Securities - Analyst
: Got it. And then looking at your time lines, thinking about the bigger commercial dynamics here, you're potentially looking at a scenario where
you may be a next to market Menin inhibitor in the NPM1 space with potentially better efficacy. How are you thinking about launching into this
space? I guess what I'm really driving at here is at this stage, do you get the sense that the community, the prescribing community sees the two
different Menin inhibitors is more distinct versus similar. I mean, what the feedback been like here?
Question: Jason Zemansky - BofA Securities - Analyst
: But that was a follow up. Thank you so much for that for the insights and color.
Question: Li Watsek - Cantor Fitzgerald & Co. - Analyst
: Hey, good afternoon. Congrats on the progress and maybe just a couple follow up questions from me. Just wondering if you can clarify the plan
for data disclosure for 007 stay around midyear. Other than RP2D dose selection, would you be sharing data at higher doses and also, can you
comment on if you have started to dose patients at 600?
Question: Li Watsek - Cantor Fitzgerald & Co. - Analyst
: Okay. And then maybe a follow-up question. Troy, you mentioned about enrollment speed here and given the very strong data from 007 study
last month, I guess what is your expectation for the enrollment rate for the 008? And also in terms of from clinical sites what's the degree of overlap
between these two studies?
Question: Li Watsek - Cantor Fitzgerald & Co. - Analyst
: Thank you very much.
Question: Peter Lawson - Barclays Bank PLC - Analyst
: Great. Thank you so much. Thanks for the update. I had a quick question on KOMET-007 combo. Just why Zifto starts on day eight, there's any
worries about drug-drug interaction or just the rationale there?
Question: Peter Lawson - Barclays Bank PLC - Analyst
: Perfect. Thank you so much. Thanks for clarifying that. And then just on the expansion cohort, that's really interesting. So patients without NPM1,
KMT2A are there particular mutations you're targeting, or is that an all-comers approach. Just curious on how you're focused.
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FEBRUARY 27, 2024 / 9:30PM, KURA.OQ - Q4 2023 Kura Oncology Inc Earnings Call
Question: Peter Lawson - Barclays Bank PLC - Analyst
: Got it. Perfect. Thanks so much. Really appreciate it.
Question: Justin Zelin - BTIG LLC - Analyst
: Thank you for taking the questions and congrats on the progress. So Troy, you mentioned on interrogating Menin other indications outside of
acute leukemia. You mentioned, some solid tumor and non-oncology indications so with that be with Zefto, or Next-Gen molecule and do you
have an idea of when we might see some early translational data from those programs?
Question: Justin Zelin - BTIG LLC - Analyst
: Great. Looking forward to it. Thanks for taking the questions.
Question: Reni Benjamin - JMP Securities - Analyst
: Hey, thanks for taking the questions, guys, and congratulations on the progress. Maybe just two questions from me. Troy, one in the prior data that
you guys had already reported from 007, you talked about 10 patients who had already received prior venetoclax, and you are still seeing a 40%
ORR. And I don't know if this was asked before or not, but does this suggest that then could potentially be taken out of that regimen and a less
toxic call it Zifto, ASA combination could or should be evaluated? Or does it suggest maybe something else that maybe Menin inhibition is really
sensitizing patients to BCL2 inhibition that's one question.
The other is more from a commercial perspective. It seems you're evaluating Zifto throughout the continuum of AML treatment and it might actually
result if I'm thinking about this right in the cannibalization of Zifto in later lines of treatment. So how does this work in the real world as you're
evaluating this? Or all these combination studies really more to maximize BD discussions and ultimately confirmatory studies will be run in hands
of a partner?
Question: Reni Benjamin - JMP Securities - Analyst
: Great. Thanks for taking the question.
Question: Brad Canino - Stifel, Nicolaus & Company - Analyst
: Hey, good afternoon. Troy, how important does response durability become at your next combo data updates?
Question: Brad Canino - Stifel, Nicolaus & Company - Analyst
: Okay. And then another question. We talked a lot about potential best-in-class drug properties on this call, and in others. But as we move towards
more substantial ven/aza triplet data from both you and other Menin inhibitors that are being developed, how do you expect potential differentiation
might emerge in those clinical data reported in the Phase 1, 2 studies?
Question: Brad Canino - Stifel, Nicolaus & Company - Analyst
: Very helpful. Thank you.
Question: Eva Privitera - TD Cowen - Analyst
: Hi, good afternoon and thank you for taking your questions. So with escalation going really well on 007 and the RP2D expected midyear, when
could Zifto potentially move into pivotal development with either chemo or ven/aza combos? And what could be a potential design? Do you think
MRD negativity could be a registrational endpoint.
Question: Eva Privitera - TD Cowen - Analyst
: Thank you, that's helpful. And a quick follow up on an earlier question about additional genetic subtypes where you're pursuing other activity,
does this patient selection algorithm enrich for the HOX/MEIS transcriptional pathway?
Question: Eva Privitera - TD Cowen - Analyst
: That helps a lot. Thank you.
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FEBRUARY 27, 2024 / 9:30PM, KURA.OQ - Q4 2023 Kura Oncology Inc Earnings Call
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