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: Eun Yang - Jefferies Group LLC - Analyst
: Sure. So bezuclastinib KIT inhibitor, it's going after three different indications. So at ASCO over the weekend, you presented the leading data from
Phase 3 trials in GIST. So Phase 3 registrational portion is enrolling at the moment, and then you gave a guidance that you would take about two
years to complete the enrollment. So we are expecting data sometime in 2025.
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
JUNE 08, 2023 / 1:30PM, COGT.OQ - Cogent Biosciences Inc at Jefferies Healthcare Conference
So in the trial, you are enrolling all comers, right? And although you mentioned that you guys are more focusing on patients with mutations, you
could potentially enrich your patient population with Exon 17 and 18 so that you can augment the effect size of a PFS benefits of a bezuclastinib.
So how you are enrolling patients? Is there are a certain percentage breakdown of different types of Exon mutations?
Question: Eun Yang - Jefferies Group LLC - Analyst
: I see. Okay. So another company, the Deciphera, they are actually planning to run -- they failed in second-line GIST Phase 3 trial, but they are actually
selecting Exon 17 and 18 patients to run a trial against the sunitinib, not in combination. So with that, do you think that there could be some
competition recruiting patients with Exon 17 and 18 in the trial?
Question: Eun Yang - Jefferies Group LLC - Analyst
: I see. That's actually good point in terms of trial enrollment. Going forward, forwarding, once it's approved, and let's just say ripretinib is approved,
bezuclastinib approved in the second-line setting, how do you think it's going to be a play out commercially?
You mentioned that there is not a lot of genotyping post-imatinib first-line therapy. But then by the time ripretinib get approved for the second-line
setting, there could be then patients who could say or patients could say hey, instead of combining, let's just go with one drug.
Question: Eun Yang - Jefferies Group LLC - Analyst
: So we heard from some academic-center patients that they are already kind of a genotyping, looking at town medical centers and using ripretinib
in that patient group. Have you heard of such cases too?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
JUNE 08, 2023 / 1:30PM, COGT.OQ - Cogent Biosciences Inc at Jefferies Healthcare Conference
Question: Eun Yang - Jefferies Group LLC - Analyst
: So in your trials, so in Phase 3, when patients progressed on bezuclastinib, they could crossover to the combination therapy?
Question: Eun Yang - Jefferies Group LLC - Analyst
: Okay. And then another indication, I guess, is the -- practically, two. But different indications is the systemic mastocytosis. You are running pivotal
portion of the trial in advanced systemic mastocytosis in Phase 2 for indolent. So can you give us an overview how you see your drug would be
differentiated compared to avapritinib currently on the market?
Question: Eun Yang - Jefferies Group LLC - Analyst
: So do you think could the -- once it's approved, FDA might just give a hey, this is a class effect that we see so bezuclastinib should not be used in
patients with platelet counts less than 50,000, or if you have a data in combination that could potentially avoid such label?
Question: Eun Yang - Jefferies Group LLC - Analyst
: I see. How about -- is it possible to run a trial in patients with platelet counts less than 50,000?
Question: Eun Yang - Jefferies Group LLC - Analyst
: Okay. On ISM, so the advantage of -- potential advantage of bezuclastinib is it's a wider therapeutic window. So you can push the dose higher and
get better efficacy out of -- at the dose. So we are going to see the data toward the end of this year.
But Blueprint Medicine, as I said, was that the lowering tryptase of level reduction doesn't necessarily correlate with the symptom improvement.
So question to you is that so at what point of like a tryptase reduction really correlate to the symptom improvement? Is there a kind of a threshold
level in ISM that doesn't really matter even though you suppress the tryptase further from the threshold point?
Question: Eun Yang - Jefferies Group LLC - Analyst
: Okay. And I want to touch on a couple of pipeline, early pipeline programs that you mentioned that you have a more update coming on toward
the end of this year. So FGFR2, there of some drugs in development. So how do you see yours is a differentiated and what kind of indications that
you would go after first?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
JUNE 08, 2023 / 1:30PM, COGT.OQ - Cogent Biosciences Inc at Jefferies Healthcare Conference
Question: Eun Yang - Jefferies Group LLC - Analyst
: Okay. And then lastly, the ErbB mutant product. So in this category, do you think the CNS penetration is really key to win the race?
Question: Eun Yang - Jefferies Group LLC - Analyst
: So do you think that this could have a potential partnership opportunity with someone has ErbB2 antibody?
Question: Eun Yang - Jefferies Group LLC - Analyst
: Okay. I think our time is up. Thank you very much, Andy.
|