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: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Now Nadim, can you start with an overview of Cullinan? Talk a little bit about your portfolio construction strategy as well; and the maturity of that
portfolio now; and its clinical stage pipeline, of course, across the Phase 1 and pivotal-stage assets.
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. And Nadim, as you mentioned all of that -- the strong cash position with six assets going to be in the clinic soon -- how actively should
investors expect you to continue to transact for more assets? And are you really comfortable already with where your portfolio is today?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. Now drilling into some of your assets, your lead compound, CLN-081, your EGFR exon 20 inhibitor. Talk about the data at a high level, safety
and efficacy relative to the approved competition that we've got in the market today.
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. You've got the current drugs. One's an antibody, and then one's a non-brain-penetrant TKI. So they both got the risk for CNS mets. As I talked
to docs, that's one of the bigger issues still with this market that they talk about, even above and beyond the safety and inconvenience of the IV.
Zipalertinib, can that address the CNS issue better? And what clinical data do you have to support this?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah, very fair point. So beyond thinking about moving towards a development stage to address that, what's the current status of the development
program as it is today? And when should investors expect perhaps another update? And what might be included within that?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. And what's the ultimate goal here? I mean, how quickly would you like to see this move to something like a front-line setting? And are you
considering that to perhaps be a monotherapy or might that be a combination approach with other specific therapies?
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APRIL 26, 2023 / 6:30PM, CGEM.OQ - Cullinan Oncology Inc at Stifel Targeted Oncology Days (Virtual)
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. And how might that strategy be impacted by the potential success and approval of amivantamab in frontline based on the PAPILLON study
that they expect data with, I think, this year?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. And can I have you overview the partnership relationship with Taiho year-round clinical development and then what the options are for
sharing the commercial rights for this asset?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. To date, with some molecules that I would classify as not as good as some of the other targeted therapies we have for lung cancer, the exon
20 mark is about [50 million] to date. What do you think the full commercial potential is for a drug with an improved clinical profile?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. Moving on to the pipeline for the rest of the conversation. CLN-619, congrats on the announcement earlier this morning for the ASCO showing
that you will have for that. Let's turn to the high-level and just outline this asset and mechanistic rationale for [algae] development.
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. And we're just coming off of ACR, where you guys had a 619 poster structure function poster, it kind of looked like. What were your conclusions
from that work presented there?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Very cool. Now outline this first-in-human Phase 1 data that you will be showing at ASCO. What [de greda] should we expect at that poster
presentation?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. I guess what PD or biomarker impacts are you looking at to confirm, one, that the mechanism of shedding prevention works in patients and,
two, that that leads to a degree of immune evasion that has decreased in these tumors?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. So we shouldn't expect too much for this work around those PD biomarkers at this ASCO update?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. Would your preclinical work predict monotherapy activity? And if so, what context?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Okay. Well, I look forward to seeing that poster. Maybe to the next clinical-stage asset, CLN-049, your FLT3-CD3 bispecific. I think mechanistic
rationale quickly for this asset -- but a lot of people are going to be familiar with FLT3 inhibitors for AML. And I think the question that comes to
mind though is, what's the therapeutic index for a very likely potent bispecific engager that's bringing in T cells against those targets that's going
to be expressed on the blasts and normal cells?
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APRIL 26, 2023 / 6:30PM, CGEM.OQ - Cullinan Oncology Inc at Stifel Targeted Oncology Days (Virtual)
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. Now as you move towards first data, which I think you've suggested will be sometime this year, help us understand that dose escalation
schema you've got and where you are at doses. Sometimes, when we see these bispecific dose escalations, you have to start at really low
sub-therapeutic doses. Will you be at a level where you'd anticipate some clinical signals this year?
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Yeah. Okay. That's clear expectations. Well, Nadim, thank you so much for having this fireside chat with us. We were able to get through most of
the clinical-stage portfolio, which I'm happy about. Exciting times this year, and I look forward to seeing the poster at ASCO.
Question: Brad Canino - Stifel Nicolaus - Stifel Financial Corp - Analyst
: Right. Thanks, everyone, for listening in.
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