Arvinas Inc at Guggenheim Partners Healthcare Talks Oncology Days (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Michael Schmidt - Guggenheim Partners - Analyst : All right, super. So we'll just jump in into Q&A. Ian, Arvinas has obviously been one of the key innovators in the TPD space and also the first company to advance a degrader program into clinical development. One thing that we get asked a lot is -- and now that there's more activity in this category -- how proprietary is the TPD technology, the PROTAC technology, and how high are barriers to entry as we see more and more programs emerge?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Right. And then from a [Python] strategy perspective, you guys have initially focused on clinically and commercially validated targets, such as ER and AR. Just talk a bit about how your target selection strategy has evolved in recent years. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 10, 2022 / 4:00PM, ARVN.OQ - Arvinas Inc at Guggenheim Partners Healthcare Talks Oncology Days (Virtual)

Question: Michael Schmidt - Guggenheim Partners - Analyst : Great. That makes a lot of sense. Maybe let's talk about your clinical programs like -- which is presumably the focus of attention at the moment. We have seen additional data from your ER degrader, ARV-471, recently which is now moving towards registration studies. Just remind us of the key takeaways so far. And you have obviously selected two doses for now at 200 and 500 milligrams once daily to be evaluated going forward. Just help us understand the rationale to select those two particular doses.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Okay, super. And then there were just a handful of Grade 3 events in the Phase 1. It looked like there was not a clear pattern, but there have been some questions on that. Just wanted you to give an overview, share your thoughts on those and your confidence that they're not really an issue for the growth.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Yeah, makes sense. And the overall frequency of AEs has been very [clean] which is consistent with what we have seen from other degraders, too. So it's an interesting -- seems to be a benefit for the class, perhaps. And then (multiple speakers) --

Question: Michael Schmidt - Guggenheim Partners - Analyst : Yeah. And then perhaps, just about the VERITAC study which is the bake-off perhaps between the two Phase 2 doses now. Just talk about the patient inclusion criteria in that study and perhaps, how it compares to the Phase 1, and what investors should expect to hear from that study later this year.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Makes sense. Yeah, makes sense. And then you and your partner, Pfizer, are also running a combination study with Ibrance. I think you've guided to disclosing first data from that this year. I guess, what are you looking for in that study and how will it inform next steps. And we've seen some combination data emerge from some of the other SERDs as well -- the Sanofi compound and the Roche compound as well. To what degree is that an opportunity to, first, differentiate 471 from the oral sort of class?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Got it. Okay, that makes sense. And I think you have guided to initiating several Phase 3 trials this year. There are some obvious ones that we can think about, but I guess, how has your thinking evolved there or when will that occur -- I guess, the initiation of those trials?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Got it. And then SERDs mechanistically, I guess, may have particular appeal in places with ESR1 mutations. Is that -- do you see that as an accelerated approval opportunity, perhaps, in that particular subset that is known to respond less well to other hormonal agents. And how do you think about ESR1 mutations as, perhaps, some opportunity for your drug?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Got it. Okay. And then as part of your collaboration with Pfizer, you are also planning combinations with other next-gen CDK inhibitors, perhaps their CDK2/4/6, perhaps others that Pfizer has in their pipeline. I guess mechanistically, which of those are compelling in your opinion and how might these be positioned in the treatment paradigm longer term?

Question: Michael Schmidt - Guggenheim Partners - Analyst : All right, super. And then perhaps switching over to ARV--110, your AR degrader program. You know, we have seen a number of data readouts. Last year, you have settled on a recommended Phase 2 dose, and the ARDENT study has been rolling for some time now. And I believe you did -- you will present data here in the very near term. Just remind us again of the intent of the ARDENT trial. And what are you looking forward to show here in order to advance the program?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Got you. What is, again, all the rationale of selecting the -- you touched on it very briefly, the T878 and the H875 mutations [offset], I guess, what makes that particularly responsive -- that genetic marker?

Question: Michael Schmidt - Guggenheim Partners - Analyst : That makes sense. Something that we've been asked about -- yeah, it makes sense. You're looking for certain efficacy bar to think about next steps, et cetera. I guess there's a hypothetical scenario where you see efficacy and just the subset but not the earlier patients or the other way around. Is that even possible and how would that inform next steps? What would that mean for the program?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Okay, that makes sense. And then I think you're also running a study looking at combination with Zytiga and then -- help us understand. It makes all of this sense, but help us understand the concept here and in what particular setting that combination might be interesting.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Yeah. And then just one last question on 110. So this ARDENT data you said is an interim look. I guess, do you think that will be enough to really advance the program into -- towards registration studies? Or would you need to see the whole study, the 100-plus patients worth of data first before making that next step decision?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Got it. Okay, cool. And then we do get questions about ARV-766 which is in Phase 1 as well and how that might be differentiated from 110, and where the opportunity is there.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Okay, makes sense. And then we know we need to wrap up so just wanted to ask one more question. You did provide some visibility into your early-stage pipeline last year. And yeah -- I guess, just remind us which of your early-stage pipeline candidates is closest to IND filing.

Question: Michael Schmidt - Guggenheim Partners - Analyst : Yeah. And you are one of the few, if not the only, companies with activity in neuroscience, as far as we know. How do you think about building out that vertical longer term? Is it something you envision doing in-house, or is there perhaps a better strategic opportunity there?

Question: Michael Schmidt - Guggenheim Partners - Analyst : Yeah, that makes sense. Okay. So with that, we will have to wrap up. Thank you, Ian. Really appreciate the time. It has been nice talking to you.