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: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. Now maybe just to back off all the way a little bit, I would say, what is a protein degrader? Because we keep hearing that term: protein
degradation -- drugging the undruggable. What does that really mean because there are many companies now sprouting out behind you in
development that also claim the title of focusing on protein degradation?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: So would you describe as a really -- a simple idea? So why has it taken this long to get to this point? So why did it take Arvinas moving into the
clinic and really making protein degradation more mainstream for -- I don't know -- 60 some other companies now to be in the clinic suddenly?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Yeah. So for 471, this is partnered with Pfizer in the breast cancer indication. I'm sure you've talked about this many times. But why did it make
sense to want to partner the program at this juncture? And why was Pfizer the best partner for you?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: What data did Pfizer have access to when you were negotiating terms with them?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And was that a competitive process?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. So you've talked about some data readouts. Let's focus on the breast cancer readouts. So you've got Phase 2 that's coming out you said
[within] year?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Second half of the year.
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: What data should we expect to see at that topline readout? And what would you consider to be positive data?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Come forward, Randy.
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: So how many doses total will you have studied?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And then if you think about what the practical way of moving forward would be, you have all this data, all these different doses. How many doses
do you think you'll ultimately need?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: How do you know 700 -- you don't need to go higher than 700 or can you go higher than 700?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay.
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: So you kind of already have decided, I'm guessing, what your Phase 3 should look like. You're waiting for that validation to come in in the middle
of the year -- or the second half of the year. But how quick of a turnaround will you need from the time that you see that Phase 1b and Phase 2 data
to start your Phase 3 or do you not need to actually see that to start?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. So how far along are you in the setup of the Phase 3? Have you chosen your sites, your principal investigators?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. And how involved are you -- is Arvinas in those efforts to design the study and do some of the legwork and prepping?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. So once you start the study -- or once you and Pfizer start the study in breast, how long do you think it'll take to enroll?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And like rough estimate, how long would the patients be observed in the study?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. So because it's still in its nascent stage as a category protein degraders, I think people have been trying to look for validation from maybe
related mechanisms for studies that other companies have run, namely, SERDs.
So can you talk to us about why people want to tag protein degraders to SERDs. And with the recent -- let's say, the AMEERA study readout from
Sanofi not being positive, what does that really mean for protein degraders for you, in particular, if anything?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Well, when did it make sense to look at metastatic breast cancer first?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Just as an indication.
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Yeah. So as far as like the actual patient population, what do you think about like relatively high percent of patients who have ER-independent
disease in second line and after? And how does that come into your calculation?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. You're pursuing several combination studies. How are you thinking about what makes the best combination? Do you have an idea, as you
sit here today, what combination is going to be most successful?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And when is that umbrella study like this you're supposed to start (multiple speakers)?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. And how many patients do you think that study could enroll?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Yeah. And does that make it complicated to understand what's happening if you have all sorts of combinations in the same study?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Will the plans be to take various interim looks at the study at certain points in time?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. Now how do you define the market opportunity? Because you're still trying to figure out what the best addressable patient populations are.
But let's just focus on the portion of 471 that's partnered with Pfizer. Like how big is that opportunity?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And then so -- I mean, north of two million? Is that --?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. We've in the past talked about prostate, but there are other things that are going on at the company that I think are probably worth spending
a few minutes on this.
The one that really strikes me is the focus on potentially moving into CNS indication. So it's still pretty differentiated. There might be another
company or two trying also to move into CNS now. But why does CNS make sense? And when could we start to see movements in that space from
you?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: I mean neuroscience is so broad. I mean would you consider Alzheimer's?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Something as complicated as Alzheimer's, ALS, Parkinson's?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And what would be the advantage of your approach again using a PROTAC platform be versus other companies who were already trying to do
Huntington's and Parkinson's and Alzheimer's focusing in on tau and synuclein and huntingtin, specifically?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And how complicated would that be in the early stages to really know if that's working? Because you have to, number one, demonstrate that there
is protein degradation happening. And secondly, you might have to pick some biomarkers. And frankly, the biomarkers in any of those indications
are still not validated, let's say.
So you're kind of going to have two balls up in the air in the early stages and how does -- how do you approach that? Would you want to do that
with a partner, or do you feel confident you can do that by yourself?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And would that be a near-term consideration to partner?
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MAY 10, 2022 / 11:00PM, ARVN.OQ - Arvinas Inc at Bank of America Healthcare Conference
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. You've talked about other early-stage programs: KRAS, BCL6, I think ARV-7. How should we be thinking about those because those are further
behind? We talk about your more advanced programs now. But should we expect those to have updates over the next 12 months?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Sure. I mean hypothetically, what indications would make most sense for these?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. I mean in a few minutes that we have, let's just do a quick recap of the prostate cancer update that you have provided a few months back.
For people in the audience that aren't familiar, can you just give us a quick one-minute review of what you presented?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Were you expecting it to be so narrowly defined when you embarked on that study?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: And what kind of planning are you doing for the broader population?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. And any guidance on when we can get color on how these studies are running?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. Maybe last question is, well, your current cash balance? And we've talked about a lot of programs in the last half hour. Are all of those going
to be supported by the cash balance that you have now?
Question: Tazeen Ahmad - Bank of America Merrill Lynch - Analyst
: Okay. Great. With that, thank you for presenting today at our conference. And thanks, everybody, for attending. We look forward to the updates
from your programs in the second half of the year.
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