Xencor, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference
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So 25 years, guys. Yeah, about like half.
Yeah. It's a big day for the program.
I'm sure it is. for obvious reasons.
Sure it is. Good. Okay, terrific.
Looks like we're live, so we'll get started here on our next session. I'm Steve Seedhouse on the biotech team here at Cantor. Really a privilege to welcome Xencor for what will prove to be a great discussion, I'm sure. I'm joined, of course, by CEO Bassil Dahiyat and Chief Strategy Officer Dane Leone. We recently actually held a great webinar with the team here, so some of this will be a refresher for folks, I think. But there was a lot discussed on that webinar that I wanted to circle back on and maybe get an update on from Bassil and Dane. But we'll broaden the conversation, of course, beyond what we focused on there.
Let's start with what's in focus for most people, which is the ENPP3-targeted T-cell engager in renal cell carcinoma, just because you have this really important data set forthcoming at ESMO in about a month or so. Would love to just ask an open-ended question. What should we expect at ESMO. What is the future outlook for that program. We'll take it from there.
Maybe I'll set up the bigger picture. This is about Xencor taking the incredibly powerful platform we built, our XmAb platform, and transitioning it and Xencor to being a late-stage development company. This presentation is really the gate for that, right? As we've advanced XmAb819 in RCC and had an initial data set last year, this is going to be a data set that helps us really define what is our go-forward dose. It is going to give a clear clinical profile for the clinical community to understand the molecule. And really what we disclose is going to allow, I think, the investment community to understand our own thinking on clinical profile and what we're going to use to support our proposed registrational study that we are still on track to start next year.
It's about the company going from having a myriad of partners advance into late phase and onto market with XmAb molecules, to Xencor advancing its own XmAb molecules. So that's how the strategy's really developed that we've been trying really hard on over the last several years. I think that's the key thing to expect. You'll kind of have a seat alongside us with the data that's going to help us design our pivotal study, and that we would go to regulators with several months later. Now we can get into the granularity, but I just wanted to make sure I set the stage there.
So fair to characterize that as basically like this, we'll be able to look at this data set, we'll be able to compare it to the landscape in RCC, and we'll be able to assess this is the internal bar that Xencor sees as what is required to advance one of your own molecules into a pivotal study and take it towards registration, and this is the quality of data and the quality of molecule that you're looking for.
Exactly. So multiple expansion cohorts with double-digit patients in each that we've characterized. Looking at our full safety and efficacy profiles. Still a little bit early on the follow-up because we've been enrolling these expansion cohorts this year, but we should be able to give the lower bounds on durability that would be a predicate for us to be able to justify design to regulators and for ourselves. To show you why we're confident to move forward.
Okay. The demographic in this study is very sort of refractory and late-stage RCC. What are the key comps we should be thinking about when we contextualize your data? Are there RCTs that you're pointing people to? Are there any real-world data sets that you're pointing people to?
Just to level set what we're even looking at when we make investment decisions around Yeah, I don't know that the landscape that we're using.
Dane, did you want to go into the precedent? There's a couple of RCTs, a couple of mechanisms that we look to as baselines for that late line RCC market.
Yeah, no, it's exactly that. There's a good amount of information, I think, that you can tease out from existing either clinical trials or academic center studies that give you a characterization of, okay, what is a patient population that's been heavily exposed to multiple lines of therapy post IO, post largely two TKIs or more look like. What you come back to across either a TKI re-challenge or a more novel mechanism with a HIF-2 alpha inhibitor is kind of in that teens response rate and 5 months or potentially lower on median PFS. That underscores really the development opportunity that we have in clear cell renal cell.
Unfortunately, the clinical landscape is still anchored on recycling modalities over and over and over again, which is the TKI class, with a diminishing clinical benefit every time you recycle that therapy, but the same toxicity that you carry with it. ENPP3 as a T-cell engager is novel, totally orthogonal to the current clinical treatment and landscape. What we liked about last year was when we presented that initial data at the Triple meeting, we had a 25% response rate, again, in an early blended patient population, but that's been the price of admission on a response rate. But we also, post day 29, had this really clean toxicity profile that we would hope could affect a much better quality of life for these patients in the late line setting.
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