Compugen Ltd. (NASDAQ:CGEN) Q4 2023 Earnings Call Transcript

Eran Ophir: Yes. So we’ve shown quite extensive with the PVRIG’s unique checkpoint and that blocking PVRIG which can sensitize tumor to TIGIT and PD-1. So and this is what we’re testing, right, the triplet combination, which is an IO, pure combination, extremely safe, very good tolerability profile and hope to see the signals mature, and we’ll share it later this year. But of course, the potential is out there. It could be combined with chemotherapies, it could be combining earlier lines of therapy. I mean this mechanism of action of PVRIG could be relevant also in many other aspects, providing a relatively safe approach that could drive T cells into the tumor, and we believe this could be combined also in regardless of the triplet combination we are pursuing.

Daina Graybosch: Great. Thank you.

Operator: The next question is from Stephen Willey of Stifel. Please go ahead.

Stephen Willey: Good morning. Thanks for taking the questions. I think you may have mentioned it on the call, but can you just maybe speak to, I guess, the efficacy metrics. I know there’s a lot of talk about the biomarker directed strategy. But can you speak a little bit to the efficacy data that you’re going to be kind of using out of the colorectal trial to make a new growth decision. And I guess I asked the question because of the historical disconnect here that tends to exist between response rate and event-driven data in this tumor type. And then, I guess, there’s obviously a lot of different IO-based regimens that are pursuing the non-liver met population. Is that something that is of interest to you to look at as a potential development opportunity? Or do you think that landscape has kind of become a bit too crowded?

Anat Cohen-Dayag: So I think that it’s fair to say that when we’re looking at what — how we will judge our data, it’s really with respect to the benchmarks and what would be relevant based on the standard — based on standard of care, but also based on other clinical trials. I think that — and let me share relate to it, but I think that it’s a fair point that you raised the data that we were seeing in the data that we’ve disclosed already is really data within the liver met population that was intriguing for us because really, this is a very hard to treat patient population. Really, there are no agents there that are really targeting this patient population. And I think that when we will have our data in front of us, we will look at the overall population, but we will also take a close look at the liver met, where we believe there we have an edge. So I’ll let Michelle speak about how we may look at our data as compared to benchmarks.

Michelle Mahler: Great. Thank you. Thanks for the question. I think that you made a very good point, and we think about the data quite similarly. So in early stage clinical trials, as you know, we often look at overall response rates as a way to test whether there’s a proof-of-concept. And it’s often seen as a target for other end points that are related to progression-free survival and overall survival. But I think also in these hard-to-treat populations, we cannot ignore the sustained, stable disease responders, keeping in mind that once a lot of these drugs go on to Phase III registration studies, the primary endpoints are no longer overall response rate. And many times, they’re reporting out a primary endpoint of overall survival.

So when we look at single-arm studies, we have to interpret survival endpoints with the limitations that we have, knowing that our data sets are small, single-arm studies, but we also have to keep in mind the big picture in terms of what are the registration end point. And so I think it’s important not to ignore the patients that have sustained responses of stable disease, and that’s where the disease control rate becomes relevant in looking at the data. So we will look at the totality of the data to be able to make these go/no-go decisions and we will also look at it with an eye towards what will be the survival benchmarks as the landscape is evolving. And with that I think happy to elaborate if you have additional questions.

Stephen Willey: And then I just guess, any interest, specifically in maybe looking at the non-liver met population in a bit more granular detail? I know you probably only have a handful of these patients represented in the proof-of-concepts.

Anat Cohen-Dayag: So I just want to clarify that you’re talking about the patients without liver metastases because that data is actually targeted to the most difficult-to-treat patient population. So in the data that was previously presented, 75% of the patient population has liver metastases which is —

Michelle Mahler: Yes.

Stephen Willey: Over that, right? But there’s obviously a subgroup of non-liver met patients that are now being pursued by a variety of companies with a various number of IO-based regimens.

Anat Cohen-Dayag: Okay. So given what we’re seeing and what we’ve presented in our patients with liver mets, it still remains an area of focus for us. I think just, Steve, I’ll just add that we recognize the fact that there is not a lot of data there for liver met at all. I think that there is some data maybe by [indiscernible] studies relating to overall survival, median overall survival of 8.7 months, et cetera. We’re taking all of this into consideration. I mean overall response rate is not there at all for liver met. And we will look at our overall response rate. We do expect that in our patient population, we have the same representation of the population in terms of the liver met, most of the, more than 70% of the patients in this line of treatment that we are enrolling are having liver met. So we expect that we have the same representation in this. And we will take a careful look at this patient population because we do think that we may have an edge there.

Stephen Willey: Okay. And then I guess on the partnering optionality front, can you just remind us, are you exclusive with Astra on COM902? Or is that just specific to the use of bispecific antibodies incorporating the TIGIT domain? And I guess I just asked the question because I mean, obviously, Gilead just made a fairly strong vote of confidence in an Fc-silent TIGIT. I know that there’s probably some scarcity value around that so.