Compugen Ltd. (NASDAQ:CGEN) Q3 2023 Earnings Call Transcript

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Unidentified Analyst: Thanks for taking our questions.

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

Steve Willey: Yes, good morning. Thanks for taking the questions. Can you just speak to, I guess, how many sites are currently active in the ovarian trial? I guess how many have you brought on just within the past few months? And I guess over the longer term, do you think you need to bring on more sites in order to expedite patient enrollment?

Anat Cohen-Dayag: Thank you, Steve. So right now we have nine sites active. We have few more. This is based on the plan that we’ve already rolled when we were thinking about ranking up. We don’t think that we should add additional sites beyond what we’ve planned and what we’re looking to do now. And the reason for this is, what I was just alluding to in the prepared remarks. So first, we believe that the closed monitoring that we’re doing now with investigators and again trying to make sure that the study is on the radar, this is something that is going to achieve the goal. And this is after we added ovarian cancer specific sites, sites that are growing, specifically ovarian cancer patients. So these two things, adding the sites, making sure that we speak with the investigators and we have – I have to say that hearing their comments about how they think about the triplet activity, mainly the durability in conjunction with the safety for these patients that really experience so many lines of treatment, we don’t really need to convince them.

So we believe that the ramp up that we’ve started to see will continue and that we don’t need to add additional sites to the study.

Steve Willey: Okay. And then I think you said that, I mean, you’re obviously assaying for PVRL2 expression, so I think you said biopsy is a mandatory. Is the ask of a patient both in on-treatment and then I guess a baseline and then multiple on treatment biopsies? Or are you just looking for one specific biopsy and I guess is that second on treatment biopsy requirement? Is that in any way rate limiting in terms of your ability to get patients to solicit consent?

Anat Cohen-Dayag: It’s a very good question, so, and maybe Henry will want to add anything about it. But in any case at any study when you ask for biopsies, this is a hurdle; obviously. Because patient needs to go through some invasive approach, but we don’t anticipate at this point in time that this is a big hurdle. We ask for mandatory biopsies at baseline prior to treatment and also on treatment. And this is really serving us in order to make sure that eventually we can go with the platinum resistant ovarian cancer data that we have into what eventually will be biomarker driven study that will allow us to maximize the potential of COM701 treatment for patients that may respond to this treatment. So at this point in time, this is mandatory. With this mandatory request, we do see a ramp up and we believe that this will not be the issue for enrollment.

Steve Willey: Okay. And then just lastly on the colorectal trial, I know this is open label. Do you have a sense as to what the distribution of patients looks like with respect to the presence or absence of liver metastases at baseline? Thanks.

Anat Cohen-Dayag: And so I’ll start and then Henry maybe wants to add. Yes, it’s open label. We’re familiar with it. While we’re not looking every day on the patient distribution, we’re familiar with it. We are this kind of study that allows for liver mets and that’s unique. And this is because we believe that there could be some edge there based on the prior data. But as I said, we continue to monitor patients. We continue to collect the data. We’re thinking very hardly on what data we should share, while the study is continuing, but we’ve made a decision that it’s better for us not to share portions of data, incomplete picture. It is better for us to have a longer term follow up and share the full picture, as I said, preferably in a medical conference when investors will be able to see the full picture of the data. Henry, anything else you would like to add on the liver mets part of the question?

Henry Adewoye: Thank you, Anat. I think you’ve covered the major part of the question. But just to give some color, looking back at the data we presented previously on the 22 subjects, patients with microsatellite stable colorectal cancer, a little above three quarters of those patients had liver mets that was the initial presentation we had. The number of patients that we anticipate will have liver mets will also probably be around that number, based solely on the fact that most of these patients have exhausted all available standard of care therapies. And in addition to that, the most common site of metastatic’s of colorectal cancer, if you just look at the anatomy of the liver. So between half to about two-thirds to about three quarters of patients will probably have liver mets on analysis?

And I’m just making an assumption here and a projection, until we do look at that data next year, like Anat has mentioned before we’ll be able to give you more substantive information on that regard.

Steve Willey: Okay, thanks for taking the questions.

Anat Cohen-Dayag: And maybe, Steve, maybe I’ll just add just to make sure that it is clear that in a biomarker driven study we will obviously only require for a baseline biopsy pretreatment biopsy, but not an un-treatment biopsy, so it will be less complicated.

Operator: This concludes the Q&A session of Compugen’s Investor Relations Conference Call. Thank you for your participation. You may go ahead and disconnect.

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