Cue Biopharma, Inc. (NASDAQ:CUE) Q2 2023 Earnings Call Transcript

Unidentified Analyst: Okay. Great. Thank you. Thank you for taking my questions. So I have two questions on my end. Starting with the CUE-101 plus pembrolizumab, the combination cohort, do you think you guys will pursue specific target population moving forward? Like because you have mentioned a lot about how this combination improves low CPS low-figure score population even better compared to, let’s say, high, for example, do you think there will be any potential signal indication that you guys would be targeting specific population. So that’s related to CUE-101. And regarding CUE-102, can you please provide a little more color on enrollment dynamics and maybe possibly additional comment on like how many pieces have been enrolled so far? And if possible, maybe additional color on like data disclosure data update at six week? So that’s all on my end. Thank you very much.

Dan Passeri : I think the first question had to do with stratifying with CPS score.

Matteo Levisetti : Yes. I can — I’m happy to take it.

Dan Passeri : Yes, go ahead.

Matteo Levisetti : Thank you for the super great questions. And so with regards to CUE-101 and pembrolizumab and the data that we’re observing, right, where we have a really meaningful tripling of response rate in the CPS low population. Also, we have about 1.6 times increase in the CPS high population. So the way I think we’re thinking about this, this is actually really a win-win for any patients that are being treated in the first-line setting with a checkpoint inhibitor such as pembrolizumab. So if you actually look at the data on the low population, it’s less than one in five patients that benefit or have a response. And so if we can push that up to 50% that’s fantastic for the patients. And then even in the CPS high population, we have a clear benefit of improving the activity there.

So I think where things stand now. Pembrolizumab is approved in the first line for treating any patients that are CPS greater than or equal to 1%. And it’s not clear that stratification really would be needed or specific targeting since really all of these patients appear to benefit more from the combination. With regards to CUE-102 the enrollment is — in my experience, been close to the fastest for a dose escalation Phase 1 advanced cancer study. And as I mentioned before, this is really borne out of the remarkable enthusiasm of the investigators. And I think also it underscores the large unmet need of patients with advanced disease in these four indications. Regarding the numbers of patients, I think we anticipate presenting the initial data on approximately 20 patients or more at SITC in November.

And the data that we’ll be presenting at that time is the initial observations on the safety and tolerability of CUE-102 monotherapy. We have already and we will fill out more some preliminary pharmacokinetic data from the dose escalation patients characterized the clinical course that’s been observed and also share any correlative data sets that we have available at that time. As I’m sure you know well, we’re working very actively with several different vendors that are going to help us do the correlative analysis, and we hope to have some of that data to share at SITC as well.

Unidentified Analyst: Thank you very much.

Operator: Thank you. [Operator Instructions] Your next question comes from Peter Lard [ph] with Oppenheimer. Please go ahead.

Unidentified Analyst: Hey guys. It’s Trevor. Thanks for taking the question. Excited to see the SITC updates. So, looking ahead to 2024, can you guys discuss some of the additional data that we might see throughout the year there?