Agenus Inc. (NASDAQ:AGEN) Q4 2022 Earnings Call Transcript

And it’s been quite effective. And most of the toxicity is sort of evenly split between Grade 1, 2 versus Grade 3, 4. And we expect that to improve substantially in terms of Grade 3, 4 with our mitigation strategy. When physicians and patients understand that toxicity can be associated with clinical benefit they will report the symptoms earlier, and they can be managed more quickly. And we think this is an important lesson learned from the first generation of I-O therapy.

Operator: Kelly Shi with Jefferies. Your line is open.

Kelly Shi: The first question is for the 23% ORR microsatellite stable colorectal cancer you have reported. Is there an update on if all the responses are confirmed the responses? And secondly, for the projected regulatory submission, in syndication in 2024, you mentioned ORR, DOR median PFS all included as efficacy signals. I’m curious have you discussed this regulator passed with FDA would have been the feedback on accelerated path? And what is the regulatory bar in different shares in color.

Dr. Garo Armen: Let me ask you, is that gist of your question, the continuation of what we have reported as response rates.

Kelly Shi: 23% ORR.

Dr. Garo Armen: Okay. So we have reported in colon cancer as of the ASCO GI meeting, 23% ORR and that hasn’t changed. In other words, we don’t have additional information that dispute what we have reported is not continuing to be the trend in the range, let’s say, 20% to 25% overall response rates in coal. I mean, as you know, we’re reporting this with ESMO GI last June, and then we reported again at SITC and again at ASCO. And with the top confirmed responses, the responses have been in the range of 20% to 25%. And as more data develops, of course, we’re going to report this at subsequent conferences.

Operator: There are no further questions at this time. I would now like to turn the call back over to our presenters for final comments.

Dr. Garo Armen: Thank you very much, everyone. It’s been a long conference call as we forward because of the density of the data that Dr. O’Day was reviewing and the momentum continues. So, we’re excited about engaging in expanded cohorts and additional announced trial that we’re undertaking. And there may be some additional surprise trials that will be announced both in the form of investigator-sponsored trials that may be the focus of attention here, including, for example, trials that will address the toxicity issue pre-emptively, and these are being done at leading institutions. So stay tuned and we will keep you restart clinical data and what is happening with our potential discussions with prospective partners. Thank you very much.

Operator: This concludes today’s conference call. We thank you for your participation. You may now disconnect.