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

And that’s an immediate acquisition of a company that has immediate sales and cash flow. And so that’s that their game plan. Now, we think highly of ADCs, but that’s not our business model. Our business model is use the body’s immune system, the power within the body to be able to overcome this miserable disease, that’s our business model. And that’s what we’ve been doing for the last 29 years and unwaveringly pursuing this, and that’s what we will continue to do. Now do we think — do we rule out the possibility of, for example, immuno-oncology agents to be used along with targeted therapies VEGF and so on and so forth. Now including ADCs, we don’t rule that out. But we look at those agents as adjunctive agent to perhaps to accentuate the response to achieve the kind of cures that we’re looking for.

So that’s our model.

Operator: Emily Bodnar with H.C. Wainwright. Your line is open.

Emily Bodnar: Is there anything that you can share about the two new patients who responded in the lung cancer cohort in terms of like background characteristics? And maybe if you could just comment like what level of response rate that you’d want to see in the Phase 1b in order to be confident in move into Phase 3?

Dr. Steven O’Day: Yes. Thank you for the question. All four of the responses have been in a PD-1 refractory resistant setting. And I think that’s what’s very important. In terms of the response rate, how — the here in this setting and other molecules are really in the 10% to 15% response rate, which is very short lived as you know. So obviously, we need to have meaningful differentiation from that to move forward.

Emily Bodnar: Makes sense. Maybe also in your Phase 2 study for MSS CRC since you’re focusing on patients without liver mets, could you kind of comment on how you expect the control arm to perform in the setting since like most of these studies have been more broadly evaluated?

Dr. Steven O’Day: So right now, we’ve reported, obviously, all patients with a 23% response rate, and we’ve also shown survival data in the non-active liver mets. And so obviously, patients without active liver mets have higher response rates and better survival. This is a subgroup that we think is a significant subgroup in colorectal cancer and will drive our earliest path to registration. So, we’re focusing the Phase 2 and the Phase 3, as Garo just said, in that patient population for response, the duration of response, PFS and most importantly, overall survival.

Dr. Garo Armen: And I think you asked the question about the control group and control group responses, Dr. O’Day.

Dr. Steven O’Day: So in this setting, in the second, third line setting in a stable colorectal cancer, the response rates to regulator long serve have been in the single digits, very low single digits. Their major impact, if you could call it that, is really in their PFS and OS, not their response rate. And that’s even limited to several months.

Emily Bodnar: All right. And maybe last question. Are you planning to share any melanoma or pancreatic data, either from the Phase 1 or Phase 2 studies this year?

Dr. Garo Armen: So, I think the — I think it’s premature to really declare when we will be able to share that data, but we’re hoping that at least internally, we have a very good glimpse at how those trials are progressing by the end of this year. And depending on the nature of the data, meaning how many patients we’ve seen respond and how many patients had reportable outcomes, we may be able to report that in the first quarter at a major conference, first quarter of next year at a major conference.