IGM Biosciences, Inc. (NASDAQ:IGMS) Q4 2022 Earnings Call Transcript

Operator: Thank you. One moment for our next question. And our next question is from Roger Song with Jefferies. Your line is open.

Roger Song: Great. Congrats on all the progress across broad IGM pipeline. So maybe two quick clarifications from us. One is for IGM-8444 DR5. As you are focused on the randomized trial for 3 mig and the 10 mig, would you keep renewing higher dose in your single-arm study, considering you may, maybe just test the safety and the PD marker? And also if or when you will report additional data from the single-arm trial? And also for the imvotamab, I noticed your €“ when you talk about the lupus in RA, we use the nomenclature severe form of the disease. Just curious as you position your T-cell engager for autoimmune disease, what is the real target population for each indication? It will be the last line of the therapy at the starting point, or you will potentially move into the early stage of the disease for those autoimmune disease, that’s two question we have. Thank you.

Fred Schwarzer: Sure. Well, Chris, do you want to take the first one and then hand off to Mary Beth to take the second one?

Chris Takimoto: Sure. So Roger, your question was really about the dose of 8444 now that we’re exploring 10 milligrams per kilogram in the randomized study. And as you’re probably aware, and we’ve talked about before in our monotherapy part of the study, we went as high as 10 milligrams per kilogram, but we did not go higher. There were no any safety signals that arose. We didn’t define dose limiting toxicities or a maximum tolerated dose, and that was also true going up to 10 milligrams per kilogram in combination with FOLFIRI chemotherapy. So there are really no safety issues there. But as we look across the program and the experience, particularly the preclinical experience the €“ in terms of the efficacy and exposures that that we’re achieving that that show activity in preclinical models, we feel that 10 milligrams per kilogram is a good dose, and we don’t feel that there’s a strong need to explore higher doses.

It is something we would potentially leave open, but at least in our thinking today, we’re really pleased with what we’re seeing at 3 milligrams per kilogram. We want to get more experience in combination at 10 milligrams per kilogram and really start to think about how we optimize the dose in that range.

Mary Beth Harler: And hi, Roger, this is Mary Beth. Sorry.

Fred Schwarzer: Well, I think there was the additional question of when we might show some of the monotherapy data there, and I think we just have not made a decision as to when and in what context we would produce additional monotherapy data. I think we’re very focused on the randomized data. We’re certainly not seeing anything in the monotherapy data that’s inconsistent with what we’ve seen to date that would cause us to question our decision to move forward into this randomized study so. But at some point, we will present those data. We just haven’t made a decision when Roger. And Mary Beth, you want to go the second question?

Mary Beth Harler: Yes. Yes. No, sure. Thanks, Roger, for the question. You’re absolutely correct. We are focusing initially on severe SLE and severe RA. Our intention is to establish initial safety and activity in those populations and then move into milder populations. So obviously a much more expansive group of patients on both fronts. This is true, particularly in light of the potential for disease modification through this approach as suggested by that CAR-T data from George . So thanks for the question.

Roger Song: Great. Thanks for the comment. Maybe just a quick follow-up maybe clarification for Fred. So what I meant is for the additional single arm data from the combination, also from the combination you have been doing now the monotherapy data, but I believe that the answer is similar. You haven’t decided that when you will produce.