Affimed N.V. (NASDAQ:AFMD) Q4 2022 Earnings Call Transcript

Andreas Harstrick: Yes. Okay. For 24, I try to remember all the different aspects. So one question was relating to the different NK cell sources, right? So whether autologous or allogeneic NK cells are more or less difficult? We cannot finally say because for AFM24 and the NK autologous cells, obviously, we have completed our IND process already has an open study. I can say that FDA was extremely collaborative on this IND. And yes, so this was remote process. Again, also for the allogeneic process with AFM13, we have very collaborative interactions with FDA. We have not completed the IND process yet. So it’s hard to compare these 2 processes. But again, the attitude and the discussions with FDA have been very constructive in those cases. And now your second part of the question was?

Srikripa Devarakonda: AFM13. So once you have the IND acceptance, I was just wondering how long it would take for you to start treating our patient? And what work you can do ahead of time to get the centers up and running?

Adi Hoess: Andreas, do you want to continue with this?

Andreas Harstrick: So, I think we — yes, we can give, of course, only detailed guidance once we have the protocol finalized and the final blessing, if you will, by FDA. Now we are already looking doing feasibility studies at sites. We have identified our primary lead investigator. We are now working with key opinion leaders in the field to smoothen the setup process of sites as good as we can. We have identified a CRO that will support us in our study conduct. But again, final time lines can only be given after we have a final protocol.

Operator: And our next question is coming from the line of Maurice Raycroft with Jefferies.

Maurice Raycroft: I was going to ask one on the AFM13 combo as well. Wondering when do you plan to update the Street on trial design — additional trial design details? And what are your latest thoughts on what the FDA wants in terms of bridging or dose lead-in for the AB101 combo?

Adi Hoess: Yes, Maurice. Thank you. So as we said in the past, we’ve had clarifying interactions with FDA and we have been basically bringing this together into the study design. So we’re obviously — we have a good understanding and very good understanding how that should look like. I think in the past, we have said that we intend to give the NK cell in combination with AFM13 as the installment over roughly 3 weeks and then we follow with 3 weekly doses of AFM13 this is procedure or lymphodepletion. And then roughly after 8 weeks basically from start of treatment, you’ve got to do a restaging and then you include a short break before you go to the second part and third party. So general — in general, we have already explained what would the study design is going to look like. So based on the feedback with FDA, we have made other patients. And as soon as we have the final IND, we can update you on the further details. I hope this helps you.

Maurice Raycroft: Yes. Yes, that’s helpful. And also wanted to ask about the monotherapy AFM24 update. So for the approximate 15 patients in CRC, non-small cell lung cancer. What’s the internal bar for success there in terms of a go or no-go decision? And will that decision be made in the second quarter or third quarter update?

Adi Hoess: I’ll hand over to Andreas.