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

Andreas Harstrick: Yes. So as you know, clinical data always have multiple aspects. So we have some ideas about response rates that we want to see. We also have some ideas about the duration of responses we want to see. We have not communicated those and it will always be a composite of these 2 parameters in addition to patient characteristics, how refractory are these patients as a pretreatment pattern. Our intention clearly is to make go/no-go decisions based on these data. And as the data are maturing, we will have think better discussions or more detailed guidance once we have disclosed this data.

Operator: And our next question coming from the line of Li Watsek from Cantor.

Li Watsek: Maybe just one on AFM13. Maybe clarify if you had additional interactions with FDA regarding your R&D filings since your pre-IND meeting? And what are the remaining steps that you have to go through to have it filed?

Adi Hoess: Wolfgang, do you want to take this question?

Wolfgang Fischer: Yes, I can take that question. Thank you. So first of all, we have the pre-IND right which — where we got feedback early in January and we got constructive feedback. We had 1 or 2 clarifying questions for the FDA and we got responses. And with this constructive feedback, right, we are currently working on the documents to submit the IND, as we said, in the first half of this year. And as Andres already mentioned before, the feedback has been very positive and constructive. So we’re looking into — and we didn’t see any road block and now we are preparing to submit.

Li Watsek: Okay. And then maybe a question on AFM28. Since now you have R&D clarity for European countries and have been rolling patients. Maybe just update us on maybe how the enrollment is ongoing? And it seems like you can make a pretty quick at response rate AML patients. So any chance that we might see some data this year?

Adi Hoess: Andreas?

Andreas Harstrick: Yes. As we said, we have CTA clearance. The study is open for enrollment. So we are just starting enrollment. There, of course, we cannot say anything about what we have seen so far. And then we have not given clear or detailed guidance about the data releases. This will come once we see the initial enrollment of these patients.

Operator: And our next question coming from the line of .

Unidentified Analyst: Again, on AFM13 203 study, I just like to know what — how many sites you are planning at this point? And what would be the overall goal in terms of just bridging the earlier study? Or you anticipate more in terms of potential status, for example, phases of the study, whether that will lead into more advanced trials? And I have a follow-up.

Adi Hoess: Wolfgang, do you want to take that?

Wolfgang Fischer: Yes, I can take that. Thank you. So a number of sites. We are working with the several side. So I do not have the exact number on the top of my head. But it’s about 12 to 15, I recall that correctly. And the objective of our trial is to confirm what we have seen in the MDS trial. This is — we are convinced and we see that the AB-101 cell is a good cell which works very well with AFM13. We have seen that in all our preclinical studies, demonstrating that. So it’s to confirm what we have seen at the end of the year.

Unidentified Analyst: Okay, great. Maybe the follow-up here is that in terms of AFM28 and prepared statement indicate that subsequently, you will use added to an NK combo study. I’m just curious in this case, would that be AB-101? Or you have other options or has not been determined in advance?

Adi Hoess: Yes, exactly. So we have not announced it, let’s put it this way. And in the moment, we’re following how AFM28 is now performing in the clinic. And then , we’re going to make the next decision on how that’s all going and which cell we are using.