Daina Graybosch: Two questions for me. One on the new AB-101 arm, I think you had known that it was a possibility that FDA would want an arm like this for contribution of components. But initially, my understanding is didn’t include it in the design because KOL feedback that they were hesitant to enroll patients into such an arm, given the preclinical data suggesting NK cells alone wouldn’t have benefit. I wonder how have your conversations gone with KOLs and sites? And what can you do to ensure enrollment into this arm and enrollment overall to the study now that this arm is a possibility? And then my second question is on AFM24. And there’s been – particularly in EGFR mutant lung cancers, but also across your indications, a lot of interesting data with antibody drug conjugates. And I wonder whether there’s potential down the road after you show benefits that combine with chemotherapy and if you’re considering that and of chemo in the form of an ADC going forward?
Andreas Harstrick: The AlloNK IL-2 arm, as you mentioned, is an arm that we added also after discussion with some of our clinical advisor key opinion leaders. Probably the only way to make such a recruiting arm is what we implemented now, that we give patients the option if they do not have a response after cycle one, they can immediately cross over to the combination treatment. So, they will have the option to receive what we believe is a more active treatment. And again, as I said, we believe that the number of patients in this arm will be relatively small as we are not expecting to see get a very high response rate here. So this is, I think, a good compromise that most of our clinical sites believe is acceptable to patients.
If you would have an arm that has only AlloNK cells without the option to cross over, I think you would have quite significant challenges to recruit in such an arm. As for AFM24, yes, we have a number of indications, especially in the non-small cell lung cancer field, where we do see ADCs coming up, and we believe that the mechanism of action of AFM24 could fit very well with ADCs. So, combination either with TKIs, for example, in the EGFR mutant field or with ADCs, both in the non-small cell lung cancer EGFR wild type and EGFR mutant fields are definitely options that we would look at after we have completed our 102 study.
Operator: Our next question comes from the line of Yanan Zhu with Wells Fargo.
Yanan Zhu: Two questions on the AFM13 program. The first one is, how is the infusions of the NK and AFM13 handled on the day of infusion? I was wondering since this is not a pre-complexed product, which component is infused first and what is the space of time between the two infusions? The second question is about how you select the two cohorts for stage two. Would that be based on two cohorts having to have the same NK component, NK dose or these two cohorts having to have the same AFM13 dose or it doesn’t matter, just the two cohorts with the best performing ORR?
Andreas Harstrick: In terms of administration and how the trial currently is designed, we start on the days where we give AFM13 or acimtamig and NK cells with acimtamig infusion. Initial infusion duration is four hours for the first cycle, but with the option to reduce the duration of the infusion if there are no infusion related reactions. Then we have a one hour break and then we have the NK cell infusion which usually is a pretty short 15 to 30 minute infusion. This is based on the previous experience, especially with rituximab and B cell lymphomas where I think, in all programs, rituximab was given first to allow some distribution of rituximab throughout the body, and then followed by the NK cells, which has quite well worked in the B cell field.
So this is how the regimen would be handled. And the second question was around selection of the appropriate cohort. Again, there is no pre-specification. So we do not necessarily have to use the same cell dose or the same acimtamig dose into two cohorts. We will do a good assessment or a thorough assessment of the risk/benefit profile both looking at efficacy and safety. And based on that, we’ll select the two most appropriate cohorts for the part two of the study.
Operator: Our next question comes from the line of Brad Canino with Stifel.
Bradley Canino: I had a two parter. One of them was answered about your view on the durability when it comes to the accelerated approval previously. So on top of that, I just want to ask, do you expect the MD Anderson presentation, which I think will include the final follow-up for the three to four cycle patients, to be a definitive demonstration of the durability of your potential commercial product or would you tell us to wait for the LuminICE-203 data to start rolling in?
Andreas Harstrick: That is a very difficult question. I think what we will show at ASH is clearly an update of both EFS or PFS survival and overall survival. I would not say this will be the final, as we already indicated in the abstract, there are still quite significant number of patients in follow-up. So there could be a further follow-up data with even longer duration of responses or survival. Now, how these data translate into the LuminICE study is a little bit more difficult to answer. We believe that the 104 study is a very good proof of concept study, which I think indicates the magnitude of clinical effect that you could expect. Based on all our preclinical data, we have shown that the AlloNK cell is very active and co-administration, if at all, trends to be even a little bit more potent than the pre-complexing.
