BioAtla, Inc. (NASDAQ:BCAB) Q4 2022 Earnings Call Transcript

Jay Short: So I’m going to start on this one and let Philly add to it. But first, it’s important to recognize the reason we even have the freedom to use this more frequent, intense dose regimen and added in is because of the CAB technology. So we’re expecting all three of these different does regimens, Q2W to Q3W, and 3Q4W to all be safe. That’s not the question we’re exploring. In fact, the CAB allow us that free to do it. And the FDA was extremely supportive of that UPS study. Our reason for exploring it is we have a chance to potentially even drive greater efficacy, and we’re happy with the efficacy we’re seeing on Q2W. So don’t misinterpret that. But if you have a chance to increase efficacy and you can do it in a way that does not extend your overall development timelines, it was a great opportunity to do that.

And in the UPS setting, we did it inside the part 2 of the Phase 2 study. Fortunately, in the actual in ROR2 setting for lung, we’re able to do it in the part 1. So we’re getting that done while we’re in the same time in the process, at least for AXL, having discussions with the FDA, and likewise ROR2 has always been six months or so behind AXL, and so it has no delay effect on it, and it gives us a chance to really potentially see even more efficacy and stronger responses. So, Philly, do you want to add to that?

Philippe Martin: Yes, I mean just to add to the first part of your question, which is which one do you if the 3Q4W doesn’t work or doesn’t meet our criteria, or does it, or meets about the same as what we’ve seen with the other dosing regimen. And that’s fine. We are happy with the other dosing regimen, and we’ll move forward with the 2Q3W and the Q2W at that point in time and select a dose. It’s not that we have to have the 3Q4W work for us to move forward. We’re just trying to maximize the efficacy we can get and leverage the CAB platform. That’s it.

Reni Benjamin: Got it. Just two other questions, I guess. The first, can you comment or just let us know are the patients who responded in non-small cell lung cancer, in the non-small cell lung cancer study, are they still responding now?

Philippe Martin: Jay, do you want to take that?

Jay Short: I think you should take that one.

Philippe Martin: Yes. I mean, we have decided not to update the data, but I can tell you that some of the patients are still responding. Yes.

Reni Benjamin: Excellent. And then just switching gears to the EpCAM bispecific, as I look at kind of the clinical trial design, it seems kind of complicated to me with a standard titration and then a standard titration with timing. I guess I’d love to just get some feedback or some commentary on where you think the therapeutic dose might be and how these, what’s the, I guess point or how these titrations help you get to what’s the ideal dosing, I guess, for this asset.

Jay Short: Yes, I’ll start and Philly, you can add into this but in group A we’re thinking that the 125 mg/kg, you might see efficacy below that but that’s around the EC 50 level. So we think that’s a dose level that you could really start to see some things. Obviously, we think it could go above that given our safety profile and our preclinical studies but Philip, you can add some additional to that. Maybe you could also add in some of the logic around what the FDA is wanting to see with respect to the group B titration.