MacroGenics, Inc. (NASDAQ:MGNX) Q1 2023 Earnings Call Transcript

Kaveri Pohlman: Thanks for the updates and congrats on the approval of ZYNYZ. For the Phase 2 trial with docetaxel or lorigerlimab, can you provide any additional color on your development strategy? Can you maybe go for a registration enabling trial if, let’s say, the interim analysis looked positive given the big five of the study?

Scott Koenig: And obviously this is designed as a controlled study, 2:1. But given that this is only a 150 patients, we do not expect that this study alone would be sufficient to meet the regulatory requirements for an approval and would then base the successful study to expand that into a full Phase 3 study. Obviously, great overarching data trumps all. But right now, we’d only intend that this study would serve as a trial for approval.

Kaveri Pohlman: And my second question is also on lorigerlimab. So based on KEYNOTE-199 and CheckMate 650 trial results, it seems like PD-1, CTLA-4 combination is more active than PD-1 alone. Any thoughts on going into MSI high cRPC prostate cancer as monotherapy, is it commercially attractive? And similarly, does the combination of PARP inhibitors make sense, because CheckMate 650 trial showed better efficacy in HRD positive patients?

Scott Koenig: So answering your question, obviously, responding — and I agree with you based on the 199 study and the 650 study, and the data that we have shown at ASCO-GU in terms of a 26% objective response rate and over 90% PSA50, and all responding patients had actually greater than PSA90 responses, that we’re in a very good position with this molecule to move it forward. With regard to MSI-high, we have not set up a trial that’s something we could consider. We certainly are looking at additional combinations. And given that the treatment regimens for prostate cancer are revolving with the use of PARP inhibitors even in early line therapy without DNA repair defects, we would consider additional combination studies of the future, but have nothing right now that would incorporate this in our current studies.

Kaveri Pohlman: And maybe a last one on the ADC, since we’re waiting for the updated data. But do you plan to show any mature data from the Phase 1 trial? I believe from the last readout in 2021, the sample size will be since — for the patients who remained on treatment.

Scott Koenig: As we have noted on previous calls, we’ve had objective response rates in all the tumor types that we looked at and had historically considered actually studying additional patients after prostate cancer in melanoma, because at that time we did not have the cash runway to justify moving forward with that, we stopped that planned study. What I have said in previous calls is that we will provide data at times when we start or plan to initiate studies in additional indications and not until then.

Kaveri Pohlman: Got it, that’s helpful. Thanks for taking my questions.

Scott Koenig: I would also like — let me just also add a comment from the earlier call that when I was discussing the treatment in the lorigerlimab study that I was talking about a single agent not a single arm study. So just to make sure that people were not confused by my statement.

Operator: Our next question comes on the line of Stephen Willey with Stifel.

Stephen Willey: So I know you’ve done a couple of licensing deals here just to gain access to some novel linker-payload technology. And I guess just wondering how that preclinical work is progressing, whether you’re specifically focused on derivatives, which is I guess kind of seemingly where the entire landscape is tilting right now, and whether the added balance sheet strength now allows you to accelerate some of those development efforts going forward?