MacroGenics, Inc. (NASDAQ:MGNX) Q3 2023 Earnings Call Transcript

Scott Koenig: Well, I have to say that [Technical Difficulty] Europe and the U.S. and in Asia. We saw a great enthusiasm for the [Technical Difficulty] patients on the study. I can’t give you any more color than they have to have in the opportunity here with vobra duo in helping their patients. And the rationale why we’re doing that that was resonated very well with the investigators as well as the patients. What the study was originally included as 100 patients, 50 in each arm. We’ve actually exceeded that. It was an overworked study. So we expect a fairly sizable amount of data to come out in 2024.

Peter Lawson: Okay. And then on ADAM9, any details why that readout was nudged back from second half of this year to ‘24?

Scott Koenig: The study is completing – is being completed out, finalizing. And we’ll – as ImmunoGen has said, they will report out in the beginning part of ‘24. As I’ve indicated to you, one of the challenges has been always with identifying the appropriate dose moving forward. They are finishing out the patients that are in the non-small cell lung cohort currently. And we will report on that in the first part of the year and with regard to next steps for that program.

Peter Lawson: Great. Okay, thanks so much.

Operator: Our next question comes from Silvan Tuerkcan with JMP Securities. Your line is open.

Silvan Tuerkcan: Hi, good evening. Congrats on the update. And thanks for taking my questions. Maybe a more big picture question. Can you comment maybe on some key takeaways from ESMO and SITC on B7-H3 as a checkpoint that more and more presentation also what we can learn from the Daiichi Merck partnership. And then the second question is; what is your role in the HEAT study on ENA? I know that investigator related and its earlier stage prostate cancer. But what is your role here and what’s your involvement?

Scott Koenig: Thank you. So with regard to the data from ESMO, first of all, as you commented on the partnership now with Daiichi, cohort includes 7300 molecule. I have to think that we’re very encouraged that the way that that partnership was constructed. And the value that Merck placed on that relationship is 7300 was being a very important part of the three target deal. It only heightens I think the value we see for vobra duo and our B7-H3 program. With regard to the specifics that they did that, Daiichi presented in their poster session. If you recall, it was a lot more in terms of improved activity in the prostate cohort that they tested. They were seeing about 5 months of our PSS as first reported about a year of vobra duo and a 25% PSA50 response.

The latter of which is not any different than previous reported. So we feel, again, very good about where vobra duo sits right now. Having this additional data that will come out to in ‘24 on the TAMARACK study to be able to move forward very effective drug with a proper dosing to mitigate some of the side effects we were seeing. With regard to the HEAT study, again, we have always had a very close relationship with and had a lot of funding with discussions with them on where the value we see lorigerlimab in settings like a neoadjuvant use of this drug. And we’re also rent also looking at opportunities for enoblituzumab in other settings as well. With regard to this being a collaborative study, it is mostly an IST. So they have full control over the execution and providing the data.

But we have constant conversations back and forth with – regarding the opportunity for a noble, and other B7-H3 molecules in the gene prostate cancer.

Silvan Tuerkcan: Thank you.

Operator: [Operator Instructions] Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.

Faisal Khurshid: Hi, guys. This is Faisal on for Jonathan. Thanks for taking our questions. So congrats on the TAMARACK enrollment. I guess now that you sort of know what kind of patients you’ve enrolled, what do you see as the right benchmarks for vobra duo in this setting?

Scott Koenig: Well, I mean, as I indicated that we were looking to achieve a similar range of activity based that we had previously, where we were seeing about half the patients achieving PSAs. I said we would look for a 40% to 60% range on PSA50 and obviously, looking hopefully for some of these patients that PSA50 with regard to the objective responses here. Again, we have reported and what I just described to Daiichi with approximately a quarter of those patients have objective responses without delay, even higher levels. And we think that there is an opportunity there given how we have improved these patients will stay on drug potentially longer when they don’t have to come off for side effects that are problematic for them.

With regard to rPFS, so again, when we look to the historical data on both Pavecto and [indiscernible] etcetera. Again, as I just reported to you with rPFS from the 7300 in the range of 5 months, we obviously would be looking hopefully for longer rPFS in the 6 months or greater. So I would say those are sort of general ranges. Nothing absolute here with regard to decisions, the totality of the data, which will decide our next steps for this program.

Faisal Khurshid: Got it. That’s super helpful. Thank you. And then recently, there was data presented for PSMA ADC and also a steep on T-cell engager like Phase 1 data in prostate cancer. Just curious your thoughts on the competitive landscape and how you see your assets positioned?

Scott Koenig: Well, I think actually we are in wonderful shape. We are managing the opportunities for patients. For PSMA ADC, if you look at the data that has been presented at various meetings, the actual spread patterns of PSMA and B7-H3 are not identical. They overlap the consumers. But there are clearly select parts of the tumors, which will express one or the other. As I pointed to that previously, as patients’ progress to latter line, PSMA tends to drop significantly where B7-H3, are maintained. So, we think that it provides greater opportunity and choices for treating, particularly older age patients. But most importantly, with regard to this particular program or having an ADC for ADC versus an ADC for PSMA, PSMA is going to be largely limited to product, where with a broad expression of B7-H3 across most solid tumors, I think that we are in a great opportunity not only to improve treatment for patients with prostate cancer, but through a whole set of other tumors.

With regards to other platform technologies, again, none of the data I see in that’s overwhelming in that regard. But again, we will have to see how that pans out. In most of these cases, again, the point I was making with regard to the PSMA specificity, it will limits the prostate cancer.

Faisal Khurshid: Thank you.

Operator: [Operator Instructions] Our next question comes from Yigal Nochomovitz with Citi. Your line is open.

Unidentified Analyst: Hi guys. This is Atif Malik [ph] on Yigal. Thanks for taking my questions and congrats on all the progress. Just a couple of quick ones. Will there be an interim look in LORIKEET? And if so, what might trigger that interim look? Also curious if you are able to share any color on powering assumptions and remind us what the trial is designed to show in terms of separation rPFS between the arms. Thanks.

Scott Koenig: So, there is a [Technical Difficulty] LORIKEET will likely be a futility analysis. We have not provided the statistics around that. But I should point out that historical data in multiple control trials in chemo-naïve population has shown rPFS is around eight months. So, we are talking on this to be able to beat that milestone and that landmark.