Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q4 2022 Earnings Call Transcript (Corrected)

Salveen Richter: Good morning. Thanks for taking my question. With regard to the oncology portfolio, what do you consider the most meaningful milestones for the next 12 months and particularly here the PSMAxCD28 asset? Thank you.

Leonard Schleifer: Well, we obviously have some important submissions we need to get in later in the year, as we mentioned, for our CD3 bispecifics. And we need to continue to get data later in the year with more patients with PSMAxCD28 bispecifics as well as from some of the other costim bispecifics. And we have to move aggressively enrolling the additional studies we planned for LAG-3. So €“ and we have to make Libtayo even more successful, we hope in the marketplace around the world. So, lots to do. I don’t know if George or Marion have anything else to add there?

George Yancopoulos: Yes. I think it’s €“ it was really critically important for us to validate individual agents in each class. That was our strategy. We wanted to develop the best-in-class checkpoint inhibitors, such as our PD-1 antibody, Libtayo, such as our LAG-3 antibody, fianlimab. We wanted to establish three bispecifics that we are best-in-class and that we are working in hem/onc settings, but also in solid tumor settings. And then, of course, we want to validate that this incredible principle of co-stimulatory bispecifics that we introduced into the world, which were truly magical in animal studies with essentially working like turnkey agents to synergize with the other two classes in animal studies that that we could reproduce that sort of activity in humans.

And to us obviously, it takes years to get to that point, but we feel we are in a very exciting position right now because, as I have said, the individual classes are validated. We are starting to see impressive combination opportunities. We talked about combining two checkpoints, combining our LAG-3 with PD-1, where it looks like we have maybe taken first-line melanoma to a different point where patients can get a lot more benefit from this combination. And now having validated those, we are expanding much more broadly. Same thing with the CD3 bispecifics, we are growing that franchise now that we have shown that our platform works, and we are working both in hem/onc and outside in solid tumor settings. And the fact that our first costim bispecific delivered the sort of exciting early data that it delivered really gets us €“ very excited about the possibility now that we have this whole rollout.

We have several of these costim bispecifics in the clinic, clearing their dose escalation safety settings, and we are now going to be rolling out data from these combinations, more data from the PSMA, costim bispecific in prostate cancer in more patients, but we are also going to be reporting on a series of other costims, including not only in combinations that we already talked about in solid tumors. But in the hem/onc space, where we are very excited, obviously, about our CD20xCD3 bispecific by itself and our BCMAxCD3 bispecific by themselves, that Len said. We are both filing for those hopefully by the end of the year, but also initiating earlier line studies. But just as importantly, we are going to be initiating combination with these costim bispecifics, which we think yet again, if these continue to work like they work not only in the animal models, but now how they are looking in the early human study, these could really leapfrog the individual agents to a whole place where they are really changing the practice of medicine and delivering much more benefit to patients, which is what we are all about.