Let's talk a little bit about Nembalekin and what it is and what it is not. This is not your grandfather's IL-2. This is quite a differentiated molecule and it's, it's quite different from many of the other uh IL-2s that have been developed uh by a number of pharmaceutical firms and biotechs over the course of the last couple of years. And I say that basically, uh, On the uh data that has come out from the early phase studies where it appears to be highly differentiated from IL-2 and to have some characteristics which are surprising to me personally, to differentiate it from IL-2 and perhaps other cytokines that are available, such as the recently approved IL 15, aisle 15 receptor alpha construct, uh, that has now been approved for. And bladder cancer. This is uh parenthetically the first cytokine approved in 30 years, uh, since interleukin 11 was approved 30 years ago. Uh, so it's clearly an engineered IL2. It is not a mimic of IL-2, the three activities that I list as differentiating it from IL-2 or other cytokines, uh, is number one, its ability to be administered as an outpatient with manageable toxicity, uh, and with single agent activity. I think that's probably the single most important aspect of the biology of this, uh, novel molecule. The second part. Is the uh Uh, surprising inability when administered at effective doses to cause increases in T. rex. Uh, IL-2 conventionally causes an increase in these, um, I. Uh, to gluttons, uh, that limit its excess or availability to CD4 and CD8 factors. And then the third point, which again, I don't know if we have complete data sets that would tell us how to understand the biology, is unlike a conventional IL2 where neutrophil counts are pretty stable, transient, and not associated with any apparent. Uh, defects is a transient neutropenia, which, uh, recovers rather quickly after uh IL 2 is no longer in the circulation. So the way I put this all together is that unlike many of the other cytokines that we have, uh, evolved over the millennia. Uh, such as gamma interferon, which is only a single copy gene. Uh, we have family of Uh, aisle 2. Like molecules, which include aisle 4, aisle 7, aisle 9, aisle 15, and aisle 21, which um Compete For access to the gamma common chain of the IL-2 receptor. Uh, as a consequence, I think it's, uh, uh, conceivable that this molecule, uh, should be thought of in a very different way, uh, as a, uh, mechanism based, um. Meaning, uh, diverting it away from the I 2 receptor alpha chain, uh, in a clever way that allows it to take on novel properties that are distinctly different from aisle 2, aisle 4, aisle 7, aisle 9, or aisle 15. Um, I think the story is still perhaps a little premature. We really only have phase one and phase two data to guide us. Um, mural will be having. Uh, mature data both in patients with mucosal melanoma. And ovarian carcinoma, uh, in the first part of 2025, in which, uh, more detailed mechanistic studies uh can be done to confirm or refute the studies that they were. Uh, able to, uh, do in the context of a phase one and phase two studies. So I'm, I'm personally very excited about the opportunity to drill down on their randomized studies to see how this molecule differentiates itself from uh any cytokine therapy, not just uh IL2.
Presenter
