Altimmune, Inc.

T cell response against antigens that are known to be important for a functional response, and that is the polymerase antigen and the core antigen. The epitopes that were selected and represented in hep T cell are highly invariant. They're hydrophobic in nature, and so they're unlikely to mutate in response to the immune pressure that will be generated. So what we have is a immunotherapeutic that is expected to be active against all of the circulating genotypes of HPV. And with combination with the adjuvant that we are using, IC31, which is preclinically looked very encouraging and in our phase one study was shown to be important for these T cell responses. We feel that we're gonna be able to generate a very robust response with surface antigen and other measures of HPV replication. That will then set us up for partnering discussions with companies that have these direct antivirals and allow us to do then phase two studies and combination therapies.

That sounds great. And do you plan to stratify patients based on surface antigen at baseline? We've seen that with the BEPI Phase III program. Can you discuss more the baseline characteristics of the Phase II trial? And if you're successful, if you're going to implement that threshold of surface antigen at baseline going forward?

Sure. That's a great question. And, you know, that's really one of the unique design elements of the Phase II study that's currently ongoing and report out here shortly is that we've selected patients that are referred to as inactive carriers. Basically, these folks have low surface antigen levels compared to many chronically infected individuals. And we felt that that would represent a population that has received direct acting antivirals, has had the surface antigen reduced by the mechanisms that I referred to earlier, and then created a better environment for the immunotherapeutic to work and boost the T cell response. So going forward, you know, we don't see selecting patients with low surface antigens. We think that the combination therapy, the first part of that with the direct acting antivirals, will accomplish that goal. And then hep T cell will work as it is in this study. So this study is really meant to, you know, look forward towards the combination studies and how the patients would present themselves for treatment with hep T cells.