All right, great. Thanks for the opportunity. I appreciate the opportunity to be able to present. So full disclosure, this was presented as a late-breaking abstract at ESMO in Barcelona, which is where these slides are from. There was an updated version that was then presented at IGCS in Dublin. And so I have some newer data that's not on these slides, but I thought for the sake of convenience, we'll use these to start. So thank you again for the opportunity to present to your echo group. This is, again, the late-breaking abstract from a phase two randomized dose optimization trial of Gotistibart, it's a mouthful, a pH-sensitive anti-CTLA4, so immunotherapy, in combination with pembrolizumab and platinum-resistant ovarian cancer. Those are my disclosures. And so as we know, effective treatment for platinum-resistant high-grade serous ovarian cancer is an unmet need. And right now there's been limited success in the use of single-agent PD-1 blockade immunotherapy in ovarian cancer, with ovarian cancer being considered a cold tumor. And so many millions of dollars have been spent in a variety of different trials without success. So dual checkpoint inhibition has been investigated targeting PD-1 and CTLA4, that did show an increased response rate, but with significant toxicity. In terms of the novelty of this, Gotistibart is a next-generation pH-sensitive anti-CTLA4 antibody. It preserves the CTLA4 immune tolerance checkpoint, and then it increases anti-tumor activity and decreases autoimmunity. So ideally would have less off-target effects. This is the schema. So patients were enrolled with platinum-resistant high-grade serous ovarian cancer, adults with prior surgery, you had to have at least one prior platinum-based therapy, but there was no limit in the number of prior lines, which is important to keep in mind. Platinum-resistant status and ECOG performance of zero to one. Initially, there was a dose adjustment made, and then the final trial was really randomized one-to-one to two different doses of Gotistibart. So one milligram per kilogram versus two milligrams per kilogram, both arms in combination with Pembrolizumab, 200 milligrams. In terms of the objective, it was to assess safety and efficacy of the combination of Gotistibart plus Pembrolizumab in platinum-resistant ovarian cancer. And then in addition to traditional endpoints of overall response rate and safety, the further objective was dose optimization. So here are our demographics. In general, the arms were well-matched. 62 patients were randomized to the one milligram per kilogram and two milligram per kilogram arms in combination with Pembrolizumab. And it's worth noting that patients were heavily pre-treated. So the number of prior regimens, the median was four and three in the two arms, but patients did receive up to nine prior treatment regimens. And so this is where the money's at, so anti-tumor activity. Some of these results have been updated. So again, these are the ESMO slides, but we had updated results at IGCS, which was presented at that meeting. So preliminary results for efficacy were shown in the spider plots. They're very encouraging. The overall response rate by blinded independent central review or BICR was 27.3% in the one milligram per kilogram group and 34.5% in the two milligram per kilogram group. The current analysis of 62 patients showed that there were three complete responses and 16 partial responses. So really your question, anytime you do a trial, is really two things. One is, does it work? So we talked about the efficacy. And the second is safety. Is it well tolerated? So regarding safety, Gutisdivar plus fixed-dose Pembrolizumab demonstrated a tolerable and manageable safety profile at both dose levels. The most common adverse event was fatigue. And the rate of grade three or higher adverse events related to either drug was 45.5% and 41.4% for the one and two milligram per kilogram arms, respectively. The most common grade three or higher adverse event was elevated LFTs, diarrhea, colitis, and adrenal insufficiency. This data is not on the slide regarding PK, but we did have PK information for IGCS. And the PK parameters did increase proportionally with dose. And PK characteristics were comparable with Gutisdivar monotherapy. So in conclusion, in this heavily free-treated platinum-resistant ovarian cancer patient population, preliminary results for the efficacy of the combination of PD-1 and next-generation pH-sensitive CTLA-4 immunotherapy were encouraging, with Bikker overall response rates of 27.3 and 34.5%, which I think if you think about how heavily pre-treated these patients were is impressive. Early results demonstrate that the combination had a manageable tolerability profile at both dose levels, and there were no new safety signals. The final dose selection would be based on totality of safety, efficacy, and pharmacology. And then if confirmed by further pre-planned analyses, the combination of Gutisdivar plus pembrolizumab in platinum-resistant ovarian cancer could be explored in a randomized setting. So there's still ongoing data analysis happening, and there's going to be a planned data safety lock coming in the next few months. And the goal is to try to get a publication out in the maybe calendar year so that we can analyze the results a little bit more carefully. And just want to thank all of you for listening, our patients that were on trial, and the group today for listening. That's it.

Gotistibart

Pembrolizumab

ovarian cancer

clinical trial

anti-CTLA4 antibody