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SITC 2021 | GTB-3550 TriKE for the treatment of MDS & AML

Jeffrey S. Miller, MD, University of Minnesota, Minneapolis, MN, gives an overview of the results of a Phase I/II study evaluating GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE) for the treatment of CD33-expressing high-risk myelodysplastic syndromes (MDS), refractory/relapsed acute myeloid leukemia (AML) or advanced systemic mastocytosis (NCT03214666). This interview took place during the 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington, D.C.

Transcript (edited for clarity)

The trial right now… So we’ve treated a total of 12 patients. We have proof of concept. It was a Phase I dose-escalation study. It’s going through data cleaning and final analysis and preparation now. Through this study, the things that I can say is there were no dose-limiting toxicities reached. And even, I think, the most important thing is the TriKE itself did in vivo what we expected based on the preclinical modeling...

The trial right now… So we’ve treated a total of 12 patients. We have proof of concept. It was a Phase I dose-escalation study. It’s going through data cleaning and final analysis and preparation now. Through this study, the things that I can say is there were no dose-limiting toxicities reached. And even, I think, the most important thing is the TriKE itself did in vivo what we expected based on the preclinical modeling. So, when you give the TriKE by continuous infusion, it was three blocks of therapy, Monday through Friday, three weeks in a row, constituted a course of therapy, and this is refractory AML and MDS patients.

So, the NK cells expanded in vivo, which was a little bit of an uncertainty to us. This is the proof of concept part. We didn’t know if there would be an overwhelming amount of tumor-induced immune suppression. These were patients with very active leukemia. And we saw that NK cells went over time, the activity increased. One of the things I think we learned from the study is we need to give multiple courses of therapy for longer period of time.

The other thing is that we identified with this clinical human proof of concept that there are probably better ways to make these molecules. So we have a new Camelid engager, which is kind of a second-generation TriKE that seems to change the biologic activity of the IL15 to be a more potent molecule. And that’s the thing that is really going to be developed further, I think, to figure out a dose and schedule to bring together for the future clinical trials.

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