Ascentage Pharma's APG-3288 receives FDA IND clearance

Ascentage Pharma announced that its next-generation BTK-targeted protein degrader APG-3288 has received IND clearance from the U.S. Food and Drug Administration and will enter a global, multicenter Phase I study in patients with relapsed or refractory B‑cell and other hematologic malignancies.

Ascentage Pharma announced that its BTK-targeted protein degrader APG-3288 has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration. The clearance permits the company to begin clinical testing of the candidate. The company said the program expands its global development pipeline in targeted protein degradation. Key facts: - APG-3288 is described as a next-generation BTK-targeted protein degrader. - The U.S. FDA granted IND clearance for APG-3288, according to the announcement. - The planned study is a global, multicenter, open-label Phase I trial. - The Phase I trial is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. - The study will enroll patients with relapsed or refractory B‑cell and other hematologic malignancies. Summary: The FDA IND clearance allows Ascentage Pharma to start first-in-human testing of APG-3288 and begins the program's clinical development. The Phase I trial will assess early safety and activity; further timelines and outcomes are undetermined at this time.