Insilico announced that ISM6331, its AI‑designed pan-TEAD inhibitor, has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease progressed on or after prior anti-PD-1 antibody therapy, with or without anti-CTLA-4 therapy, and platinum-based chemotherapy.
The company said this is the first Fast Track granted to a program in its AI-driven pipeline and that the designation provides enhanced FDA engagement and may make the program eligible for rolling review, Accelerated Approval and Priority Review, subject to meeting relevant criteria.
According to the company, ISM6331 was nominated in June 2023, received Orphan Drug Designation for mesothelioma in June 2024, and dosed its first patient in a global Phase I trial in January 2025; the company says initial Phase I data has been accepted for a brief oral presentation at ESMO 2026.
The company claims preclinical studies showed broad anti-tumor activity, potent low-dose effects and a favorable safety and ADMET profile, and notes the candidate was engineered using its Chemistry42 platform.
