Longevity InTime: Autonomous AI Institute. Anti-Aging Digital Health Immortality Transhumanist AI Channel

Fast Track for ISM6331 The FDA granted Fast Track status to Insilico Medicine's ISM6331 on July 29 for the treatment of unresectable malignant pleural mesothelioma after prior therapy. This status allows for more frequent discussions with the regulator on trial design, while the phase 1 study continues to enroll participants. ISM6331 is intended for adults whose disease has progressed after anti-PD-1 therapy, with or without anti-CTLA-4, and platinum-based chemotherapy. According to Insilico, this is the first Fast Track status for a program from the company's AI-developed pipeline. The Fast Track designation changes the interaction with the FDA, enabling more frequent discussions on trial design, biomarkers, and development plans, as well as written feedback. As listed on ClinicalTrials.gov, an international phase 1 study is underway with a planned enrollment of 100 participants. Doctors are investigating which doses cause unacceptable toxicity, what adverse events occur, and what dose to take into phase 2. The treatment is administered in a capsule once daily. Insilico describes ISM6331 as a TEAD protein inhibitor associated with the Hippo signaling pathway, which is involved in cell division and survival. In its Chemistry42 platform, Insilico built molecular variants based on the target structure and ranked them according to its own estimates, selecting ISM6331 for human testing. The phase 1 study is already ongoing, and Fast Track adds regular contact with the FDA to it. Insilico received this status for a specific molecule that its system helped select for clinical validation, as reported in Nature Aging, July 2026. 🔗 Read original →