MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors
MaaT Pharma, a clinical-stage biotechnology company, has scheduled a Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for October 2026. This meeting will focus on Chemistry, Manufacturing, and Controls (CMC) for MaaT034, a novel Microbiome Ecosystem Therapy (MET-C) candidate. MaaT034 is designed to be evaluated in combination with PD-(L)1 inhibitors for advanced solid tumors, including second-line advanced non-small cell lung cancer (NSCLC) and refractory advanced melanoma. The company aims to initiate a First-in-Human study in late 2027, pending regulatory clearance and funding. MaaT034 is the first candidate from MaaT Pharma's MET-C platform, which utilizes artificial intelligence and co-culture technology to produce functionally selected microbial ecosystems.