MaaT Pharma: pre-IND meeting with the FDA scheduled for October for MaaT034
The Lyon-based biotech company has detailed the next regulatory and clinical steps for MaaT034, its drug candidate intended for advanced solid tumors.
This announcement comes as the company redirects its development efforts following the negative opinion from the EMA on Xervyteg, communicated on September 18, 2026.
A meeting with the FDA scheduled for October 2026
MaaT Pharma announced the holding of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration, scheduled for October 2026. This meeting will be primarily focused on CMC (Chemistry, Manufacturing, and Controls) aspects.
The company presents this step as the next key regulatory milestone toward the clinical development of MaaT034. The advancement of the program toward the clinical stage is based on preclinical results presented at the annual congresses of AACR and SITC since 2023.
MaaT034 in combination with PD-(L)1 inhibitors in solid tumors
MaaT034 is intended to be evaluated in combination with PD-(L)1 inhibitors in certain advanced solid tumors, particularly non-small cell lung cancer in second line and advanced refractory melanoma, as well as other tumors presenting unmet medical needs.
A first-in-human study was designed to determine the optimal dosing regimen and pretreatment schedule, as well as to generate the first clinical proof-of-concept data. Its launch could be initiated in late 2027, subject to obtaining the necessary regulatory approvals and appropriate funding.
To support this development, the company indicates it is exploring funding opportunities with investors and strategic partnerships with pharmaceutical companies.
