Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine IMA203 TCR-T Monotherapy

 

• RMAT designation granted by FDA CBER for IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types
• Regulatory activities underway with an initial focus on a registration-directed trial in melanoma as step one to leverage the full breadth of PRAME

Houston, Texas and Tuebingen, Germany, October 24, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

“The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics. “The close support from the FDA resulting from the RMAT status enhances our efforts to accelerate bringing IMA203 to cancer patients by enabling real-time discussions on patient populations, trial design and CMC.”

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.