Posted by Michael Wonder on 24 Oct 2023
Immatics receives FDA regenerative medicine advanced therapy designation for ACTengine IMA203 TCR-T monotherapy
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step one to leverage the full breadth of PRAME.
Immatics today announced that its IMA203 TCR-T program has received regenerative medicine advanced therapy designation from the FDA Center for Biologics Evaluation and Research 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.
