anzutresgene autoleucel (IMA203)

P1, N=15, Recruiting, Immatics US, Inc. | Not yet recruiting --> Recruiting

P1/2, N=375, Recruiting, Immatics US, Inc. | Phase classification: P1 --> P1/2 | Trial completion date: Dec 2028 --> Jun 2032

P1, N=15, Not yet recruiting, Immatics US, Inc. | Initiation date: May 2025 --> Aug 2025

P1, N=15, Not yet recruiting, Immatics US, Inc.

Overall, IMA203 showed promising anti-tumor activity in multiple solid tumors, including refractory melanoma. ClinicalTrials.gov identifier: NCT03686124 .

P3, N=360, Recruiting, Immatics US, Inc. | Not yet recruiting --> Recruiting

P3, N=360, Not yet recruiting, Immatics US, Inc.

P1, N=476, Recruiting, Immatics US, Inc. | N=186 --> 476

Here, we describe the in-depth characterization of an HLA-A*02:01-presented peptide derived from the cancer germline antigen preferentially expressed antigen in melanoma (PRAME) that opens an avenue of new opportunities for patients with solid cancers which we aim to leverage by two distinct TCR-based therapeutic modalities, TCR-engineered T cells (ACTengine® IMA203) and TCR Bispecifics (TCER® IMA402). Conclusions Here, we demonstrate comprehensive target characterization and validation data supporting the nearly ideal target properties of PRAME that can be exploited for the benefit of patients: PRAME is highly cancer-associated, homogenously expressed, presented at high target density, highly prevalent across many solid cancers and clinically validated, underlining its potential to reach a large cancer patient population. Trial Registration NCT03686124 Ethics Approval The study was approved by the institutional review board/ethics committee as required for each participating site.