Immatics Advances Melanoma T-Cell Therapy into Late-Stage Clinical Trials

Late-Stage Clinical Development:
Immatics has announced the progression of its ACTengine IMA203 T-cell therapy into late-stage clinical trials for the treatment of metastatic melanoma.

Updated Phase 1b Data:
The company has presented updated Phase 1b clinical data on ACTengine IMA203, showing significant tumor shrinkage and durable responses in heavily pretreated metastatic melanoma patients.

SUPRAME Phase 3 Trial: Immatics plans to initiate the SUPRAME Phase 3 trial in December 2024, evaluating IMA203 in 360 HLA-A*02:
01-positive patients with second-line or later unresectable or metastatic melanoma.

Clinical Outcomes:
The Phase 1b trial demonstrated a median progression-free survival (PFS) of 6.0 months and a median overall survival (OS) that has not been reached. Approximately half of the patients showed more than 50% tumor reduction, with a median PFS of over one year.

Manufacturing Capabilities:
Immatics has streamlined manufacturing processes, enabling the production of IMA203 cell therapy products within 7 days, followed by a 7-day QC release testing at a success rate of over 95%.

Regulatory Progress:
The company completed a Type D meeting with the FDA, confirming the recommended Phase 2 dose (RP2D) and the CMC package for the SUPRAME trial. The primary endpoint for full approval will be median PFS.

Clinical Expansion:
Immatics is expanding its clinical footprint beyond melanoma to address a broader patient population, focusing on ovarian and uterine cancers.