(RTTNews) - Immatics N.V. (IMTX) Thursday reported updated data from the Phase 1b study of its ACTengine cell therapy IMA203 in melanoma patients.
ACTengine is a personalized therapy in which a patient's own immune cells are collected, genetically modified to attack cancer tumors, and then reinfused back to the patient as their treatment.
In the Phase 1b dose expansion part of the study, heavily pretreated patients with metastatic melanoma were treated with IMA203. Data from the study showed a significant positive shift in median progression-free survival (PFS) and overall survival (OS) between patients in Phase 1a dose escalation study and Phase 1b dose expansion study.
Further, IMA203 maintained a favorable tolerability profile with no treatment-related Grade 5 adverse events.
Based on the Phase 1b data, the company plans to proceed directly to a registration-enabling Phase 3 study of IMA203 dubbed SUPRAME in metastatic melanoma patients. The study is expected to start in December this year with a pre-specified interim analysis planned for early 2026.
Immatics aims to submit a Biologics License Application (BLA) in early 2027.