Transgene: Anti-Cancer Vaccine TG4050 Advances to Key Phase 2 Milestone
Transgene announces the completion of patient randomization in the Phase 2 segment of its clinical trial evaluating TG4050, a personalized therapeutic vaccine aimed at adjuvant treatment of head and neck cancers. The study continues towards its primary endpoint.
Completion of Patient Inclusion for Phase 2
The biotech company based in Strasbourg has finalized the inclusion of patients for the Phase 2 part of the multicenter randomized trial (NCT04183166) assessing TG4050 in monotherapy versus observational wait. The therapeutic vaccine is designed to induce strong and specific immune responses to prevent the risk of relapse in adjuvant situations, i.e., after surgical operation and (chemo)radiotherapy. TG4050 encodes neoantigens, mutations specific to each patient, identified and selected via NEC's prediction system based on artificial intelligence.
Primary Endpoint: Disease-Free Survival (DFS) at Two Years
The primary endpoint of the study is the two-year disease-free survival (DFS). Transgene plans to communicate the main results by the end of the first quarter of 2028 at the latest. The company also anticipates the release of initial immunological data from Phase 2 in the second half of 2026. Phase 1 data showed that repeated subcutaneous injections of TG4050 were well tolerated, with no unexpected adverse effects, and provided a strong clinical proof of concept: all patients treated in Phase 1 were in clinical remission and without recurrence after at least two years of follow-up.
