Head-and-neck squamous-cell carcinoma (HNSCC) — a frequent neoantigen-vaccine setting.
[RECRUITING · PHASE1 · Metaclipse Therapeutics Corporation] The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squ…
Adjuvant TG4050 was well tolerated and generated long-lasting neoantigen-specific T-cell responses in resected HPV-negative HNSCC. Adjuvant treatment with the individualized, viral vector–based neoantigen vaccine TG4050 was safe and induced durable neoantigen-specific CD8-positiv…
Nature published a randomized Phase I trial of a viral-based individualized neoantigen vaccine given as adjuvant treatment in resected head and neck squamous cell carcinoma. The design is the signal: randomization this early, in a post-surgical adjuvant setting, points to intent to move neoantigen vaccines out of advanced disease and into earlier-line use in a new tumor type. The available summary carries no efficacy numbers, so conclusions should wait on the full paper.
Personalized neoantigen vaccines are moving from early proof to later-stage clinical validation. In melanoma, Moderna and Merck’s mRNA vaccine intismeran, combined with pembrolizumab, met the primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in a phase 3 trial. In head and neck cancer, Transgene’s personalized vaccine TG4050 induced durable immune responses in a phase 1 trial, but efficacy remains unconfirmed. The contrast matters for investors: melanoma has a positive efficacy signal, while head and neck still requires confirmatory data.
In a phase 1 trial, the MVA-vectored neoantigen vaccine TG4050 produced no dose-limiting toxicities or relapses in those with resected, HPV-negative HNSCC. TG4050, a modified Vaccinia Ankara (MVA) viral vector–based individualized neoantigen therapeutic vaccine encoding up to 30 …
All 16 patients who received TG4050 after standard treatment remained disease-free, compared with 13 of 16 patients in the control group All 16 patients treated with an individualized cancer vaccine after surgery for locally advanced head and neck cancer remained disease-free aft…
Log in here to read the desired article. French biotech Transgene said all 16 head and neck cancer patients treated with its personalized cancer vaccine TG4050 in a randomized Phase 1 trial remained disease-free after three years, while three of 16 patients in the control arm rel…
Transgene and NEC Corporation have reported sustained 100% three-year disease-free survival (DFS) among patients treated with the individualized neoantigen therapeutic vaccine TG4050 in the Phase 1 portion of a randomized Phase 1/2 trial in resected, locally advanced HPV-negative…
Researchers Ottensmeier, Delord, and Lalanne report on a randomized Phase I trial of a viral-based individualized neoantigen vaccine for patients with resected HNSCC. Designed as an adjuvant treatment to target microscopic residual disease, the vaccine is customized to each patient's specific tumor mutations rather than targeting a common antigen. This approach addresses the biological diversity of HNSCC and aims to reduce recurrence rates where standard therapies have limitations.
January 09, 2026 02:00 ET | Source: Transgene S.A. Transgene S.A. TG4050 elicits strong polyepitopic, polyclonal, durable cytotoxic and effector neoantigen-specific CD8 T cell responses Results reinforce TG4050 potential as an individualized cancer immunotherapy Strasbourg, Franc…