Transgene cancer vaccine keeps patients relapse-free for three years
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 relapsed.
Why it matters: The result extends an unusually clean early efficacy signal for TG4050, which is designed to prevent cancer from returning after surgery and standard adjuvant treatment. But the study is small and was primarily designed to assess safety, leaving a larger ongoing Phase 2 trial to determine whether the apparent benefit holds up.
Zoom in: The Phase 1 trial enrolled 32 evaluable patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma. Sixteen received TG4050 immediately after standard treatment, while 16 were initially observed and could receive the vaccine if their cancer returned.
- After a median follow-up now reaching 41 months, none of the vaccinated patients had relapsed, compared with three patients in the control arm. No unexpected safety signals were reported.
- The full Phase 1 results were also published in Nature Communications. The publication reports vaccine-induced T-cell responses against patient-specific tumor mutations in 73.3% of patients treated immediately, with a median of three neoantigens recognized among responders.
How it works: TG4050 combines technologies from Transgene and Japanese technology group NEC. Tumor sequencing identifies mutations specific to each patient, NEC’s AI-based system ranks those most likely to provoke an immune response, and Transgene packages up to 30 selected neoantigens into its modified vaccinia Ankara viral vector. The resulting vaccine is manufactured individually for each patient.
Backstory: The relationship between Transgene and NEC dates to 2018, followed by a clinical-development collaboration in 2019 that combined Transgene’s myvac platform with NEC’s neoantigen prediction technology. The partners initially shared the costs of TG4050’s Phase 1 development and expanded the collaboration in 2024 to jointly finance the Phase 2 head and neck cancer study.
- That relationship changed again in April. Transgene licensed access to NEC’s prediction platform for further development of TG4050, giving the French biotech rights intended to support future development, commercialization and partnering. NEC received €2.5 million in Transgene shares and is due another €2.5 million in cash through early 2028, plus undisclosed milestones and a double-digit share of future profits or licensing revenues.
What’s next: Transgene completed randomization of the Phase 2 portion of the trial in April. Its primary efficacy measure is disease-free survival after two years of median follow-up, with top-line results expected by the end of Q1 2028.
