Transgene Announces Promising Results for its Personalized Vaccine Against Head and Neck Cancers
Strasbourg-based biotechnology group Transgene has announced the pre-publication on medRxiv of a detailed analysis of Phase I trial data evaluating TG4050, a personalized therapeutic vaccine against head and neck cancers. According to the press release, no recurrence has been observed after at least two years in patients treated in an adjuvant setting.
Phase I Clinical Trial Outcomes
The Phase I clinical trial focused on patients with operable, locally advanced, HPV-negative head and neck cancer. According to the company, TG4050 achieved 100% recurrence-free survival after at least two years when administered as monotherapy in an adjuvant treatment setting. The therapeutic vaccine is based on the myvac platform and encodes up to 30 selected neoantigens, delivered by a Modified Ankara Virus vector. The trial included 32 evaluable patients in its Phase I part. Half of the participants received the vaccine immediately after adjuvant treatment, while the other half received it at disease recurrence, in addition to standard treatment. The group indicates that TG4050 was well tolerated and revealed no unexpected safety signals.
Translational Data Insights
According to published translational data, TG4050 induced specific T cell responses to neoantigens in 73% of the 15 evaluable patients. The company notes that these responses are durable and that cytotoxic and effector markers are expressed at least one year after the end of treatment. The data demonstrate that the vaccine induces cytotoxic CD8 T cell responses specific to the neoantigens contained in the vaccine. These cells exhibit markers suggesting potential long-term activity, according to Transgene. An overview of these data was presented at the annual conference of the Society for Immunotherapy of Cancer. The complete analysis is now available on medRxiv, a scientific pre-publication platform, and the paper has been submitted to a peer-reviewed scientific journal for formal evaluation.
Ongoing Phase I/II Clinical Trial
The Phase I/II clinical trial, identified under the number NCT04183166, is currently ongoing. Transgene indicates that the initial immunogenicity data from the Phase II part will be available in the second half of 2026. Preliminary efficacy data will be communicated as soon as all patients have a two-year follow-up post-randomization, unless an event such as a relapse, death, or lack of follow-up occurs earlier. TG4050 is the first product from Transgene's myvac platform, which combines bioengineering, digital transformation, and vectorization. The neoantigen selection system is based on artificial intelligence developed by NEC, Transgene's technology partner. The group emphasizes that in head and neck cancer, about one-third of patients experience a recurrence within two years following surgery despite existing therapeutic options.
