On January 9, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the preprint publication on medRxiv of a comprehensive analysis of both the clinical and translational data from the Phase I part of its randomized Phase I/II trial of TG4050, an individualized neoantigen therapeutic vaccine (INTV).
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The manuscript is now available on medRxiv – a preprint platform that enables early scientific visibility by sharing research ahead of journal peer review.
In parallel, the article has been submitted to a peer-reviewed journal and is currently under evaluation.
TG4050: an individualized therapeutic cancer vaccine shows 100% two-year disease-free survival as monotherapy in the adjuvant treatment of operable head and neck cancers
Despite the availability of current treatments, including immune checkpoint inhibitors, about one-third of patients with head and neck squamous cell carcinoma (HNSCC) experience recurrence within two years after surgery. Transgene’s trial with TG4050 was designed to assess whether inducing neoantigen-specific T-cell responses following treatment with an INTV encoding up to 30 predicted tumor neoantigens delivered via a Modified Ankara Virus (MVA) vector could help reduce the risk of relapse.
Half of the participants received TG4050 immediately after completing primary adjuvant treatment, while the other half were administered the vaccine at the time of disease recurrence, as an additional therapy alongside the standard of care.
With 100% disease-free survival at two years, the data suggest that individualized treatment with TG4050 does have the potential to prevent cancer relapses when administered as monotherapy in an adjuvant treatment regimen in patients with high risk, resected, locally advanced HPV-negative HNSCC. In addition, TG4050 was well-tolerated and showed no unexpected safety signals.
Detailed translational findings from patients treated with TG4050 confirm durable, neoantigen-specific T-cell responses
The translational data show that TG4050 induced neoantigen-specific T cell responses in the majority of treated patients (73% of 15 evaluable patients). These responses were durable, with cytotoxic and effector phenotype markers expressed up to one year after the end of treatment.
An overview of these data were first presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (see press release) and support TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy in patients with HNSCC.
TG4050 is currently under further evaluation in a randomized Phase I/II clinical trial (NCT04183166), in patients with HNSCC.
"The publication of TG4050’s Phase I results on medRxiv is an important step for Transgene. Making these data available to the global scientific community underscores our commitment to transparency and scientific rigor. The findings show encouraging evidence of TG4050’s ability to induce durable, neoantigen-specific immune responses and its potential in preventing relapse in patients with HPV-negative operable head and neck cancer. We look forward to advancing TG4050 through Phase II with the same determination and patient-centered approach" said Katell Bidet-Huang, Head of translational medicine at Transgene.
The preprint on medRxiv provides early access to these important clinical findings ahead of peer-reviewed journal publication.
Title: "Viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: immunogenicity and efficacy from a randomized Phase I trial"
(Press release, Transgene, JAN 9, 2026, View Source [SID1234661862])