Transgene (TRGNF,TNG.PA), a biotechnology company developing virus-based immunotherapies for cancer, announced the preprint publication on medRxiv of comprehensive clinical and translational data from the Phase I part of its randomized Phase I/II trial of TG4050, an individualized neoantigen therapeutic vaccine (INTV). The manuscript is now available on medRxiv, providing early scientific visibility ahead of peer review, and has also been submitted to a peer-reviewed journal for evaluation.
TG4050 is designed as a personalized cancer vaccine and has shown promising results, with 100% two-year disease-free survival as monotherapy in the adjuvant treatment of operable head and neck cancers. This outcome is particularly significant given that nearly one-third of patients with head and neck squamous cell carcinoma (HNSCC) typically relapse within two years of surgery despite existing treatments, including immune checkpoint inhibitors. The trial was designed to evaluate whether TG4050, which encodes up to 30 predicted tumor neoantigens delivered via a Modified Ankara Virus (MVA) vector, could reduce relapse risk. In the study, half of the participants received TG4050 immediately after completing primary adjuvant treatment, while the other half were vaccinated at the time of disease recurrence alongside standard care.
The findings suggest that TG4050 has strong potential to prevent cancer relapse when administered as monotherapy in patients with high-risk, resected, locally advanced HPV-negative HNSCC. The vaccine was well tolerated, with no unexpected safety signals reported. Translational data further confirmed that TG4050 induced durable, neoantigen-specific T cell responses in most patients (73% of 15 evaluable cases). These responses were characterized by cytotoxic and effector phenotype markers that persisted up to one year after treatment.
An overview of these results was first presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data reinforce TG4050's ability to elicit polyepitopic, polyclonal, cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to relapse prevention. TG4050 is currently under further evaluation in the ongoing randomized Phase I/II clinical trial (NCT04183166) in patients with HNSCC.
Transgene shares on the Paris exchange were trading at EUR 0.9680, reflecting a gain of 0.0260 points or 2.76%.
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