Transgene Publishes Phase I Data Supporting TG4050’s Potential in Preventing Head and Neck Cancer Relapse

Core Insights - TG4050 demonstrates strong potential as an individualized cancer immunotherapy, showing 100% two-year disease-free survival in patients with operable head and neck cancers [3][5][8] Clinical Trial Results - The Phase I/II trial of TG4050 involved patients with HPV-negative head and neck squamous cell carcinoma (HNSCC), where one-third of patients typically experience recurrence within two years post-surgery [3] - Half of the participants received TG4050 immediately after primary adjuvant treatment, while the other half received it at the time of disease recurrence [4][16] - The trial results indicate that TG4050 can prevent cancer relapses when used as monotherapy in high-risk, resected, locally advanced HPV-negative HNSCC patients [5] Immunogenicity and T-cell Responses - TG4050 induced neoantigen-specific T-cell responses in 73% of evaluable patients, with these responses being durable for up to one year post-treatment [6][7] - The vaccine was well-tolerated, showing no unexpected safety signals, reinforcing its potential for further development [5][8] Publication and Transparency - The results of the Phase I trial have been published on medRxiv, emphasizing the company's commitment to transparency and scientific rigor [2][8] - The findings are currently under evaluation for publication in a peer-reviewed journal [2] Future Developments - TG4050 is undergoing further evaluation in a randomized Phase I/II clinical trial (NCT04183166), with first immunogenicity data from the Phase II part expected in the second half of 2026 [7][16]