Strasbourg, France, October 3, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, will present a poster highlighting in-depth analysis of the neoantigen-specific T cell response from the randomized Phase I trial of its individualized therapeutic cancer vaccine, TG4050, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). SITC will take place November 5 to 9, 2025, in National Har ...

2025 Half-Year Results and Business Update Positive Phase I data with TG4050 in operable Head and Neck Squamous Cell Carcinoma (HNSCC) 100% disease-free survival after 2 years of follow-up — data presented in a rapid oral presentation at ASCO (June 2025) Transgene to report additional immunological data at a scientific conference in Q4 2025 Ongoing Phase II part with TG4050 in operable HNSCC Patient screening completed, completion of randomization expected in Q4 2025First immunogenicity data expected in H2 ...

Core Insights - Transgene's TG4050 has demonstrated 100% Disease-Free Survival (DFS) after a minimum of two years in the Phase I part of the clinical trial, confirming its clinical proof of principle [1][2] - The company is progressing with the Phase II part of the trial, expecting to complete patient randomization by the end of 2025, with initial immunogenicity data anticipated in H2 2026 and preliminary efficacy data in H2 2027 [3][4] Company Overview - Transgene is a biotechnology company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset based on the myvac® platform [7][10] - The myvac® platform utilizes artificial intelligence from NEC to optimize antigen selection for individualized cancer treatment [8][10] Clinical Trial Details - The Phase I/II clinical trial for TG4050 targets HPV-negative squamous head and neck cancers, with approximately 80 patients expected to be enrolled and randomized [3][12] - The trial evaluates the efficacy of TG4050 as an adjuvant treatment following surgery and adjuvant therapy, with a focus on patients at risk of relapse [12] Future Developments - Transgene is preparing for a new Phase I trial in a second, undisclosed indication, aiming to initiate it in Q4 2025 [5][11] - The company is committed to advancing the development of TG4050 and enhancing its manufacturing capabilities to meet the demands of a competitive market [4][11]

Core Insights - Transgene will present two-year disease-free survival data from the Phase I part of the TG4050 trial at ASCO 2025 [1][3] - TG4050 is an individualized neoantigen therapeutic cancer vaccine developed using Transgene's myvac® platform and NEC's AI capabilities [2][10] - The Phase I/II trial is focused on HPV-negative head and neck cancers, with the Phase II part currently enrolling patients internationally [3][12] Company Overview - Transgene is a biotechnology company specializing in virus-based immunotherapies for cancer treatment [5][7] - The company’s lead asset, TG4050, is the first individualized therapeutic vaccine based on the myvac® platform [5][10] - Transgene is also developing other viral vector-based immunotherapies, including TG4001 for HPV-positive cancers [7] Clinical Trial Details - The Phase I/II trial evaluates TG4050 as a single agent in the adjuvant treatment of HPV-negative head and neck cancers [3][12] - The trial includes a randomized study design with 32 evaluable patients in the Phase I part [12] - The Phase II extension is currently enrolling patients, indicating ongoing development and potential for future data [3][12] Presentation and Recognition - The rapid oral presentation at ASCO will take place on June 1, 2025, highlighting the clinical data and collaborative efforts in the trial [1][3] - Transgene's findings on TG4050 were selected for presentation among numerous high-quality submissions, reflecting the significance of their work [3]