TNG Transgene SA

Transgene to Present New Immunological Data from Phase I Trial of Individualized Therapeutic Cancer Vaccine, TG4050, at SITC 2025

Transgene to Present New Immunological Data from Phase I Trial of Individualized Therapeutic Cancer Vaccine, TG4050, at SITC 2025

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 Harbor, Maryland, USA.

Poster details

Title: “Profiling of the neoantigen-specific T cell response after adjuvant TG4050 individualized therapeutic vaccination in a randomized Phase 1 trial for locally advanced resected HPV negative HNSCC”.

  • Poster and abstract number: 502
  • Date: November 8, 2025
  • Author: C. Le Tourneau

The abstract will be available on the SITC website on November 4, 2025, at 9 a.m. ET.

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. TG4050 is being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers ().

Transgene previously presented in a rapid oral presentation at the ASCO conference in June 2025, that all patients from Phase I who received TG4050 remained disease-free after a minimum of 2-year follow-up, comparing favorably to the observational arm which saw 3 out of 16 patients relapse during the same time period.

Transgene and NEC are continuing the joint development of TG4050 in this indication with a Phase II extension of the trial, which is currently enrolling patients.

***

About Transgene

Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company’s clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the myvac® platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The Company has other viral vector-based assets, including BT-001, an oncolytic virus based on the Invir.IO® viral backbone, which is in clinical development. The Company also conducts innovative discovery and preclinical work, aimed at developing novel immunotherapies.

With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.

Additional information about Transgene is available at:

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Contacts

Transgene: 
Media:Investors & Analysts:
Caroline ToschLucie Larguier
Corporate and Scientific Communications ManagerChief Financial Officer (CFO)
+33 (0)3 68 33 27 38Nadege Bartoli
Investor Relations Analyst

and Financial Communications Officer
MEDiSTRAVA+33 (0)3 88 27 91 00/03
Frazer Hall/Sylvie Berrebi
+ 44 (0)203 928 6900 
 



Disclaimer Transgene

This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document, available on the AMF website (-france.org) or on Transgene’s website (). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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03/10/2025

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