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 and BioInvent are presenting updated data on BT-001, an oncolytic virus, at the ESMO Annual Meeting in October 2025 [1][2] - BT-001 is being evaluated in a Phase I/IIa study for its efficacy in treating advanced solid tumors [4] Group 1: Study Details - The study is a multicenter, open-label, dose-escalation trial assessing BT-001 as a monotherapy and in combination with pembrolizumab [4] - The Phase I part of the study has shown that BT-001 is well tolerated and has demonstrated initial efficacy, with clinical responses observed in 2 out of 6 refractory patients [3][4] - The treatment has converted "cold" tumors into "hot" tumors, inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment [3] Group 2: Product Information - BT-001 is developed using Transgene's Invir.IO® platform and incorporates a Treg-depleting recombinant human anti-CTLA-4 antibody from BioInvent [3] - The collaboration between Transgene and BioInvent is a 50/50 partnership focused on the development of oncolytic viruses [3] Group 3: Company Background - Transgene specializes in designing and developing virus-based immunotherapies for cancer treatment, with a portfolio that includes multiple viral vector-based immunotherapeutics [6][8] - BioInvent focuses on discovering and developing novel immune-modulatory antibodies for cancer therapy, with several candidates in clinical programs [8]

Core Points - Transgene has appointed Emmanuelle Quilès as an independent Director to its Board of Directors, succeeding Philippe Archinard, who is retiring [1][3] - Emmanuelle Quilès brings over 25 years of experience in strategic leadership roles within the global pharmaceutical industry, previously serving as Worldwide Vice President at Janssen Global Commercial Strategy Organization [2][5] - The appointment is effective from July 9, 2025, and Quilès will serve the remainder of Archinard's term until the 2026 Annual Shareholders' Meeting [3] Company Overview - Transgene is a biotechnology company focused on designing and developing virus-based immunotherapies for cancer treatment, with a portfolio that includes TG4050, TG4001, BT-001, and TG6050 [8] - The company utilizes its myvac® platform for individualized therapeutic vaccines and the Invir.IO® platform for multifunctional oncolytic viruses [9][10] - Transgene's clinical-stage programs are aimed at providing targeted immunotherapies, with a focus on precision medicine [8][9]

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 is a biotechnology company focused on developing virus-based immunotherapies for cancer treatment, with a particular emphasis on individualized therapies [2][3] - The company announced upcoming meetings with institutional investors and leaders in the biotechnology ecosystem to discuss its clinical data and treatment landscape for head and neck cancers [1][6] Company Overview - Transgene's lead asset, TG4050, is the first individualized therapeutic vaccine based on the myvac® platform, showing proof of principle in patients for adjuvant treatment of head and neck cancers [2] - The company also has a portfolio that includes TG4001 for HPV-positive cancers and two oncolytic viruses, BT-001 and TG6050, based on the Invir.IO® viral backbone [2] Technological Innovations - The myvac® platform allows for the creation of personalized virus-based immunotherapies tailored to individual patient mutations, utilizing AI capabilities from partner NEC [3] - Transgene is leveraging its expertise in viral vector engineering to develop a new generation of multifunctional oncolytic viruses through its proprietary Invir.IO® platform [4] Upcoming Events - Transgene will participate in several key industry events, including the BIO International Convention on June 16, 2025, in Boston, and the International Neoantigen Summit on June 24, 2025, in Amsterdam [6]

Core Viewpoint - Transgene is set to present positive clinical data for its individualized neoantigen cancer vaccine, TG4050, at the 2025 ASCO Annual Meeting, highlighting advancements in cancer immunotherapy [1][2]. Company Overview - Transgene is a biotechnology company focused on developing virus-based immunotherapies for cancer treatment, with a clinical-stage portfolio that includes TG4050, TG4001, BT-001, and TG6050 [3]. - TG4050 is the first individualized therapeutic vaccine based on the myvac® platform, showing proof of principle in treating head and neck cancers [3]. - The company utilizes its proprietary Invir.IO® platform to engineer multifunctional oncolytic viruses, enhancing its viral vector capabilities [5]. Upcoming Event - A live webcast discussing the latest findings on TG4050 will occur on June 6, 2025, featuring Transgene's management and Prof. Christian Ottensmeier, focusing on the treatment landscape for early-stage HPV-negative head and neck cancer [2].

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]

Core Points - The Combined Ordinary and Extraordinary General Meeting of Transgene's shareholders took place on May 15, 2025, where various resolutions were voted on and approved [1][2] - The meeting resulted in the renewal of the terms of office for several Board Members, maintaining a diverse and independent Board composition [3][4] - A share capital reduction was approved, decreasing the par value of shares from €0.50 to €0.30, along with the delegation of authority for a potential reverse stock split [5] Company Overview - Transgene is a biotechnology company focused on developing targeted immunotherapies for cancer treatment, with a portfolio that includes viral vector-based immunotherapeutics [7] - The lead asset, TG4050, is an individualized therapeutic vaccine aimed at head and neck cancers, showcasing the company's innovative approach to precision medicine [8] - Transgene utilizes its proprietary Invir.IO® platform to engineer multifunctional oncolytic viruses, enhancing its capabilities in viral vector technology [9]