Core Insights - Transgene reported positive Phase I data for TG4050, showing 100% disease-free survival after a median follow-up of 30 months in operable head and neck squamous cell carcinoma (HNSCC) patients [3][4][8] - The company is progressing into Phase II trials for TG4050, with initial patient screening completed and randomization expected by the end of 2025 [6][7] - Transgene's financial position is stable, with funding secured until the end of December 2026, allowing for continued development of its lead asset [22][23] Financial Performance - Operating income for the first half of 2025 was €4.6 million, an increase from €3.4 million in the same period of 2024 [20] - Research and development expenses rose to €17.9 million from €15.4 million year-over-year, while general and administrative expenses decreased to €3.8 million from €4.6 million [20] - As of June 30, 2025, Transgene had €16.8 million in cash, slightly up from €16.7 million at the end of 2024, with a cash burn of €18.8 million in the first half of 2025 [21] Clinical Development - TG4050 is the first candidate from Transgene's myvac® platform, which aims to provide individualized therapeutic cancer vaccines [4][26] - The company is preparing to initiate a new Phase I trial for a second indication, expanding the myvac® platform's potential [9] - Additional immunological data from the Phase I study will be presented in Q4 2025, with first immunogenicity data from the Phase II trial expected in H2 2026 [5][8] Governance and Leadership - Simone Steiner joined Transgene as Chief Technical Officer in April 2025, bringing expertise in CAR-T cell therapies to enhance the manufacturing of myvac®-based immunotherapies [16] - Emmanuelle Quilès was appointed as an independent Board member in July 2025, contributing 25 years of experience in the pharmaceutical industry [17] Other Assets and Collaborations - Transgene is also developing BT-001, an oncolytic virus, with updated data to be presented at ESMO 2025 [10][11] - The company is evaluating TG4001 for HPV-positive cancers and TG6050 for advanced non-small cell lung cancer, with ongoing assessments of their clinical development paths [13][14][15]

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 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 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]