Economia
Transgene Completes Initial Patient Screening in Phase II Part of TG4050 Trial in Operable Head and Neck Cancer
Phase I part showed 100% Disease-Free Survival (DFS) after a minimum of 2-year follow-up – providing clinical proof of principle for TG4050
Randomization of all patients expected to be completed by end 2025
First immunogenicity data of Phase II part expected in H2 2026
Preliminary efficacy data expected in H2 2027
Strasbourg, France, June 19, 2025, 8:00 a.m. CET – today announced the , as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166 ) . TG4050, Transgene’s lead asset, is based on its proprietary ® platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection for individual patients.
Translational data showed sustained T cell responses at 24 months in these patients. The results, which met including safety, feasibility, immune activation and disease-free survival (DFS, defined as survival without recurrence or death for any cause), were presented in an oral presentation at the recent American Society of Clinical Oncology ( ) annual meeting.
Transgene expects to complete randomization of all patients in the Phase II part by the end of 2025, following a second screening of patients conducted after surgery and adjuvant (chemo)radiotherapy. These screenings represent key steps during which patients are evaluated to determine whether they meet the eligibility criteria to participate in the clinical trial. In total, approximately 80 patients with a complete response to adjuvant therapy are anticipated to be enrolled and subsequently randomized in the Phase I/II trial.
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myvac®
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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 platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The portfolio also includes other viral-vector-based immunotherapies: TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO® viral backbone. The Company also conducts innovative discovery and preclinical work, aimed at developing novel viral vector-based modalities.
With Transgene’s platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The
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.
With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.
Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene
is a viral vector (MVA – Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors.
c®-derived products are designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded “Investment for the Future” funding from Bpifrance for the development of its platform
TG4050 is the first ®-derived product being evaluated in clinical trials. Click here to watch a short video on
®.
TG4050 is a clinical stage individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.
TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient. Positive data have been generated in the adjuvant setting of head and neck cancer (NCT04183166). A Phase II part is ongoing, Transgene is preparing an additional trial in a second indication, with aim to initiate the trial in Q4 2025.
TG4050 is being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. In the Phase I part, thirty-two evaluable patients have been included. The Phase II part is ongoing internationally. Overall approximately 80 patients will be randomized in the trial.
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