On June 18, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the completion of initial patient screening in the randomized multicenter Phase II part of its Phase I/II clinical trial with TG4050, an individualized neoantigen therapeutic vaccine, as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166) (Press release, Transgene, JUN 18, 2025, View Source [SID1234653982]). TG4050, Transgene’s lead asset, is based on its proprietary myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection for individual patients.
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All patients treated with TG4050 in the Phase I part of the trial remained disease-free after a minimum of two years of follow-up, confirming clinical proof of principle. Translational data showed sustained T cell responses at 24 months in these patients. The results, which met all trial endpoints 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 (ASCO) (Free ASCO Whitepaper) (ASCO 2025) 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. First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026, and preliminary efficacy data are expected in H2 2027.
Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene added: "Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and at the same time explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible."
Dr. Alessandro Riva, CEO of Transgene commented: "The positive results from the Phase I part of our TG4050 trial support the strong potential of our myvac platform. The successful completion of the first screening of the randomized Phase II part in less than a year and ahead of schedule underscores the investigators’ commitment to rapidly advance the development of TG4050. In the ongoing Phase II part of the trial, we have been able to scale efficiently, strengthen our manufacturing capabilities and operate with the agility needed to lead in a highly competitive and fast-moving environment.
The myvac individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025."