Transgene (Euronext Paris: TNG) announced the completion of initial patient screening in the Phase 2 portion of its ongoing Phase 1/2 clinical trial of TG4050—an individualized neoantigen therapeutic vaccine—administered as a single agent in the adjuvant treatment of HPV-negative squamous carcinoma of the head and neck.
TG4050 is based on the company’s proprietary myvac platform. All patients treated with TG4050 in the Phase 1 part of the trial remained disease-free after a minimum of two years of follow-up, establishing clinical proof of principle. Transgene expects to complete randomization of all patients in the Phase 2 portion by the end of 2025, following a second round of screening of patients conducted post-surgery and after adjuvant (chemo) radiotherapy. Initial immunogenicity data from Phase 2 are expected in Q2 2026, with preliminary efficacy results anticipated in Q2 2027.
Dr. Emmanuelle Dochy, MD, CMO of Transgene, commented, “Timely completion of first patient screening of the Phase 2 part of our Phase 1/2 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, added, “The positive results from the Phase 1 part of our TG4050 trial support the strong potential of our myvac platform. The successful completion of the first screening of the randomized Phase 2 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 2 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 1 trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025.”
