Transgene has completed the initial subject screening for the Phase II segment of its Phase I/II trial of individualised neoantigen therapeutic vaccine, TG4050, as a monotherapy in the adjuvant treatment of human papillomavirus (HPV)-negative squamous head and neck cancers.
The vaccine is based on the myvac platform powered by its partner NEC’s AI to enhance antigen selection.
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During the Phase I portion of the trial, all subjects treated with the vaccine remained disease-free post a minimum follow-up of two years, demonstrating clinical proof of principle.
Translational data indicated that these subjects showed sustained T cell responses at 24 months.
Meeting all trial endpoints, the findings were shared at the American Society of Clinical Oncology (ASCO 2025) annual meeting.
The company anticipates completing the randomisation of all subjects in the Phase II part by the end of this year, after a second screening carried out post-surgery and adjuvant radiotherapy.
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By GlobalDataAround 80 subjects who have completely responded to adjuvant therapy are expected to be enrolled and randomised in the Phase I/II trial.
The first immunogenicity data from the Phase II part are projected to be available in the second half of 2026, with preliminary efficacy data anticipated in the second half of 2027.
The trial is assessing the treatment benefits of the vaccine in individuals at risk of relapse.
So far, 32 evaluable patients have been included in the Phase I part, with the Phase II continuing globally.
Transgene chief medical officer Dr Emmanuelle Dochy said: “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.”
