Transgene has completed patient randomisation in the phase 2 part of its phase 1/2 clinical trial evaluating TG4050, an individualised neoantigen therapeutic vaccine being developed for the adjuvant treatment of head and neck cancer.
The study has now enrolled 38 patients in the phase 2 cohort, with top line two‑year disease‑free survival data expected by the end of the first quarter of 2028.
TG4050, created using Transgene’s myvac platform, is designed to generate a targeted immune response to help prevent relapse following surgery and adjuvant chemoradiotherapy. The company said the completion of randomisation marks a significant step forward for the programme.
Dr Alessandro Riva, Chairman and CEO of Transgene, explained: “Completing randomization in the phase 2 part of the study is an important milestone for TG4050 and for our myvac platform and confirms the expected readout timing of the primary endpoint of the phase 1/2 trial by the end of Q1 2028, while we plan to release first immunological data in H2 2026.
“We are grateful to the patients, investigators and site personnel who contribute to advancing this promising, individualised immunotherapy. We look forward to the upcoming analyses as we continue our efforts to provide an innovative individualised treatment option for patients diagnosed with operable squamous head and neck cancer.”
The randomised multicentre phase 1/2 trial is comparing TG4050 as a single agent with watchful waiting in patients with locoregionally advanced HPV‑negative head and neck cancer. The primary endpoint is two‑year disease‑free survival, which will be assessed once all phase 2 participants reach the required follow‑up period or experience an earlier event.
Phase 1 data have already shown that TG4050 was well tolerated and induced durable immune responses, with all treated patients disease‑free at two years. Further three‑year follow‑up from the phase 1 cohort is expected in mid‑2026.
