Transgene: 16 patients treated with TG4050 in phase 1 without relapse at three years, according to the company
Transgene and NEC have published three-year follow-up data from phase 1 of a trial evaluating TG4050, the first individualized neoantigen therapeutic vaccine from the Myvac platform, in head and neck cancer.
These results, published in the journal Nature Communications, focus on patients at high risk of relapse after surgery and (chemo)-radiotherapy, and bring together for the first time the complete clinical and translational data from phase 1.
16 treated patients remain relapse-free at 41 months median follow-up
Three-year follow-up data show that the 16 patients treated with TG4050 in the phase 1 part of the randomized phase 1/2 trial remained relapse-free (100% disease-free survival), after a median follow-up of 41 months.
In the control arm, 3 patients out of 16 experienced a relapse over the same period. The trial involves patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma.
TG4050, which encodes up to 30 neoantigen specificities for each patient, continues to demonstrate a favorable tolerability profile, with no unexpected safety signals.
Immune responses detected in 73.3% of treated patients
The publication in Nature Communications details the clinical and translational data from phase 1. Neoantigen-specific CD8+ T lymphocyte responses were observed, with a response detected in 73.3% of patients treated with TG4050.
The median number of neoantigen-generating responses was three per responder. According to the press release, these responses were maintained during treatment and persisted more than one year after the last vaccination.
TG4050 combines Transgene's Myvac platform and NEC's artificial intelligence-based neoantigen prediction system, which is responsible for identifying tumor targets.
First phase 2 data expected in second half of 2026
TG4050 continues its evaluation in the randomized phase 1/2 trial (NCT04183166) in patients with resected head and neck cancer.
According to the disclosed timeline, the first immunological data from the phase 2 part are expected in the second half of 2026, and efficacy data at two years (disease-free survival) by the first quarter of 2028 at the latest.
For the 2025 financial year, published on March 15, 2026, Transgene's accounts showed a net loss of €37.5 million.
