Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announced the completion of patient randomization in the Phase 2 part of the Phase 1/2 clinical trial evaluating TG4050, an individualized neoantigen therapeutic vaccine (INTV) developed from Transgene’s myvac® platform.

38 patients have been randomized in the Phase 2 part of the Phase 1/2 trial for adjuvant treatment of head and neck cancer (HNSCC[1]). With the primary endpoint of the trial being 2-year disease-free survival (DFS), Transgene is advancing the study and expects to communicate top line results by the end of Q1 2028.

TG4050 is designed to stimulate a strong and individualized immune response aimed at preventing relapse in patients following surgery and adjuvant (chemo)radiotherapy.

Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented: “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, individualized immunotherapy. We look forward to the upcoming analyses as we continue our efforts to provide an innovative individualized treatment option for patients diagnosed with operable squamous head and neck cancer.”

The primary objective of the randomized multicenter Phase 1/2 trial (NCT04183166) is to compare the efficacy of TG4050 as a single agent versus watchful waiting in the adjuvant treatment of locoregionally advanced HPV-negative head and neck cancer (HNSCC).

The primary endpoint of the trial is 2-year disease-free survival (DFS) and is expected to read out as soon as all patients from the Phase 2 part achieve 2-year follow-up from randomization unless an event (relapse, death) occurs earlier, with results anticipated by the end of Q1 2028.

Data from patients in the Phase 1 part of the trial have already shown that multiple subcutaneous injections of TG4050 were well-tolerated with no unexpected safety signals.

3-year DFS follow-up of Phase 1 patients is expected in Q2/Q3 2026.

TG4050, as a monotherapy, met all trial endpoints in the Phase 1 part of the trial and induced long-lasting immune responses to vaccine neoantigens that were sustained for up to two years after treatment initiation. All patients treated with TG4050 were disease-free at 2-years (median follow-up: 30 months), confirming robust clinical proof of principle.

The positive clinical and translational data[2] suggest that individualized treatment with TG4050 has the potential to prevent cancer relapses when administered as monotherapy in an adjuvant treatment regimen in patients with high risk, resected, locally advanced HPV-negative HNSCC.

[1] Head and neck squamous cell carcinoma – HNSCC

[2] A comprehensive analysis of the clinical and translational data from the Phase 1 part of the randomized Phase 1/2 trial of INTV-TG4050 was published on the preprint platform medRxiv[2], in January 2026 (see press release). The article is under review by a peer-reviewed journal.