- Enrolment completed in Phase 2 part of head and neck cancer clinical trial (TG4050) – Topline data expected by the end of Q1 2028 as per plan
- Phase 1 data from TG4050 in head and neck cancer published on medRxiv
- License agreement signed with NEC Bio to advance clinical development of TG4050 in head and neck cancer
- Financial visibility until early 2028
Strasbourg, France, April 29, 2026, 5:45 p.m. CET – Transgene (PARIS:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today provides a business update on its myvac® platform, and its individualized neoantigen therapeutic vaccine (INTV) TG4050, and upcoming plans, including its financial position as of March 31, 2026.
TG4050, Transgene’s first INTV from its myvac® platform continues to progress according to plan in the adjuvant treatment of head and neck cancer
TG4050 is designed to stimulate a strong and individualized immune response aimed at preventing relapse in HPV-negative head and neck cancer (HNSCC1) patients following surgery and adjuvant (chemo)radiotherapy. It is currently under evaluation in a randomized multicenter Phase 1/2 clinical trial (NCT04183166).
As a monotherapy, TG4050 met all trial endpoints in the Phase 1 part of the trial and induced long-lasting immune responses to individualized vaccine neoantigens that were sustained for up to two years after treatment initiation. All patients treated were disease-free at 2 years, providing robust clinical proof of principle.
A comprehensive analysis of these positive clinical and translational data from the Phase 1 part of the randomized Phase 1/2 trial of TG4050 was published on the preprint platform medRxiv, in January 2026 (see press release). The data suggest that individualized treatment with TG4050 has the potential to prevent cancer relapses. The article is under review by a peer-reviewed journal. These data have also been presented orally at the World Vaccine Congress (WVC) (see press release).
- 3-year disease-free survival (DFS) follow-up of Phase 1 patients is expected in Q2/Q3 2026.
Transgene announced that the randomization of the Phase 2 part of the Phase 1/2 trial for adjuvant treatment of HNSCC has been completed (see press release).
- The primary endpoint of the trial is 2-year DFS. Transgene expects to communicate these top-line results by the end of Q1 2028.
Early April 2026, Transgene and NEC Bio signed a license agreement to advance the clinical development of TG4050 in head and neck cancer (see press release). Transgene secures access to NEC’s AI-based neoantigen prediction platform, as well as rights to enable TG4050’s further clinical development and to support commercialization and potential partnering of the program. Under this agreement, Transgene has paid a technology access fee of €2.5 million in Transgene shares as well as a first tranche of €0.5 million from a total payment of a total €2.5 million in cash that will be paid out in several instalments through early 2028. Additional development and milestone payments will be paid upon progress of the clinical development of TG4050 in head and neck cancer.
Expanding the value of the myvac® platform
Transgene’s INTV platform, myvac®, has the potential to generate INTVs that could be used to improve treatment across a range of solid tumors where in many cases a significant unmet medical need remains.
- In parallel with the ongoing Phase 1/2 trial in HNSCC, Transgene is progressing with start-up activities for a new Phase 1 trial in a second indication in an early treatment setting, with …