Transgene reports 100% DFS at 41 months for TG4050 HNSCC vaccine
Transgene has published Phase 1 data from its individualisedcancer vaccine TG4050 in Nature Communications, reporting sustained 100% disease-free survival (DFS) in treated patients after a median follow-up of 41 months. Three of 16 patients in the control arm relapsed over the same period. The Strasbourg-based biotech said patient randomisation for the Phase 2 part of the same Phase 1/2 trial was completed in April 2026, with topline results expected by the end of Q1 2028.
TG4050 is the lead asset from Transgene's myvac platform, which encodes patient-specific neoantigens into a Modified Vaccinia Ankara (MVA) viral vector. The vaccine targets patients with resected locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC), with two-year DFS as the Phase 2 primary endpoint. Approximately 35% of patients in this population still relapse within two years despite current standard-of-care, including the emerging use of immune checkpoint inhibitors in the perioperative setting.
Second INTV and platform expansion
Transgene has also initiated a randomised Phase 1 trial for TG4070, its second individualised neoantigen therapeutic vaccine (INTV), in resected non-small cell lung cancer. TG4070 is being evaluated in combination with nivolumab, the anti-PD-1 checkpoint inhibitor, in patients who have received neoadjuvant nivolumab plus chemotherapy. Principal investigator is Prof. Nicolas Girard of Institut Curie in Paris.
TG4070 is the first myvac candidate to incorporate SNIPER, Transgene's in-house AI-driven bioinformatics tool for neoantigen selection, alongside a scalable cell-line manufacturing process the company says enables more efficient and automated production. Transgene is also transitioning TG4050 to cell-line manufacturing as it prepares for a potential pivotal trial. In April 2026, the company signed a licence agreement with NEC Bio B.V. granting access to NEC's AI-based neoantigen prediction platform to support that effort, with a technology access fee structured partly in Transgene shares and partly in cash instalments through early 2028.
Market context and competitive landscape
The individualised cancer vaccine space has grown sharply in profile following Moderna and Merck's positive data for mRNA-4157 in combination with pembrolizumab, particularly in melanoma and NSCLC. Transgene's MVA-based approach differs in vector modality and manufacturing architecture, and the company is positioning cell-line production as a scalability advantage over lipid nanoparticle-delivered mRNA vaccines. Whether that distinction translates into a commercial differentiator will depend substantially on the Phase 2 readout in 2028.
Transgene also reported positive preclinical data for TG-MVA, a next-generation prophylactic vaccine against mpox and smallpox, presented at the World Congress on Infectious Diseases in June 2026. The programme leverages existing MVA cell-line infrastructure and is framed around biosecurity and pandemic preparedness, bringing it into a market that has attracted government procurement interest since the 2022 mpox outbreak.
On the leadership front, Anne Stehlin has joined as Chief Quality Officer, bringing experience from Lonza and Basilea Pharmaceutica, while Katell Bidet Huang has been appointed Interim Chief Scientific Officer following the departure of Maurizio Ceppi.
Financially, Transgene held €92.8 million in cash and equivalents as of 30 June 2026, against a cash burn of €20.3 million in the first half. The company said it has sufficient funds to support operations until early 2028, aligning its runway with the anticipated Phase 2 topline readout. First immunological data from the TG4050 Phase 2 cohort are expected in the second half of 2026, with a scientific conference presentation targeted for the first half of 2027.