On September 2, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported sustained 100% three-year disease-free survival (DFS) in patients treated with TG4050 in the Phase 1 part of a randomized Phase 1/2 trial evaluating TG4050, the first individualized neoantigen therapeutic vaccine (INTV) based on the myvac platform, in patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC).
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The companies also announced the publication of the Phase 1 comprehensive clinical and translational data from the study, for the first time in the peer-reviewed journal Nature Communications.
Three-year follow-up data from the Phase 1 trial continue to demonstrate durable clinical outcomes in the adjuvant setting, with all 16 TG4050-treated patients remaining disease-free while three of 16 patients in the control arm experienced relapse after a median follow-up of 41 months. TG4050, encoding up to 30 patient-specific neoantigens, also continues to demonstrate a favorable safety profile with no unexpected safety findings.
The peer-reviewed publication builds on the Phase 1 results first shared with the scientific community through a prepublication on medRxiv and presents comprehensive clinical and translational findings based on the study’s primary data cut-off, including detailed analyses of vaccine-induced immune responses. Together, the clinical and translational findings provide further evidence supporting TG4050 as a potential individualized immunotherapy for patients with head and neck cancer at high risk of relapse following surgery and (chemo)-radiotherapy.
"The publication of these data in Nature Communications, together with the sustained three-year disease-free survival observed with TG4050 monotherapy, represents an important milestone for Transgene," commented Alessandro Riva, MD, Chairman and Chief Executive Officer of Transgene. "Beyond the encouraging clinical outcomes, the sustained neoantigen-specific immune responses observed over time provide important evidence that our individualized therapeutic vaccine approach can generate durable anti-tumor immunity, strengthening our confidence in TG4050 as a potential new treatment option for head and neck cancer patients at high risk of relapse."
"The latest three-year follow-up data further reinforce the ability of individualized neoantigenbased immunotherapy and the capacity of TG4050 to deliver continued clinical benefit for patients with head and neck cancer," said Masaki Kondo, Corporate Executive and Managing Director, Life Science Division of NEC Corporation. "These results additionally demonstrate that NEC’s AI-powered neoantigen prediction can identify highly relevant tumor targets capable of generating clinically meaningful immune responses. We are proud of our collaboration with Transgene and remain committed to advancing innovative technologies that help bring individualized cancer treatments to patients."
The Phase 1 clinical and translational data published in Nature Communications demonstrate robust and persistent neoantigen-specific CD8+ T-cell responses consistent with the proposed vaccine’s mechanism of action. Vaccine-induced responses were detected in 73.3% of patients treated with TG4050, with a median of three responding neoantigens per responder. These responses were maintained throughout treatment and persisted for more than one year after the last vaccination, providing evidence of durable anti-tumor immunity.
"Robust and persistent CD8+ T-cell responses against patient-specific tumor neoantigens were observed following TG4050 vaccination, supporting the vaccine’s ability to generate a targeted anti-tumor immune response. These results further reinforce the potential of TG4050 as an individualized immunotherapy for patients with head and neck cancer at risk of recurrence for whom there is a major unmet need," added Prof. Christian Ottensmeier, MD, PhD, FRCP, University of Liverpool, La Jolla Institute for Immunology and Principal Investigator.
TG4050 continues to be evaluated in the ongoing randomized Phase 1/2 clinical trial (NCT04183166) in patients with resected HNSCC. Key upcoming milestones include first immunological data and two-year efficacy data (DFS) from the Phase 2 study respectively in H2 2026 and Q1 2028.
(Press release, Transgene, SEP 2, 2026, View Source [SID1234670538])