Transgene and NEC Extend their Collaboration to Continue Joint Clinical Development of Neoantigen Cancer Vaccine TG4050

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Transgene and NEC plan to start an extension of the randomized Phase I trial into a randomized Phase I/II study in 2024 to further demonstrate the potential of TG4050 as an adjuvant treatment of head and neck cancers

Strasbourg, France & Tokyo, Japan, January 8, 2024, 5:45 p.m. CET/January 9,^, 2024, 09:00 a.m. JST – 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, have announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualized neoantigen cancer vaccine TG4050.

TG4050 is currently being evaluated in a randomized multicenter Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. Based on promising data obtained in the Phase I^[*] trial (NCT04183166), Transgene and NEC are preparing a randomized Phase I/II extension of this trial slated to start in 2024. This new trial builds on compelling first signs of efficacy and induction of specific T-cell responses with the aim of generating a comprehensive set of immunological and clinical data to further demonstrate the potential of TG4050.

Transgene and NEC expect to present additional immunological and clinical data from the Phase I trial at a scientific conference in the first half of 2024.

TG4050 is based on Transgene’s viral vector based myvac platform and powered by NEC’s cutting-edge AI capabilities for the identification and prediction of the most immunogenic neoantigens.

Alessandro Riva, Chairman and CEO of Transgene, commented: “We are pleased to announce the extension of our agreement with NEC, which marks a significant milestone in our collaboration. We are looking forward to continuing to treat patients in our clinical studies with our individualized cancer vaccine TG4050. The compelling initial Phase I data presented with NEC at ASCO 2023 showed that all evaluable patients treated with TG4050 monotherapy developed a specific immune response and remained disease-free.
Our joint clinical development plan builds on these promising data in a setting where there is no approved treatment to prevent patient relapse after adjuvant chemoradiotherapy. We believe that TG4050, by combining a powerful and immunogenic viral vector with an extremely sophisticated neoantigen selection tool, has the potential to address major medical needs in the adjuvant treatment of solid tumors.”