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Transgene and NEC Corporation have announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualised neoantigen cancer vaccine TG4050.
TG4050 is currently being evaluated in a randomised multicentre Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. Based on promising data obtained in this Phase I trial, Transgene and NEC are preparing a randomised 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(R) 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 with our individualised 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 tumours."
Masamitsu Kitase, Corporate SVP, Head of Healthcare and Life Sciences Division, NEC Corporation, commented: "Transgene has been our trusted partner in developing our joint neoantigen asset TG4050. I am excited that the positive results from the Phase I study have encouraged us to further collaborate on this very promising asset for treating head and neck cancers. We are happy that our state-of-the-art artificial intelligence (AI)/ machine learning (ML) models help in predicting clinically meaningful neoantigens which impact patient outcomes. NEC's Healthcare and Life Sciences Division is committed to bringing novel AI-based treatments to patients across the globe and achieving meaningful advances in the pharmaceutical industry."