In January 2024 Transgene and NEC announced that they are planning to start an extension of a Phase I trial into a Phase I/II study to “further demonstrate the potential” of TG4050 as an adjuvant treatment of head and neck cancers. TG4050 is being evaluated in a randomised multicentre Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. With “promising data” under their belts, the two companies are preparing to extend the trial, building on “compelling first signs of efficacy and induction of specific T-cell responses”.
TG4050 and myvac
Transgene states that the approach is based on the Modified Vaccinia Ankara (MVA) viral vector, previously validated in clinical trials.
“myvac is designed to stimulate and educate the patient’s immune system to recognise and destroy tumours using their own cancer specific genetic mutations.”
Through artificial intelligence algorithms, neoantigens are sequenced and selected before integration into the genome of the viral vector. When administered, myvac “triggers a cascade of immune responses against a variety of targets”. The first product candidate from myvac is TG4050, codeveloped with NEC.
Alessandro Riva, Chair and CEO of Transgene, believes that TG4050, which combines a “powerful and immunogenic viral vector with an extremely sophisticated neoantigen selection tool”, can “address major medical needs”.
“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.”
Masamitsu Kitase, Corporate SVP, Head of Healthcare and Life Sciences Division at NEC, commented on the “trusted” partnership.
“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.”
The “state-of-the-art” artificial intelligence/machine learning models” are useful in predicting “clinically meaningful neoantigens”, affecting patient outcomes. NEC is “committed” to “meaningful advances” in this arena.
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