Transgene announced in June 2024 that the first patient has been enrolled in the Phase II part of a randomised Phase I/II clinical trial of TG4050 in the adjuvant treatment of head and neck cancer. Patient screening and enrolment are underway, with hopes of enrolling 80 patients internationally to continue the trial after Phase I data showed immunogenicity and first signs of clinical benefit. TG4050 is based on Transgene’s myvac viral vector platform and NEC’s cutting-edge AI capabilities for the identification and prediction of the most immunogenic neoantigens for every patient.
“TG4050 is the only individualised neoantigen cancer vaccine currently being developed in a randomised trial in the adjuvant treatment of head and neck cancer.”
The vaccine shows promise
Transgene states that “promising” data from Phase I showed “strong immunogenicity” and a “persistent cellular immune response” as well as “signs for clinical benefit for patients”. At the time of analysis all patients who received TG4050 were disease-free. Therefore, Transgene and partner NEC are moving into an extension of the randomised trial.
The Phase II will continue investigating single-agent TG4050 in patients with newly diagnosed, locoregionally advanced, HPV-negative, squamous cell carcinoma of the head and neck (SCCHN) in the adjuvant setting following completion of surgery and chemoradiotherapy. The international, multicentre, open label, two-arm trial is screening patients in Toulouse and Paris, in France, with other sites to be added in Europe and the US in the coming months.
A significant medical need
Despite advancements in the treatment of SCCHN, Transgene identifies a “significant medical need” for patients, including in the adjuvant setting. With the current standard of care, 30% to 40% of patients are expected to relapse within 24 months after surgery and adjuvant therapy. Dr Maud Brandely, Chief Medical Officer of Transgene, described the inclusion of the first patient as a “further milestone” for the company.
“In the ongoing trial, TG4050 is targeting patients with head and neck cancer at high-risk of relapse, with the aim of extending disease-free survival. The Phase I data we have generated indicate that TG4050 enables the induction of specific cellular immune responses that persist up to 7 months post treatment initiation, with all treated patients remaining disease-free after a median follow-up of 18.6 months.”
Dr Brandely is “encouraged” by the “promising clinical outcomes” and looks forward to generating more data.
“Personalised cancer vaccines are an extremely exciting development and, if successful, could also be utilised to treat other forms of cancer to improve and extend the lives of patients.”
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