Transgene - First Patient Enrolled in Phase II Part of Randomized Phase I/II Trial Evaluating Lead Cancer Vaccine TG4050 in Head and Neck Cancer

Patient screening and enrollment initiated for the Phase II part of the international randomized Phase I/II trial with an overall sample size of approximately 80 patients

Last patient enrollment for Phase II part expected in Q4 2025

Strasbourg, France, June 3, 2024, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer today announces that the first patient has been enrolled in the Phase II part of the randomized Phase I/II clinical trial of the individualized therapeutic cancer vaccine, TG4050, in the adjuvant treatment of head and neck cancer. Patient screening and enrollment are active, with the aim of enrolling 80 patients internationally in the overall Phase I/II trial.

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 each patient. The therapeutic vaccine, TG4050, is being jointly developed by Transgene and NEC in head and neck cancer.

TG4050 advancing to Phase II part based on Phase I data showing immunogenicity and first signs of clinical benefit

The promising TG4050 Phase I data presented at AACR 2024 (see press release distributed on April 9, 2024, here) showed strong immunogenicity, persistent cellular immune response as well as signs of clinical benefit for patients. At the time of the analysis, only patients in the control arm had relapsed, while all patients who received TG4050 were disease-free. Based on these promising data, Transgene and its partner NEC have decided to move forward with an extension of the randomized trial consisting of a Phase II part. This Phase II part 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.

Although some advancements in the treatment of SCCHN have been made, there remains a significant medical need for these patients, including in the adjuvant setting. With the current standard of care, 30% to 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Despite completed Phase III trials, immune checkpoint inhibitors have yet to demonstrate significant benefits for these patients.

TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene commented, “The inclusion of the first patient in the Phase II part of our Phase I/II trial marks a further milestone for Transgene. 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. We are encouraged by these promising clinical outcomes and look forward to generating data from the Phase II part of the trial. Personalized cancer vaccines are an extremely exciting development and, if successful, could also be utilized to treat other forms of cancer to improve and extend the lives of patients.”

This international, multicenter, open label, two-arm trial is currently screening patients in France at IUCT-Oncopole (Toulouse) and Institut Curie (Paris). Additional sites in France, Europe and the US will be added in the coming months. Overall, the Phase I/II trial will randomize approximately 80 patients. The inclusion of the last patient in the Phase II part of the study is expected in Q4 2025.

TG4050 is designed based on each patient’s tumor

TG4050 is an individualized immunotherapy derived from Transgene’s myvac® platform, combining Transgene’s biotechnology known-how and expertise with NEC’s artificial intelligence (AI) capabilities. Cancer vaccines of this type are individually designed to stimulate and educate the patient’s immune system to fight against their own cancer. This viral-based immunotherapy integrates about thirty tumor neoantigen, identified and selected from tumor sequencing to generate the most effective immune response.