Transgene SA is to collaborate with the European Organization for Research and Treatment of Cancer (EORTC) for the conduct of a randomized phase 2b study of TG4001 in patients with HPV16 positive Oropharyngeal Squamous Cell Carcinomas (OSCCs).
The study will be a multinational, placebo controlled, randomized, phase 2b trial led by the EORTC in which TG4001 will be administered in combination with chemo-radiotherapy in patients with HPV16 positive OSCCs whose tumor is locally advanced (non-metastatic). The main objective of the study will be to show a reduction in the relapse rate in patients receiving TG4001 in addition to this standard of care. Approximately 200 patients should be enrolled.