AI-based Immunotherapy for Ovarian, Head and Neck Cancers Evaluated in Two Phase I Trials

NEW YORK – Transgene and NEC Corporation announced Monday that they have advanced Transgene's immunotherapy vaccine TG4050 into two Phase I trials for patients with human papillomavirus-negative, squamous cell head and neck cancer who are at high risk of relapse after surgery, and ovarian cancer patients who have received first-line therapy after surgery. 

The ovarian cancer trial is open to patients in the US at the Mayo Clinic and at the Institut Curie in France. The head and neck cancer trial is open to patients at Southampton University in the UK and at the Institut Curie in France. 

TG4050 is a virus-based immunotherapy that's designed to target up to 30 patient-specific cancer cell mutations, or neoantigens. Technology company NEC developed a Neoantigen Prediction System that uses AI to select the most responsive sequences. Transgene, a biotech company, then integrates the selected neoantigen sequences into a viral vector based off the Modified Vaccinia virus Ankara. 

The ovarian cancer trial will be a single-arm study of TG4050. The head and neck cancer trial will be a randomized, two-arm study where patients will either receive TG4050 alone or in combination with standard of care. Both trials will evaluate safety, feasibility, and activity of the vaccine.

California-based company Gritstone Oncology is developing a similar technology. Its AI-based immunotherapy saw positive safety results from a Phase I study.