Transgene announced promising preliminary Phase I data on TG4050, its individualized neoantigen cancer vaccine, at the AACR Annual Meeting 2022. Powered by NEC's cutting-edge AI capabilities, TG4050 is being evaluated in two ongoing multicenter Phase I trials in patients with ovarian cancer and head and neck cancer.TG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancer and HPV-negative head and neck cancers. In a first Phase I trial, TG4050 is being administered to patients with HPV-negative head and neck cancer.

A personalized treatment is created for each patient after they complete surgery and while receive an adjuvant therapy. Half of the participants receive their vaccine immediately after they complete their adjuvant treatment. The other half is given TG4050 as an additional treatment at the time of recurrence of the disease.

This randomized study is evaluating the treatment benefits of TG4050 in patients who have a high risk of relapse. Up to 30 patients will receive TG4050 in France, in the UK and in the USA. The principal investigator of the trial is Prof. Christian Ottensmeier, MD, PhD, Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool.

In France, the clinical trial is being conducted, at Institut Curie, Paris, by Prof. Christophe Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i) and at the IUCT Oncopole, Toulouse, by Prof. Jean-Pierre Delord. In the USA, the trial is being led by Dr. Yujie Zhao, MD, PhD, at the Mayo Clinic. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.

In parallel, a Phase I clinical trial of TG4050 is enrolling patients with ovarian cancer. The first patient has been dosed in the USA. This second trial is including patients after surgery and first-line chemotherapy.

Dr. Matthew Block, MD, PhD, Consultant Medical Oncology, Consultant Immunology and Associate Professor of Oncology at the Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is being conducted by Prof. Le Tourneau, MD, PhD, at Institut Curie and by Dr. Alexandra Martinez, MD, Associate Head of Surgical Department, at IUCT-Oncopole. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.