Clinical Trials

Date: 2017-09-19

Type of information: Treatment of the first patient

phase: 1b-2

Announcement: treatment of the first patient

Company: Transgene (France)

Product: TG4001 in combination with avelumab

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor/immunotherapy product. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth.
Pfizer and Merck KGaA are jointly developing avelumab (MSB0010718C), an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple types of cancer.
TG4001 is a therapeutic vaccine based on a non-propagative, highly attenuated vaccinia vector (MVA) which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). It has been designed to have a two-pronged antiviral approach: to alert the immune system specifically to HPV16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through interleukin-2.
The combination of TG4001 and avelumab aims to target two distinct steps in the immune response to target cancer cells.

Disease: human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy

Therapeutic area: Cancer - Oncology

Country: France

Trial details:

This multi-center, open-label trial will assess the safety and tolerability, as well as the anti-tumor activity and efficacy of this immunotherapy combination regimen in up to 50 patients (NCT03260023).

Latest news:

• On September 19, 2017, Transgene announced that the first patient has been treated at the Curie Institute, Paris, France, in a Phase 1b/2 clinical trial evaluating the combination of TG4001 with avelumab as a treatment for human papillomavirus type 16 positive (HPV-16+) recurrent or metastatic cancers, such as oropharyngeal squamous cell carcinoma of the head and neck (SCCHN). This subtype of cancer represents more than 80% of oropharynx cancers.
Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at the Curie Institute, and a world expert in head and neck cancers, is the Principal Investigator of the study.