Agreements

Date: 2016-10-11

Type of information: Clinical research agreement

Compound: TG4001 in combination with avelumab

Company: Merck KGaA (Germany) Pfizer (USA - NY) Transgene (France)

Therapeutic area: Cancer - Oncology

Type agreement: collaboration - clinical research

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

Details:

• On October 11, 2016, Transgene announced it has entered a collaboration agreement with Merck KGaA and Pfizer under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy. This is an exclusive agreement between the parties to study the combination of these two classes of investigational agents in HPV-positive HNSCC. Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at Institut Curie, and a world expert in ENT cancers, will be the Principal Investigator of the Phase 1/2 study. This trial is expected to begin in France, with the first patient expected to be recruited in H1 2017. It will seek to recruit patients with recurrent and/or metastatic virus-positive oropharyngeal squamous cell carcinoma that have progressed after definitive local treatment or chemotherapy, and cannot be treated with surgical resection and/or re-irradiation.

Financial terms:

Latest news:

• On September 19, 2017, Transgene announced that the first patient has been treated at the Curie Institute, Paris, France, in the 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).