Agreements

Date: 2017-04-25

Type of information: Clinical research agreement

Compound: TG4010 and Opdivo®

Company: BMS (USA - NY) Transgene (France)

Therapeutic area: Cancer - Oncology

Type agreement: clinical research

Action mechanism:

immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. TG4010 is a therapeutic vaccine expressing the MUC1 antigen and interleukin-2 (IL2), a cytokine that stimulates the immune system. The MUC1 protein is normally found on the surface of certain cells in many tissue types. In tumor cells, several modifications of MUC1 can occur which distinguish it from MUC1 in normal cells. These changes transform the MUC1 protein into a highly immunogenic tumor associated antigen (TAA) and make it an attractive target for cancer immunotherapy. TG4010 is designed to help the body’s immune system identify cancerous cells carrying the MUC1 TAA as a target to be destroyed. In addition to lung cancer, the MUC1 TAA is expressed in other solid tumor types, including breast, colorectal, kidney and prostate cancers.
Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.

Disease: non-small cell lung cancer (NSCLC)

Details:

• On April 25, 2017, BMS and Transgene announced a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with BMS' Opdivo® (nivolumab) + standard chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer in patients whose tumors have low or undetectable levels of PD-L1.
The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine designed to generate an immune response against MUC1 expressing tumors such as non-squamous non-small cell lung cancer, in conjunction with BMS' immune checkpoint inhibitor, Opdivo®, designed to alleviate immune suppression. Both therapies will be combined with standard chemotherapy in first line NSCLC patients. The Phase 2 trial will evaluate objective tumor responses, and disease control in patients provided the regimen of TG4010 + Opdivo® + standard chimiotherapy, whose tumors express low and undetectable levels of PD-L1. In addition, the study will evaluate safety and tolerability of this regimen together with other efficacy metrics. This multi-center single-arm trial is expected to deliver first results in 2018.
Under the terms of the agreement, Transgene will be the sponsor of the trial. BMS will provide Opdivo® for use in the study.

Financial terms:

Latest news:

• On September 11, 2017, Transgene announced that the FDA has granted clearance to proceed with a Phase 2 clinical trial of TG4010 in combination with Opdivo® (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in the USA.