Clinical Trials

Date: 2017-09-11

Type of information: Clinical trial authorisation

phase: 2

Announcement: clinical trial authorization

Company: Transgene (France)

Product: TG4010 and nivolumab

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 a human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Transgene has signed a clinical collaboration agreement with BMS, which will provide nivolumab for the study.

Disease: advanced non-squamous non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The Phase 2 trial will evaluate objective tumor responses and disease control. The study will also assess the safety and tolerability of the regimen together with other efficacy parameters. This multi-center single-arm trial will enroll patients both in the USA and Europe. Transgene is the sponsor of this international trial.

Latest news:

• On September 11, 2017, Transgene announced that the FDA has granted Transgene Investigational New Drug (IND) 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. Both therapies will be combined with standard chemotherapy in first-line NSCLC patients, whose tumors express low and undetectable levels of PD-L1. The first patient is expected to be included at the end of 2017.