Date: 2017-12-20
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and TAR-200 (GemRIS™)
Company: BMS (USA - NY) Taris Biomedical (USA - MA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody/immune checkpoint inhibitor/medical device .
- Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them.
- The TARIS® System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent continuously in the bladder over seven days.
Disease: muscle invasive bladder cancer (MIBC)
Details:
- • On December 20, 2017, TARIS Biomedical and BMS announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with BMS' programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo® (nivolumab).
- The Phase 1b trial will evaluate the combination in patients with muscle invasive bladder cancer (MIBC) who are scheduled for radical cystectomy.
Financial terms:
- In conjunction with this collaboration, BMS also made an equity investment in TARIS.
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