Date: 2017-04-11
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and APX005M
Company: BMS (USA - NY) Apexigen (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody/immune chekcpoint inhibitor. Opdivo® (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.
- Opdivo® is the world’s first approved drug targeting PD-1. This antibody has been generated under a research collaboration entered into in May 2005 between Ono and Medarex. When Medarex was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the anti-human PD-1 monoclonal antibody in North America. Through the collaboration agreement entered into in September 2011 between Ono and BMS, Ono granted BMS exclusive rights to develop and commercialize Opdivo® in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound.
- APX005M is an immuno-activating monoclonal antibody targeting CD40, a key immune co-stimulatory receptor essential to regulating the activation of both innate and adaptive immune responses against cancer.
Disease: second-line metastatic NSCLC patients who have failed prior chemotherapy, metastatic melanoma patients who have failed prior I-O therapy
Details:
- • On April 11, 2017, BMs and Apexigen announced a clinical trial collaboration to evaluate Opdivo® (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumors. The proposed collaboration will evaluate the safety, tolerability and preliminary efficacy of APX005M in combination with Opdivo in second-line metastatic NSCLC patients who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior I-O therapy.
- Preclinical data suggest that APX005M mimics the endogenous immune activation process through activation of CD40. A receptor on the surface of antigen presenting cells of the immune system, CD40 plays a fundamental role in the activation of both innate and adaptive immune system mechanisms. Opdivo is designed to overcome PD-1 pathway related immune suppression. The companies will explore the potential of combining these two agents with the goal of effectively activating antigen presenting cells (APC) in the tumor microenvironment, thus driving a more productive and sustained immune response against the tumor.
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