Date: 2016-06-30
Type of information: Clinical research agreement
Compound: enadenotucirev and nivolumab
Company: BMS (USA - NY) PsiOxus Therapeutics (UK)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: immunotherapy product/oncolytic virus/monoclonal antibody/immune checkpoint inhibitor. Enadenotucirev (chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions) is a chimeric oncolytic vaccine. It is currently undergoing phase I/II testing in platinum-resistant ovarian cancer patients across multiple UK cancer centres. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) phase I/II clinical trial aims to assess the safety and efficacy of PsiOxus’ novel oncolytic vaccine. Enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, non small cell lung cancer and renal cancer. Nivolumab is an investigational, 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.
Disease:
Details: * On June 30, 2016, BMS and PsiOxus Therapeutics announced an exclusive clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with BMS' Opdivo® (nivolumab) to treat a range of tumor types in late-stage cancer patients. The clinical collaboration will support Phase 1 studies to determine whether combining these two agents can significantly improve the proportion of patients achieving objective tumor responses, the extent of tumor shrinkage, and/or the durability of responses.
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