Bristol-Myers Squibb and PsiOxus Therapeutics, a UK-based biopharmaceutical company, have formed 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 Bristol-Myers Squibb's immuno-oncology agent, Opdivo (nivolumab), to treat a range of tumor types in late-stage cancer patients.

Under agreement, Bristol-Myers Squibb will make a one-time upfront payment of $10 million to PsiOxus, and the parties will share development costs. PsiOxus will be responsible for conducting the Phase I study with patient recruitment expected to start in the third quarter of 2016. Additionally, the companies will work exclusively with each other on anti-PD-1/PD-L1 antagonist antibody and enadenotucirev combination regimens, and Bristol-Myers Squibb will have a time-limited right of exclusive negotiation for commercial rights to enadenotucirev.

Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed to alleviate immune suppression. The clinical collaboration will support Phase I 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.

Opdivo is a PD-1 immune checkpoint inhibitor currently approved in 50 countries globally for the treatment of patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy, in 50 countries globally for the treatment of patients with unresectable or metastatic melanoma as mono-or combination therapy, in 34 countries globally for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy and in the US for the treatment of patients with classical Hodgkin's Lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

PsiOxus' enadenotucirev is an oncolytic group B adenovirus therapeutic that is given intravenously and is currently in Phase 1 clinical studies for multiple solid tumor types. Enadenotucirev is a virus that selectively replicates in tumor cells but not in normal cells. Such viruses promote anti-tumor responses through a dual mechanism of action that is dependent on selective tumor cell killing and the induction of systemic anti-tumor immunity.

Source: Bristol-Myers Squibb