Bristol-Myers Squibb Company and PsiOxus Therapeutics, Ltd. (PsiOxus) 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 Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) to treat a range of tumor types in late-stage cancer patients.
Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed to alleviate immune suppression. 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.
“This collaboration continues to expand our clinical development of Opdivo and explores how oncolytic viruses may provide a complementary mechanism to address tumors that are resistant to I-O therapy,” said Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb. “We are excited to partner with PsiOxus to evaluate the combination of Opdivo and enadenotucirev to accelerate our understanding of its potential as a new therapeutic option for cancer patients.”
“We are delighted to collaborate with Bristol-Myers Squibb and to investigate enadenotucirev with Opdivo in several tumor types,” stated John Beadle, M.D., Chief Executive Officer, PsiOxus. “They are our ideal partner since we share a common vision of exploring novel combinations such as enadenotucirev andOpdivo to expand the range of patients who potentially respond favorably to checkpoint inhibitor therapy.”
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 (NSCLC) 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 (RCC) who have received prior anti-angiogenic therapy and in the U.S. for the treatment of patients with classical Hodgkin’s Lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) 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. Preclinical data demonstrate that this approach is potentially applicable to a broad range of epithelially derived solid tumors, many of which have compelling unmet needs even when treated with checkpoint inhibitors.
Under the terms of this 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 1 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.
Filed Under: Drug Discovery