The Bristol-Myers Squibb (BMS) immuno-oncology treatment Opdivo® (nivolumab) will be studied in combination with PsiOxus Therapeutics’ enadenotucirev in treating a range of tumor types in late-stage cancer patients, the companies said today.
BMS and PsiOxus said they have agreed to an exclusive clinical collaboration to assess the safety, tolerability, and preliminary efficacy of the combination. The clinical collaboration is designed to support Phase I studies to determine whether combining the two treatments can significantly improve the proportion of patients achieving objective tumor responses, as well as 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 [immuno-onocology] therapy,” Jean Viallet, M.D., BMS global clinical research lead, oncology, said in a statement.
BMS agreed to make a one-time $10 million upfront payment to PsiOxus, while the companies agreed to share development costs. PsiOxus will oversee conducting the Phase I study, with patient recruitment expected to start in the third quarter of this year.
The companies said they also agreed to work exclusively with each other on anti-programmed death-1/anti-programmed death ligand-1 (anti-PD-1/PD-L1) antagonist antibody and enadenotucirev combination regimens, with BMS having a time-limited right of exclusive negotiation for commercial rights to enadenotucirev.
Opdivo generated $942 million in worldwide product revenue for BMS last year, and $704 million in the first quarter of this year. Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and now has regulatory approval in 51 countries including the U.S., the EU, and Japan.
Enadenotucirev is an oncolytic virus based on an oncolytic group B adenovirus that selectively replicates in tumor cells but not in normal cells. Enadenotucirev’s design allows it to be delivered systemically via intravenous administration.
Phase I/II clinical trials are ongoing with enadenotucirev in four clinical trials in a variety of cancer indications—including colorectal, ovarian, bladder, lung, and renal cell—using intravenous dosing. According to PsiOxus, preclinical data has shown that this approach is potentially applicable to a broad range of epithelially derived solid tumors.
PsiOxus, a portfolio company of Imperial Innovations Group, focuses on developing immune-oncology treatments using its Tumor-Specific Immuno-Gene (T-SIGn) therapy platform, which is based on the company's oncolytic virus, enadenotucirev.
“In addition to this program, PsiOxus is also developing a next-generation technology, which ‘arms’ the enadenotucirev virus with genes that enable the creation of a broad range of unique oncolytic immune therapeutics within tumor cells. This is also very exciting, albeit still at a preclinical stage,” said Russ Cummings, CEO of Imperial Innovations.
