Bristol-Myers Squibb ($BMY) and PsiOxus Therapeutics have partnered to put a pair of candidates into Phase I testing to treat several tumor types in late-stage cancer patients. The testing will combine the biopharma’s FDA-approved immuno-oncology agent Opdivo (nivolumab) with PsiOxus’ enadenotucirev, an oncolytic adenovirus.
The expectation is that enadenotucirev will have immune stimulating effects that could complement Opdivo’s immune suppression activity. They will start Phase I testing to find if the combo can significantly improve objective tumor responses, the extent of tumor shrinkage and 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 Dr. Jean Viallet, Global Clinical Research Lead in Oncology at Bristol-Myers Squibb, said in a statement.
Under the deal, BMS will make an upfront payment of $10 million to the Oxford, UK-based startup. The partners will also share development costs. PsiOxus is responsible for patient recruitment in the Phase I study, which is slated to start next quarter.
The companies will also work together exclusively on anti-PD-1/PD-L1 antagonist antibody and enadenotucirev combination regimens--with BMS gaining an exclusive right to negotiate for the commercialization rights to enadenotucirev.
Enadenotucirev is an oncolytic group B adenovirus; it is in Phase I testing in multiple solid tumor types. Given intravenously, it is a virus that is intended to replicate in tumor cells, but not in normal cells. It is designed to promote anti-tumor response via a dual mechanism of action: selective tumor cell killing and the induction of systemic anti-tumor immunity.
Preclinical data showed activity in across epithelially derived solid tumors, which typically have unmet needs even after checkpoint inhibitor treatment.
PsiOxus is backed by investors including Invesco, GlaxoSmithKline’s SR One, Lundbeckfond Ventures, Mercia Technologies and Woodford Investment Management. Last spring, it got a $38.5 million Series C round.
Opdivo is a PD-1 immune checkpoint inhibitor that is approved to treat metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy; unresectable or metastatic melanoma as mono-or combination therapy; advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy; and classical Hodgkin’s Lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin.
“We share a common vision of exploring novel combinations such as enadenotucirev and Opdivo to expand the range of patients who potentially respond favorably to checkpoint inhibitor therapy,” PsiOxus CEO Dr. John Beadle said of the deal.
- here is the announcement
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