Published 30th June 2016

PsiOxus and Bristol-Myers Squibb announce combination study and Immuno-Oncology clinical collaboration

Imperial Innovations Group plc (AIM: IVO or ‘the Group’, ‘Innovations’) notes today’s announcement by portfolio company PsiOxus Therapeutics (‘PsiOxus’ or the ‘Company’) of 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 tumour 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 I studies to determine whether combining these two agents can significantly improve the proportion of patients achieving objective tumour responses, the extent of tumour shrinkage, and/or the durability of responses.

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 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.

The upfront payment and contribution towards development costs by BMS are non-dilutive, so Innovations holding (27.9%) is unchanged.

John Beadle, M.D., Chief Executive Officer of PsiOxus commented:

“We are delighted to collaborate with Bristol-Myers Squibb to investigate enadenotucirev with Opdivo in several tumour types. Our two companies share a common vision of using enadenotucirev in combination with Opdivo to expand the range of patients who respond favourably to checkpoint inhibitor therapy.”

Russ Cummings, CEO at Imperial Innovations, added:

“This collaboration is significant because, over and above the upfront payment, Bristol-Myers Squibb is jointly funding the costs of an expanded range of clinical trials. Both parties will learn more about enadenotucirev’s potential to work in combination with checkpoint inhibitors and there is an exclusive period for Bristol-Myers Squibb to negotiate commercial rights to enadenotucirev.

“In addition to this program, PsiOxus is also developing a next generation technology, which “arms” the enadenotucirev virus with genes that enables the creation of a broad range of unique oncolytic immune therapeutics within tumour cells. This is also very exciting, albeit still at a pre-clinical stage.”

Enadenotucirev is an oncolytic virus based on an oncolytic group B adenovirus that selectively replicates in tumour cells but not in normal cells. Enadenotucirev’s unique 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. Pre-clinical data demonstrates that this approach is potentially applicable to a broad range of epithelially derived solid tumours many of which have compelling unmet needs even when treated with checkpoint inhibitors.

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and currently has regulatory approval in 51 countries including the United States, Japan and in the European Union.