Imperial Innovations Group Regulatory News (IVO)

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30 June 2016

Imperial Innovations Group plc

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.

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Notes to editors

About Imperial Innovations - www.imperialinnovations.co.uk 

Imperial Innovations Group plc ("Innovations") creates, builds and invests in pioneering technology companies and licensing opportunities developed from outstanding scientific research from the 'Golden Triangle', the geographical region broadly bounded by London, Cambridge and Oxford. This area has an unrivalled cluster of outstanding academic research and technology businesses, and is home to four of the world's top 10 universities, as well as leading research institutions, the cream of the UK's science and technology businesses and many of its leading investors.

Innovations supports scientists and entrepreneurs in the commercialisation of their ideas, through the licensing of intellectual property, by leading the formation of new companies, by recruiting high-calibre management teams and by providing investment and encouraging co-investment. Innovations remains an active investor over the life of its portfolio companies, with the majority of Innovations' investment going into businesses in which it is already a shareholder.

Since becoming a public company in 2006, Innovations has raised more than £440 million of equity from investors, which has enabled it to invest in some of the most exciting spin-outs to come out of UK academic research. In addition, the Group has agreed £80.0 million in loan facilities from the European Investment Bank (EIB).

Between Innovations' admission to AIM (August 2006) and 31 July 2015, Innovations had invested a total of £236.8 million across its portfolio companies, which had raised collectively investment of £1.3 billion.

About PsiOxus Therapeutics Ltd - www.psioxus.com

PsiOxus Therapeutics, an Oxford, UK-based development stage biotechnology company focused upon immune-oncology, has developed a patented platform for delivering tumor-targeted oncolytic immune therapeutics systemically. The Tumour-Specific Immuno-Gene (T-SIGn) therapy platform is based on the company's oncolytic virus, enadenotucirev, which has unique properties that allow it to be delivered systemically via intravenous administration and to replicate only in tumour cells. The anti-cancer capability can be further enhanced through "arming" - a process that involves the addition of new genes into the virus. The armed T-SIGn platform makes possible creation of a broad range of systemically delivered oncolytic immune therapeutics including oncolytic viruses that express one or more antibodies, cytokines, immunomodulatory proteins, or nucleotide (RNA) based payloads. The T-SIGn platform is in preclinical stage, while phase I/II clinical trials are ongoing with enadenotucirev in different tumour types and with different combinations including checkpoint inhibitors and conventional chemotherapeutics.