Bristol-Myers Squibb and PsiOxus Therapeutics announce immuno-oncology clinical collaboration

Bristol-Myers SquibbBristol-Myers Squibb Company (NYSE: BMY) and PsiOxus Therapeutics, Ltd. (PsiOxus) today 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 and Opdivo 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.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.

We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents and continue to study the role of combinations in cancer.

We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO and LAG-3. These pathways may lead to potential new treatment options - in combination or monotherapy - to help patients fight different types of cancers.

Our collaboration with academia, as well as small and large biotech and pharmaceutical companies, to research the potential of Immuno-Oncology and non-Immuno-Oncology combinations helps achieve our goal of providing new treatment options in clinical practice.

At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.

About Opdivo
Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway's suppressive signaling on the immune system, including the interference with an anti-tumor immune response.

Opdivo's broad global development program is based on Bristol-Myers Squibb's understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression. To date, the Opdivo clinical development program has enrolled more than 18,000 patients.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agents and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

About PsiOxus Therapeutics Ltd.
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 Tumor-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 tumor 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 tumor types and with different combinations including checkpoint inhibitors and conventional chemotherapeutics.

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