Bristol-Myers Squibb Signs Exclusive Worldwide License Agreement with PsiOxus Therapeutics for NG-348, an “Armed” Oncolytic Virus to Address Solid Tumors

NEW YORK & OXFORD, United Kingdom–(BUSINESS WIRE)– Bristol-Myers
Squibb Company (NYSE: BMY) and PsiOxus
Therapeutics, Ltd. (PsiOxus) today announced an agreement granting
Bristol-Myers Squibb exclusive worldwide rights to NG-348, a
pre-clinical stage, “armed” oncolytic virus with the goal of addressing
solid tumors. The agreement is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act.

Oncolytic virus therapy utilizes modified viruses like the adenovirus
(otherwise known as the common cold virus) that selectively replicate
within tumor cells and not within normal tissue. Such viruses stimulate
an inflammatory response in the tumor microenvironment, resulting in the
accumulation of tumor infiltrating lymphocytes. The NG-348 virus uses
PsiOxus’ proprietary Tumor-Specific Immuno-gene Therapy (T-SIGn)
platform to “arm” the virus with two additional immuno-therapeutic
transgenes.

“PsiOxus has developed a novel platform of tumor-targeted delivery with
oncolytic viruses focused on cancer and shares our passion for helping
more patients respond to treatment,” said Fouad Namouni, M.D., head of
Development, Oncology, Bristol-Myers Squibb. “We are excited to bring
our deep expertise in Immuno-Oncology to the continued development of
NG-348 and to better understand the potential role of oncolytic viruses
in enhancing checkpoint blockade in multiple types of cancer in the
tumor microenvironment.”

“NG-348, represents the first of our T-SIGn armed-viruses,” stated John
Beadle, M.D., Chief Executive Officer, PsiOxus, “We are thrilled to
partner once again with Bristol-Myers Squibb, a leader in
Immuno-Oncology, to drive this program into clinical development with
the aim of providing a potential treatment to cancer patients.”

Under the terms of the agreement, Bristol-Myers Squibb will grant
PsiOxus a $50 million upfront payment and will be solely responsible for
global clinical development and commercialization activities related to
NG-348. PsiOxus is also eligible to receive up to $886 million in
development, regulatory and sales-based milestones, as well as royalties
on net sales. Bristol-Myers Squibb will also be responsible for
providing PsiOxus funding to support activities related to the
preclinical development of NG-348.

This agreement follows a June 2016 agreement between the two companies
where Bristol-Myers Squibb and PsiOxus entered into an exclusive
clinical collaboration to study enadenotucirev, PsiOxus’ systemically
administered “unarmed” oncolytic adenovirus therapeutic.

About NG-348

NG-348 is designed to drive T-cell immune responses locally within the
tumor microenvironment. It is a transgene-modified variant of PsiOxus’s
enadenotucirev virus that encodes two immunomodulatory MiTe proteins in
its genome. The two Membrane-integrated T-cell-engaging (MiTe) proteins
encoded within NG-348 are:

• A membrane anchored full-length human CD80
• A membrane anchored antibody fragment specific for the T-cell receptor
  CD3 protein

When expressed together on the surface of NG-348 infected tumor cells,
these two membrane proteins provide both the T-cell receptor (signal 1)
and costimulatory (signal 2) activation signals required to polyclonally
activate tumor-infiltrating T-cells in an antigen independent manner.

The expression of both transgenes encoded in the NG-348 virus is
controlled by the endogenous virus major late promoter. This restricts
expression of the proteins to the surface of cells permissive to virus
infection (i.e. tumor cells) and prevents off-target expression in the
cells from healthy tissues. NG-348 infected tumor cells can potently
activate both CD4 and CD8 human T-cells, both in vitro and in a human
tumor xenograft model. By contrast, non-tumor cells exposed to NG-348 do
not express the MiTe proteins or activate T-cells.

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. For more information about
Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter,
YouTube
and Facebook.

About PsiOxus Therapeutics

PsiOxus Therapeutics aims to be the world’s leading immuno-oncolytic
virus company, delivering medicines of value to patients with cancer.
Our work is product and platform based with a focus on discovering and
developing innovative immunotherapies for the treatment of solid tumors.
Our products utilize enadenotucirev, our proprietary first generation
oncolytic virus and our proprietary platform technology for next
generation oncolytic viruses, Tumor-Specific Immuno-Gene Therapy
(T-SIGn). The T-SIGn therapy platform is based on the company’s
oncolytic virus, enadenotucirev, which has 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. www.psioxus.com

Bristol-Myers Squibb Forward-looking Statement

This press release contains “forward-looking statements” as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be
guaranteed. Among other risks, there can be no guarantee that the
investigational compounds discussed in this release will be successfully
developed or approved for any of the indications described in this
release. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Bristol-Myers
Squibb’s business, particularly those identified in the cautionary
factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K
for the year ended December 31, 2015 in our Quarterly Reports on Form
10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.

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