Bristol-Myers Squibb Signs Exclusive Worldwide License Agreement with PsiOxus Therapeutics for NG-348, an “Armed” Oncolyt...
December 20 2016 - 6:59AM
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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version on businesswire.com: http://www.businesswire.com/news/home/20161220005066/en/
Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Tim Power,
609-252-7509timothy.power@bms.comBill Szablewski,
609-252-5894william.szablewski@bms.comorPsiOxus Therapeutics
Ltd.John Beadle, +44 1235 42 98 40john.beadle@psioxus.com
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