SHP656 program utilizes Xenetic's PolyXen™
platform technology to conjugate polysialic acid to therapeutic
blood-clotting factors
Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the discovery, research and development of next-generation biologic
drugs and novel orphan oncology therapeutics, announced today that
it has received an update on the Phase 1/2 clinical study conducted
by its partner Shire, evaluating SHP656 (“PSA-recombinant Factor
VIII”, “PSA-rFVIII”), which is being developed as a long-acting
therapeutic for the treatment of hemophilia A utilizing Xenetic's
PolyXen™ platform technology to conjugate polysialic acid to
therapeutic blood-clotting factors. The Phase 1/2 study
demonstrated SHP656’s efficacy and pharmacokinetic data
commensurate with the profile of an extended half-life rFVIII
product. Additionally, there were no drug-related adverse events,
serious adverse events, or rFVIII inhibitors reported. However, in
this study, a pre-defined once-weekly dosing criterion was not
met.
"Despite not achieving the principal objective of once-weekly
dosing in this Phase 1/2 study, our PolyXen technology clearly
works as a platform to successfully extend the circulating
half-life of rFVIII with no drug-related serious adverse events,”
stated M. Scott Maguire, Xenetic’s Chief Executive Officer.
“Including our own studies with a polysialylated erythropoietin
(“PSA-EPO”, “ErepoXen®”) candidate, this is the second instance in
which PolyXen has been demonstrated, in a human clinical trial
setting, to confer extended half-life to a biotherapeutic, while
maintaining pharmacological activity and a favorable safety and
tolerability profile. Moving forward, we believe data from
Shire’s SHP656 program continues to support the broad utility of
our proprietary PolyXen technology platform, and we remain focused
on building a growing pipeline of partnerships utilizing this
proven platform. We truly value our continuing relationship with
Shire and look forward to exploring other potential applications of
PolyXen within the Shire portfolio,” added Mr. Maguire.
“While Shire is disappointed by this outcome, the company is
encouraged by the knowledge gained through this research and
remains committed to transforming the treatment landscape for
patients with bleeding disorders. Given the potential application
of polysialic acid technology, the companies will explore future
collaborations,” stated Philip Vickers, Ph.D., Global Head of
Research & Development at Shire.
About PolyXen™
PolyXen™ is a patent-protected platform technology for creating
proprietary, next-generation protein therapeutics by attaching
polysialic acid (“PSA”), a biodegradable polymer found in living
systems, to existing protein or peptide therapeutics, which can
improve their pharmacological properties.
Attachment of PSA (“polysialylation”) to a therapeutic increases
its apparent size, which reduces systemic clearance rates, while
shielding the protein from other degradation pathways. The PolyXen
platform permits optimization of a target therapeutic’s
pharmacological properties, by controlling the amount, size, and
sites of attachment of the PSA polymers.
In clinical and preclinical settings, therapeutic proteins
polysialylated with the PolyXen™ platform have been shown to have
extended circulating half-life, improved thermodynamic stability
and resistance to proteases, while retaining pharmacological
activity. Numerous human clinical trials to date have shown no
evidence of PSA- induced immunogenicity.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a clinical-stage biopharmaceutical
company focused on the discovery, research and development of
next-generation biologic drugs and novel orphan oncology
therapeutics. Xenetic's proprietary drug development platforms
include PolyXen™, which enables next-generation biologic drugs by
improving their half-life and other pharmacological properties.
Xenetic's lead investigational product candidates include oncology
therapeutic XBIO-101 (sodium cridanimod) for the treatment of
progesterone resistant endometrial cancer (EC), and a
polysialylated form of erythropoietin for the treatment of anemia
in pre-dialysis patients with chronic kidney disease.
Xenetic is party to an agreement with Baxalta US Inc. and
Baxalta AB (wholly owned subsidiaries of Shire plc) covering the
development of a novel series of polysialylated blood coagulation
factors. This collaboration relies on Xenetic's PolyXen technology
to conjugate polysialic acid (“PSA”) to therapeutic blood-clotting
factors, with the goal of improving the pharmacokinetic profile and
extending the active life of these biologic molecules. Shire is a
significant stockholder of the Company, having invested $10 million
in the Company during 2014. The agreement is an exclusive research,
development and license agreement which grants Shire a worldwide,
exclusive, royalty-bearing license to Xenetic's PSA patented and
proprietary technology in combination with Shire's proprietary
molecules designed for the treatment of blood and bleeding
disorders. Under the agreement, Xenetic may receive regulatory and
sales target payments for total potential milestone receipts of up
to $100 million and additional royalties on sales. The first
program under this agreement was a next generation Factor VIII, and
this program was terminated by Shire following a Phase 1/2 trial.
Xenetic and Shire are currently exploring whether to engage in
further development of other blood coagulation factors.
Additionally, Xenetic has previously received strategic investments
from OPKO Health (Nasdaq: OPK), Serum Institute of India Limited
and Pharmsynthez.
Xenetic is also developing a broad pipeline of clinical
candidates for next-generation biologics and novel oncology
therapeutics in a number of orphan disease indications. For more
information, please visit the company's website
at www.xeneticbio.com and connect on Twitter, LinkedIn,
Facebook and Google+.
Forward-Looking Statements
This press release contains "forward-looking statements," as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), which statements may be identified by words
such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding
expected benefits of NGS cancer panels, the ability to accurately
determine the heritable factors increasing the risk of cancer,
permitting tailored treatment, screening and prevention of cancer
in patients, as well as other non-historical statements about our
expectations, beliefs or intentions regarding our business,
technologies and products, financial condition, strategies or
prospects. Many factors could cause our actual activities or
results to differ materially from the activities and results
anticipated in forward-looking statements. These factors include
those described in our filings with the Securities and Exchange
Commission, as well as the risks inherent in funding, developing
and obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments. In addition, forward-looking
statements may also be adversely affected by general market
factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that
may arise, patent positions and litigation, among other factors.
The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We
intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
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Jenene Thomas Communications, LLC.Jenene Thomas,
908-938-1475jenene@jenenethomascommunications.com
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