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
Xenetic received a $3 million milestone payment from Shire plc
(LSE: SHP, NASDAQ: SHPG) related to Shire’s advancing the Phase
1/2a clinical study for the PSA-Recombinant SHP656 or Factor VIII
(“FVIII”) being developed as a long-acting therapeutic for the
treatment of hemophilia. The stated goal of Shire is to introduce
an innovative FVIII protein that can significantly prolong the
circulating half-life of the FVIII protein, with the objective of
providing a once weekly treatment or reaching higher trough
activity levels for greater efficacy.
“We are thrilled with the progress that Shire has made
developing the SHP656 program, which is currently in Phase 1/2a
clinical trials for the treatment of hemophilia,” said Scott
Maguire, Xenetic’s Chief Executive Officer. “We look forward to the
continued development of SHP656 utilizing our proprietary PolyXen™
platform technology with the goal of having a once weekly or less
frequent dosing, thereby making it the longest acting hemophilia A
factor replacement treatment in development in the $9.3 billion
global hemophilia market(1).”
Xenetic announced its exclusive research, development, license
and supply agreement with Shire plc (formerly Baxalta, Baxter
Incorporated and Baxter Healthcare) in January 2014. The
collaboration with Shire utilizes Xenetic's PolyXen platform
technology to conjugate polysialic acid (“PSA”) to therapeutic
blood-clotting factors, with the goal of improving the
pharmacokinetic profile and extending the active half-life of these
biologic molecules. Shire is running and funding the SHP656
program, which is currently in a Phase 1/2a clinical trial. Shire
filed a Clinical Trial Application (“CTA”) for the program in Q4
2015 and commenced human clinical trials during the first quarter
of 2016.
Under the January 2014 license deal, Xenetic is entitled to up
to $100 million in potential development, regulatory, sales and
deadline extension receipts, which are contingent on the
performance of Shire achieving certain milestones. Xenetic is also
entitled to royalties on potential net sales. In connection with
this deal, in 2014 Shire made a $10 million equity
investment in the Company. Combined with a previous $3 million
equity investment, Shire is one of the Company's largest
shareholders.
Shire is a leading global biotechnology company focused on
serving people affected by rare diseases and highly specialized
conditions.
(1) Source:
http://www.grandviewresearch.com/industry-analysis/hemophilia-treatment-industry
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 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 FDA orphan designated oncology therapeutic sodium
cridanimod for the treatment of progesterone receptor negative
endometrial cancer, and a polysialylated form of erythropoietin for
the treatment of anemia in pre-dialysis patients with chronic
kidney disease.
Xenetic is also working together with Shire plc
(formerly Baxalta, Baxter Incorporated and Baxter Healthcare)
to develop a novel series of polysialylated blood coagulation
factors, including a next generation Factor VIII. 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 one of the
Company's largest shareholders having invested $10 million in
the common stock of 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 plus royalties on
sales.
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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