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Xenetic Biosciences Commences Patient Enrollment in Phase 2 Study Evaluating XBIO-101 in Conjunction with Progestin Therapy for the Treatment of Endometrial Cancer

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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, today announced that patient enrollment
has commenced in its Phase 2 clinical study of XBIO-101
(sodium cridanimod) in conjunction with progestin therapy for the
treatment of endometrial cancer, in a population of patients who have
either failed progestin monotherapy or who have been identified as
having progesterone receptor negative ("PrR-") tumors.

XBIO-101, Xenetic's lead product candidate in development, is a
small-molecule immunomodulator and interferon inducer which, in
preliminary studies, has been shown to increase progesterone receptor
("PrR") expression in endometrial tumor tissue.

"We are very pleased to commence patient enrollment in this Phase 2
study with our flagship product candidate and believe this trial is
designed to provide greater understanding of XBIO-101 for the treatment
of progestin resistant endometrial cancer," stated M.
Scott Maguire, Xenetic's CEO
. "Based on these preliminary findings,
we believe that XBIO-101 has the potential to increase the expression of
PrR on endometrial tumors thereby making them more responsive to
treatment with traditional progestin therapy, and ultimately provide a
much-needed solution for late stage endometrial cancer patients."

The primary objective of the open-label, multi-center, single-arm,
two-period Phase 2 study is to assess the antitumor activity of XBIO-101
in conjunction with progestin therapy as measured by Overall Disease
Control Rate ("ODCR") in women with recurrent or persistent endometrial
carcinoma not amenable to surgical treatment or radiotherapy who have
either failed progestin monotherapy or who have been identified as PrR-.
Secondary objectives include assessments of efficacy and
safety/tolerability parameters.

The study is expected to enroll a total of 72 women with recurrent or
persistent endometrial cancer not amenable to surgical treatment or
radiotherapy but suitable to be treated with progestins. All subjects
determined to be PrR- at screening, as well as those subjects who
experience disease progression after at least 4 weeks of progestin
monotherapy, will receive XBIO-101 in combination with continued
progestin treatment. Subjects will receive treatment until disease
progression as defined according to RECIST 1.1 criteria.

For more information about the Phase 2 clinical study of XBIO-101 in
conjunction with progestin therapy for the treatment of endometrial
cancer, please visit clinicaltrials.gov
and reference Identifier NCT03077698.

About Endometrial Cancer

Endometrial cancer is the most common malignancy of the female genital
tract and represents a major health concern, as overall five-year
survival rates have not improved over the past three decades. Annually
in the United States, an estimated 60,050 patients are diagnosed with
endometrial cancer and 10,470 deaths occur from this disease,
representing 1.8% of all cancer deaths in the US. The incidence of
endometrial cancer is on the rise with a lifetime risk of approximately
3% while the disease-specific mortality of endometrial carcinoma has
been rising in the last 25 years. Endometrial cancer patients whose
tumors no longer express progesterone receptors are not candidates for
progestin-based therapy. Patients who fail monotherapy with progestins
have no additional treatment options. XBIO-101 may improve sensitivity
to progestin therapy in subjects with advanced or recurrent PrR tumors.

About XBIO-101

XBIO-101 is a small-molecule immunomodulator and interferon inducer
which, in preliminary studies, has been shown to increase progesterone
receptor ("PrR") expression in endometrial tissue. Restoration of PrR
expression may re-sensitize endometrial tumor tissue to progestin
therapy in previously unresponsive tumors.

Xenetic has commenced patient enrollment in the Phase 2 clinical study
of XBIO-101 in conjunction with progestin therapy for the treatment of
progestin resistant endometrial cancer, and has filed a protocol under
its existing Investigational New Drug application ("IND") to expand the
development of XBIO-101 into a biomarker study for the treatment of
triple negative breast cancer ("TNBC").

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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