Xenetic Biosciences, Inc. Enters Into Asset Purchase Agreement With Financing Component for the Rights to Develop, Market and License Oncologic Drug Candidate Virexxa(TM)
(Thomson Reuters ONE) -
LEXINGTON, Mass., Nov. 16, 2015 (GLOBE NEWSWIRE) -- Xenetic Biosciences, Inc.
(OTCQB:XBIO) (the "Company"), a biopharmaceutical company focused on developing
next-generation biologic drugs and novel oncology therapeutics, announces that
it has entered into an Asset Purchase Agreement (the "APA") with AS Kevelt, an
Estonian biotech company ("Kevelt") and OJSC Pharmsynthez ("Pharmsynthez", and
together with Kevelt, "Sellers"). Pursuant to the APA, the Sellers will transfer
to the Company certain intellectual property rights with respect to Virexxa(TM),
and the Company will receive the worldwide rights to develop, market and license
Virexxa for all uses, except for certain excluded uses within the Commonwealth
of Independent States (the "CIS"), in exchange for 111.5 million shares of
Company common stock and certain other consideration. Virexxa is a Phase II
oncology drug candidate which is under investigation for the treatment of
certain endometrial cancers. As part of this total consideration, the Company
will also acquire Kevelt's U.S. Orphan Drug designation for the use of Virexxa
in the treatment of progesterone receptor negative endometrial cancer in
conjunction with progesterone therapy.
The APA also contains a financing component wherein the Company will receive
from Pharmsynthez up to $3.5 million in bridge financing and a commitment of an
additional $6.5 million in financing as part of a planned capital raise of at
least $15 million and up-list to a national securities exchange.
"This transaction provides us with our first U.S. FDA IND-enabled clinical
candidate for an orphan cancer indication," said M. Scott Maguire, Chief
Executive Officer of Xenetic Biosciences. "Virexxa with orphan designation in
the U.S. adds to our Phase II portfolio which also includes ErepoXen, our long-
acting anemia drug candidate. As well as expanding our pipeline, the Company is
pleased to receive financial commitments of up to $10M to fund our further
development, as well as financial commitments to back our planned uplisting to
a national securities exchange, an objective that remains a priority for the
Company's board."
This press release is not intended to describe this transaction in its entirety
and the reader should refer to SEC form 8-K and related exhibits filed on
November 16, 2015 for a complete description of this APA transaction.
About Virexxa(TM)
Virexxa(TM) (sodium cridanimod) 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.
Virexxa is under investigation in a U.S. FDA IND-enabled Phase 2 open-label,
multi-center, single arm study of sodium cridanimod in progesterone receptor
negative recurrent or persistent endometrial carcinoma. This study will
investigate the effect of sodium cridanimod on the levels of PrR in tumor tissue
and how this effect correlates to a patient's clinical response to progestin
therapy.
Endometrial cancer is the most common gynecological malignancy and represents a
major health concern, as overall five-year survival rates have not improved over
the past three decades. Endometrial cancer patients whose tumors no longer
express progesterone receptors are not candidates for progestin-based therapy.
Virexxa may improve sensitivity to progestin therapy in subjects with advanced
or recurrent PrR -negative tumors.
For more information:
clinicaltrials.gov/show/NCT02064725
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company developing next-
generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary
drug technology platforms include PolyXen(TM), designed to develop next
generation biologic drugs by extending the efficacy, safety and half-life of
biologic drugs, and OncoHist(TM) for the development of novel oncology drugs
focused on orphan indications.
Xenetic's lead product candidates include ErepoXen(TM), a polysialylated form of
erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with
chronic kidney disease, and OncoHist(TM), a novel recombinant human histone H1.3
molecule for the treatment of refractory Acute Myeloid Leukemia (AML) with
potential to treat numerous other cancer indications. Xenetic is collaborating
with Russian-based OJSC Pharmsynthez (who is an affiliate of a significant
shareholder in Xenetic) and the Serum Institute of India to test additional drug
candidates and to de-risk the development process with clinical data generated
in Russia and India before Xenetic takes these candidates into the clinic in the
Western markets.
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+.
Xenetic is working together with Baxalta Incorporated (formerly 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 PSA to therapeutic blood-clotting
factors, with the goal of improving the pharmacokinetic profile and extending
the active life of these biologic molecules. Baxalta is one of the Company's
largest shareholders having invested in a number of rounds with the most recent
investment of $10M last year. The agreement is an exclusive research,
development and license agreement which grants Baxalta a worldwide, exclusive,
royalty-bearing license to Xenetic's PSA patented and proprietary technology in
combination with Baxalta'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.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not limited to,
the potential safety, tolerability and efficacy of our product candidates and
the advancement of our clinical trials. Forward-looking statements can be
identified by terminology such as "anticipate," "believe," "could," "could
increase the likelihood," "estimate," "expect," "intend," "is planned," "may,"
"should," "will," "will enable," "would be expected," "designed to," "look
forward," "may provide," "would" or similar terms, variations of such terms or
the negative of those terms. Any forward-looking statements in this press
release are based on management's current expectations of future events and are
subject to a number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include, but are not
limited to, the risk of cessation or delay of any of the ongoing or planned
clinical trials and/or our development of our product candidates, the risk that
the results of previously conducted studies involving similar product candidates
will not be repeated or observed in ongoing or future studies involving current
product candidates, the risk that our collaboration with Baxter will not
continue or will not be successful, and the risk that any one or more of our
product candidates will not be successfully developed and commercialized. For a
discussion of other risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled "Risk Factors" in our
Annual Report on Form 10-K, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent filings with the
Securities and Exchange Commission. All information in this press release is as
of the date of the release, and Xenetic undertakes no duty to update this
information unless required by law.
Contact:
Xenetic Biosciences Inc.
www.xeneticbio.com
M. Scott Maguire, Chief Executive Officer
781 778 7720
j.mccusker(at)xeneticbio.com
UK/European contact:
Arlington Group Asset Management Limited
Ross Ainger
+44 (0)207 389 5012
rainger(at)agam.co.uk
Brokers and Analysts:
Chesapeake Group
+1-410-825-3930
info(at)chesapeakegp.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Xenetic Biosciences, Inc. via GlobeNewswire
[HUG#1967241]
Unternehmensinformation / Kurzprofil:
Datum: 16.11.2015 - 18:41 Uhr
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News-ID 434920
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contact information:
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