ROCKVILLE, Md., Feb. 8, 2022 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: SYN), a diversified
clinical-stage company developing therapeutics designed to treat
diseases in areas of high unmet need, today announced that VCN
Biosciences, S.L.'s (VCN) VCN-01 received Orphan Drug Designation
for retinoblastoma from the U.S. Food & Drug Administration
(FDA). This announcement follows Synthetic Biologics' recent
announcement that it had entered a definitive agreement to
acquire VCN, which is subject to conditions that must be met prior
to closing. VCN is developing a new oncolytic adenovirus (OV)
platform designed to trigger tumor cell death and promote immune
cell infiltration into tumors.
The FDA's Office of Orphan Products Development grants orphan
status to drugs being developed to treat, diagnose or prevent a
rare disease or condition affecting fewer than 200,000 people in
the United States. Orphan Drug
Designation is designed to provide drug developers with various
benefits to support the development of novel drugs, including the
potential for market exclusivity for seven years upon FDA approval,
eligibility for tax credits for qualified clinical trials, waiver
of application fees, reduced annual product fees, clinical protocol
assistance and potential qualification for expedited development
programs.
Steven Shallcross, Chief
Executive Officer and Chief Financial Officer of Synthetic
Biologics, commented, "We are pleased to report that VCN's VCN-01
was granted Orphan Drug Designation for retinoblastoma by the
FDA. We believe VCN-01 may represent a novel rescue
therapy for patients who fail standard therapy, or may be used as
an adjunct to chemotherapy, to provide improved outcomes for these
patients. We are highly encouraged by the preliminary
clinical data thus far and look forward to conducting a pivotal
Phase 2/3 trial in these patients following our expected completion
of the acquisition."
About VCN Biosciences
VCN Biosciences is a clinical-stage immuno-oncology company
focused on the development of the next generation of oncolytic
adenoviruses. VCN candidates are designed to obtain clinical
activity after systemic administration and are able to remodel the
complex matrix in the tumor to allow enhanced spreading of
therapeutic molecules and the immune system. VCN Biosciences lead
product, VCN-01, is a oncolytic adenovirus with unique
characteristics being studied in clinical trials for cancers for
which there is no cure, including pancreatic carcinoma and
retinoblastoma. For more information, please visit
www.vcnbiosciences.com.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is diversified
clinical-stage company developing therapeutics designed to treat
diseases in areas of high unmet need. The Company recently
announced it has entered into a definitive agreement to acquire VCN
Biosciences, S.L. (VCN), which is developing a new oncolytic
adenovirus (OV) platform designed for intravenous (IV) delivery to
trigger tumor cell death and promote immune cell infiltration into
tumors. The transaction is expected to close during the first
quarter of 2022, and is subject to, among other things, the
approval by the Spanish government of the Company's acquisition of
VCN under Spain's Foreign
Investment Act and other customary closing conditions. In addition,
the Company's lead candidates are: (1) SYN-004 (ribaxamase) which
is designed to degrade certain commonly used intravenous (IV)
beta-lactam antibiotics within the gastrointestinal (GI) tract to
prevent (a) microbiome damage, (b) Clostridioides
difficile infection (CDI), (c) overgrowth of pathogenic
organisms, (d) the emergence of antimicrobial resistance (AMR), and
(e) acute graft-versus-host-disease (aGVHD) in allogeneic
hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a
recombinant oral formulation of the enzyme intestinal alkaline
phosphatase (IAP) produced under cGMP conditions and intended to
treat both local GI and systemic diseases. For more information,
please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. In
some cases forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions, and include statements
regarding the proposed acquisition of VCN by Synthetic Biologics,
the planned acquisition of VCN, VCN-01 representing a novel
rescue therapy for patients who fail standard therapy, or being
used as an adjunct to chemotherapy, to provide improved outcomes
for these patients, and conducting a pivotal Phase 2/3 trial in
these patients following the expected completion of the
acquisition . These forward-looking statements are
based on management's expectations and assumptions as of the date
of this press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from current expectations
include, among others, the risk associated with Synthetic
Biologics and VCN's ability to satisfy the conditions to
consummate the proposed acquisition, including obtaining necessary
governmental approvals, the timing of the closing of the proposed
acquisition, the occurrence of any event, change or other
circumstance or condition that could give rise to the termination
of the Stock Purchase Agreement between VCN, the shareholders of
VCN and Synthetic Biologics, unanticipated difficulties or
expenditures relating to the proposed acquisition or development of
VCN's drug candidates, the response of business partners and
competitors to the announcement of the proposed acquisition, and/or
potential difficulties in employee retention as a result of the
announcement and pendency of the proposed acquisition, whether the
combined business of Synthetic Biologics and VCN will be
successful, Synthetic Biologics' and VCN's product candidates
demonstrating safety and effectiveness, as well as results that are
consistent with prior results, the ability to initiate clinical
trials and if initiated, the ability to complete them on time and
achieve the desired results and benefits continuing enrollment as
expected, the ability to obtain regulatory approval for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to
Synthetic Biologics' and VCN's ability to promote or commercialize
their product candidates for the specific indications, acceptance
of product candidates in the marketplace and the successful
development, marketing or sale of Synthetic Biologics' and VCN's
products, developments by competitors that render such products
obsolete or non-competitive, Synthetic Biologics' and VCN's ability
to maintain license agreements, the continued maintenance and
growth of Synthetic Biologics' and VCN's patent estate and other
factors described in Synthetic Biologics' Annual Report on Form
10-K for the year ended December 31,
2020 and its other filings with the SEC, including
subsequent periodic reports on Forms 10-Q and 8-K. The information
in this release is provided only as of the date of this release,
and Synthetic Biologics undertakes no obligation to update any
forward-looking statements contained in this release on account of
new information, future events, or otherwise, except as required by
law.
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SOURCE Synthetic Biologics, Inc.