ROCKVILLE, Md.,
Dec. 14, 2021
/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 it has signed 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. Total upfront consideration for the
acquisition is $4.7 million in cash
plus the assumption of $2.4 million
of VCN liabilities. Additionally, VCN will receive shares of
Synthetic Biologics' common stock representing 19.99% of the total
shares outstanding of the Company's common stock. The Company has
also agreed to an additional $70.3
million of payments contingent upon the achievement of
future milestones, a majority of which are tied to late-stage
clinical development and regulatory achievements. 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. Additional details regarding
the transaction are available in the Company's Current Report on
Form 8-K, which has been filed with the Securities and Exchange
Commission and is available on the Company's website.
VCN's technology platform is designed to overcome critical
challenges that restrict the development of the majority of OV
therapies today. Unlike many OVs that can only be administered by
direct intratumoral injection, VCN's OVs are designed for systemic
intravenous administration to target primary as well as metastatic
tumors. Once inside the tumor, VCN's OVs are designed to replicate
selectively and aggressively, and to produce hyaluronidase (PH20),
an enzyme that digests hyaluronan, a key component of the dense
tumor stroma that often plays a crucial role in tumor progression.
Degradation of tumor stroma has been shown to diminish a
significant physical and immunosuppressive barrier to cancer
treatment and thereby improve access to the tumor by additional
therapies such as chemo and immuno-therapies. Results from
previously completed clinical trials demonstrate that this process
can occur for weeks or months following a single intravenous
injection with a VCN OV. VCN is seeking to leverage these unique
capabilities to address cancers with a high unmet need.
VCN OVs are also designed to be administered intratumorally or
intravitreally (in the eye), either as a monotherapy or in
combination with standard of care, to treat a wide variety of
cancer indications. Combination treatment of VCN OVs with a variety
of chemotherapies and immunotherapies such as checkpoint inhibitors
and CAR-T cells are in early clinical testing or planned. VCN has
the rights to four exclusive patents for proprietary technologies,
as well as technologies developed in collaboration with the
Virotherapy Group of the Catalan Institute of Oncology
(ICO-IDIBELL), with a number of additional patents pending.
VCN's lead drug candidate, VCN-01, has been evaluated in four
Phase 1 clinical trials to date, including in patients with
pancreatic cancer, head and neck squamous cell carcinoma, and
retinoblastoma (Rb). In a Phase 1 clinical trial, patients with
metastatic pancreatic ductal adenocarcinoma (PDAC) received the
combination therapy of intravenous VCN-01 with the standard of care
chemotherapy Gemcitabine plus Abraxane® (G/A). Best results were
observed when VCN-01 was administered one week before the first G/A
dose. VCN-01 was well tolerated and when combined with G/A
demonstrated an improved median overall and progression free
survival, as well as a high response rate compared to G/A alone.
These data compare favorably with current standard of care and are
the basis of a planned Phase 2 clinical trial of the higher dosing
level.
VCN-01 is also being studied as a monotherapy in patients with
retinoblastoma (RB) who previously failed chemotherapy.
Intravitreal administration of VCN-01 produced a complete remission
and a reduction of tumors in several patients. These promising
outcomes form the basis for an Orphan Drug application with the FDA
and are planned to be explored in a larger future clinical
trial.
VCN is also developing a next generation Albumin Shield™
technology platform, VCN-11, which builds upon the pre-clinical and
clinical results of VCN-01. VCN-11 incorporates an albumin binding
domain in the virus outer shell designed to enable the virus to
coat itself with host serum albumin, potentially preventing its
inactivation by neutralizing antibodies in the bloodstream en route
to the tumor. The addition of the Albumin Shield technology is not
expected to interfere with VCN-11's ability to target tumor cells
and may allow for repeated administration to optimize tumor
exposure.
Steven A. Shallcross, Chief
Executive Officer of Synthetic Biologics, commented, "We are
excited to announce this transformative acquisition, as VCN's
platform represents a potentially breakthrough approach to cancer
treatment with oncolytic viruses by allowing for systemic delivery,
high selectivity and enhanced tumor access. In addition to
triggering tumor cell death, these therapies have been shown to
elicit a strong anti-tumor immune response. The results of the
Phase 1 clinical trial in PDAC, a highly aggressive and lethal
malignancy, are very encouraging with respect to tumor response and
survival. Significantly, biopsies in these patients confirmed up
regulation of tumor immune markers and induction of a robust
antitumor immune response, including increased tumor infiltration
by cytotoxic T-cells. These results suggest VCN-01 holds
significant potential to increase the addressable market for
checkpoint inhibitors and CAR-T therapies, as these therapies have
historically been less effective immunologically against "cold"
tumors like PDAC."
"Based on encouraging results of prior preclinical and clinical
trials of VCN-01, we plan to initiate a controlled Phase 2 clinical
trial of VCN-01 at multiple centers across the US and EU. There is
a significant unmet need for a safe and effective therapy for
patients with pancreatic cancer, a condition in which most people
diagnosed do not survive more than a year following their initial
diagnosis. Based on highly encouraging early clinical results, we
also plan to conduct a registrational trial in pediatric patients
with advanced Rb. Importantly, this is an underserved patient
population and we believe VCN-01 holds tremendous promise to
preserve the eyes of these patients, who are typically less than
two years old at diagnosis. We believe these trials can be
conducted relatively quickly and efficiently. At the same time, we
are also evaluating investigator-sponsored studies combining VCN-01
with CAR-T therapies, as well as VCN-01 in other orphan indications
such as glioblastoma. We look forward to providing additional
details on the timing and design of these trials in the near
future."
"VCN was founded by internationally recognized experts in
oncolytic adenoviruses for cancer treatment and I will be delighted
to welcome them to our team. VCN's novel therapies allow for a
robust and efficient manufacturing process, with an attractive cost
structure. The platform is supported by a growing intellectual
property (IP) portfolio that provides it patent protection through
at least 2030 with additional patents underway that we believe
would further strengthen our IP portfolio. Importantly, VCN-01 has
been granted Orphan Drug Designation by the European Medicines
Agency (EMA), which may provide a number of benefits including up
to ten years of market exclusivity. Importantly, we have a
strong balance sheet with over $72.1
million of cash as of September 30,
2021, which we believe will provide us significant runway to
both support our existing programs, as well as to able to advance
VCN-01 and VCN-011 through important milestones that we believe
will drive significant shareholder value."
Manel Cascalló, PhD, Chief Executive Officer of VCN, noted,
"Joining together with Synthetic Biologics is a significant
opportunity as it allows us to partner with an experienced team,
well-versed in drug development, manufacturing, and
commercialization. We anticipate the combined company will have the
financial resources to fund our clinical programs to key value
inflection points and we look forward to a successful future
together."
Conference Call
Synthetic Biologics will hold a conference call today,
December 14, 2021, at
10:00 a.m. Eastern Time. The dial-in
information for the call is as follows, U.S. toll free:
1-888-347-5280 or International: +1 412-902-4280. Participants are
asked to dial in 15 minutes before the start of the call to
register. The call will also be webcast over the Internet at
https://www.webcaster4.com/Webcast/Page/1096/43946. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/43946, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified
clinical-stage company developing therapeutics designed to treat
diseases in areas of high unmet need. 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.
About A.G.P./Alliance Global Partners
A.G.P./Alliance Global Partners served as excusive financial
advisor to Synthetic Biologics in connection with the
transaction.
A.G.P./Alliance Global Partners is a regional investment banking
and advisory firm that has been a member of FINRA and registered
with the SEC since 1980. A.G.P. specializes in wealth management
and the middle-market institutional arena. With full-service
capabilities, we possess a global ability to handle domestic as
well as international customers. In addition, A.G.P. provides
capital markets and corporate services. We offer advanced market
expertise and deep industry knowledge to institutional clients and
issuers alike. The core members of our team have been extremely
active in the small and mid-cap investment banking space,
including, but not limited to, Follow-On Offerings, PIPEs and
Registered Directs.
About Tungsten Advisors
Tungsten Advisors served as the exclusive financial advisor to
VCN Biosciences SL. Tungsten Advisors (www.tungstenadv.com) is an
investment banking firm focused on strategic advisory and corporate
finance for healthcare and technology companies. Tungsten provides
transactional services including financings (private
placements/PIPEs), corporate partnering and mergers and
acquisitions (M&A). Tungsten also focuses on company incubation
and makes direct investments alongside the creation of new
companies in healthcare and technology.
This Press Release is for informational purposes only and does
not constitute an offer, invitation, solicitation, or
recommendation to buy, sell, subscribe for, or issue any
securities. While the information provided herein is believed to be
accurate and reliable, Tungsten Partners, LLC d/b/a Tungsten
Advisors and Ashland Securities, LLC make no representations or
warranties, expressed or implied, as to the accuracy or
completeness of such information. All information contained herein
is preliminary, limited and subject to completion, correction or
amendment. It should not be construed as investment, legal, or tax
advice and may not be reproduced or distributed to any person.
Certain Principals of Tungsten Partners, LLC are registered
representatives of Ashland Securities, LLC Member FINRA, SIPC.
Tungsten Partners, LLC and Ashland Securities, LLC are separate and
unaffiliated entities. Securities and Investment Banking
Services are offered through Ashland Securities, LLC.
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,
closing the transaction during the first quarter of 2022, VCN's
platform representing a potentially breakthrough approach to cancer
treatment with oncolytic viruses by allowing for systemic delivery,
high selectivity and enhanced tumor access, VCN-01 holding
significant potential to increase the addressable market for
checkpoint inhibitors and CAR-T therapies, plans to initiate a
controlled Phase 2 clinical trial of VCN-01 at multiple centers
across the US and EU, plans to conduct a registrational trial in
pediatric patients with advanced Rb, providing additional details
on the timing and design of the trials in the near future and
Synthetic Biologics' balance sheet providing significant runway
to both support Synthetic Biologics' existing programs, as
well as to able to advance VCN-01 and VCN-011 through important
milestones that will drive significant shareholder
value. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/synthetic-biologics-announces-planned-transformative-acquisition-of-vcn-biosciences-developer-of-a-novel-oncolytic-virus-platform-targeting-pancreatic-and-other-solid-tumors-301443793.html
SOURCE Synthetic Biologics, Inc.