SERB Pharmaceuticals pursuing therapeutic
treatment against ricin poisoning using
Soligenix ricin antigen
PRINCETON, N.J., July 25,
2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX)
(Soligenix or the Company), a late-stage biopharmaceutical company
focused on developing and commercializing products to treat rare
diseases where there is an unmet medical need, announced today that
it has signed a worldwide exclusive license to supply its ricin
antigen to SERB Pharmaceuticals (SERB), for development of a novel
therapeutic treatment against ricin toxin poisoning. There is an
unmet need for protection against this highly potent toxin for
which there is no vaccine or therapeutic intervention
available.
"We are pleased to be partnering with Soligenix on the use of
their antigen to accelerate our ricin therapeutic program. With no
current therapeutic options, the threat of ricin represents a
significant unmet need in the field of biodefense and medical
countermeasures," said Anthony
Higham, CEO of SERB Pharmaceuticals. "Our expertise in
antibody development and the commercial scale manufacturing
capabilities acquired with BTG together with SERB's track record of
reliably providing a portfolio of high-quality Chemical,
Biological, Radiological, and Nuclear (CBRN) antidotes, uniquely
positions us to successfully deliver a solution."
"Beyond our own development of a heat stable ricin vaccine
(RiVax®) to protect against lethal ricin poisoning,
which has been supported with more than $30
million dollars to date by the U.S. government, we felt it
important to also partner with SERB in the development of its ricin
therapeutic drug candidate," stated Christopher J. Schaber, PhD, President and CEO
of Soligenix. "SERB is a leader in the field of medical
countermeasures to protect the public and military forces. By
supplying our novel ricin antigen as an important component of
their formulation, we are hopeful that it will assist in
accelerating development of this early-stage
program."
In pursuit of a ricin antidote, SERB will leverage its unique
broad-spectrum polyclonal antibody platform, gained in its
acquisition of BTG Specialty Pharmaceuticals. This specialized
manufacturing process generates binding fragments from antibodies
that are specific to a given antigen, helping to ensure potency and
purity. This platform is currently used to manufacture two of the
company's currently marketed products, CroFab®
and DigiFab®.
The antibodies will be generated using a modified form of the
ricin toxin, developed by Soligenix. The modifications
have removed the biological activity of the protein so
that it is not toxic, while still retaining its shape to trigger an
effective antibody response.
The specific licensing terms have not been disclosed at this
time, but consist of a manufacturing supply agreement and small
royalty percentage upon commercialization.
The Ricin Threat
Ricin is a source of concern because it is a relatively easy to
obtain, easy to weaponize and highly potent toxin. Ricin can be
extracted from the seeds of the castor oil plant, Ricinus
communis. Ricin is one of the most toxic biological agents
known—a Category B bioterrorism agent and a Schedule number 1
chemical warfare agent.
Ricin has been a threat since governments began experimenting
with it during World War I. Most famously used in the assassination
of Bulgarian writer Georgi Markov in 1978, ricin has been developed
and deployed with alarming frequency. Several ricin attacks have
been prevented in Europe and
the United States in recent years,
ranging from a militant group in Germany prevented from launching a ricin
attack by police in 2017 to the 2020 delivery of letters laced with
ricin to the White House.
About SERB
Pharmaceuticals
SERB is a growing pharmaceutical company and a dedicated ally to
healthcare providers treating patients with critical conditions,
focusing on emergency care and rare diseases. For over 30 years we
have made treating these complex and life-threatening conditions
possible, supporting clinicians, healthcare systems and governments
while offering hope to patients and their families. As a fully
integrated company, we have the experience and capabilities to
acquire, develop, and manufacture our medicines to the highest
standards, and make them available worldwide through our secure
supply chain. SERB acquired BTG Specialty
Pharmaceuticals in March of 2021.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our Specialized
BioTherapeutics business segment is developing and moving toward
potential commercialization of HyBryte™ (SGX301 or synthetic
hypericin) as a novel photodynamic therapy utilizing safe visible
light for the treatment of cutaneous T-cell lymphoma (CTCL). With a
successful Phase 3 study completed, regulatory approval is being
sought and commercialization activities for this product candidate
are being advanced initially in the U.S. Development programs in
this business segment also include our first-in-class innate
defense regulator (IDR) technology, dusquetide (SGX942) for the
treatment of inflammatory diseases, including oral mucositis in
head and neck cancer, and proprietary formulations of oral
beclomethasone 17,21-dipropionate (BDP) for the
prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including pediatric Crohn's
disease (SGX203).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, and SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and our vaccine programs
targeting filoviruses (such as Marburg and Ebola) and CiVax™, our
vaccine candidate for the prevention of COVID-19 (caused by
SARS-CoV-2). The development of our vaccine programs incorporates
the use of our proprietary heat stabilization platform technology,
known as ThermoVax®. To date, this business segment has
been supported with government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID), the
Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced
Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at https://www.soligenix.com and
follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that
reflect Soligenix, Inc.'s current expectations about its future
results, performance, prospects and opportunities, including but
not limited to, potential market sizes, patient populations and
clinical trial enrollment. Statements that are not historical
facts, such as "anticipates," "estimates," "believes," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"potential," or similar expressions, are forward-looking
statements. These statements are subject to a number of risks,
uncertainties and other factors that could cause actual events or
results in future periods to differ materially from what is
expressed in, or implied by, these statements, such as experienced
with the COVID-19 outbreak. Soligenix cannot assure you that it
will be able to successfully develop, achieve regulatory approval
for or commercialize products based on its technologies,
particularly in light of the significant uncertainty inherent in
developing therapeutics and vaccines against bioterror threats,
conducting preclinical and clinical trials of therapeutics and
vaccines, obtaining regulatory approvals and manufacturing
therapeutics and vaccines, that product development and
commercialization efforts will not be reduced or discontinued due
to difficulties or delays in clinical trials or due to lack of
progress or positive results from research and development efforts,
that it will be able to successfully obtain any further funding to
support product development and commercialization efforts,
including grants and awards, maintain its existing grants which are
subject to performance requirements, enter into any biodefense
procurement contracts with the U.S. Government or other countries,
that it will be able to compete with larger and better financed
competitors in the biotechnology industry, that changes in health
care practice, third party reimbursement limitations and Federal
and/or state health care reform initiatives will not negatively
affect its business, or that the U.S. Congress may not pass any
legislation that would provide additional funding for the Project
BioShield program. In addition, there can be no assurance as to the
timing or success of any of its clinical/preclinical trials.
Despite the statistically significant result achieved in the
HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of
cutaneous T-cell lymphoma, there can be no assurance that a
marketing authorization from the FDA or EMA will be successful.
Further, there can be no assurance that RiVax® will qualify
for a biodefense Priority Review Voucher (PRV) or that the prior
sales of PRVs will be indicative of any potential sales price for a
PRV for RiVax®. Also, no assurance can be provided that the Company
will receive or continue to receive non-dilutive government funding
from grants and contracts that have been or may be awarded or for
which the Company will apply in the future. These and other risk
factors are described from time to time in filings with the
Securities and Exchange Commission, including, but not limited to,
Soligenix's reports on Forms 10-Q and 10-K. Unless required by law,
Soligenix assumes no obligation to update or revise any
forward-looking statements as a result of new information or future
events.
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SOURCE Soligenix, Inc.