Single-vial thermostabilized bivalent
vaccine demonstrates simultaneous protection against
two lethal viruses
PRINCETON, N.J., Jan. 2, 2024
/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 a
publication describing the preclinical efficacy of a novel,
single-vial, bivalent vaccine providing 100% protection against
both Sudan ebolavirus
(SUDV) and Marburg marburgvirus (MARV) infections. In
collaboration with University of Hawaiʻi at Mānoa (UHM), the
manuscript entitled "Thermostable bivalent filovirus vaccine
protects against severe and lethal Sudan ebolavirus and marburgvirus
infection", has been published in Vaccine.
This vaccine candidate has been previously demonstrated to be
stable to high temperature storage for at least 2 years at 40
degrees Celsius (104 degrees Fahrenheit). There are currently no
approved vaccines or therapeutics for either SUDV or MARV
infections. Vaccines are available for Zaire ebolavirus (EBOV) infections but
they provide no protection against SUDV or MARV infection. The
published paper describes the potency of the bivalent formulation
against both viruses, demonstrating 100% protection in the most
rigorous non-human primate challenge models.
"Filoviruses such as Zaire
ebolavirus, Sudan
ebolavirus and Marburg marburgvirus are some of the most
lethal viruses known, and they are endemic in areas of the world
where the power supply and distribution network can be uncertain. A
thermostabilized vaccine in a single vial format would
significantly enhance any public health response to a new outbreak,
at its source," stated Axel Lehrer,
PhD, Associate Professor, Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A.
Burns School of Medicine, UHM. "Our work to date has
demonstrated the feasibility of rapid and efficient manufacturing,
as well as the ability to thermostabilize multiple antigens that
can then be stored for extended times at temperatures exceeding 100
degrees Fahrenheit. The use of a bivalent vaccine has the potential
to both prevent future infections with these pathogens and
potentially mitigate future outbreak events, potentially using an
accelerated dosing regimen."
"Our combined vaccine platform includes 3 major
components: a robust protein manufacturing process that has been
demonstrated on multiple protein antigens, a novel nano-emulsion
adjuvant which induces broad immunity and a formulation procedure
which enables thermostabilization of the combination of adjuvant
and antigens in a single vial," stated Oreola Donini, PhD, Senior
Vice President and Chief Scientific Officer of Soligenix. "Elements
of this vaccine platform have been utilized in our ricin toxin,
filovirus and COVID-19 vaccine candidates, indicating its broad
applicability. The ability to package the vaccine candidates in a
single vial further adds to their developability, whether as a
multivalent or individual monovalent vaccine, particularly against
Marburg marburgvirus and Sudan ebolavirus where there are currently
no available vaccines."
Under the Company's Public Health Solutions business segment,
ongoing collaborations with Dr. Lehrer have demonstrated the
feasibility of developing thermally-stable subunit protein vaccine
formulations for filoviruses. The thermostabilized filovirus
vaccine program is continuing to advance with the support of a
National Institute of Health (NIH) grant R01-AI132323 (awarded to
UHM) and a Small Business Innovation Research grant
(#1R44AI157593-01; awarded to Soligenix, Inc.). Work to date has
demonstrated the compatibility of lyophilizing both antigen and
adjuvant in the same vial, with reconstitution with sterile water
for injection immediately prior to use. This simple delivery
format, as well as the compatibility with ambient storage, enables
vaccines that significantly reduce the logistical hurdles that have
been required for addressing the current pandemic or deployment of
other Ebola virus vaccines in recent outbreaks in Central and
West Africa.
About Filovirus Infection
Ebola Virus Disease is caused by one of six species of
Ebolavirus, four of which are known to cause disease in humans,
including its best-known member, Zaire ebolavirus (Ebola virus), with
Sudan ebolavirus being the
second-most common cause of human infection in this genus. All
species of ebolavirus belong to the Filoviridae family, a family
that further contains the equally human pathogenic Marburg virus.
Filoviruses are believed to be harbored in various animal species
in Africa, particularly bats,
although the specific reservoir host for many of these viruses is
still unknown. There have been several known Ebola and Marburg
Virus Disease outbreaks since 1967, with the largest outbreak
starting in 2014 in Western Africa
that involved over 26,000 confirmed/probable/suspected cases with
an estimated death toll of more than 11,000 people according to the
Centers for Disease Control and Prevention (CDC). These numbers
also include some cases of virus introduction and limited spread in
Europe and the United States. In 2022 and 2023 several
SUDV and MARV outbreaks were observed in continental Africa.
Transmission of filoviruses requires direct contact with bodily
fluids from an infected person or contact with infected animals.
The mortality rates following filovirus infections are extremely
high, and, in the absence of wide availability of effective
therapeutics, are affected by the quality of supportive care
available with a focus on early initiation of treatment. Resolution
of the disease largely depends on the patient's own immune system.
There are limited treatment options for Ebola Virus Disease and no
available treatments for Sudan Virus or Marburg Virus Disease,
although steady progress has also been made in development of
immunotherapeutics for filoviruses beyond Zaire ebolavirus. There are approved
vaccines for Ebola virus (Zaire
ebolavirus), requiring stringent ultra-low cold-chain storage,
but no efficacious vaccines yet available for Marburg virus
(Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).
About John A. Burns School of
Medicine, University of Hawai'i at Manoa
The John A. Burns School Medicine (JABSOM) at the University of
Hawaiʻi at Mānoa is one of the leading medical institutions and one
of the most ethnically diverse institutions in the United States. For more than a decade,
JABSOM has ranked in the top 10% of allopathic medical schools for
graduate retention with one of our UH-sponsored residency programs.
Hawaiʻi's cultural diversity and geographical setting affords
JABSOM a unique research environment to excel in research directed
at eliminating diseases that disproportionately affect people in
Hawaii and the Pacific region.
JABSOM faculty bring in extramural funds of $46 million into the state, annually. In
addition, JABSOM was the first U.S. medical school to create a
clinical department dedicated to the health and well-being of an
indigenous population, Native Hawaiians.
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 sodium) 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
expansion of synthetic hypericin (SGX302) into psoriasis, 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 (SGX945) in
Behçet's Disease. The Company also is developing proprietary
formulations of oral beclomethasone 17,21-dipropionate (BDP) for
the prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation such as pediatric Crohn's
disease (SGX203).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, as well as our vaccine programs targeting filoviruses
(such as Marburg, Sudan 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, and include the
expected amount and use of proceeds from the offering and the
expected closing date of the offering. 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.
Notwithstanding the result in the HyBryte™ (SGX301) Phase 3
clinical trial for the treatment of cutaneous T-cell lymphoma and
the Phase 2a clinical trial of SGX302 for the treatment of
psoriasis, there can be no assurance as to the timing or success of
the clinical trials of SGX302 for the treatment of psoriasis.
Despite the positive efficacy results demonstrated in the Phase 2
and 3 clinical studies of SGX942 for the treatment of oral
mucositis due to chemoradiation therapy for head and neck cancer,
there can be no assurance as to the timing or success of the
clinical trials of SGX945 for the treatment of Behçet's Disease.
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 (the "SEC"), 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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