- Vaccines stable for at least two years when stored at 40
degrees Celsius / 104 degrees Fahrenheit
- Only subunit (protein) vaccine platform shown to protect
against potentially lethal Ebola and Marburg viruses
- No cold chain storage and transport required as compared to
other filovirus vaccines
PRINCETON, N.J., Sept. 25,
2023 /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
two-year stability of its thermostabilized bivalent and trivalent
filovirus vaccine candidates at temperatures of 40 degrees Celsius
(104 degrees Fahrenheit) when formulated in a single vial, needing
reconstitution only with sterile water immediately prior to use.
This follows the previous successful demonstration of 100%
protection of non-human primates (NHPs) against lethal
Sudan ebolavirus and
Marburg marburgvirus challenge with the bivalent vaccine.
This important milestone is part of an ongoing collaboration with
the University of Hawaiʻi at Mānoa (UHM), demonstrating the
successful presentation of one or more antigen(s) within the same
formulation while maintaining full potency and thermostability,
including vaccines for Sudan
ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™).
It further demonstrates the broad applicability of the heat stable
vaccine platform, and its potential role in the United States (U.S.) Administration's
initiative for pandemic preparedness.
"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.
There are no licensed vaccines for either Sudan or Marburg viruses, while vaccines for
Zaire ebolavirus are
constrained by cold chain logistics. A heat stable vaccine in a
single vial format would significantly enhance any public health
preparedness or 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 at temperatures exceeding 100 degrees Fahrenheit. Having a
vaccine platform available such as this has the potential to
accelerate worldwide vaccination campaigns addressing future health
emergencies, including another global pandemic."
"Our next generation combined vaccine platform includes three
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 antigen in a single vial," stated
Oreola Donini, PhD, Senior Vice President and Chief Scientific
Officer of Soligenix. "Elements of this vaccine platform have also
been utilized in our ricin toxin (RiVax®) and COVID-19
vaccine (CiVax™) candidates, indicating its broad
applicability, including at least one-year thermostability at 40
degrees Celsius (104 degrees Fahrenheit). The ability to stably
package more than one vaccine candidate in a single vial platform
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, as well as work conducted
by Theodore Randolph, PhD,
Professor, Center for Pharmaceutical Biotechnology, Department of
Chemical and Biological Engineering at the University of Colorado, Boulder 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 Institutes of Health (NIH) grant (#R01-AI132323;
awarded to the University of Hawaiʻi) 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 using sterile water for injection immediately prior
to vaccination. 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.
The antigens and adjuvants used in our filovirus vaccines
represent the only recombinant subunit vaccines to date that have
demonstrated full protection against challenge with Zaire ebolavirus, Sudan ebolavirus and Marburg
marburgvirus in NHPs. Lyophilization of the antigens within
monovalent vaccine formulations has also been demonstrated to
thermostabilize the antigens at temperatures as high as 40 degrees
Celsius (104 degrees Fahrenheit) for up to 12 weeks, enabling
transport and storage at ambient temperature, even under
challenging conditions. No currently licensed lyophilized vaccine
that contains adjuvant is presented in a single vial format and
there are few reports of successfully using nano-emulsions in
lyophilized formulations. Previous work has demonstrated the use of
a single vial platform to co-lyophilize antigen(s) and a
nano-emulsion adjuvant, CoVaccine HT™, maintaining key adjuvant
stability characteristics including particle size and colloidal
stability, as well as maintaining immunogenicity. This most recent
milestone confirms the robust thermostabilization provided by this
vaccine platform.
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 family. 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, and involved over 26,000
confirmed/probable/suspected cases with an estimated death toll of
over 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.
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 are yet available for Marburg virus
(Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).
Filoviruses are one of the virus families identified as having
the ability to cause pandemics. On the heels of the COVID-19
pandemic the U.S. government is accelerating its investment in
pandemic preparedness, including having "the ability to rapidly
make vaccines effective against any virus family". Specific
initiatives have been spear-headed by the White House
and Biden-Harris administration, as evidenced by the "American
Pandemic Preparedness: Transforming Our Capabilities" white paper
released in September 2021.
About John A. Burns School of
Medicine, University of Hawaiʻi at
Mānoa
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 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, as well as 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, 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.
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, the Company's preliminary prospectus
(Registration No. 333-271049) filed with the SEC on May 4, 2023, and 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.