PRINCETON, N.J., Aug. 23, 2021 /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 formulation
of single-vial platform presentations of monovalent (single
antigen), bivalent (two antigens) and trivalent (three antigens)
combinations of filovirus vaccine candidates. In
collaboration with University of Hawaiʻi at Mānoa (UHM) and
University of Colorado (UC) co-authors,
the manuscript entitled "Single-Vial Filovirus Glycoprotein
Vaccines: Biophysical Characteristics and Immunogenicity after
Co-lyophilization with Adjuvant", has been published in
Vaccine.
The antigens and adjuvants used in this study have been
previously demonstrated to protect non-human primates
(NHPs) from subsequent infection. 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 storage at ambient temperature. 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 these lyophilized formulations. The
published paper describes 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. Further, antibody responses
previously shown for monovalent vaccines were maintained in both
mice and NHPs for the trivalent single-vial co-lyophilized vaccine
candidates. Most recently, one of these trivalent formulations has
also been shown to protect 75% of vaccinated NHPs against
subsequent Sudan ebolavirus
challenge, with further development to test efficacy against other
filovirus infections ongoing.
"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 (JABSOM), 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 like the one we are unfortunately experiencing with
COVID-19."
"Our 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 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
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 Institute of Health (NIH) grant R01-AI132323 (awarded
to the University of Hawaii) 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 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).
About John A. Burns School of
Medicine, University of Hawai'i at Manoa
The University of Hawai'i at
Manoa is one of the most
ethnically diverse institutions of higher education. Hawai'i's
cultural diversity and geographical setting affords the JABSOM a
unique research environment to excel in health disparity research.
JABSOM faculty bring external funding of about $40 million annually into Hawai'i.
About the University of Colorado
Center for Pharmaceutical Biotechnology
The University of Colorado Center for Pharmaceutical
Biotechnology is a research consortium operated jointly between the
University of Colorado, Boulder, and
the University of Colorado Anschutz
Medical Campus. Housed within the Departments of Chemical and
Biological Engineering and the Skaggs School of Pharmacy, the
Center works with pharmaceutical industry partners to address
questions regarding stability and delivery of biopharmaceutical
drugs and vaccines.
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) and acute radiation enteritis
(SGX201).
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.