PRINCETON, N.J., Sept. 25, 2017 /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 Soligenix will be participating in a
Research Project (R01) grant awarded to the University of Hawai'i
at Manoa (UH Manoa) for the development of a thermostabilized Ebola
vaccine, with Soligenix awarded funding of approximately
$700,000 over 5 years.
Previous collaborations with Axel
Lehrer, PhD of the Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A. Burns School of Medicine
(JABSOM), UH Manoa and Hawaii Biotech, Inc. (HBI) demonstrated the
feasibility of developing a heat stable subunit Ebola
vaccine. Under the terms of the subaward, Soligenix will
continue to support vaccine formulation development with its
proprietary vaccine thermostabilization technology,
ThermoVax®. Ultimately, the objective
is to produce a thermostable trivalent filovirus vaccine for
protection against Ebola and related diseases, allowing worldwide
distribution without the need for cold storage.
The most advanced Ebola vaccines involve the use of vesicular
stomatitis virus (VSV) and adenovirus vectors – live, viral vectors
which complicate the manufacturing, stability and storage
requirements. Dr. Lehrer's vaccine is based on highly
purified recombinant protein antigens, circumventing many of these
manufacturing difficulties. Dr. Lehrer and HBI have developed
a robust manufacturing process for the required proteins.
Thermostabilization may allow for a product that can avoid the need
for cold-chain distribution and storage, yielding a vaccine ideal
for use in both the developed and developing world.
"Filoviruses are endemic in areas of the world where the power
supply can be uncertain, making a thermostable Ebola vaccine
particularly valuable," stated Dr. Lehrer, Assistant Professor,
Department of Tropical Medicine, Medical Microbiology and
Pharmacology at the JABSOM. "We are delighted to have been
awarded this grant to further develop a thermostabilized subunit
vaccine for Ebola and look forward to continuing our collaboration
with Soligenix."
"We believe that creating a vaccine with enhanced stability at
elevated temperatures, which can obviate the costs and logistical
burdens associated with cold chain storage and distribution, has
the potential to provide a distinct advantage over other Ebola
vaccines currently in development," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "Work with the Ebola vaccine
expands upon our thermostabilization platform which has already
been successfully utilized with other heat sensitive vaccine
candidates, such as for ricin toxin, and anthrax. We continue
to actively pursue government grants and contracts across our
entire biodefense and biotherapeutics pipeline and are appreciative
of the ongoing support, with non-dilutive awards now exceeding
$8M in 2017."
About Ebola
Ebola Virus Disease (EVD) is caused by one of five species of
Ebolavirus, four of which cause disease in humans, including its
best-known member, Zaire Ebolavirus (Ebola virus). All
species of Ebolavirus belong to the Filoviridae family, a family
that further contains the equally human pathogenic
Marburgvirus. The Ebola virus is believed to be harbored in
various animal species in Africa,
although the specific reservoir host is still unknown. There
have been several known EVD outbreaks in Africa since 1976, with the largest outbreak
starting in 2014 in Western
Africa.
Transmission of Ebola requires direct contact of bodily fluids
from an infected person or contact with infected animals. The
mortality rate from Ebola infection is extremely high, and can
sometimes be affected by the quality of supportive care available
with a focus on early initiation of treatment. Symptoms of
Ebola virus infection include high fever, severe headache, muscle
pain, weakness, fatigue, diarrhea, vomiting, abdominal pain and
unexplained hemorrhage. Resolution of the disease largely
depends on the patient's own immune system. There is no
approved treatment and no approved vaccine for Ebola, although
research into both has accelerated since the onset of the 2014
outbreak.
The Ebola outbreak in 2014 primarily spanned three West African
countries, 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), including
some cases in Europe and the
United States. The widespread nature of the infection and its
devastating impact has further illustrated the need to develop an
Ebola vaccine to prevent future and possibly more significant
outbreaks.
About ThermoVax®
The ThermoVax® technology is designed to eliminate
the cold chain production, distribution and storage logistics
required for most vaccines. The technology utilizes precise
lyophilization of protein immunogens with conventional aluminum
adjuvants in combination with secondary adjuvants for rapid onset
of protective immunity with the fewest number of vaccinations. Cold
chain requirements add considerable cost to the production and
storage of current conventional vaccines. Elimination of the cold
chain would also enhance the utility of these vaccines for emerging
markets and for other applications requiring but lacking reliable
cold chain capabilities. For vaccines that are intended for
long-term stockpiling, such as for use in biodefense or in pandemic
situations, the utilization of ThermoVax® has the
potential to facilitate easier storage and distribution of
Strategic National Stockpile vaccines in emergency situations.
The underlying ThermoVax® technology has been
developed by Drs. John Carpenter and
Theodore Randolph at the
University of Colorado.
By employing ThermoVax® during the final formulation
of RiVax®, the vaccine has demonstrated enhanced
stability and the ability to withstand temperatures at least as
high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one
year. Similar stabilization at temperatures as high as 50 degrees
Celsius for up to 3 months (maximum timepoint tested) have also
been demonstrated with other antigens (e.g., human papillomavirus,
Ebola and anthrax).
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 John A. Burns School
of Medicine (JABSOM) a unique research environment to excel in
health disparity research. JABSOM faculty bring external funding of
about $42 million annually into
Hawai'i.
About Hawaii Biotech, Inc.
Hawaii Biotech (HBI) is a privately held biotechnology company
focused on the development of prophylactic vaccines for established
and emerging infectious diseases and anti-toxin drugs for
biological threats. HBI has developed proprietary expertise in the
production of recombinant proteins that have application to the
manufacture of safe and effective vaccines, diagnostic kits, and as
research tools. HBI completed successful first-in-human Phase 1
clinical studies with both West Nile virus and dengue vaccines in
healthy human subjects. HBI has developed a product pipeline of
recombinant subunit vaccines, including vaccine candidates for West
Nile virus, tick-borne flavivirus, malaria, Crimean-Congo
hemorrhagic fever, and Ebola. The company is also continuing
the development of small molecule anti-toxin drugs for anthrax and
botulism. HBI, founded in Hawaii
in 1982, is headquartered in suburban Honolulu. For more information, please visit:
www.hibiotech.com.
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 BioTherapeutics business
segment is developing SGX301 as a novel photodynamic therapy
utilizing safe visible light for the treatment of cutaneous T-cell
lymphoma, our first-in-class innate defense regulator (IDR)
technology, dusquetide (SGX942) for the treatment of 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 Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, OrbeShield®, our GI acute radiation syndrome
therapeutic candidate and SGX943, our therapeutic candidate for
antibiotic resistant and emerging infectious disease. 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) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
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. These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. 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. 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 US 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 US 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 the Phase 3 clinical trial of SGX942
(dusquetide) as a treatment for oral mucositis in patients with
head and neck cancer receiving chemoradiation therapy and the Phase
3 clinical trial of SGX301 (synthetic hypericin) for the treatment
of cutaneous T-cell lymphoma. 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.