PRINCETON, N.J., Feb. 27, 2020 /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 its ongoing collaboration with the
University of Hawai'i at Manoa (UHM) and Hawaii Biotech Inc.
(HBI) has resulted in what the Company believes is a significant
milestone in the development of heat stable filovirus vaccines, in
which the platform has demonstrated feasible thermostable
formulations and protection in non-human primate models with both
monovalent and bivalent vaccine candidates in the three most deadly
human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).
Under the Company's Public Health Solutions business segment,
ongoing collaborations with Axel
Lehrer, PhD of the Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A. Burns School of Medicine
(JABSOM), UHM and HBI have demonstrated the feasibility of
developing heat stable subunit protein vaccines for
filovirus. Protective efficacy has been demonstrated in
non-human primates against infection with Ebola virus, Sudan virus, and Marburg
virus. Protection has been achieved with both monovalent and
bivalent vaccine combinations. Formulation conditions have been
identified to enable heat stabilization of each antigen, alone or
in combination, for at least 12 weeks at 40 degrees Celsius (104
degrees Fahrenheit). Soligenix and its collaborators are now
focusing specifically on accelerating development of a Marburg
virus (MARV) vaccine, which is one of the most deadly viruses and
has caused multiple disease outbreaks with significant mortality
since the 1960s and for which there exists no approved vaccine or
treatment.
"Filoviruses are endemic in areas of the world where the power
supply can be uncertain, making a thermostable vaccine particularly
valuable," stated Dr. Lehrer, Assistant Professor, Department of
Tropical Medicine, Medical Microbiology and Pharmacology at the
JABSOM. "Our work to date has demonstrated not only the
feasibility of rapid and efficient manufacturing, but also the
potential for a broadly applicable and easily distributed vaccine.
With Marburg virus continuing to be an unmet medical need of
priority to the US government, we are now focusing and accelerating
evaluations of the Marburg virus vaccine specifically."
"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 vaccines
currently in development," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "In concert with US government
feedback, we will now look to focus specifically on Marburg
virus."
About Filovirus Infection
Ebola Virus Disease 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 Marburg
virus. 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 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), including some cases 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 rate from filovirus infections are extremely high,
and can sometimes be 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 is no approved treatment
for Ebola or Marburg although research into both has accelerated
since the onset of the 2014 outbreak and significant progress has
been made in advanced clinical testing of immunotherapeutics for
Zaire ebolavirus. There is
an approved vaccine, requiring storage at less than -60 °C for
Ebola virus (Zaire
ebolavirus), but no protection is 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 John A. Burns School
of Medicine (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 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 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 Specialized
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 Public Health Solutions 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), the
Defense Threat Reduction Agents (DTRA) 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. 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 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 (including the outcome of the interim
analysis) or the Phase 3 clinical trial of SGX301 (synthetic
hypericin) for the treatment of cutaneous T-cell lymphoma.
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®. 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.