PRINCETON, N.J., Sept. 15, 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 publication of nonclinical results
characterizing filovirus protein antigens (including for Ebola and
Marburg viruses) and their thermostabilization. The article,
authored by collaborators at the University of
Colorado, University of Hawaiʻi at Mānoa (UHM) and
Soligenix, is titled, "Preservation of Quaternary Structure in
Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search
for Stability-Indicating Assays" and has been accepted for
publication in the Journal of Pharmaceutical Sciences. A
copy of manuscript has been made available here.
Under the Company's Public Health Solutions business segment,
ongoing collaborations with Axel
Lehrer, PhD, Associate Professor, Department of Tropical
Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM
and Hawaii Biotech Inc. (HBI), 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 heat stable subunit protein vaccine formulations for
filovirus vaccines. Protective efficacy has been demonstrated
in non-human primates against infection with Ebola virus,
Sudan virus, and Marburg
virus. 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). These most recent results demonstrate the
thermostabilization of three virus glycoproteins (from
Zaire ebolavirus,
Sudan ebolavirus and
Marburg marburgvirus), and the identification of key
stability-indicating assays to further support mono-, bi- and
tri-valent vaccine formulations.
"Filoviruses are endemic in areas of the world where the power
supply can be uncertain, making a thermostable vaccine particularly
valuable," stated Dr. Lehrer, "Our work to date has demonstrated
not only the feasibility of rapid and efficient manufacturing, but
also the applicability of thermostabilization and 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."
"The continued advances in the filovirus program demonstrates
the program's maturity and overall developability," noted Oreola
Donini, PhD, Senior Vice President and Chief Scientific Officer of
Soligenix. "The compatibility with thermostabilization, and
the identification of key stability indicating assays, are both
hallmarks of a potentially broadly applicable vaccine
platform. Using this platform, we also continue to accelerate
our joint COVID-19 vaccine effort, called CiVax™, with Dr. Lehrer
and look forward to further developments for both programs."
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). 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), 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 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,
SGX943, our therapeutic candidate for antibiotic resistant and
emerging infectious disease, and vaccine programs targeting both
filoviruses (such as Marburg and Ebola) and coronaviruses. 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
Biomedical Advanced Research and Development Authority (BARDA), and
the Defense Threat Reduction Agency (DTRA).
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, 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 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, or any of
our other clinical/preclinical trials. Despite the
statistically significant result achieved in the 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.