PRINCETON, N.J., March 23, 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 Hawaiʻi at Mānoa (UH Mānoa) is being expanded to
assess potential coronavirus vaccines (including COVID-19).
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), UH Mānoa have demonstrated the feasibility of developing
heat stable subunit filovirus vaccines, including Ebola virus
disease caused by either Zaire or
Sudan ebolavirus variants, as well
as Marburg virus disease, 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 expanding the technology
platform to assess compatibility with coronaviruses including
SARS-CoV-2, the cause of COVID-19.
The vaccine platform includes three essential components:
1) a protein antigen,
specifically a viral surface glycoprotein, which mediates entry and
fusion of the virus with host cells and is manufactured with a
proprietary insect cell expression system coupled with
protein-specific affinity purification;
2) an adjuvant which has been shown to enhance both cell
mediated and humoral immunity; and
3) a formulation which enables thermostabilization of
the resulting mixture, avoiding the need for cold chain storage and
The resulting vaccine is broadly applicable, including to
individuals often excluded from common viral vector vaccine
approaches such as children, the elderly and the immunocompromised.
These same components can now be applied to coronavirus vaccine,
using well-defined surface glycoprotein(s) from one or more
coronaviruses, which will include key antigens expected to be
protective for COVID-19. The protection of elderly and
immunocompromised populations are particularly important in the
context of COVID-19.
"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. We are delighted
with our successes on development of filovirus and flavivirus
vaccines using our platform and look forward to accelerated studies
with the coronaviruses," stated Dr. Lehrer, Assistant Professor,
Department of Tropical Medicine, Medical Microbiology and
Pharmacology at the JABSOM.
"It is rewarding to see ongoing work by JABSOM investigators and
collaborators expanding on successful research on filovirus
vaccines (protecting against viruses such as Ebola and Marburg
virus) that may help us make unique life-saving contributions
during this difficult time in healthcare. The prospect of a science
lab in Hawaiʻi helping develop a vaccine amid the COVID-19 pandemic
is a testament to the importance of local research in Hawaiʻi,"
stated JABSOM Dean Jerris R. Hedges, MD, MS, MMM.
"We believe that creating a vaccine with enhanced stability at
elevated temperatures that 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 and simplifies worldwide distribution,"
stated Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "With the rapid
advancement of the filovirus vaccine platform, we feel the program
is optimally poised to look at other viruses and infections,
About Coronavirus Infection
Coronavirus infections can cause a wide spectrum of disease in
humans, ranging from a common cold to a more severe respiratory
infection, such as Severe Acute Respiratory Syndrome (SARS) and
Middle East Respiratory Syndrome (MERS), which have a case
mortality rate of approximately 10% and 30%, respectively.
Similar to filoviruses, coronaviruses also are endemic in wildlife
populations and can be transmitted to humans with close contact.
The COVID-19 outbreak, caused by SARS-COV-2, is the most recent
example of species crossover seen with this virus family.
Although the case fatality rate of COVID-19 is still under
investigation, COVID-19 has been declared a global pandemic by the
World Health Organization. The global impact of this emerging
infection demonstrates the need for robust technology platforms to
rapidly develop new vaccines for novel diseases. There is currently
no approved treatment for any coronavirus infection, nor any
About John A. Burns School of Medicine, University of Hawai'i
The John A. Burns School of Medicine (JABSOM) at the University
of Hawai'i at Mānoa is one of the leading medical education
institutions in the United States. For the last three years,
JABSOM has been a leader in National Institutes of Health research
awards among community-based public medical schools (i.e., public
medical schools without a university hospital). JABSOM has also
been a leader in the rate of MD graduates (who are also residency
trained in state) retained as practitioners in-state. In addition,
Hawai'i's cultural diversity and geographical setting affords
JABSOM a unique research environment to excel in health disparity
research. JABSOM faculty bring external funding of about
$40 million annually into the
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, or any of our other clinical/preclinical
trial. 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.
SOURCE Soligenix, Inc.