PRINCETON, N.J., Dec. 28, 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 the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), has awarded Soligenix a Direct to Phase II Small
Business Innovation Research (SBIR) grant of approximately
$1.5 million to support manufacture,
formulation (including thermostabilization) and characterization of
COVID-19 (Coronavirus Disease 2019) and EVD (Ebola Virus Disease)
vaccine candidates in conjunction with the CoVaccine HT™
(CoVaccine) adjuvant. This award also will support immune
characterization of this novel, emulsified adjuvant that has unique
potency and compatibility with lyophilization strategies to enable
thermostabilization of subunit vaccines.
CiVax™ is the Company's heat stable subunit vaccine candidate
for the prevention of COVID-19, the infection caused by
SARS-CoV-2. Ongoing collaborations with Axel Lehrer, PhD, Associate Professor
(Vaccinology) in the Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A.
Burns School of Medicine (JABSOM), University of Hawaiʻi at
Mānoa (UHM) have demonstrated the feasibility of developing a
highly immunogenic vaccine for COVID-19. With significant
research dedicated worldwide to the generation of COVID-19
vaccines, it is noteworthy that the essential attributes of a
vaccine successful in controlling the ongoing pandemic are believed
to include the ability to rapidly stimulate a Th1/Th2 balanced
antibody response, raising significant virus neutralizing
antibodies, as well as induce potent cell-mediated immunity.
Previous work with the CoVaccine adjuvant, which Soligenix licensed
from BTG Specialty Pharmaceuticals, a division of Boston Scientific
Corporation, has indicated that CoVaccine has these critical
characteristics. In addition, unlike other vaccine candidates
that have logistical challenges due to cold chain requirements (in
some cases requiring maintenance of temperatures less than -70
degrees Celsius), the underlying technology platform has
demonstrated the ability to produce single vial vaccines which are
stable up to temperatures at least as high as +40 degrees
Celsius.
The awarded grant enables detailed immunogenicity evaluation of
CoVaccine in the presence of either the SARS-CoV-2 Spike protein
antigen or the Zaire ebolavirus
glycoprotein antigen in both mice and non-human primates, and will
significantly enhance both vaccine programs. It also will
enable re-initiation of key CoVaccine manufacturing processes.
Many programs are focused on the development of vaccines for
COVID-19 and two vaccines have recently received Emergency Use
Approval by the FDA. However, the worldwide extent of the
problem suggests that a complete solution to the pandemic will
require parallel approaches. Moreover, there is the potential
need for annual vaccinations. The total number of vaccine
doses required to control the ongoing pandemic also suggests that
multiple vaccines, based on different manufacturing platforms, will
be necessary to efficiently vaccinate the worldwide
population. Subunit vaccines are considered the gold standard
for vaccine safety, but are relatively under-represented in
fast-tracked COVID-19 vaccine candidates to date. Unlike
virally vectored vaccines, there is no limit to the number of times
the adjuvant and antigen can be used and the typical safety profile
of a subunit vaccine results in a vaccine that is suitable for
immune compromised or elderly populations as well. Further,
while RNA vaccines are rapid to manufacture, the requirements for
cold chain distribution remain a real constraint.
"We are appreciative of the continued support provided by NIAID
for our thermostabilization program," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "This SBIR grant award will further
advance our studies with the CoVaccine adjuvant, as well as our
CiVax™ and filovirus vaccine programs. We remain dedicated to
progressing our Public Health Solutions business segment and look
forward to accelerating our CiVax™ program in particular with this
funding."
NIAID support is being provided through SBIR grant number 1 R44
AI157593-01.
About CiVax™
CiVax™ is the Company's heat stable subunit vaccine candidate
for the prevention of COVID-19, the infection caused by
SARS-CoV-2. 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, JABSOM, UHM have
demonstrated the feasibility of developing heat stable subunit
filovirus vaccines, including hemorrhagic disease caused by
Zaire ebolavirus,
Sudan ebolavirus as well as
Marburg marburgvirus, 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). In March
2020, Soligenix and its collaborators expanded the
technology platform to assess compatibility with vaccine candidates
targeting SARS-CoV-2, the cause of COVID-19.
The vaccine platform includes three essential components:
- 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;
- an adjuvant which has been shown to enhance both cell mediated
and humoral immunity; and
- a formulation which enables thermostabilization of the
resulting mixture, avoiding the need for cold chain storage and
shipping.
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. The protection of elderly and
immunocompromised populations are particularly important in the
context of COVID-19. The ability to provide a thermostabilized,
single vial vaccine, is particularly important in the context of
rapid and broad vaccine distribution.
These same components are now being applied to coronavirus
vaccine, using the well-defined surface glycoprotein, known as the
Spike protein, as the antigen. Nonclinical work in mice with a
prototype vaccine recently have been published, demonstrating the
ability of the CoVaccine adjuvant in combination with a prototype
antigen, to:
- stimulate immunity within 14 days after the first
vaccination;
- induce a balanced Th1 response, believed to be critical to
inducing immunity without aggravating disease pathology;
- induce a neutralizing antibody response; and
- induce a cell mediated immune response.
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 a suspected 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 urgent need for robust
technology platforms to rapidly develop new vaccines for novel
diseases. The only FDA sanctioned treatments for COVID-19 are
available under Emergency Use Authorization. There are
currently two vaccines available under FDA Emergency Use
Authorization.
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 our research
programs to identify and develop novel vaccine candidates targeting
viral infection including Ebola, Marburg and SARS-CoV-2 (the cause
of COVID-19). 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, 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. 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.