PRINCETON, N.J., July 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 publication of pre-clinical
immunogenicity studies for its CiVax™ program (heat stable COVID-19
vaccine), demonstrating immunity of both broad-spectrum antibody
and cell-mediated, rapid onset immunity is possible using the
CoVaccine HT™ (CoVaccine) adjuvant. The article, authored by
collaborators at the University of Hawaiʻi at Mānoa (UHM), is
titled, "CoVaccine HT™ adjuvant potentiates robust immune responses
to recombinant SARS-CoV-2 spike-S1 immunization," and has been
submitted for peer-review to the journal npj Vaccines. An
accelerated preprint of the manuscript has been made available
here.
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, Assistant Professor in the
Department of Tropical Medicine, Medical Microbiology and
Pharmacology, John A. Burns School of Medicine (JABSOM), UHM have
demonstrated the feasibility of developing a broadly 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 balanced antibody response,
including an enhanced Th1 response, which includes raising
significant virus neutralizing antibodies and potent cell-mediated
immunity, demonstrated by T-cell activation. 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 these results, Lehrer and his colleagues
now demonstrate these attributes of CoVaccine, specifically in the
context of SARS-CoV-2. Moreover, these results, using a
prototype antigen, also demonstrate a rapid onset of immunity with
antibody responses detected within 14 days after the first
vaccination.
Many programs have been initiated seeking a vaccine for
COVID-19, but the novelty of the virus and previous challenges
developing potent vaccines for the related SARS-CoV (Severe Acute
Respiratory Syndrome Coronavirus) and MERS-CoV (Middle East
Respiratory Syndrome Coronavirus), suggest that a timely solution
requires parallel approaches. 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. In contrast, while RNA
and DNA vaccines are rapid to manufacture, there is a lack of
regulatory precedent (no RNA or DNA vaccine has been approved to
date).
"Our work to date has demonstrated not only the feasibility of
rapid and efficient manufacturing of the required vaccine antigens,
but also the potential for a broadly applicable and easily
distributed vaccine," stated Dr. Lehrer. "We are delighted
with our earlier successes on development of filovirus and
flavivirus vaccines with this platform. The results in our
latest manuscript confirm that the advantages of our vaccine
platform with the CoVaccine adjuvant can also be realized in the
context of SARS-CoV-2, while we continue our work to rapidly
advance development of a heat stable subunit COVID-19 vaccine in
collaboration with Soligenix."
"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 COVID-19
vaccines currently in development and simplifies worldwide
distribution," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "Our approach appears to be unique in its use of a
well-established, well-understood, and safe, subunit platform
coupled with a novel adjuvant and a thermostabilizing
formulation. We are very encouraged with the latest results
and look forward to continuing to advance development of
CiVax™."
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 is
currently no approved vaccine.
About John A. Burns School of Medicine, University of Hawai'i
at Manoa
The John A. Burns School of Medicine (JABSOM) at the UHM 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 state.
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.