PRINCETON, N.J., Sept. 3, 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 it will be hosting an Investor Webcast
Event Thursday, September 10, 2020,
from 4:00 – 5:00 pm Eastern Time on
the use of its thermostabilized glycoprotein vaccine platform for
the development of a COVID-19 vaccine, called CiVax™.
Utilizing a novel adjuvant, CoVaccine HT™, the platform has
yielded a prototype vaccine with strong induction of both cell
mediated and neutralizing antibody immunity in preclinical studies.
More recent work with recombinant, affinity-purified SARS-CoV-2
Spike protein antigens have demonstrated similarly compelling data
as well as an ability to induce a strong antibody response within 7
days of the initial vaccine dose. Combined with the previously
demonstrated ability of this platform to produce heat stable
vaccines at temperatures exceeding 100 degrees fahrenheit (40
degrees Celsius), which can be shipped and stored at ambient
temperatures, as well as the accepted safety of protein vaccines
also in higher-risk populations, such as the young, elderly and
immunocompromised, the CiVax™ program has the potential to
yield an easily distributed and broadly applicable vaccine to
address both the immediate emergency of the COVID-19 pandemic and
any potential need for future seasonal vaccinations. Preliminary
results with the prototype vaccine are available at the following
link:
https://www.biorxiv.org/content/10.1101/2020.07.24.220715v1.
Conference Call Thursday, September 10 at 4:00 pm
Eastern Time
The Company will share information on its thermostabilized
glycoprotein vaccine platform for the development of a COVID-19
vaccine on Thursday, September 10, 2020 during a webcast
event. A question and answer (Q&A) session with the featured
experts and management will follow the presentations. If you would
like to ask a question during the Q&A, please submit your
request via email to ir@soligenix.com at least 15 minutes
prior to the scheduled start of the call. For a more detailed
technical response, you are encouraged to e-mail questions no later
than September 8, 2020.
Live Event:
https://www.webcaster4.com/Webcast/Page/2498/37323
U.S. toll free: 1-866-652-5200
International: 1-412-317-6060
Please request to be entered into the Soligenix call.
An audio recording and transcript of the presentation will be
archived for 30 days following the event.
The Investor Event will include presentations from the
following:
Dr. Axel Lehrer, Associate
Professor, Dept. of Tropical Medicine, University of Hawaiʻi at
Mānoa, School of Medicine
Dr. Oreola Donini, Chief Scientific Officer of
Soligenix
Mr. Dan Ring, Vice
President, Business Development of Soligenix
Dr. Christopher J Schaber, President and Chief Executive
Officer of Soligenix
Featured Expert Biographical Background
Axel Lehrer, PhD
Axel Lehrer, Dr. rer. nat.,
Associate Professor, Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A.
Burns School of Medicine (JABSOM), University of Hawaiʻi at
Mānoa (UHM). Dr. Lehrer has been researching vaccines since 2002 in
both commercial and academic settings. He has primarily worked on
developing vaccines for filoviruses such as Ebola virus, but also
contributed to the development of flavivirus vaccines (Zika virus,
Tick-borne encephalitis (TBE) virus, West Nile virus and Dengue
virus). His research mostly employs recombinant viral subunits
expressed and purified from an insect cell expression system. Dr.
Lehrer's is trained in biochemistry, molecular biology, virology,
as well as immunology and his research has received funding from
NIH and other federal sources.
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:
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 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. Pre-clinical work in mice with a
prototype vaccine recently have been made available, 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. With more than 25 million cases and over
800,000 fatalities, 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 in the US or EU, even though there is
an intense global effort under way to develop vaccines using a
variety of platforms.
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. 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.