PRINCETON, N.J., April 16, 2020 /PRNewswire/ -- Soligenix,
Inc. (Nasdaq: SNGX) ("Soligenix"), 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 has executed an agreement for the exclusive worldwide
license of CoVaccine HT™, a novel vaccine adjuvant, from BTG
Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific
Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the
cause of COVID-19 and pandemic flu.
CoVaccine HT is a novel adjuvant, which has been shown to
enhance both cell-mediated and antibody-mediated immunity.
Soligenix and its collaborators, including the University of
Hawaiʻi at Mānoa and Dr. Axel
Lehrer, have successfully demonstrated the utility of
CoVaccine HT in the development of its heat stable filovirus
vaccine program, with vaccine candidates against Ebola and Marburg
virus disease. Given this previous success, CoVaccine HT will
potentially be an important component of Soligenix's vaccine
technology platform currently being assessed for use against
coronaviruses including SARS-CoV-2, the cause of COVID-19.
"BTG has a long track record of technological innovation in the
production of antibodies for rescue medicines. We're pleased that,
in the hands of Soligenix, CoVaccine HT could potentially play a
role in helping to address the current pandemic," said Anthony Higham, President of BTG.
"We are very excited to include CoVaccine HT into our heat
stable vaccine platform technology. It has the potential to provide
a distinct advantage over other vaccines currently in development,"
stated Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "With the rapid
advancement of the vaccine platform, we feel the program is
optimally poised to look at other viruses, including
coronaviruses."
The agreement was executed between Soligenix and Protherics
Medicines Development, one of the companies that make up the BTG
Specialty Pharmaceutical business, which owns the CoVaccine HT
intellectual property. Terms of the deal are not being
disclosed.
About CoVaccine HT™ Adjuvant
An adjuvant is a substance which enhances the immune response
and so helps maximize the production of antibodies. The CoVaccine
HT adjuvant is a sucrose fatty acid sulphate ester that increases
both humoral and cell-mediated immune responses to experimental
vaccines following intramuscular administration.
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 are also 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,
the global impact of this emerging infection demonstrates the need
for a robust technology platform to rapidly develop new vaccines
for novel diseases. There is currently no approved treatment for
any coronavirus infection, nor any approved vaccine.
About BTG Specialty Pharmaceuticals
BTG Specialty Pharmaceuticals, a division of Boston Scientific
Corporation, provides rescue medicines typically used in emergency
rooms and intensive care units to treat patients for whom there are
limited treatment options. BTG is dedicated to the
development, manufacture, and commercialization of quality
medicines that make a real difference to patients and their
families. BTG's current portfolio of antidotes
counteracts certain snake venoms and the toxicity associated
with some heart and cancer medications. To learn more, please
visit: btgsp.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 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. 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.