PRINCETON, N.J., May 11, 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 immunogenicity studies
for RiVax® (heat stable
ricin toxin vaccine) identifying novel correlates of immune
protection to facilitate potential approval under the United States
Food and Drug Administration (FDA) "Animal Rule." The
article, titled "A Multivariate Model Combining Endpoint and
Epitope-specific Antibody Responses as a Correlate of Protection to
Ricin Toxin," has been submitted to the peer-reviewed medical
journal Vaccine and a preprint is available here.
RiVax® is the Company's vaccine
candidate for the prevention of death following exposure to a
lethal dose of ricin toxin using a unique antigen that is
completely devoid of the toxic activity of ricin. Further
formulated by Soligenix to have enhanced thermostability,
RiVax® has demonstrated up to 100%
protection in mice and non-human primates (NHPs) subsequently
exposed to lethal doses of ricin toxin either systemically or by
aerosol. In studies conducted in collaboration with the
laboratory of Dr. Nicholas Mantis,
Research Scientist, Division of Infectious Diseases, Wadsworth
Center, New York State Department
of Health, species independent tests to evaluate the protective
immunogenicity of the vaccine were developed. These tests
will facilitate potential approval of
RiVax® under the FDA Animal Rule which
requires the evaluation of efficacy in animals
(RiVax® has demonstrated up to 100%
protection in NHPs exposed to lethal aerosolized ricin), safety in
humans (the RiVax® antigen has been
demonstrated to be well-tolerated in human Phase 1 clinical
studies) and immunogenicity correlated between animal models and
humans.
"These results continue to reinforce the link between the
antibody response to the vaccination and the potency of the
RiVax® vaccine," stated Dr.
Oreola Donini, Chief Scientific Officer of Soligenix. "This,
and other ongoing work in our collaboration with Dr. Mantis and his
team, has continued to corroborate the efficacy of
RiVax® and will facilitate its
potential approval."
Approval for RiVax® will
be pursued under the FDA "Animal Rule," which is applied to
products where testing in clinical efficacy trials would be
unethical. In the case of a ricin toxin vaccine, clinical
efficacy testing of the vaccine is unethical since it would require
intentionally exposing humans to ricin toxin. The Animal Rule
is generally associated with the approval of medical
countermeasures for biodefense purposes.
In addition to being protective and thermostable,
RiVax® has demonstrated that a reduced
number of vaccinations may establish protection, potentially
utilizing only two doses instead of three.
RiVax® studies are supported by a
contract (# HHSN272201400039C) award of up to $21.2 million from the National Institute of
Allergy and Infectious Diseases (NIAID). Non-dilutive funding
for the development of RiVax® has exceeded
$40 million to date.
RiVax® has received Orphan Drug
designations from both the FDA and European Medicines Agency (EMA)
and, upon approval, has the potential to qualify for a biodefense
Priority Review Voucher (PRV).
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and potential
biological weapon because of its stability and high potency, and
the fact that it is readily extracted from by-products of castor
oil production. Ricin comes in many forms including powder,
mist or pellet. Ricin can also be dissolved in water and
other liquids. The US Centers for Disease Control and
Prevention estimates that the lethal dose in humans is about the
size of a grain of salt. Ricin toxin illness causes tissue
necrosis and general organ failure leading to death within several
days of exposure. Ricin is especially toxic when
inhaled. Ricin works by entering cells of the body and
preventing the cells from making the proteins they need.
Without the proteins, cells die, which is eventually harmful to the
entire body.
There are currently no effective treatments for ricin
poisoning. The successful development of an effective vaccine
against ricin toxin may act as a deterrent against the actual use
of ricin as a biological weapon and could be used to vaccinate
military personnel and civilian emergency responders at high risk
of potential exposure in the event of a biological attack.
About RiVax®
RiVax® is Soligenix's proprietary heat
stable recombinant subunit vaccine developed to protect against
exposure to ricin toxin, the threat of which has been highlighted
in the news with an envelope addressed to President Trump that was
thought to contain this potent and potentially lethal toxin.
With RiVax®, Soligenix is a world leader in
the area of ricin toxin vaccine research.
RiVax® contains a genetically altered
version of a Ricin Toxin A (RTA) chain containing two mutations
that inactivate the toxicity of the ricin molecule which was
originally invented at the University of
Texas Southwestern. Phase 1 clinical studies to date
have demonstrated the safety of the antigen and adjuvant, as well
as the generation of ricin neutralizing antibodies which are
increased in the presence of the alum adjuvant. In animal
studies, the alum formulation of RiVax® also induced
higher titers and longer-lasting antibodies than the adjuvant-free
vaccine. Vaccination with the thermostabilized
alum-adjuvanted RiVax® formulation in a large animal
model provided 100% protection (p<0.0001) against acute exposure
to aerosolized ricin, the most lethal route of exposure for
ricin. The protected animals also had no signs of gross lung
damage, a serious and enduring ramification with long-term
consequences for survivors of ricin exposure. These results
are described in a publication available here.
Heat stabilization of RiVax® is achieved
with the Company's proprietary ThermoVax®
technology, designed to eliminate the cold-chain production,
distribution and storage logistics required for most
vaccines. The technology utilizes precise lyophilization of
protein immunogens with conventional aluminum adjuvants in
combination with secondary adjuvants for rapid onset of protective
immunity with the fewest number of vaccinations. By employing
ThermoVax® during the final formulation of
RiVax®, the vaccine has demonstrated enhanced stability
and the ability to withstand temperatures at least as high as 40
degrees Celsius (104 degrees Fahrenheit) for up to one year. These
results are described in a publication available here.
The development of RiVax® has been
funded through a series of grants from both the NIAID and the FDA
and ongoing development is sponsored by NIAID contract
#HHSN272201400039C. Non-dilutive funding for the development of
RiVax® has exceeded $40 million to date.
RiVax® is being developed under the FDA
"Animal Rule" and potentially would be added to the Strategic
National Stockpile and dispensed in the event of a terrorist
threat. RiVax® has received orphan
drug designation in the US and in Europe.
As a new chemical entity, an FDA approved
RiVax® vaccine has the potential to qualify
for a biodefense PRV, which allows the holder accelerated review of
a drug application. Approved under the 21st Century Health
Cures Act in late 2016, the biodefense PRV is awarded upon approval
as a medical countermeasure when the active ingredient(s) have not
been otherwise approved for use in any context. PRVs are
transferable and can be sold, with sales in recent years in excess
of $100 million. When redeemed,
PRVs entitle the user to an accelerated review period of six
months, saving a median of seven months' review time as calculated
in 2009. However, the FDA must be advised 90 days in advance
of the use of the PRV and the use of a PRV is associated with an
additional user fee ($2.1 million in
2020).
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.