PRINCETON, N.J., Dec. 8, 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 has demonstrated extended
protection with its heat stable ricin toxin vaccine,
RiVax®. Mice, vaccinated twice on Days 1 and 21 were
protected for at least 365 days against subsequent ricin challenge.
These results demonstrate that the thermostabilized vaccine
formulation is capable of eliciting enduring protection in mice.
Coupled with previous demonstration of efficacy in mice and
non-human primates (NHPs) as well as long-term thermostability (at
least 1 year at 40°C or 104°F), these results reinforce the
practicality of stockpiling and potentially utilizing the
RiVax® vaccine in warfighters and civilian first
responders without the complexities that arise for vaccines that
require cold chain handling. This same thermostabilization approach
is also being advanced in the development of Soligenix's CiVax™
vaccine for COVID-19.
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. Formulated
by Soligenix to have enhanced thermostability,
RiVax® has demonstrated up to 100%
protection in mice and NHPs subsequently exposed to lethal doses of
ricin toxin either systemically or by aerosol. Most recently,
mice have been shown to be protected from ricin challenge at 10
times the lethal dose for at least 12 months
post-vaccination.
"These results continue to reinforce the convenience and
practicality of the RiVax® vaccine," stated Dr. Oreola
Donini, Chief Scientific Officer of Soligenix. "This, and
other ongoing work, has continued to corroborate the efficacy of
RiVax® and will facilitate its
potential approval."
Approval for RiVax® will
be pursued under the US Food and Drug Administration (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. The
Animal Rule 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 (biomarkers have been identified, see publication here).
RiVax® studies are supported by a
contract (# HHSN272201400039C) award of approximately $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 and
Fast Track designations from the FDA, and, upon approval, has the
potential to qualify for a biodefense Priority Review
Voucher (PRV). In addition,
RiVax® has received Orphan Drug
designation from the European Medicines Agency (EMA).
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and is considered
both a bioterrorism agent and a chemical warfare agent 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 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.