PRINCETON, N.J., Feb. 13, 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 its RiVax® (heat stable
ricin toxin vaccine) development program for prevention of ricin
intoxication has received "Fast Track" designation from the US Food
and Drug Administration (FDA).
Fast track is a designation that the FDA reserves for a drug
intended to treat a serious or life- threatening condition and
one that demonstrates the potential to address an unmet medical
need for the condition. Fast track designation is intended to
facilitate the development and expedite the review of new drugs and
biologics. For instance, should events warrant, Soligenix will
be eligible to submit a biologics license application (BLA) for
RiVax® on a rolling basis, permitting the FDA to
review sections of the BLA prior to receiving the complete
submission. Additionally, BLAs for fast track development
programs ordinarily will be eligible for priority review, which
imparts an abbreviated review time of approximately six months.
"We are very pleased to have been granted fast track designation
from the FDA to go along with the orphan drug designation
previously received," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "We believe that the FDA's action in granting fast
track designation validates the unmet medical need that currently
exists for a vaccine providing protection against lethal ricin
toxin exposure and for the potential key role
RiVax® can serve as a part of the US Strategic
National Stockpile."
The development of RiVax® has been funded through a
series of grants from both the National Institute of Allergy and
Infectious Diseases (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.
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 recently
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. A Phase 1A clinical trial was
conducted with a formulation of RiVax® that did not
contain an adjuvant. This trial revealed dose dependent
seroconversion as well as lack of toxicity of the molecule when
administered intramuscularly to human volunteers. The
adjuvant-free formulation of RiVax® induced toxin
neutralizing antibodies that lasted up to 127 days after the third
vaccination in several individuals.
To increase the longevity and magnitude of toxin neutralizing
antibodies, RiVax® was subsequently formulated with an
adjuvant of aluminum salts (known colloquially as alum) for a Phase
1B clinical trial. Alum is an
adjuvant that is used in many human vaccines, including most
vaccines used in infants. The results of the Phase
1B study indicated that
alum-adjuvanted RiVax® was safe and well tolerated, and
induced greater ricin neutralizing antibody levels in humans than
adjuvant-free RiVax®. 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 National Institute of Allergy and
Infectious Diseases (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 Priority
Review Voucher (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, OrbeShield®, our GI acute radiation syndrome
therapeutic candidate and SGX943, our therapeutic candidate for
antibiotic resistant and emerging infectious disease. 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 U.S.
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 U.S. 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 the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. 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.