PRINCETON, N.J., June 13, 2019 /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 Dr. Oreola Donini, Chief
Scientific Officer, will be presenting data from the ricin toxin
vaccine (RiVax®) program describing
development of the vaccine under the Food and Drug Administration
(FDA) Animal Rule. The presentation will be given at the
upcoming 13th Annual CounterACT Network Research Symposium on
June 18-20, 2019 to be held at the
New York Academy of Sciences, NY.
Oral Presentation:
RiVax: Protection against Inhaled Ricin
Intoxication presented by Dr. Oreola Donini, Chief
Scientific Officer, Soligenix, Inc., on June
18, 2019 from 2:00-2:15 PM
EDT.
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. The
RiVax® antigen has demonstrated safety
in two Phase 1 clinical studies. When formulated using
Soligenix's proprietary heat stabilization technology
(ThermoVax®), RiVax® has
demonstrated significantly enhanced thermostability and 100%
protection in non-human primates in preclinical aerosol challenge
models. RiVax® is being developed under the FDA
Animal Rule, one of the topics of discussion at the CounterACT
Research Symposium.
The development of RiVax® has been
sponsored through a series of grants from both National Institute
of Allergy and Infectious Diseases (NIAID) and the Food and Drug
Administration (FDA) and ongoing development is sponsored by NIAID
contract # HHSN272201400039C.
About 13th Annual CounterACT Network Research
Symposium
The CounterACT program is sponsored by the National
Institute of Health and its primary purpose is to integrate
research with the latest technological advances in science and
medicine for a more rapid and effective response to chemical
emergencies. The Research Symposium is presented by
Rutgers University, New York Medical College, and the New York Academy
of Sciences and will bring together chemists, toxicologists, drug
developers, pharmacists, clinicians, and public health researchers.
More information about the 13th Annual CounterACT
Network Research Symposium can be found here.
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 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 it needs. 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 recent 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. 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 sponsored through
a series of grants from both NIAID, and the FDA and ongoing
development is sponsored by NIAID contract
#HHSN272201400039C. The planned Phase 2 clinical trial is
contingent upon exercise of the final option by the U.S. government
under NIAID contract #HHSN272201400039C and/or through other
funding sources. RiVax® potentially would be added
to the Strategic National Stockpile and dispensed in the event of a
terrorist attack. RiVax® has received orphan drug
designation in the U.S. 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 ($2.7 million in
2017).
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 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 Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
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) 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 timing or success of the
preclinical/clinical trials of RiVax®,
that RiVax® will be approved for the PRV
program or the amount for which a PRV
for RiVax® can be sold. 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.