PRINCETON, N.J., June 21, 2017 /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 the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health, has exercised an option for the evaluation of
RiVax® to fund additional animal efficacy studies. The
overall objectives of the contract are to advance the development
of Soligenix's thermostabilization technology,
ThermoVax®, in combination with the Company's ricin
toxin vaccine, RiVax®, as a medical countermeasure to
prevent the effects of ricin exposure.
The exercised option for contract #HHSN272201400039C will
provide Soligenix with approximately $2M in additional funding, bringing the total
amount awarded to date under this contract to $18.7M. If all contract options are
exercised, the total award of up to $24.7
million will support the preclinical, manufacturing and
clinical development activities necessary to advance heat stable
RiVax® with the US Food and Drug Administration
(FDA).
"The exercise of this option demonstrates the positive and
productive collaboration between NIAID and the Soligenix team,"
stated Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "We look
forward to accelerating our work with NIAID and engaging the FDA to
advance the RiVax® program. We thank the NIAID team for
its continued support and contribution to the Soligenix development
program."
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 in rapid deployment scenarios
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. 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
preclinical 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.
The development of RiVax® has been sponsored through
a series of grants from both NIAID, part of the National Institutes
of Health, and the FDA, which were granted to Soligenix and to the
University of Texas Southwestern
(UTSW), where the vaccine protein originated. To date, Soligenix,
Ellen Vitetta, PhD and her
colleagues at UTSW have collectively received approximately
$25 million in funding from NIAID for
development of RiVax® and related vaccine technologies.
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 from
the FDA.
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 varying
from between $125 million to $350
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 ThermoVax®
The ThermoVax® technology is 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. Cold
chain requirements add considerable cost to the production and
storage of current conventional vaccines. Elimination of the
cold chain would also enhance the utility of these vaccines for
emerging markets and for other applications requiring but lacking
reliable cold chain capabilities. For vaccines that are
intended for long-term stockpiling, such as for use in biodefense
or in pandemic situations, the utilization of ThermoVax®
has the potential to facilitate easier storage and distribution of
Strategic National Stockpile vaccines in emergency situations. The
underlying ThermoVax® technology has been developed by
Drs. John Carpenter and Theodore Randolph at the University of Colorado.
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. Similar stabilization at temperatures as high as 50 degrees
Celsius for up to 3 months (maximum timepoint tested) have also
been demonstrated with other antigens (e.g., human papillomavirus,
Ebola and anthrax).
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, 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) 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.