Provides MarVax™ Heat Stable Vaccine Seven
Years of U.S. Market Exclusivity Upon FDA
Approval
PRINCETON, N.J., April 15,
2024 /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 Office of Orphan Products Development of the United States (U.S.) Food and Drug
Administration (FDA) has granted orphan drug designation to the
active ingredient in MarVax™, the subunit protein vaccine of
recombinantly expressed Marburg marburgvirus
(MARV) glycoprotein, for "the prevention and post-exposure
prophylaxis against MARV infection."
The U.S. Orphan Drug Act is intended to assist and encourage
companies to develop safe and effective therapies for the treatment
of rare diseases and disorders, defined as one that affects fewer
than 200,000 people in the U.S. In addition to providing a
seven-year term of market exclusivity upon final FDA approval,
orphan drug designation also positions Soligenix to be able to
leverage a wide range of financial and regulatory benefits,
including government grants for conducting clinical trials, waiver
of expensive FDA user fees for the potential submission of a
Biologics License Application (BLA), and certain tax credits.
"Marburg marburgvirus causes Marburg Virus Disease, a
highly related disease to the more commonly known Ebola Virus
Disease. Although MARV has caused fewer outbreaks, they remain
highly fatal and a significant risk in continental Africa, with the most recent outbreak
occurring in 2023. There is no approved vaccine for MARV, and the
only approved vaccines for filovirus type disease is specific to
Zaire ebolavirus. Unlike
the approved vaccines, which depend on using a different inactive
or attenuated virus to stimulate the immune system, MarVax™ is a
heat stable subunit vaccine with adjuvant. Subunit vaccines are a
gold standard technology for safety and are also broadly applicable
across the population, especially when combined with an effective
adjuvant," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "Elements of this subunit vaccine platform have been
utilized in our ricin toxin, filovirus and COVID-19 vaccine
candidates, indicating its broad applicability. We have also
demonstrated the ability to package more than one vaccine antigen
in a single vaccine, particularly against MARV and Sudan ebolavirus where there are currently
no available vaccines. The FDA's decision to grant orphan drug
designation to both the MARV and Sudan ebolavirus vaccine candidates
signifies an important step for Soligenix as we continue to advance
the program and adds significantly to the existing patent estate
surrounding this novel technology and the filovirus
program."
About MarVax™
MarVax™ is a subunit protein vaccine of recombinantly expressed
Marburg marburgvirus (MARV) glycoprotein, developed in
partnership with Dr. Axel Lehrer at
the University of Hawaiʽi at Mānoa. The vaccine includes a protein
found on the surface of MARV, to engender an appropriate immune
response without posing a risk of infection, as well as a novel
adjuvant which stimulates both humoral and cell mediated immune
responses, in combination with Generally Regarded as Safe (GRAS)
excipients that enable lyophilization (i.e., freeze-drying) of the
vaccine. The resulting product is manufactured as a heat stable
powder in a vial which is reconstituted with generically available
water for injection immediately prior to use. Stability studies
have demonstrated that MarVax™ is heat stable for at least 2 years
at temperatures of at least 40 degrees Celsius (104 degrees
Fahrenheit). MarVax™ has demonstrated 100% protection of non-human
primates exposed to a lethal injection of MARV.
Manufacture of the recombinant protein utilized in MarVax™
utilizes a robust protein manufacturing process, developed and
tested in other subunit vaccines advanced through clinical testing.
Similarly, the selected adjuvant, while novel, has also been
independently tested in Phase 1 and Phase 2 clinical studies.
MarVax™ can also be expressed as part of a multivalent vaccine, in
combination with antigens against Sudan ebolavirus for example.
About Marburg marburgvirus Infection
Marburg Virus Disease is caused by MARV, a member of the
Filoviridae family that also includes Sudan ebolavirus (causing Sudan Virus
Disease) and Zaire
ebolavirus (causing Ebola Virus Disease). Filoviruses are
believed to be harbored in various animal species in Africa, particularly bats, although the
specific reservoir host for many of these viruses is still unknown.
There have been several known Ebola (both Sudan and Zaire) and Marburg Virus Disease outbreaks
since 1967 with the most recent MARV outbreaks occurring in
February – June 2023 in Equatorial Guinea and in March – May 2023 in Tanzania, with no relationship between the two
outbreaks, according to the Centers for Disease Control and
Prevention (CDC). Cases of Marburg Virus Disease were also recorded
in Ghana in 2022 and 2021.
Transmission of filoviruses requires direct contact with bodily
fluids from an infected person or contact with infected animals.
The mortality rates following filovirus infections are extremely
high, and, in the absence of wide availability of effective
therapeutics, are affected by the quality of supportive care
available with a focus on early initiation of treatment. Resolution
of the disease largely depends on the patient's own immune system.
While there are limited treatment options for disease caused by
Zaire ebolavirus, there are
no available treatments or vaccines available for Marburg Virus
Disease. The approved vaccines for Ebola virus (Zaire ebolavirus) utilize a viral vector
approach which has contraindications for some individuals and
require stringent ultra-low cold-chain storage, inhibiting their
broad use in challenging conditions where power supply can be
uncertain and ambient temperature can be very high.
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 and moving toward
potential commercialization of HyBryte™ (SGX301 or synthetic
hypericin sodium) as a novel photodynamic therapy utilizing safe
visible light for the treatment of cutaneous T-cell lymphoma
(CTCL). With successful completion of the second Phase 3 study,
regulatory approvals will be sought to support potential
commercialization worldwide. Development programs in this business
segment also include expansion of synthetic hypericin (SGX302) into
psoriasis, our first-in-class innate defense regulator (IDR)
technology, dusquetide (SGX942) for the treatment of inflammatory
diseases, including oral mucositis in head and neck cancer, and
(SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes
development programs for RiVax®, our ricin toxin vaccine
candidate, as well as our vaccine programs targeting filoviruses
(such as Marburg and Ebola) and CiVax™, our vaccine candidate for
the prevention of COVID-19 (caused by SARS-CoV-2). 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 Agency (DTRA) and the Biomedical Advanced
Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at https://www.soligenix.com and follow
us on LinkedIn and Twitter at @Soligenix_Inc.
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, and include the
expected amount and use of proceeds from the offering and the
expected closing date of the offering. 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 any of its clinical/preclinical
trials. Despite the statistically significant result achieved in
the first HyBryte™ (SGX301) Phase 3 clinical trial for the
treatment of cutaneous T-cell lymphoma, there can be no assurance
that the second HyBryte™ (SGX301) Phase 3 clinical trial will be
successful or that a marketing authorization from the FDA or EMA
will be granted. Additionally, although the EMA has agreed to the
key design components of the second HyBryte™ (SGX301) Phase 3
clinical trial, no assurance can be given that the Company will be
able to modify the development path to adequately address the FDA's
concerns or that the FDA will not require a longer duration
comparative study. Notwithstanding the result in the first HyBryte™
(SGX301) Phase 3 clinical trial for the treatment of cutaneous
T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the
treatment of psoriasis, there can be no assurance as to the timing
or success of the clinical trials of SGX302 for the treatment of
psoriasis. Despite the positive efficacy results demonstrated in
the Phase 2 and 3 clinical studies of SGX942 for the treatment of
oral mucositis due to chemoradiation therapy for head and neck
cancer, there can be no assurance as to the timing or success of
the clinical trials of SGX945 for the treatment of Behçet's
Disease. 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 (the "SEC"), including, but not
limited to, the Company's preliminary prospectus (Registration No.
333-271049) filed with the SEC on May 4,
2023, and 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.