- Includes thermostabilized Ebola vaccines MarVax™ and
SuVax™
- Includes nanoemulsion adjuvant compatible with
lyophilization
PRINCETON, N.J., April 25,
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
it has received notice of intent to grant additional patents based
on its patent application titled "Compositions and Methods of
Manufacturing Trivalent Filovirus Vaccines" in the United Kingdom and South Africa, with other international
jurisdictions pending. The Company has previously announced
multiple issued patents within the same patent family in
the United States (U.S.). The
allowed claims are directed to unique, proprietary compositions and
methods related to combinations of glycoprotein antigens with
nanoemulsion adjuvants comprising sucrose fatty acid esters prior
to lyophilization. The described vaccine platform has previously
been successfully applied to mono-, bi- and tri-valent candidates
for Zaire ebolavirus,
Sudan ebolavirus and
Marburg marburgvirus, including monovalent vaccines SuVax™
(targeting Sudan
ebolavirus) and MarVax™ (targeting Marburg
marburgvirus).
The candidate filovirus vaccines have been previously shown to
completely protect non-human primates (NHPs) from subsequent
infection, and represent the only recombinant subunit vaccines that
have demonstrated efficacy against Zaire ebolavirus and other filoviruses in
NHPs. Lyophilization (i.e., freeze drying) of the antigens with
bivalent vaccine formulations has also been demonstrated to
thermostabilize the antigens at temperatures as high as 40 degrees
Celsius (104 degrees Fahrenheit) for up to two years, enabling
storage at ambient temperature. No currently licensed lyophilized
vaccine that contains an adjuvant is presented in a single vial
format and there are few reports of successfully using
nanoemulsions in lyophilized formulations. Previous work has
demonstrated the use of a single vial platform to co-lyophilize
antigen(s) and a nanoemulsion adjuvant, CoVaccine HT™, maintaining
key adjuvant stability characteristics including particle size and
colloidal stability, as well as maintaining immunogenicity.
"Filoviruses such as Zaire
ebolavirus, Sudan
ebolavirus and Marburg marburgvirus are some of the most
lethal viruses known, and they are endemic in areas of the world
where the power supply and distribution network can be uncertain.
There are no vaccines for either Sudan or Marburg viruses, while approved
vaccines for Zaire
ebolavirus are constrained by cold chain logistics.
Availability of a single-vial, heat stable vaccine would
significantly enhance global public health preparedness or response
to a new outbreak, at its source," stated Axel Lehrer, PhD, Associate Professor,
Department of Tropical Medicine, Medical Microbiology and
Pharmacology, John A. Burns School
of Medicine, University of Hawaiʽi at Mānoa. "Our work to date has
demonstrated the feasibility of rapid and efficient manufacturing,
as well as the ability to thermostabilize multiple antigens that
can then be stored at temperatures exceeding 100 degrees
Fahrenheit. Having a vaccine platform such as this available has
the potential to accelerate worldwide vaccination campaigns
addressing future health emergencies, including other global
pandemics as seen with COVID-19."
"Our next generation combined vaccine platform includes three
major components: a robust protein manufacturing process that has
been demonstrated on multiple protein antigens, a novel
nanoemulsion adjuvant which induces broad immunity and a
formulation procedure which enables thermostabilization of the
combination of adjuvant and antigen in a single vial," stated
Oreola Donini, PhD, Senior Vice President and Chief Scientific
Officer of Soligenix. "Elements of this vaccine platform have been
utilized in our ricin toxin, filovirus and COVID-19 vaccine
candidates, indicating its broad applicability. We continue to
focus on vaccine development against Sudan ebolavirus and Marburg
marburgvirus where there are currently no available
vaccines."
Work to date has demonstrated the compatibility of lyophilizing
both antigen and adjuvant in the same vial, with reconstitution
with sterile water for injection immediately prior to use. This
simple delivery format, as well as the compatibility with ambient
storage, significantly reduces logistical hurdles when vaccinating
large groups of individuals as required for example when addressing
a global pandemic or for the deployment of vaccines in outbreaks
occurring in remote areas or with unreliable power supply.
Under the Company's Public Health Solutions business segment,
ongoing collaborations with Dr. Lehrer, have demonstrated the
feasibility of developing thermally-stable subunit protein vaccine
formulations for filoviruses. The thermostabilized filovirus
vaccine program has been supported by a National Institute of
Health (NIH) grant R01-AI132323 (awarded to the University of Hawaii) and a Small Business
Innovation Research grant (#1R44AI157593-01; awarded to
Soligenix).
About SuVax™
SuVax™ is a subunit protein vaccine of recombinantly expressed
Sudan Ebola virus 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 Sudan ebolavirus
(SUDV), 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. SuVax™, as a heat stable protein subunit
vaccine, has protected 100% of non-human primates exposed to a
lethal injection of SUDV. Stability studies have demonstrated that
SuVax™ is heat stable for at least 2 years at temperatures of at
least 40 degrees Celsius (104 degrees Fahrenheit).
Manufacture of the recombinant protein utilized in SuVax™
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.
SuVax™ can also be expressed as part of a multivalent vaccine, in
combination with antigens against Marburg marburgvirus
(MARV) for example.
Soligenix has been granted Orphan Drug Designation by the U.S.
Food and Drug Administration (FDA) for the prevention and
post-exposure prophylaxis against Sudan ebolavirus infection. 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, and certain tax
credits.
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 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.
Soligenix has been granted Orphan Drug Designation by the FDA
for the prevention and post-exposure prophylaxis against Marburg
marburgvirus infection.
About Filovirus Infection
Ebola Virus Disease is caused by one of six species of
Ebolavirus, four of which are known to cause disease in humans,
including its best-known member, Zaire ebolavirus (Ebola virus), with
Sudan ebolavirus being the
second-most common cause of human infection in this family. All
species of ebolavirus belong to the Filoviridae family, a family
that further contains the equally human pathogenic Marburg virus.
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. The most recent SUDV outbreak occurred in August –
October, 2022 in Uganda according
to the Centers for Disease Control and Prevention (CDC). The most
recent MARV outbreaks occurred in February – June 2023 in Equatorial
Guinea and in March – May 2023
in Tanzania, with no relationship
between the two outbreaks, according to the 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.
There are limited treatment options for Ebola Virus Disease and no
available treatments for Sudan Virus or Marburg Virus Disease,
although steady progress has also been made in development of
immunotherapeutics for filoviruses beyond Zaire ebolavirus. There are approved
vaccines for Ebola virus (Zaire
ebolavirus), requiring stringent ultra-low cold-chain storage,
but no efficacious vaccines are yet available for Marburg virus
(Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).
Filoviruses are one of the virus families identified as having
the ability to cause pandemics. On the heels of the COVID-19
pandemic, the U.S. government is accelerating its investment in
pandemic preparedness, including having "the ability to rapidly
make vaccines effective against any virus family." Specific
initiatives have been spear-headed by the White House and
Biden-Harris administration, as evidenced by the "American Pandemic
Preparedness: Transforming Our Capabilities" white paper released
in September 2021.
About John A. Burns School of
Medicine, University of Hawai'i at Mānoa
The John A. Burns School Medicine (JABSOM) at the University of
Hawaiʻi at Mānoa is one of the leading medical institutions and one
of the most ethnically diverse institutions in the United States. For more than a decade,
JABSOM has ranked in the top 10% of allopathic medical schools for
graduate retention with one of our UH-sponsored residency programs.
Hawaiʻi's cultural diversity and geographical setting affords
JABSOM an unique research environment to excel in research directed
at eliminating diseases that disproportionately affect people in
Hawaii and the Pacific region.
JABSOM faculty bring in extramural funds of $46 million into the state, annually. In
addition, JABSOM was the first U.S. medical school to create a
clinical department dedicated to the health and well-being of an
indigenous population, Native Hawaiians.
About Soligenix
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) 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's current expectations about its future results,
performance, prospects and opportunities, including but not limited
to, potential market sizes, patient populations, clinical trial
enrollment, the expected timing for closing the offering described
herein and the intended use of proceeds therefrom. 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. 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,
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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