Advanced subunit vaccine technology,
including SuVax™ and MarVax™, to be discussed alongside mRNA
and viral vectored vaccine approaches
PRINCETON, N.J.,
June 14,
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 Professor Axel Lehrer, University of Hawaiʽi at Mānoa
(UHM), will be presenting key data from the Company's thermostable
vaccine technology platform developed in collaboration with
UHM, including results from the filovirus vaccine candidates for
both Sudan ebolavirus
(SuVax™) and Marburg marburgvirus (MarVax™). The
presentation will be given at the upcoming American Society of
Microbiology (ASM) Microbe Conference, Atlanta, Georgia, USA, June 13-17, 2024. The presentation will be
followed by a panel discussion comparing advanced vaccine
technologies and their advantages and disadvantages.
Oral Presentation / Panel Discussion:
Session Title: Immune Responses to Viral
Vaccine Platforms: Comparison of Live, mRNA, and Protein Subunit
Vaccines on June 17, 2024
from 8:15-10:15 am. The official
conference program can be found here.
Oral Presentation Title: Thermostable,
adjuvanted protein subunit vaccines reduce logistical concerns and
induce durable immunity presented by Axel Lehrer; University of Hawaiʽi at Mānoa,
Honolulu, HI on June 17, 2024 at 8:45 AM -
9:15 AM.
Under the Company's Public Health Solutions business segment,
Soligenix is developing thermostabilized subunit vaccines.
Thermostabilization is achieved by using a combination of Generally
Recognized as Safe (GRAS) excipients and lyophilization
(freeze-drying) to yield a single-vial presentation of vaccine that
is stable at ambient and higher temperatures and that can be
reconstituted with water for injection immediately prior to use.
Mono-, bi- and tri-valent vaccine candidates for filoviruses
(including Sudan ebolavirus
and Marburg marburgvirus) have demonstrated complete
protection in non-human primate challenge studies using
thermostabilized formulations. Soligenix has recently been granted
Orphan Drug Designation for the prevention and post-exposure
prophylaxis against both Sudan
ebolavirus and Marburg marburgvirus.
About the ASM Microbe Conference
ASM Microbe is presented annually by the American Society for
Microbiology (ASM) and is the largest microbial sciences gathering
in the world. With 8 thematic scientific tracks, including clinical
infections and vaccines (CIV), and over 200 sessions, this
conference is a key event every year. More information about the
conference, and registration to attend can be found here.
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 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 used 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 United
States Food and Drug Administration 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 (BLA), 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 used as part of a multivalent vaccine, in
combination with antigens against Sudan ebolavirus for example.
Soligenix has been granted Orphan Drug Designation by the United
States Food and Drug Administration for the prevention and
post-exposure prophylaxis against Marburg marburgvirus
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 BLA, and certain tax credits.
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 US 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 Hawaiʽi 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, 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.