PRINCETON, N.J. — Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today a publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. In collaboration with University of Hawaiʻi at Mānoa (UHM), the manuscript entitled “Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection“, has been published in Vaccine.
This vaccine candidate has been previously demonstrated to be stable to high temperature storage for at least 2 years at 40 degrees Celsius (104 degrees Fahrenheit). There are currently no approved vaccines or therapeutics for either SUDV or MARV infections. Vaccines are available for Zaire ebolavirus (EBOV) infections but they provide no protection against SUDV or MARV infection. The published paper describes the potency of the bivalent formulation against both viruses, demonstrating 100% protection in the most rigorous non-human primate challenge models.
“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. A thermostabilized vaccine in a single vial format would significantly enhance any public health 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, UHM. “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 for extended times at temperatures exceeding 100 degrees Fahrenheit. The use of a bivalent vaccine has the potential to both prevent future infections with these pathogens and potentially mitigate future outbreak events, potentially using an accelerated dosing regimen.”
“Our combined vaccine platform includes 3 major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigens 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. The ability to package the vaccine candidates in a single vial further adds to their developability, whether as a multivalent or individual monovalent vaccine, particularly against Marburg marburgvirus and Sudan ebolavirus where there are currently no available vaccines.”
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 is continuing to advance with the support of a National Institute of Health (NIH) grant R01-AI132323 (awarded to UHM) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix, Inc.). 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, enables vaccines that significantly reduce the logistical hurdles that have been required for addressing the current pandemic or deployment of other Ebola virus vaccines in recent outbreaks in Central and West Africa.
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 genus. 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 and Marburg Virus Disease outbreaks since 1967, with the largest outbreak starting in 2014 in Western Africa that involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of more than 11,000 people according to the Centers for Disease Control and Prevention (CDC). These numbers also include some cases of virus introduction and limited spread in Europe and the United States. In 2022 and 2023 several SUDV and MARV outbreaks were observed in continental Africa.
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 yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).
About John A. Burns School of Medicine, University of Hawai’i at Manoa
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 a 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 a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. 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. The Company also is developing proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation such as pediatric Crohn’s disease (SGX203).
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Phone (609) 538-8200