Soligenix (SNGX) Announces Publication Demonstrating Complete Protection Against Filovirus Disease in Nonhuman Primate Models of Ebola and Marburg Viruses

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 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.

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