Soligenix, Inc. (SNGX) Announces Publication Demonstrating Enduring Protection of its Thermostable RiVax Vaccine

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 publication of pre-clinical immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled "Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been accepted for publication in the journal mSphere (available here). The article results from collaborative work with the Wadsworth Center of the New York State Department of Health. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at 40°C or 104°F), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling. This same thermostabilization approach is also being advanced in the development of Soligenix's CiVax™ vaccine for COVID-19.

RiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. Formulated by Soligenix to have enhanced thermostability, RiVax® has demonstrated up to 100% protection in mice and NHPs subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol. Most recently, mice have been shown to be protected from ricin challenge at 10 times the lethal dose for at least 12 months post-vaccination.

"These results continue to reinforce the convenience and practicality of the RiVax® vaccine," stated Dr. Oreola Donini, Chief Scientific Officer of Soligenix. "This, and other ongoing work, has continued to corroborate the efficacy of RiVax® and will facilitate its potential approval."

Approval for RiVax® will be pursued under the United States (U.S.) Food and Drug Administration (FDA) "Animal Rule," which is applied to products where testing in clinical efficacy trials would be unethical. In the case of a ricin toxin vaccine, clinical efficacy testing of the vaccine is unethical since it would require intentionally exposing humans to ricin toxin. The Animal Rule is generally associated with the approval of medical countermeasures for biodefense purposes. The Animal Rule requires the evaluation of efficacy in animals (RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin), safety in humans (the RiVax® antigen has been demonstrated to be well-tolerated in human Phase 1 clinical studies) and immunogenicity correlated between animal models and humans (biomarkers have been identified, see publication here).

RiVax® studies have been supported by a contract (# HHSN272201400039C) award of approximately $21.2 million from the National Institute of Allergy and Infectious Diseases (NIAID). Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.

RiVax® has received Orphan Drug and Fast Track designations from the FDA, and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher (PRV). In addition, RiVax® has received Orphan Drug designation from the European Medicines Agency (EMA).

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