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Soligenix Announces Publication of Correlates of Immune Protection for the RiVax® Ricin Toxin Vaccine
PRINCETON, N.J., May 11, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"PRINCETON, N.J., May 11, 2020 /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 publication of immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) \"Animal Rule.\" The article, titled \"A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin,\" has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here.\nRiVax® 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. Further formulated by Soligenix to have enhanced thermostability, RiVax® has demonstrated up to 100% protection in mice and non-human primates (NHPs) subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol. In studies conducted in collaboration with the laboratory of Dr. Nicholas Mantis, Research Scientist, Division of Infectious Diseases, Wadsworth Center, New York State Department of Health, species independent tests to evaluate the protective immunogenicity of the vaccine were developed. These tests will facilitate potential approval of RiVax® under the FDA Animal Rule which 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.\n\"These results continue to reinforce the link between the antibody response to the vaccination and the potency of the RiVax® vaccine,\" stated Dr. Oreola Donini, Chief Scientific Officer of Soligenix. \"This, and other ongoing work in our collaboration with Dr. Mantis and his team, has continued to corroborate the efficacy of RiVax® and will facilitate its potential approval.\"\nApproval for RiVax® will be pursued under the FDA \"Animal Rule,\" which is applied to p...