Soligenix, Inc. (Nasdaq: SNGX) shares traded higher on Monday after the company announced its publication of immunogenicity studies for RiVax® (heat stable ricin toxin vaccine). The publication identifies novel correlates of immune protection that the company believes may facilitate potential approval under the United States Food and Drug Administration (FDA) “Animal Rule.”
According to Soligenix, 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 for viewing here.
The RiVax® vaccine candidate is being developed under the company’s Public Health Segment and is a 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. Studies thus far have shown the vaccine formulation to have enhanced thermostability. In addition, RiVax® also 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.
Studies Show Effectiveness Against Ricin Toxin
Soligenix also announced that 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, that species independent tests to evaluate the protective immunogenicity of the vaccine were developed.
Importantly, the tests will facilitate potential approval of RiVax® under the FDA Animal Rule which requires the evaluation of efficacy in animals. Previous testing of RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin. In human testing, the RiVax® antigen has been demonstrated to be well-tolerated in Phase 1 clinical studies. Also, immunogenicity correlated between animal models and humans.
Dr. Oreola Donini, Chief Scientific Officer of Soligenix, stated, “These results continue to reinforce the link between the antibody response to the vaccination and the potency of the RiVax® vaccine.” She added, “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.”
Expedited “Animal Rule” Approval
Soligenix will be seeking an expedited review/approval pathway for RiVax® under the FDA “Animal Rule,” which is applied to products where human testing in clinical efficacy trials would be unethical since it would require intentionally exposing subjects to the ricin toxin. In similar applications, the “Animal Rule” is generally appropriated with the approval of medical countermeasures for biodefense purposes.
Bolstering a case for eventual approval, the RiVax® vaccine candidate has not only proven to be both protective and thermostable, but it has also demonstrated that a reduced number of vaccinations may establish protection, potentially utilizing only two doses instead of three.
Soligenix also pointed out that the RiVax® studies are supported by a contract award of up to $21.2 million from the National Institute of Allergy and Infectious Diseases (NIAID). Cumulative non-dilutive funding for the development of RiVax® has exceeded $40 million to date.
Also highly notable, RiVax® has received both Orphan Drug and Fast Track designations from the FDA, and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher (PRV). RiVax® also has received Orphan Drug designation from the European Medicines Agency (EMA).
In addition to the news of the RiVax® publication, Soligenix is advancing two Phase 3 trials, SGX301 and SGX942. SGX301 is targeting the treatment of cutaneous T-cell lymphoma and has recently published impressive and statistically significant efficacy results. Late-stage topline data for SGX942 is expected to be published in the second half of this year.
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