Dor achieves manufacturing milestone for ricin vaccine

The completion of current good manufacturing practices (cGMP) manufacture of RiVax forms one of the crucial milestones in the development of the vaccine, which is being conducted under a $6.4 million grant from the US National Institute of Allergy and Infectious Diseases.

The safety and immunogenicity of RiVax has recently been evaluated in a phase I clinical trial in healthy volunteers, and the results were published earlier this year in the Proceedings of the National Academy of Sciences.

Having achieved the cGMP milestone, the company now plans to conduct further studies directed towards providing safety and immunogenicity data needed for licensure of the vaccine by the FDA.

Further animal testing is also planned to provide correlation of antibody levels in human serum with protection against ricin exposure in animal models. Because vaccine efficacy for exposure of humans to ricin toxin can only be tested in animals, the FDA has established a two animal rule. Under this rule, the FDA can permit human licensure of a vaccine by relying on results from animal trials when human trials cannot ethically evaluate efficacy.

“We are pleased that we have achieved this critical milestone and are encouraged that we will have a means to manufacture RiVax at the scale necessary for potential future immunization programs of civilian or military personnel,” stated Michael Sember, president and CEO of Dor BioPharma.