Under the agreement, Cambrex will provide process development and cGMP (current good manufacturing processes) production services for RiVax.
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon.
DOR will work with Cambrex pursuant to DOR’s recently awarded $5.2 million National Institutes of Health (NIH) ricin vaccine development grant. The specific milestones for the RiVax development program to be undertaken by Cambrex include development of a robust process for production and purification of the vaccine.
Under the current agreement, Cambrex will be developing the manufacturing process to enable large scale production to produce quantities sufficient for additional clinical testing, fulfillment of all FDA requirements for licensure and, if approved, commercial production.
DOR has previously demonstrated the safety and effectiveness of RiVax in multiple relevant animal models. The company recently announced the initiation of an investigator-sponsored phase I clinical study to be conducted at the University of Texas, to test the safety and immunogenicity of RiVax in human volunteers.
Once these conditions are satisfied, the federal government has the authority under the BioShield Act of 2004 to procure bioterror countermeasures for addition to the strategic national stockpile prior to FDA approval.
“We believe RiVax could be an integral part of the US government’s biodefense arsenal,” stated Dr Gregory Davenport, president of DOR’s biodefense division. “Cambrex has significant cGMP capacity and a proven track record of manufacturing other developmental vaccines. We are pleased to be working with Cambrex as we endeavor to meet all the requirements for potential procurement by the US government.”