DOR BioPharma, Inc. and a subsidiary of Cambrex Corporation have entered into an agreement with respect to process development for potential large scale production of DOR’s proprietary ricin vaccine, RiVax. Under the agreement, Cambrex will provide process development and cGMP 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.
“We believe RiVax could be an integral part of the U.S. Government’s biodefense arsenal,” stated Gregory J. Davenport, Ph.D., 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 U.S. Government.”
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 funded under the grant 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, approved, commercial production.
“If these milestones are successfully achieved, DOR will have sufficient vaccine available for future clinical trials, and will be capable of manufacturing RiVax at scale,” commented Alexander P. Haig, Executive Chairman of DOR. “Our goal is to position ourselves as a qualified supplier of ricin vaccine to the U.S. Government. We intend to aggressively pursue all future procurement contracts with the ultimate goal of providing a safe and effective ricin vaccine to our military and at-risk civilians.”
“We are excited to work with DOR on the RiVax project,” commented Gary Mossman, Chief Operating Officer of Cambrex. “We have extensive experience developing production capabilities for vaccines of all types, and we feel privileged to work on this important vaccine that could be a critical component of our national defense.”
In accordance with current FDA guidance, DOR has previously demonstrated the safety and effectiveness of RiVax in multiple relevant animal models. The company has 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 using previously produced cGMP material from UT Southwestern. 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 Food and Drug Administration approval.