DOR BioPharma, Inc, a late-stage biotechnology company, has been awarded an approximate $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). The grant will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines, including RiVax, that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.


The development of heat-stable vaccines will take advantage of combining several novel formulation processes with well-characterized adjuvants that have been evaluated in numerous vaccine field trials. The formulation and process technology funded by the grant will be applied to the further development of RiVax, a subunit vaccine for prevention of ricin toxin lethality and morbidity. The grant will also address the development of manufacturing processes and animal model systems necessary for the preclinical characterization of vaccine formulations. Further, the grant will fund the concurrent development of at least one other protein subunit vaccine, which is currently expected to be an anthrax vaccine. This could lead to new subunit vaccines that would bypass current cold chain requirements for storage and distribution. Vaccines to be stored in the Strategic National Stockpile (SNS) and used under emergency situations for biodefense are expected to have long-term shelf life.

"The novel technology supported by this grant will potentially develop new vaccines to address the practical issue of long-term stability in stockpiled vaccines and can subsequently be applied to other vaccine products," said Robert N Brey, chief scientific officer of DOR. "These new vaccines could be stored for long periods of time at ambient temperature, and avoid the current need for a well-controlled environmental cold chain. This would result in more useful vaccines for both civilian and military purposes."

"This grant award further validates the previous work and merits of our biodefense program," said Christopher J Schaber, president and CEO of DOR. "We are very pleased that NIAID has chosen to support the development of a thermostable vaccine platform, as there are very few viable technology options at present that can effectively address heat stable vaccines. Our progress to date with RiVax(TM) has been impressive, and we believe that application of thermostabilization technology will accelerate the efforts to develop RiVax(TM) and other vaccines such as anthrax for potential use by the military and for the Strategic National Stockpile."


Dr Schaber continued, "This $9.4 million grant puts our biodefense and vaccine business on solid footing and supports the necessary corporate infrastructure to continue to execute on these important programs."

RiVax is DOR's proprietary vaccine developed to protect against exposure to ricin toxin and is the most advanced vaccine in the company's portfolio.

Ricin toxin is thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production.

DOR BioPharma is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.