DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the"Company"), a late-stage biopharmaceutical company, announced today that ithas entered into a one-year exclusive option with the President and Fellowsof Harvard College to license analogues of anthrax toxin for prospectiveuse in vaccines against anthrax, a potentially fatal disease caused by thespore-forming, gram-positive bacterium Bacillus anthracis. The option,which was obtained through negotiation with Harvard University's Office ofTechnology Development, encompasses an issued U.S. patent that coversengineered variants of protective antigen (PA) developed in the HarvardMedical School laboratory of Dr. John Collier. PA is the principaldeterminant of protective immunity to anthrax and is being developed forsecond- and third-generation anthrax vaccines.
Overall concern about the use of anthrax spores, as well as ricin toxin, asweapons of bioterrorism has been highlighted in a recently released FBIBioterror report, entitled Terrorism 2002-2005, as "the most prevalentagents involved in WMD investigations"(http://www.fbi.gov/publications/terror/terrorism2002_2005.pdf).
There has been a major effort on the part of the federal government todevelop vaccines for use both pre- andpost-exposure to improve upon the vaccine currently in use. This vaccine,known as AVA (for anthrax vaccine adsorbed), consists of a defined, butimpure mixture of bacterial components. The vaccine is FDA approved, butrequires multiple injections followed by annual boosters. Vaccines such asAVA or those based on the purified, recombinant anthrax toxin component PA(rPA) induce antibodies that neutralize anthrax holotoxin and can stronglyprotect animals from inhaled anthrax spores.
Several of the protein variants developed by Dr. Collier have been shown tobe more immunogenic than native rPA, perhaps because they are processedmore efficiently by cellular antigen processing pathways. DOR believesthat it will be able to develop the Collier anthrax vaccine into one withan improved stability profile, an issue that has proven challenging in thedevelopment of other anthrax vaccines.
Dr. Collier commented: "One of the key features of a successor to AVAvaccine will be a vaccine that not only has long-term stability, but onethat can be administered in the fewest possible doses to induce the highestlevel of toxin neutralizing antibodies."
"Access to the engineered anthrax PA variants as candidate vaccines makesan excellent fit into our biodefense portfolio and should allow us to makekey strides in our biodefense development initiatives," stated ChristopherJ. Schaber, PhD, President and CEO of DOR BioPharma. "To our knowledge, weare now the only company in the world developing vaccines against the toptwo bioterror threats, as recently identified by the FBI. In keeping withour current biodefense development model, our strategy will be to quicklyfile for grants to further develop the anthrax vaccine candidate. Webelieve that the engineered PA variants can be used in platformtechnologies for delivery of single use or combination biodefense vaccinesand will be useful for generating stable vaccines that induce antibodies infewer doses than the conventional AVA vaccine or other rPA vaccinescurrently under development. A significant improvement for stockpiledvaccines would be extended stability, which is not expected fromconventional vaccines.
