On October 19, 2012, by Notice of Allowance given to iBio, Inc., the United States Patent and Trademark Office allowed patent application 12/668,258 entitled “Yersinia Pestis Antigens, Vaccine Compositions and Related Methods.” The claims cover plague antigens comprising Yersinia pestis F1 protein fused to the company’s thermostable iBioModulator™ protein, as well as vaccine compositions and a method for producing a protective immune response to the antigen. The patent has not yet issued, but the published application relating to the soon-to-be issued patent is US Patent Application No. 20110027304.

Plague is a disease caused by the bacterium Yersinia pestis and primarily infects animals, but can spread to humans through bites from infected fleas or contact with infected animals. It is also considered a potential bioterrorism weapon, and therefore a priority for effective vaccine development. There is no plague vaccine currently approved for use in the United States.

Killed whole-cell plague vaccines have been reported to protect against bubonic plague in animal models, but they were not effective against pneumonic plague. By contrast, data previously published in the peer-reviewed scientific journal, Vaccine, demonstrated that a recombinant plague vaccine incorporating the iBioModulator protein, and produced via the iBio platform in green plants, provided complete protection of non-human primates against pneumonic plague.

More recently, the soon-to-be issued patent relating to a potential vaccine to protect against the plague also caught the attention of none other than the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.  While the ‘304 patent application primarily deals with plague, the techniques also have applicability to anthrax and other bacterial pathogens. In fact, on December 5, 2012, iBIO announced that NIH awarded the company a contract to research and develop a new generation anthrax vaccine. This new generation anthrax vaccine will be developed with the iBio platform. The first year of funding will be $1.76 million with a total contract amount of up to $9.9 million, depending on the exercise of contract options.

As iBio works to expand its portfolio of assets relevant to bio-defense and infectious disease product applications, data from peer-reviewed scientific journals demonstrate the effectiveness of the iBio platform for development and production of vaccine candidates for bacterial pathogens, such as plague and anthrax, and viral pathogens such as influenza and human papilloma virus.

iBio’s strategy for development of therapeutic and vaccine product applications of its technology platforms is through commercial collaboration and licensing internationally with corporations and government entities. In September 2012, iBio and GE Healthcare announced the formation of a new global alliance, and iBio’s technology is being used for development of a new recombinant yellow fever vaccine under a commercial license and product development collaboration with Fiocruz/Bio-Manguinhos.

Phase 1 clinical trials of influenza vaccine candidates produced via the iBio platform were funded by the U.S. Department of Defense and the Bill & Melinda Gates Foundations. iBio previously announced success in the use of its platform for the production of a variety of therapeutic protein candidates including monoclonal antibodies and human blood plasma proteins. The company is currently seeking additional partners for new vaccine candidates and for biotherapeutic products based on its platform technologies. Given the fear of bioterrorism, this and other solutions will certainly gain the attention of those in government charged with protecting and defending against both foreign and domestic attacks.

Tags: Anthrax Vaccine

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