iBio Adds Anthrax Antibodies to Product Pipeline
NEWARK, DE -- (Marketwired) -- 02/25/15 -- iBio, Inc. (NYSE MKT: IBIO), a leader in plant-based biotechnology for developing and manufacturing biological products, today announced the issue of US patent serial No. 8,962,278 titled "COMPOSITIONS AND METHODS FOR PRODUCTION OF IMMUNOGLOBULINS." The patent will join patent family members previously issued in China, India, Korea and Europe.
"This technology continues the expansion of iBio's antibody portfolio and broadens our patent protection for product candidates addressing anthrax, both for natural outbreaks and for possible biodefense considerations," said Wayne P. Fitzmaurice Ph.D., iBio's Vice President, Intellectual Property. "These monoclonal antibodies will complement our vaccine technology such as is described in our U.S. patent 8,277,816 covering compositions of matter and methods of producing and formulating anthrax vaccines."
Claims involve human monoclonal antibodies specifically recognizing the Protective Antigen (PA) or the Lethal Factor (LF) of Bacillus anthracis, the bacteria causing anthrax. In mouse and non-human primate studies such antibodies, produced with the use of iBio's iBioLaunch™ gene expression platform technology, prevented death in 100% of animals given an otherwise lethal doses of anthrax spores.
"A non-glycosylated version of this antibody binds PA, neutralizes anthrax LeTx activity in vitro and possesses superior efficacy compared with the glycosylated form of this antibody in non-human primates -- a significantly longer half-life and 100% protection against a lethal dose of aerosolized anthrax spore challenge after a single i.v. administration," said Terence Ryan, Ph.D., Chief Scientific Officer of iBio. "These results suggest that this monoclonal antibody may be a useful tool for the treatment of inhalation anthrax in humans."
In addition to its proprietary fibrosis therapeutic program and the production of monoclonal antibody candidates, iBio is exploring the commercialization of its iBioLaunch gene expression platform technology for viral and bacterial infectious disease applications through collaborations with third parties. The company's technology has been successfully applied to the development of an anthrax vaccine candidate, and a Phase 1 clinical trial of the safety and immunogenicity of this experimental vaccine, produced at the Fraunhofer USA Center for Molecular Biotechnology under a research license from iBio, is being conducted at Walter Reed Army Institute of Research. The clinical trial is projected to be completed in July 2015 (ClinicalTrials.gov Identifier: NCT02239172). Funding for this vaccine program was awarded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, in December 2012.
The FDA considers Bacillus anthracis to be a category A bioterrorism agent, meaning that it poses the greatest possible threat to humans. Anthrax spores, which are easily spread by release in the air, are resistant to destruction, and produce toxins that can cause massive and irreversible tissue injury and death.
About iBio, Inc.
iBio is developing a proprietary product, IBIO-CFB03, for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis, and other fibrotic diseases using its iBioLaunch™ gene expression platform. The company also offers proprietary products and product licenses to others, based on its proprietary iBioLaunch gene expression and iBioModulator™ thermostable immunomodulator protein platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines. In Brazil, iBio has formed a subsidiary company, iBio do Brasil Biofarmaceutical Ltda., and has been collaborating with the Oswaldo Cruz Foundation (Fiocruz) since 2011 to develop a recombinant yellow fever vaccine based on iBio technology.
The iBioLaunch gene expression platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. The iBioModulator™ platform is complementary to the iBioLaunch gene expression platform and is designed to significantly improve vaccine products with both higher potency and greater duration of effect. Further information is available at: www.ibioinc.com.
STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
Source: iBio, Inc.
Released February 25, 2015