iBio, Inc., a biotechnology company, focuses on commercializing its proprietary platform technologies, iBioLaunch and iBioModulator; and developing select product candidates based upon these platforms. iBioLaunch is a proprietary, transformative platform technology for development and production of biologics using transient gene expression in hydroponically grown, unmodified green plants. iBioModulator is a proprietary technology platform that is designed to improve the potency and duration of effect of both prophylactic and therapeutic vaccines produced with any recombinant expression technology, including iBioLaunch. In addition to the clinical development of the company’s vaccine candidates, Bio-Manguinhos/FioCruz, or FioCruz, a unit of the Oswaldo Cruz Foundation, a central agency of the Ministry of Health of Brazil, is sponsoring the development an iBioLaunch-produced yellow fever vaccine to replace the vaccine it makes in chicken eggs for the populations of Brazil and approximately 20 other nations. The company developed its iBioModulator technology based on the use of a modified form of the cellulose degrading enzyme lichenase from Clostridium thermocellum, a thermophilic and anaerobic bacterium. Product Candidates Therapeutic Protein Product Candidates Using iBioLaunch, the company has expressed and demonstrated the feasibility of production of all classes of therapeutic proteins. IBIO-CFB03, a Proprietary Product for Treatment of Fibrosis The company has licensed and is developing, on its iBioLaunch platform, a new product that the company has designated ‘IBIO-CFB03’ for treatment of idiopathic pulmonary fibrosis and systemic sclerosis, both fatal and incurable diseases. Recombinant forms of Plasma Derived Products Using iBioLaunch, the company has produced human C1 esterase inhibitor and human alpha 1-antitrypsin, each of which is important therapeutic products that have been derived from human blood plasma. Other Therapeutic Proteins In addition to the recombinant form of plasma derived products, using iBioLaunch, the company has been able to express and demonstrate the feasibility of production of all other classes of therapeutic proteins. The therapeutic proteins that the company has produced range from large and complex monoclonal antibodies to smaller proteins, such as interferons, growth factors, and enzymes. All the candidate therapeutic proteins manufactured using iBioLaunch have assembled correctly assembled and demonstrated full activity in relevant bioassays. The company is evaluating various potential proprietary iBioLaunch produced therapeutic protein candidates for further development internally at the company or together with collaborators. Vaccine Candidates The company has used iBioLaunch to express and demonstrate the feasibility of production of a range of vaccine candidates, including vaccine candidates that have been impossible to produce on a commercially practical basis using conventional manufacturing systems. Additionally, the company used iBioModulator to improve the performance of therapeutic vaccine candidates. The company’s collaborator, FioCruz, is advancing the development of an iBioLaunch-produced yellow fever vaccine candidate. Biodefense Countermeasures In addition to the company’s demonstration of the feasibility of iBioLaunch produced monoclonal antibody candidates for the treatment of anthrax, next generation anthrax vaccine candidates derived from the iBioLaunch platform have been evaluated by the company’s collaborator, Fraunhofer Center for Molecular Biology (Fraunhofer), pursuant to a funding award granted to Fraunhofer in 2012 by the National Institute of Allergy and Infectious Diseases. Strategic Alliances and Collaborations The company has a global alliance with GE Healthcare to commercialize the company’s plant-based technologies for the manufacture of biopharmaceuticals and vaccines. The company has a license with Caliber Biotherapeutics LLC, a for-profit biotechnology company that is focused on the development and commercialization of therapeutic proteins. This license to Caliber Biotherapeutics LLC is for use of the iBioLaunch platform in connection with the development of an undisclosed monoclonal antibody-based therapeutic protein for an oncology indication. Strategy The company’s strategy to engage in partnering and out-licensing of its technology platforms seeks to preserve the opportunity for the company to share in the successful development and commercialization of product candidates by its licensees while improving its own capital and financial resources for development, alone or through commercial alliances with others, of high-potential product candidates based upon the company’s platforms. The company’s strategy is to enter important markets through license agreements and commercial collaborations and its current marketing efforts focus on those decision makers whom the company expects would be attracted to the cost and efficiency advantages that might be obtained through use of its platforms. Intellectual Property The company owns 20 U.S. patents and 28 international patents. Additionally, the company has 1 international patent application allowed, as well as 6 U.S. and 20 international applications pending. International patents and applications include various foreign countries, including Australia, Brazil, Canada, China, Hong Kong, India, Korea, and various countries in Europe. The company continues to prepare patent applications relating to its expanding technology in the U.S. and internationally. Government Regulation and Product Approval Any products that the company or a licensee manufactures or distributes under FDA approval are subject to continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the products. Significant Events In January 2016, IBio Inc. announced it would set up a joint venture with Eastern Capital Ltd. subsidiaries to develop pharmaceuticals from plants. The joint company, named IBio CMO LLC, will be 70% owned by IBio and 30% owned by affiliates of Eastern Capital.
(IBIO:Consolidated issues listed on NYSE MKT LLC)
600 Madison Avenue
New York, NY 10022
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