iBio Adds Biotherapeutic Product for Treatment of Fibrosis to Its Proprietary Product Pipeline

January 30, 2014

NEWARK, DE--(Marketwired - Jan 30, 2014) - iBio, Inc. ( NYSE MKT : IBIO ), a leading provider of plant-based biotechnology for developing and manufacturing biopharmaceutical products, has added a proprietary biotherapeutic product for the treatment of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis to its product pipeline.

iBio obtained an exclusive license to patents and related intellectual property for this novel therapy, and then entered a collaboration agreement with the Medical University of South Carolina (MUSC), represented by Dr. Carol Feghali-Bostwick, the inventor and now the Kitty Trask Holt and SmartState® SC Centers of Economic Excellence Endowed Professor at MUSC, that will enable iBio to advance the development of a potentially breakthrough biotherapeutic product against these otherwise unstoppable diseases.

Effective treatment of IPF, systemic sclerosis and localized scleroderma, represents an unmet medical need. Although some limited results have been claimed for existing therapies, there are currently no effective therapies for stopping or reversing fibrosis.

Data published in 2012 by Dr. Feghali-Bostwick demonstrates that certain endostatin-derived peptides are useful for both inhibition and reversal of fibrosis in preclinical mouse models of fibrosis as well as in human skin (Science Translational Medicine, 2012). iBio has initially expressed the active pharmaceutical ingredient for this product using its patented iBioLaunch™ technology, and plans to make clinical development of this product a key priority in the proprietary application of iBioLaunch.

The prevalence of systemic sclerosis is 150 to 300 cases per million persons in the U.S. and Europe (Current Opinion in Rheumatology, 2012). The prevalence of IPF, depending on the diagnostic criteria used, ranges from 140 to 279 cases per million persons in the U.S. and up to 234 cases per million in Europe (European Respiratory Review, 2012). According to GlobalData, the market across the U.S. and European Union just for IPF therapy is expected to grow at a compound annual growth rate of 87% from $49 million in 2012 to more than $1.1 billion by 2017.

"By bringing together iBio technology with the discovery work led by Professor Feghali-Bostwick, our goal is to begin human clinical trials in 2014," said Robert B. Kay, iBio's chairman and CEO. "If the results are consistent with the pre-clinical results, we will request a Breakthrough Therapy Designation from the FDA for our product in order to make it available for use at the earliest possible time.

"iBio technology has been successful in addressing complex protein production problems for vaccine development that were difficult or impossible to solve with other technologies, and those products are now advancing into Phase 1 human clinical trials," noted Kay. "We expect similar success with the expression of this new product."

Dr. Feghali-Bostwick commented: "Our findings to date suggest that certain endostatin-derived peptides are effective in different mouse models of fibrosis and in human skin. We are thus optimistic about the potential efficacy of this product candidate in patients and are very enthusiastic to collaborate with iBio to develop it as a therapy. MUSC's Division of Rheumatology & Immunology is one of the top ranked programs in the country by US News and World Report and an international leader in the field of scleroderma clinical care and research. We are fortunate to partner with iBio and are confident that together we can make this therapy a reality."

About Systemic Sclerosis and Idiopathic Pulmonary Fibrosis

Systemic sclerosis is a disorder that affects connective tissue of skin and internal organs as well as the walls of blood vessels. Early diagnosis and individualized therapy can be helpful, but treatment of systemic sclerosis is limited to symptom management. No currently approved drug has been proven to arrest the underlying process or processes that drive progression of the disease.

IPF is a life-shortening lung disease with a rapidly progressing negative impact on quality of life leading to death within an average of three to five years after diagnosis. Until recently, the scientific community believed that IPF was caused by inflammation; however, numerous attempts at therapy with anti-inflammatory agents and immunomodulatory drugs were unsuccessful. More recently, endothelin receptor antagonists were also proven to be ineffective. For some patients, lung transplantation may be a treatment option.

About iBio, Inc.

iBio develops and offers proprietary products and product licenses, based on its proprietary iBioLaunch and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines. In Brazil, iBio has been collaborating with Oswaldo Cruz Foundation (Fiocruz) and Fraunhofer Center for Molecular Biotechnology since 2011 to develop a recombinant yellow fever vaccine based upon iBio technology.

The iBioLaunch 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 platform and designed to significantly improve vaccine products with both higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. Further information is available at: www.ibioinc.com.

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