The new patent, US 9,365,616, on an invention by iBio’s collaborators, Dr. Carol Feghali-Bostwick and colleagues, is entitled “USE OF ENDOSTATIN PEPTIDES FOR THE TREATMENT OF FIBROSIS” and includes claims covering composition of matter and methods of use for endostatin-related peptides. Previously issued members of this patent family include US patents 8,507,441 and 8,716,232.
iBio obtained exclusive licenses to the prior patents and related intellectual property developed by Dr. Feghali-Bostwick and then entered into an ongoing collaboration agreement with Dr. Feghali-Bostwick’s current institution, the Medical University of South Carolina (MUSC), which led to further development and invention of the potentially breakthrough biotherapeutic approach to fibrotic diseases described by this family of patents.
Data published by Dr. Feghali-Bostwick, now the Kitty Trask Holt and SmartState® SC Centers of Economic Excellence Endowed Professor at MUSC, indicate that the endostatin-derived peptides covered by these patents demonstrated both inhibition and reversal of fibrosis in generally accepted preclinical mouse models of fibrosis as well as in human skin. iBio has produced the active pharmaceutical ingredients for the product candidates covered by these patents using its patented proprietary gene expression technology and expects to manufacture material for human clinical trials, and for large-scale production of any product that receives regulatory approval, in the Bryan, Texas facilities of iBio’s new subsidiary, iBio CMO LLC.
About Systemic Sclerosis and Idiopathic Pulmonary Fibrosis
Systemic sclerosis is a fibrotic 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. Organ fibrosis is responsible for health care costs exceeding $10 billion per year, and it is estimated that the number of deaths due to fibrosis is double the number of deaths due to cancer. Organ fibrosis is responsible for nearly half of deaths in developed countries and results in significant physical, emotional, and financial burdens as well. Idiopathic pulmonary fibrosis is a life-shortening fibrotic 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. IPF has a worse survival rate than most cancers except for pancreatic cancer and certain lung cancers.
About iBio, Inc.
iBio is developing proprietary products for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, produced using the Company’s proprietary gene expression technology, is the first product candidate from this program being advanced for IND development. The Company also offers proprietary products and product licenses to others based on its proprietary technologies, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines.
iBio CMO LLC is a 70 percent subsidiary of iBio jointly owned with affiliates of Eastern Capital Limited for development and large-scale manufacture of plant-made pharmaceuticals. The iBio CMO multiproduct facility includes laboratory and pilot-scale operations as well as large-scale automated hydroponic systems capable of growing over 4 million plants as “in process inventory” and producing over 300 kilograms of finished therapeutic protein per year. This translates into more than a half million doses per year of a typical therapeutic antibody and approximately 50 million vaccine doses every three weeks. Facility capacity can be doubled by adding additional plant growth equipment in a space already reserved for that purpose. iBio CMO’s lease includes the right to develop another facility on the balance of the leased property that would have the effect of quadrupling capacity from the current level. iBio CMO offers a range of pharmaceutical product and process development, analytical, and manufacturing services.
In Brazil, iBio has formed a subsidiary company, iBio do Brasil Biofarmaceutical Ltda., and has been collaborating with the Oswaldo Cruz Foundation (Fiocruz) to develop a recombinant yellow fever vaccine based on iBio technology. Further information is available at: www.ibioinc.com.
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