iBio Arranges Production of IBIO-CFB03 for Clinical Development With Caliber Biotherapeutics
NEWARK, DE -- (Marketwired) -- 04/27/15 -- iBio, Inc. (NYSE MKT: IBIO), has engaged Caliber Biotherapeutics LLC to scale-up and produce materials for clinical development of the first of iBio's proprietary anti-fibrosis products, IBIO-CFB03. Caliber's production will be used for IND-enabling toxicology studies and initial human clinical trials of IBIO-CFB03.
iBio is the exclusive worldwide licensee of the patents developed by Dr. Carol Feghali-Bostwick for therapies against fibrotic diseases. Dr. Feghali-Bostwick, the inventor of IBIO-CFB03, is collaborating with iBio for the development of various applications of her invention to address systemic sclerosis, idiopathic pulmonary fibrosis, and scleroderma. She is the Kitty Trask Holt Endowed Chair and Professor of Medicine in the Division of Rheumatology and Immunology at the Medical University of South Carolina where iBio expects the first human clinical trials of IBIO-CFB03 to be conducted.
The expansion in 2014 of iBio's exclusive technology collaboration with Novici Biotech LLC broadened iBio's fibrosis therapeutics program through a combination of the strengths of iBio's proprietary iBioLaunch™ platform technology with Novici's patented optimization technology. iBio then engaged CBR International Corporation for strategic regulatory and clinical services and assembled a Clinical Advisory Board of internationally recognized experts in fibrotic diseases to assist the company in clinical product development and human trial design.
"Our engagement of Caliber, which has pilot and full-scale production capabilities, enables us to satisfy all of our production needs for human clinical trials of IBIO-CFB03," said Robert Erwin, iBio's President.
Caliber, located in College Station, Texas, operates the world's largest plant-made pharmaceutical protein manufacturing facility. Caliber's facilities and operations have been supported by the Cancer Prevention and Research Institution of Texas (CPRIT), U.S. Defense Advanced Research Projects Agency (DARPA) and several Texas based life sciences investors. Caliber is a licensee of iBioLaunch technology for research purposes and for commercial development of other product candidates. iBio also granted Caliber a license to iBioLaunch technology for the production of antibodies that target the Ebola virus, and is currently engaged in a collaboration with Caliber and Novici for the optimization of undisclosed biotherapeutics.
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 iBioLaunch™ gene expression platform, is the first product candidate from this program designated for IND development. 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 April 27, 2015