iBio Fibrosis Therapeutics Program Receives NIH Grant Support

NEW YORK, NY--(Marketwired - Sep 9, 2015) - iBio, Inc. (NYSE MKT: IBIO), a leader in plant-based biotechnology for developing and manufacturing biopharmaceutical products, announced the award of a grant to fund further development of its proprietary therapeutic product for treatment of fibrotic diseases from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) under its Small Business Technology Transfer (STTR) program. The Fast-Track award will support the work of principal investigators Carol Feghali-Bostwick, Ph.D., of The Medical University of South Carolina (MUSC) and Hal Padgett, Ph.D., of Novici Biotech LLC (Novici) and their research teams. The funded project is entitled, "Peptide Based Therapy for Lung Fibrosis." The commercial sponsor of the program is iBio, Inc.

"Our anti-fibrotic molecules were discovered and refined using phenotypic screening techniques rather than direct mechanistic targeting of a single modulator of fibrosis such as TGF-beta, giving us a high degree of confidence that these molecules can produce positive outcomes in fibrosis with broad applicability in a variety of fibrotic diseases," said Terence Ryan, Ph.D., iBio's Chief Scientific Officer. "We are encouraged by the positive reviews that led to approval of this grant application."

The NIH STTR Fast-track mechanism provides for a submission and review process whereby both Phase I and Phase II grant proposals are submitted together and reviewed as a single application, thus reducing the funding gap that may occur between phases. This grant was approved for funding as of September 1, beginning with approximately $200,000 for Phase I. Phase II funding of approximately $1.5 million may commence once the milestones for Phase I have been completed and a progress report is submitted and approved by the NHLBI. Steady progress has been made on project objectives during the grant application review period, and the principal investigators expect to submit a timely progress report.

"Our collaboration with iBio and Novici is yielding exciting progress," said Dr. Feghali-Bostwick, MUSC's SmartState® and Kitty Trask Holt Endowed Chair and Professor of Medicine. "I look forward to working with this team to translate laboratory bench discoveries into effective therapies."

iBio is extending the pioneering research of Dr. Feghali-Bostwick to develop proprietary products for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis and systemic sclerosis/ scleroderma. Dr. Feghali-Bostwick's published data demonstrate that certain peptides derived from human endostatin prevent and reverse fibrosis in tissue culture models of fibrosis (TGFβ-stimulated human donor fibroblasts and skin tissues) as measured by reduction in skin thickening and collagen deposition. In addition, the peptides have been shown to prevent and reverse pulmonary fibrosis in a widely accepted animal model of fibrosis (intratracheal bleomycin treatment). IBIO-CFB03, produced using the company's iBioLaunch™ gene expression platform, is the first product candidate from this program being advanced for clinical development.