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iBio, Inc. (NYSE AMEX: IBIO) today announced the engagement of CBR International Corporation (CBR) for strategic regulatory and clinical services to advance iBio’s Orphan Drug designated, plant-produced human alpha galactosidase A (“α-Gal A”) enzyme candidate for development as a therapeutic option for patients with Fabry disease.
“We expect this engagement to significantly accelerate our path to the clinic for this important product application of our platform technology,” said Robert Erwin, President of iBio. “CBR managed the successful application for Orphan Drug designation of plant-made α-Gal A, and has substantial experience in this field. They will join the team comprising our regular research and development collaborator, Fraunhofer USA Center for Molecular Biotechnology and our manufacturing partner, Kentucky Bioprocessing, LLC.”
This Fabry disease therapeutic program is part of iBio’s broader program to bring forward approximately ten more candidate proteins for commercialization as “biosimilar” or “biobetter” therapeutic products. iBio intends to advance these candidates at least to a point sufficient to demonstrate the advantages of making them using the iBioLaunch™ platform technology and then enter into collaborative arrangements with industry partners. iBio already has demonstrated the applicability of its platform technology to most therapeutic protein classes, ranging from cytokines and growth factors to enzymes and antibodies.
Dr. Jeanne Novak, President and CEO of CBR commented, “Enzyme replacement therapy has been constrained by production limitations, interruptions and treatment cost. Patients with Fabry disease who do not receive enzyme replacement therapy are at increased risk of strokes, heart attack, heart disease, and renal failure. iBio’s innovative platform technology promises to add greater capacity for the supply of therapeutic protein biologics so that α-Gal A and other critical enzymes can be made available to more patients who need them in the future. We are confident that CBR’s clinical and regulatory expertise and extensive prior experience with α-Gal A will help expedite the development of iBio’s Fabry disease product program.”