iBio Announces Production of Biosimilar Rituximab with its iBioLaunch™ Technology
NEWARK, Del., Oct. 5, 2011 /PRNewswire/ -- iBio, Inc. (NYSE AMEX: IBIO), announced that its proprietary iBioLaunch™ technology for the production of biotherapeutic proteins and vaccine antigens in whole green plants has been used to produce a functional monoclonal antibody copy of rituximab, used in the medical treatment of lymphomas, autoimmune diseases, and transplant rejection. Rituximab is a chimeric mouse-human monoclonal antibody that binds to the CD20 antigen presented on the B-cell surface.
Scientists at iBio's research and development partner, the Fraunhofer USA Center for Molecular Biotechnology, have expressed the antibody heavy and light chains in whole plants using another novel iBioLaunch vector system developed for multi-chain proteins like antibodies. The expression of rituximab in plants resulted in a balanced expression of heavy and light chains which self-assembled into the appropriate antibody structure, which was then purified from the plant tissue.
Purified, iBioLaunch-produced rituximab was shown to bind to B lymphocytes from donor blood samples, indicating that it was recognizing its antigen presented on the B-cell surface. In further experiments, plant produced rituximab was incubated at various concentrations with donor peripheral blood mononuclear cells (PBMC), and shown to cause a dose-dependent depletion of B-cells as measured by flow cytometry staining of another B-cell surface antigen, CD19. At the highest doses tested, greater than 90% of donor B cells were lost from the lymphocyte population, showing that plant-produced rituxmab is able to demonstrate the antigen recognition and target cell cytotoxicity observed with rituximab manufactured in mammalian cell systems. The B-cell cytotoxicity is specific to rituximab, which was demonstrated in experiments that used another plant-produced monoclonal antibody as a control for any plant-specific B-cell depletion activity.
"The production of functional rituximab in plants suggests that many if not all monoclonal antibodies can be produced using the iBioLaunch™ system," said Terence Ryan, Ph.D., iBio's Senior Vice President. "This success dramatically extends the commercial opportunities for our technology beyond its previous applications for the production of viral antigens for vaccines, and replacement protein biotherapeutics such as alpha-galactosidase, alpha-1 antitrypsin, and C1 esterase inhibitor."
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch™ platform, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. Advantages over other systems include: success with proteins difficult or impossible to produce with other methods; broadly applicable to biologics, including monoclonal antibodies, other therapeutic proteins and vaccines; enables rapid development and validation of modular, scalable, and optionally robotic, multi-product manufacturing facilities; production time measured in weeks instead of months or more. Additional benefits include a practically unlimited surge capacity for remedial action against bioterrorism and pandemic disease; product entry that is unconstrained by traditional process patents, and significantly lower capital and operating costs for comparable production. 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.
Robert Erwin, President
Douglas Beck, Chief Financial Officer
SOURCE iBio, Inc.