iBio, Inc. and Caliber Biotherapeutics Establish License and Collaboration Relationship
Published: Feb 19, 2013
NEWARK, Del. and BRYAN, Texas, Feb. 19, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO), and Caliber Biotherapeutics LLC (Caliber) today announced execution of a License and Collaboration Agreement for development and production of recombinant plant-based biopharmaceuticals using iBio's proprietary iBioLaunch technology and Caliber's unique and proprietary plant-based manufacturing capabilities.
The new relationship establishes a turn-key plant-based biopharmaceutical development capability, from the earliest stage of product selection and optimization through large-scale production. iBio and Caliber will use their combined capabilities for their own product portfolios, starting with an undisclosed monoclonal antibody for oncology indications, where Caliber and its affiliates have demonstrated expertise. The Companies also will make their combined capabilities available to third parties through licensing and partnering arrangements for other recombinant plant-based biotherapeutics and vaccines.
iBio's patented iBioLaunch technology, developed over nine years at a cost of more than US$100 million, causes common green plants to produce commercial quantities of targeted human proteins in proper form for use as the active pharmaceutical ingredients for the development and production of biopharmaceuticals. Caliber owns and operates the world's largest-capacity cGMP commercial manufacturing facility for plant-made biopharmaceutical products.
iBio's technology platform is broadly applicable to recombinant vaccines and biotherapeutic products, including: monoclonal antibodies; proteins otherwise derived from blood plasma; and replacement enzymes used to treat a variety of orphan diseases. The technology has demonstrated capabilities to express proteins that were not commercially feasible to produce using other systems, and unlike technologies dependent on transgenic cells and organisms, utilizes advanced informatics and new synthetic biology techniques for superior clinical product design and delivery. Human clinical trials of product candidates produced with iBio's technology have been funded by the U.S. Department of Defense and the Bill & Melinda Gates Foundation.
Caliber's current facility capacity for therapeutic protein at typical yields is over 300 kilograms of active pharmaceutical ingredient per year (which would yield around one billion doses of a typical subunit vaccine product or 300,000 doses of a typical antibody product), which can be quickly expanded based on demand. The facility design enables concurrent development and production of multiple products and rapid changeover. The Caliber facility together with the iBioLaunch technology also enables extraordinary surge capacity for vaccines and biotherapeutics against pandemic disease and bioterrorism.
Under the terms of the agreement, iBio will receive license and milestone fees for development of product targets selected by Caliber. Caliber will be responsible for funding clinical development and commercialization of such collaboration products, and iBio will receive royalties on product sales and other revenues. Detailed financial terms of the agreement have not been disclosed.
"This combination is a major advance for recombinant biopharmaceuticals," said Robert B. Kay, Executive Chairman and CEO of iBio. "By bringing together our intellectual property, facilities, and know-how, we not only will accelerate and improve development of our own product pipelines, but also enable third-party developers and sponsors to access turn-key solutions for their product candidates through licenses and partnerships with us."
Dr. Rahul Singhvi, Managing Director of Caliber Biotherapeutics, stated: "This new collaboration with iBio enables us to develop products addressing important unmet medical needs that uniquely benefit from Nicotiana benthamiana plant-based expression technology. The combination of iBio's state-of-the-art expression technology and Caliber's innovative manufacturing infrastructure makes the promise of plant-based pharmaceuticals very real. We are excited about combining our joint capabilities to create valuable products that would otherwise be commercially impossible to produce or develop."
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch and iBioModulator platforms, 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 therapeutic proteins and vaccines; 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. The iBioModulator platform is complementary to the iBioLaunch platform and enables significantly improved vaccine products with higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. Further information is available at: www.ibioinc.com.
About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics, LLC is a biotechnology company based in Bryan, Texas with a mission to develop and commercialize protein-based therapeutics that improve outcomes for patients with cancer and other diseases. The Company utilizes technological innovations in biological research, product development and manufacturing to create treatments with increased safety and effectiveness--while reducing both costs and development time. Caliber has created a rich pipeline of monoclonal antibody-based products, including biobetter product candidates applying its expertise in the Nicotiana benthamiana plant-based expression and manufacturing of recombinant proteins. Caliber operates the world's largest N. benthamiana expression based protein manufacturing facility, in Bryan, Texas. For more information, please visit www.caliberbio.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.
Caliber Safe Harbor:
This release contains forward-looking statements that are not based on historical fact. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.
Robert Erwin, President
Caliber Biotherapeutics, LLC
Rahul Singhvi, Managing Director
SOURCE iBio, Inc.