Eastern and iBio have capitalized a newly-formed subsidiary of iBio called iBio CMO LLC to create a contract manufacturing organization for development, scale-up and large-scale manufacturing of biologicals. The Eastern Affiliates contributed $15 million in cash to the venture for 30% of the equity. iBio contributed research and manufacturing licenses of iBio's proprietary intellectual property for plant-made production of biopharmaceuticals. iBio will retain a 70% equity interest.
iBio CMO entered into a 35 year operating lease with the Eastern Affiliates, to control a 139,000 square foot Class A life sciences building located on approximately 21 acres in Bryan, TX. The facility, previously owned by Caliber Biotherapeutics and its affiliates, and now owned by the Eastern Affiliates, is located on a technology corridor abutting the campus of Texas A & M University, home of the National Center for Therapeutics Manufacturing, a leading center for research in the production of vaccines and protein therapeutics.
“We expect these transactions to be transformative for iBio,” said Robert Kay, chairman, iBio. “They give us control over a beautifully engineered, fully-equipped, large-scale facility to implement iBio's proprietary plant-made biopharmaceutical development and manufacturing technologies. They also provide substantial capital to both iBio and iBio CMO to support progress of iBio's fibrosis products into human clinical trials, and enable us to offer the rapidly expanding and underserved biologics development market contract manufacturing, using the superior attributes of our proprietary, plant-based technologies.”
“We have an excellent working relationship with iBio and a shared vision of its potential, both as a contract manufacturing organization and as a developer of biopharmaceutical products,” said Mark VanDevelde, a director of Eastern Capital Limited, located in the Cayman Islands. “iBio's commanding IP position in low cost plant-based biologics manufacture and its conservative capital management contributed to Eastern's decision to substantially increase its financial investment in iBio.”
Certain key former employees of Caliber Biotherapeutics have joined iBio CMO to continue ongoing operations and the projects currently underway for iBio in the facility. iBio and Caliber have worked closely together since 2012, collaborating on a range of projects, such as antiviral therapeutic antibodies, including those for Dengue fever and Ebola virus disease. The collaboration was extended in 2013 to include additional technologies developed by iBio, in collaboration with Novici Biotech, designed to offer superior alternatives to traditional methods of biopharmaceutical development and manufacturing.
iBio's proprietary technology was the basis for early success of the Accelerating Critical Therapeutics program of the Defense Advanced Research Projects Agency (DARPA). iBio technology was then licensed to Caliber for the DARPA “Blue Angel” project. The “Blue Angel” project demonstrated successful use of the technology on a commercial scale. The iBio CMO facility can grow over 4 million plants hydroponically as “in process inventory” and can deliver over 300 kilograms of finished therapeutic protein per year. This translates into more than a half million doses per year of a typical therapeutic antibody. In the context of a vaccine intended to control a pandemic outbreak, this translates into 50 million vaccine doses produced from availability of vaccine gene sequence to delivery in twelve weeks of completed product, and the ability to produce approximately 50 million doses every three weeks thereafter. Facility capacity can be doubled by adding additional plant growth equipment in a space already reserved for that purpose.
“Despite significant recent investments by major pharmaceutical and industrial companies in legacy cell culture-based manufacturing facilities, there is still a looming worldwide shortage of biologics development and manufacturing capacity. Meanwhile, growth of the biopharmaceutical sector is accelerating,” said Robert Erwin, president, iBio. “We now have both the technology and the capacity to enable biologics companies to focus on the value of their products rather than on the time, cost and other development challenges of cell lines used in traditional biologics manufacturing.”