Full Press Release Details
Annual Meeting in College Station, Texas
NEW YORK, NY--(Marketwired - Apr
7, 2016) - iBio, Inc. (NYSE MKT: IBIO) - Speaking to shareholders at the iBio, Inc. (NYSE MKT: IBIO)
Annual Meeting today, Chairman and Chief Executive Officer Robert B. Kay highlighted the Company's most important achievements
since its last Annual Meeting -- first, the creation of a new subsidiary for product development and large-scale manufacturing
using the Company's proprietary plant-based technologies, and second, significantly advancing the Company's own product candidates
against fibrotic diseases toward human clinical trials targeted to commence in 2016.
the contract manufacturing joint venture, between our recently formed subsidiary -- iBio CMO LLC -- and affiliates of Eastern
Capital, to be transformative for iBio because we are now in a position to use our proprietary technologies to perform for our
clients and ourselves each phase of biopharmaceutical development and commercial manufacturing from the early phases of product
selection, innovation and development through full-scale commercial production," Kay said. "These new, comprehensive
capabilities enable us to now provide a complete solution for product developer clients and ourselves."
Robert Erwin, iBio's
President, summarizing the Company's progress during the prior year described the commercial advances achieved with its technologies,
including demonstrated time saving advantages for early stage product selection and development and also its advantages in
eliminating both time-consuming cell line selection and then bioreactor scale-up once a product lead is selected. He then
described some of the ways iBio is continuing to expand its capabilities by replacing older technologies with new proprietary
inventions and methodologies.
of this is the success that has come from our engagement of Novici Biotech to create entirely new compositions of matter as prospective
product candidates, develop and employ new methodologies to increase the production yield of iBio's and clients' products with
a particular focus on monoclonal antibodies, and create novel gene expression vectors and process technologies," said Mr.
Erwin. "Based on laboratory and animal tests, our product application successes include creating 'biobetter' versions of
certain antibodies, some of which are for indications not yet addressed by commercial antibodies against viral diseases and some
of which are derived from antibodies in current clinical use for cancer and infectious disease.
the power of our proprietary technologies to benefit our own products in our collaboration with Dr. Carol Feghali-Bostwick's laboratory
through which we advanced development of our lead systemic sclerosis product candidate, IBIO-CFB03, and also broadened our fibrosis
portfolio to include novel therapeutic candidates of potential value for additional fibrotic disease indications. The success
of this work has proven once again that our technology can overcome challenges against various difficult product opportunities,
previous examples being antigens for malaria and hookworm vaccines."
IBIO-CFB03 as a Proprietary Therapeutic Product for Fibrotic Disease
the ability of the Company's advanced technology to successfully modify product composition. He described how we were able
to take our fibrosis product, initially produced by conventional chemical synthesis -- a slow and expensive process -- and more
rapidly and less expensively produce a superior version using our proprietary technologies to make a recombinant derivative in
plants. This transition reduced the projected cost of manufacturing large scale quantities of drug substance and also significantly
improved the pharmaceutical properties of the active ingredient.
Mr. Erwin also described
the rationale for the Company's selection of systemic sclerosis as its first clinical indication in the fibrotic disease area,
including that early stage clinical trials for systemic sclerosis will target endpoints that can be objectively measured more
rapidly than is possible with idiopathic pulmonary fibrosis (IPF), making the path to demonstration of efficacy shorter. He
disclosed and summarized the Company's pre-IND meeting with the FDA in December, 2015 in which preclinical toxicology, manufacturing,
and clinical trial design plans were reviewed and discussed, and he commented on plans beyond the first clinical trial.
iBio's collaborator,
and the lead inventor of IBIO-CFB03, Dr. Carol Feghali-Bostwick, spoke to shareholders about her enthusiasm for the steady movement
of her research results toward the clinic and her experience with iBio as a part of her overall effort to alter the clinical course
of fibrotic disease. She described the results of her use of human tissue explants in her research and discovery efforts and the
significance of those results in providing confidence in the clinical prospects for IBIO-CFB03.
with iBio continues to be a rewarding experience," said Dr. Feghali-Bostwick. "Together, we are expanding the range
of possibilities for clinical application of this research, and look forward to soon see the first clinical trial begin."
plans and expectations for the fibrosis product development program, Mr. Erwin said, "We plan to request U.S. and European
Orphan Drug designation for our product, first with systemic sclerosis and later for IPF. Based on preliminary laboratory data,
we are also considering additional indications for other fibrotic diseases. We are optimistic about broadening and extending our
fibrosis therapeutics intellectual property and managing this as a program rather than a single product."
iBio Patent Portfolio
iBio's ongoing development of new patentable products and processes and listed the following U.S. patents issued during calendar
iBio CMO to Become the Global Leader in Delivery of Plant-Made Pharmaceuticals
iBio's Senior Vice President of Business Development & Strategy, provided an overview of plans to establish iBio as the leading
supplier of plant-made pharmaceuticals to international markets. He described three categories of clients or collaborators expected
to benefit from the combination of iBio's technology and iBio CMO's experience and capacity:
case, we anticipate supporting our collaborators with product and process development services, initial manufacturing, and technology
transfer under product-specific licenses from iBio, Inc., each of which represents a significant revenue opportunity," said
Mr. Hicks. "In the second case, we expect to generate revenue by providing high quality manufacturing services for companies
at any stage in their product development and manufacturing cycle. In the third case, we see opportunities for ongoing benefit
to iBio and iBio CMO from successful early-stage joint product development with our collaborators."
and Capacity Features of iBio CMO
iBio Senior Vice President, Product Development and Manufacturing, concluded with a review and summary of proprietary features
built into the iBio CMO facility that are significant advances over earlier generation plant based methods. These include:
Opportunities for iBio's Plant-Made Proprietary Technologies
Ph.D., President and Chief Executive Officer of BioProcess Technology Consultants, Inc. (BPTC), a firm that provides strategic,
technical, and regulatory consulting services for the manufacture of biopharmaceutical products, and a contractor to iBio, described
the basis for his optimism about the global opportunities for iBio's proprietary plant-made pharmaceutical technologies and the
iBIo CMO capabilities. His comments included observations on efficiency and scale-up advantages of iBio's technology and the importance
of commercial technology transfer in addressing important growing international markets.
Between iBio and the Texas A&M University System
Director for Global and Corporate Partnerships of The Texas A & M University System (TAMUS), discussed the planned Master
Joint Development Agreement between iBio and TAMUS. The agreement is intended to facilitate a broad series
of interactions that will form the basis of a center of excellence in plant-made therapeutics. The bioresearch and engineering
expertise of Texas A & M and iBio's capabilities to develop and manufacture biopharmaceuticals will
be focused on opportunities for new protein products such as vaccines and monoclonal antibodies.
actions were approved by the Company's shareholders at the annual meeting, in each case by at least 90% of shares voted:
proprietary products for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis,
and scleroderma. IBIO-CFB03, produced using the Company's proprietary gene expression technology, is the first product candidate
from this program being advanced for IND development. The Company also offers proprietary products and product licenses to others
based on its proprietary technologies, providing collaborators full support for turn-key implementation of its technology for
protein therapeutics and vaccines.
a 70 percent subsidiary of iBio jointly owned with affiliates of Eastern Capital Limited for development and large-scale manufacture
of plant-made pharmaceuticals. The iBio CMO multiproduct facility includes laboratory and pilot-scale operations as well
as large-scale automated hydroponic systems capable of growing over 4 million plants as "in process inventory" and delivery
of 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 and approximately 50 million vaccine doses every three weeks. Facility capacity can be doubled
by adding additional plant growth equipment in a space already reserved for that purpose. iBio CMO's lease includes the right
to develop another facility on the balance of the leased property that would have the effect of quadrupling capacity from the
current level. iBio CMO offers a range of pharmaceutical product and process development, analytical, and manufacturing services.
In Brazil, iBio has formed a subsidiary
company, iBio do Brasil Biofarmaceutical Ltda., and has been collaborating with the Oswaldo Cruz Foundation (Fiocruz) to develop
a recombinant yellow fever vaccine based on iBio technology. Further information is available at:www.ibioinc.com.
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
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