iBio Expands Antibody Development and Production Services to Include Fc Fusion Therapeutics
March 07 2018 - 8:45AM
IBIO, INC. (NYSE AMERICAN:IBIO) (“iBio”) announced the expansion of
its CDMO capabilities and services to include the development and
cGMP manufacturing of Fc fusion proteins for therapeutic
pharmaceutical applications.
Fc fusion proteins are typically created using Chinese hamster
ovary (“CHO”) cells and combining the active portion of a desirable
protein with the naturally stable “tail portion” of an antibody
protein. The resulting hybrid protein can exhibit important
commercial and clinical advantages over both the original protein
and traditional antibodies.
Numerous Fc fusion proteins have been approved by the FDA for a
range of applications including colorectal cancer, macular
degeneration, hemophilia, and others. Additional Fc fusion proteins
are in various stages of research and clinical development.
iBio is now able to offer clients committed to the clinical
development of proprietary Fc fusion products the use of iBio’s
proprietary, plant-based technologies and facilities to achieve the
same competitive advantages it offers its antibody clients. These
include more rapid and economical evaluation of multiple lead
candidates during early development and significant time and cost
savings during each stage of scale up of production from laboratory
quantities to cGMP pilot lots for GLP toxicology and human clinical
trials and then for commercial manufacturing. In addition, by using
iBio’s proprietary plant-based technology instead of CHO or other
mammalian cell technologies, iBio generates monoclonal antibody
vectors entirely free of any viral transforming functions or
contamination from parental lines. iBio’s “lab to launch”
capability and capacity for biologics development now extends to
this important Fc fusion therapeutic protein category.
“We have proven Fc fusion manufacturing success with our own
proprietary Fc fusion protein candidate for the treatment of
fibrotic disease and with other Fc fusions, and now look forward to
assisting others with promising Fc fusion proteins in preclinical
and early clinical development,” said Dr. Barry Holtz, President of
iBio CDMO.
About iBio, Inc.
iBio, a leader in developing plant-based biopharmaceuticals,
provides a range of product and process development, analytical,
and manufacturing services at the large-scale development and
manufacturing facility of its subsidiary iBio CDMO, LLC in Bryan,
Texas. The facility houses laboratory and pilot-scale
operations, as well as large-scale automated hydroponic systems
capable of growing over four million plants as "in process
inventory" and delivering over 300 kilograms of therapeutic protein
pharmaceutical active ingredient per year.
iBio applies its technology for the benefit of its clients and
the advancement of its own product interests. The Company’s
pipeline is comprised of proprietary candidates for the treatment
of a range of fibrotic diseases including idiopathic pulmonary
fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on
the Company's proprietary gene expression technology, is the
Company’s lead therapeutic candidate being advanced for IND
development.
Further information is available at: www.ibioinc.com
Cautionary Statement Regarding Forward Looking
Statements
This release may contain "forward-looking statements" that are
within the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
identified by certain words or phrases such as "may", "will",
"aim", "will likely result", "believe", "expect", "will continue",
"anticipate", "estimate", "intend", "plan", "contemplate", "seek
to", "future", "objective", "goal", "project", "should", "will
pursue" and similar expressions or variations of such expressions.
These forward-looking statements reflect the Company's current
expectations about its future plans and performance. These
forward-looking statements rely on a number of assumptions and
estimates which could be inaccurate and which are subject to risks
and uncertainties. Actual results could vary materially from those
anticipated or expressed in any forward-looking statement made by
the Company. Please refer to the preliminary prospectus supplement,
the accompanying prospectus, and the Company’s most recent Forms
10-Q and 10-K and subsequent filings with the SEC for a further
discussion of these risks and uncertainties. The Company disclaims
any obligation or intent to update the forward-looking statements
in order to reflect events or circumstances after the date of this
release.
Contact:
ICR, Inc.Investor ContactStephanie CarringtonTel. +1
646-277-1282stephanie.carrington@icrinc.com
Media ContactJim HeinsTel. +1
203-682-8215James.heins@icrinc.com
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