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.
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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.
Forward-Looking Statements
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.
Contacts
iBio, Inc.
Corporate:
Robert Erwin, President
302-355-2335
rerwin@ibioinc.com
Caliber Biotherapeutics, LLC
Rahul Singhvi, Managing Director
240-308-0225
rsinghvi@caliberbio.com
SOURCE iBio, Inc.