iBio’s Collaboration with South Africa’s AzarGen Biotechnologies Advances to Next Stage
September 17 2019 - 4:15PM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”) today
announced that it has entered into the initial Statement of Work
(“SOW1”) under its Memorandum of Understanding (“MOU”) with AzarGen
Biotechnologies (Pty.) Ltd. (“AzarGen”).
Following iBio’s successful use of its
technologies and manufacturing capabilities to advance the
development of AzarGen’s surfactant protein therapeutic through an
initial assessment of production feasibility, in May 2017, the two
companies expanded their collaboration by initiating the
development of a plant-made rituximab for the South African market
under the MOU.
Pursuant to the SOW1, iBio will manufacture
research quantities of a plant-made rituximab for AzarGen using
iBio’s proprietary FastPharming™ System. Following
batch production, the drug product candidate will undergo testing
via iBio CDMO’s bioanalytical services.
“After demonstrating the success of our platform
through our opening project with AzarGen, we are now advancing to
the next stage of the two companies’ collaboration,” commented
Robert B. Kay, iBio’s Chairman and CEO. “We look forward to helping
AzarGen develop a plant-based, bio-similar rituximab product for
the South African market.”
“The early success in combining iBio’s and
AzarGen's advanced genetic engineering and synthetic biology
techniques in plants really empowered us to evolve our business
plans and product priorities to initiate development of a
biosimilar version of rituximab,” said Dr. Mauritz Venter, CEO of
AzarGen. “As we continue to move toward the initiation of advanced
pre-clinical activities, we are confident that iBio CDMO is ideally
suited to provide us with the requisite long-term process
development and cGMP manufacturing support. We are excited to take
this important step forward in advancing this program. Focusing on
accessibility and affordability of biological medicine for the
African continent, we look forward to initiating additional
projects with iBio as we progress.”
Rituximab was first approved by the U.S. Food
and Drug Administration in 1997 for treatment of certain B cell
non-Hodgkin lymphomas. Since that time, its clinical uses have
expanded to encompass treatment of chronic lymphocytic leukemia, as
well as a range of autoimmune diseases, including certain types of
rheumatoid arthritis. Rituximab has been placed on the World Health
Organization’s List of Essential Medicines and it was ranked as one
of the world’s top-10 selling pharmaceuticals in 2018.
About AzarGen Biotechnologies (Pty)
Ltd
AzarGen is a biotechnology company focused on
developing human therapeutic proteins using advanced genetic
engineering and synthetic biology techniques in plants. The
company’s lead therapeutic candidates are: a biosimilar version of
an anti-cancer monoclonal antibody and a recombinant human
surfactant protein targeted for various respiratory disease
conditions. AzarGen has developed proprietary synthetic DNA
promoters for various expression platform applications in
plant-made pharmaceuticals, synthetic biology and GM-crop
improvement. The AzarGen management team is supported by an
experienced advisory board for strategic guidance and intellectual
property management. Based in Stellenbosch, South Africa, AzarGen
is supported by South Africa’s Industrial Development Corporation
(IDC). Further information is available at www.azargen.com.
About iBio
iBio is a global leader in plant-based
biopharmaceutical contract development and cGMP manufacturing
services. Our wholly-owned subsidiary, iBio CDMO LLC, uses
the FastPharming™ System – which combines plant
protein expression, automated hydroponics, and glycan engineering
technologies – to rapidly deliver gram quantities of high-quality
biologics for research or further manufacturing uses from its
120,000 square foot facility in Bryan, Texas. In addition to
contract manufacturing, iBio also offers process development,
bioanalytical, and fill-finish services, along with Factory
Solutions for the design and build of facilities for plant-made
monoclonal antibodies, vaccines, bioinks and more. iBio also uses
its advanced manufacturing capabilities in the development of its
own therapeutic pipeline, including its lead asset, IBIO-100
(formerly CFB-03) for the treatment of fibrotic diseases. For more
information, visit www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSSTATEMENTS 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
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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
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THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION.
Contact:
Stephen KilmerInvestor Relations(646) 274-3580
skilmer@ibioinc.com
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