iBio Supporting AzarGen Biotechnologies’ Development of a Rituximab Biosimilar
March 26 2020 - 4:20PM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”) today
announced that it has entered into a second Statement of Work under
its Master Joint Development Agreement (the “MJDA”) with AzarGen
Biotechnologies (Pty.) Ltd. (“AzarGen”). Signed in 2018, the
MJDA contemplates initial contract development and manufacturing of
AzarGen’s biosimilars at iBio’s Bryan, Texas facility. Ultimately,
iBio plans to transfer its
proprietary
FastPharming Manufacturing
System™ to AzarGen in South Africa for production of critical
biological medicines for the African continent.
“We are proud to be supporting AzarGen in the
development of their lead biosimilar product,” commented Thomas F.
Isett, iBio’s Co-Chairman and CEO. “Rituximab is an important
treatment for certain autoimmune diseases and cancers. By using our
FastPharming System™ to produce rituximab in
plants, we are confident that AzarGen will not only benefit from
the speed, quality and safety advantages of the platform, but also
enjoy iBio’s continued support for their efforts to transfer the
technology to make newer biologics more readily available at lower
costs to people living in Africa.”
In September 2019, AzarGen contracted with iBio
to manufacture research quantities of rituximab for bioanalytical
testing. Having successfully completed the initial work, iBio will
now manufacture and characterize additional supplies to enable
pre-clinical studies comparing plant-made rituximab to the original
molecule made using genetically engineered mammalian cells.
“We are pleased with the progress iBio has made
toward helping us advance our rituximab biosimilar toward
preclinical studies,” said Dr. Mauritz Venter, CEO of AzarGen. “We
are looking forward to the results of the analyses in hopes of
developing a more affordable alternative for the African
market.”
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, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming System™ combines
vertical farming, automated hydroponics, and glycan engineering
technologies to rapidly deliver gram quantities of high-quality
monoclonal antibodies, vaccines, bioinks and other proteins. The
Company’s subsidiary, iBio CDMO LLC, provides
FastPharming Contract Development and
Manufacturing Services via its 130,000 square foot facility in
Bryan, Texas. Originally built in 2010 with funding from the U.S.
Defense Advanced Research Projects Agency (DARPA), iBio’s
FastPharming Facility was part of the “Blue Angel”
initiative to establish factories capable of rapid delivery of
medical countermeasures in response to a disease pandemic. iBio’s
FastGlycaneering Development Service™ includes an
array of new glycosylation technologies for engineering
high-performance recombinant proteins. Additionally, iBio is
developing proprietary products which include IBIO-100 for the
treatment of fibrotic diseases and IBIO-200, a COVID-19 vaccine.
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
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.
Contact:
Stephen KilmerInvestor Relations(646) 274-3580
skilmer@ibioinc.com
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