NEWARK, DE, USA I March 26, 2013 I iBio, Inc. (NYSE MKT: IBIO) today announced the addition of its proprietary iBioLaunch™-produced recombinant C1 esterase inhibitor to the group of product candidates selected for clinical development by the Company and its collaborators. Other candidates currently undergoing tests required for Investigational New Drug Applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria, and yellow fever.
Plasma-derived C1 esterase inhibitor is an Orphan Drug approved by the FDA to treat or prevent the symptoms of hereditary angioedema (HAE), an inherited disorder caused by low levels of C1 esterase inhibitor that causes swelling of the face, hands, feet, throat, stomach, bowels, or sexual organs. Annual global sales of HAE treatments are expected to exceed $1 billion as new treatment options penetrate the market. Additionally, C1 esterase inhibitors are the subject of multiple research programs investigating their potential use in the treatment of other inflammatory diseases.
C1 esterase inhibitor is a protease inhibitor involved in regulation of the complement pathway. The expression of recombinant C1 esterase inhibitor in plants using the iBioLaunch expression platform was undertaken to provide an alternative to the current method of production that involves purification from human donor plasma. iBio expects the properties of its iBioLaunch-produced C1 inhibitor to be useful in the treatment of hereditary angioedema and other inflammatory disorders.
iBio has produced a truncated version of C1 that retains full enzyme inhibition activity, but eliminates the need for potentially difficult and expensive post-translational modifications of the full-length protein. Production of a form with reduced post-translational modification also results in a more homogeneous product that may provide clinical benefits and ease regulatory concerns.
"Since our iBioLaunch technology is robustly applicable to most biopharmaceuticals, our commercialization strategy includes using iBioLaunch for iBio’s self-development of selected products like C1; licensing iBioLaunch to others for commercialization of a particular product, like the oncology antibody license we recently announced; and collaborating with major industry participants for the development of large-scale facilities that are based on and will use our technology under license for ongoing development and manufacture of multiple products," said Robert B. Kay, Chairman and CEO of iBio. "Based upon our recent progress with multi-product facility development, we expect to report soon on our achievements in that category."
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. The iBioModulator platform is complementary to the iBioLaunch platform and is designed to significantly improve vaccine products with both 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.
SOURCE: iBio
Post Views: 113
NEWARK, DE, USA I March 26, 2013 I iBio, Inc. (NYSE MKT: IBIO) today announced the addition of its proprietary iBioLaunch™-produced recombinant C1 esterase inhibitor to the group of product candidates selected for clinical development by the Company and its collaborators. Other candidates currently undergoing tests required for Investigational New Drug Applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria, and yellow fever.
Plasma-derived C1 esterase inhibitor is an Orphan Drug approved by the FDA to treat or prevent the symptoms of hereditary angioedema (HAE), an inherited disorder caused by low levels of C1 esterase inhibitor that causes swelling of the face, hands, feet, throat, stomach, bowels, or sexual organs. Annual global sales of HAE treatments are expected to exceed $1 billion as new treatment options penetrate the market. Additionally, C1 esterase inhibitors are the subject of multiple research programs investigating their potential use in the treatment of other inflammatory diseases.
C1 esterase inhibitor is a protease inhibitor involved in regulation of the complement pathway. The expression of recombinant C1 esterase inhibitor in plants using the iBioLaunch expression platform was undertaken to provide an alternative to the current method of production that involves purification from human donor plasma. iBio expects the properties of its iBioLaunch-produced C1 inhibitor to be useful in the treatment of hereditary angioedema and other inflammatory disorders.
iBio has produced a truncated version of C1 that retains full enzyme inhibition activity, but eliminates the need for potentially difficult and expensive post-translational modifications of the full-length protein. Production of a form with reduced post-translational modification also results in a more homogeneous product that may provide clinical benefits and ease regulatory concerns.
"Since our iBioLaunch technology is robustly applicable to most biopharmaceuticals, our commercialization strategy includes using iBioLaunch for iBio’s self-development of selected products like C1; licensing iBioLaunch to others for commercialization of a particular product, like the oncology antibody license we recently announced; and collaborating with major industry participants for the development of large-scale facilities that are based on and will use our technology under license for ongoing development and manufacture of multiple products," said Robert B. Kay, Chairman and CEO of iBio. "Based upon our recent progress with multi-product facility development, we expect to report soon on our achievements in that category."
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. The iBioModulator platform is complementary to the iBioLaunch platform and is designed to significantly improve vaccine products with both 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.
SOURCE: iBio
Post Views: 113
