Nov. 17, 2011
(NYSE AMEX: IBIO) today announced that it successfully used its proprietary iBioLaunch technology to produce full length as well as a modified form of C1 esterase inhibitor in green plants.
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
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.
iBio expects the properties of its iBioLaunch-produced C1 inhibitors to be useful in the treatment of HAE and other inflammatory disorders and expects to partner the products for clinical development as part of its commercial collaboration and licensing strategy.
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. Although therapeutic proteins purified from human plasma are tested for the absence of known pathogenic viruses, recombinant production of such proteins in a plant system that does not utilize any animal products can further reduce risk.
"These results continue the successful application of iBio's technology for the production of therapeutic proteins in plants, and further confirm the flexibility and speed of this technology when applied to difficult-to-express proteins," said Dr.
, iBio's Senior Vice President. "The efficiency of our technology enables us to simultaneously evaluate both 'bio-similar' and 'bio-better' versions of important protein biologics."
iBio previously announced production of full-length C1 esterase inhibitor and has now produced a truncated version 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.