Plants produce recombinant apolipoprotein AI on a commercial level
Canadian SemBioSys achieves critical milestone
SemBioSys Genetics Inc. has successfully developed commercial levels of apolipoprotein AI and its variant apolipoprotein AI (Milano) (collectively referred to as Apo AI) in safflower seed lines. Apo AI is believed by many clinicians to be the basis for the next generation of cardiovascular drugs, which represented a CDN$35 billion market in 2006. Apo AI is a major component of "good cholesterol" or HDL (high density lipoprotein) which naturally removes atheroscleroticplaque from arteries. This achievement is a key milestone for SemBioSys'cardiovascular drug development program. SemBioSys' plant-produced Apo AIoffers the potential to overcome the manufacturing challenges of traditionalfermentation-based technologies that have impeded the commercial developmentof Apo AI.
"Apo AI is a promising new therapy for the treatment of cardiovascular disease which is the largest drug market in the world. Unlike statins, the lead drug class in this market, which halt plaque build-up, clinical results from Apo AI have actually demonstrated significant plaque reduction. We believe manufacturing capacity and cost are major commercialization issues for pharmaceutical companies developing Apo AI. Today's announcement demonstrates that safflower seed is an enabling production vehicle for Apo AI with the scale and economics necessary to allow for the commercialization of this potentially transformative therapy," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "This is great news for the area of cardiovascular disease therapy. With the recent setbacks reported with other HDL modulators like torcetrapib and AGI-1067, Apo AI is clearly positioned at the forefront of cardiovascular disease therapy (see Nature 2006 Dec 14; pages 794-5). As an enabling manufacturing solution, we believe our Apo AI development program represents an attractive partnership opportunity for companies developing such cardiovascular therapies and with these results we will initiate formal partnering activities."
These results further validate the broad utility of SemBioSys' seed-based production system for critical, large volume biopharmaceuticals in short supply. SemBioSys' technology addresses protein extraction and purification as well as bulk protein production. SemBioSys estimates it can reduce capital costs for protein production by up to 70% and cost of goods by 40% or more with its rapidly scalable system. The Company has also produced authentic human insulin in safflower, which is expected to enter clinical trials in early 2008.
As a next step, SemBioSys expects to confirm the in vivo efficacy of Arabidopsis-produced Apo AI in the third quarter of 2007. SemBioSys intends to scale-up production of safflower-produced Apo AI and perform the necessary preclinical work in 2008 in order to initiate clinical trials in 2009.
High dosing (up to 20 grams per course of patient treatment) coupled with a large patient population is expected to drive volume demand of several tonnes of Apo AI per year, underscoring the value of a highly scalable plant manufacturing solution.
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