Icosagen, a private European protein therapeutics CRDMO, and EPOK Therapeutics Inc., a pre-clinical-stage biopharmaceutical company, based in Toronto, Canada,  announced the successful completion of a development project for EPOK's novel antibody EPRA-0322.  

EPOK selected Icosagen and its proprietary IcoCell® CHO cell line development platform as the basis for a robust, scalable clinical and commercial manufacturing platform for its lead candidate for the treatment of anemia related to Chronic Kidney Disease. EPRA-0322 is a potent mono-specific erythropoietin (EPO) receptor agonist and a complex, highly engineered antibody-like therapeutic protein with a tetravalent Diabody-Fc-Fab architecture, requiring a molecule-centric development approach to ensure efficient expression, product quality, and eventually commercial-scale manufacturability.

"The stable IcoCell® CHO cell line and process developed by Icosagen has been instrumental in advancing our therapeutic lead program EPRA-0322 toward IND submission," said Sanjeev Munshi, PhD, Chief Executive Officer of EPOK Therapeutics. "Icosagen's scientific and technical expertise in developing our therapeutic protein has been outstanding. The resulting clone showed excellent productivity, and the upstream process development team rapidly boosted the original titer significantly. Strong productivity, desired product quality attributes, and process robustness have been critical for seamless scale-up and large-scale GMP manufacturing for first-in-human clinical trials. We are very grateful for this excellent partnership and look forward to working with Icosagen again in the future."

“Among the thousands of molecules we have worked with, EPRA-0322 stands out as an elegant, meticulously designed and exciting protein”, said Dr. Mart Ustav Jr., Chief Scientific Officer of Icosagen. “Our philosophy goes beyond simply generating high-performing CHO cell lines – we comprehensively study the specific characteristics of each molecule and create a development and manufacturing path that preserves them all the way to the clinic.”

This approach is particularly important for innovative, non-platform therapeutic protein modalities, where productivity alone is not the sole determinant for success in drug development. To reduce later development risk, Icosagen’s integrated CRDMO concept simultaneously brings together expression, developability assessment, analytics and manufacturing sciences early in development. This creates CHO producer cell lines with titers of up to 10 g/L in classical fed-batch bioreactors.