Cerenis Therapeutics has advanced its lead clinical candidate, CER-001, into Phase III development across Europe and North America to evaluate efficacy to regress atherosclerosis, and safety of CER-001 in patients with Familial Primary HypoalphAlipoproteinemia (FPHA), a rare orphan disease.
 
CER-001 is an engineered complex of recombinant human apoA-I, the major structural protein of High-Density Lipoprotein (HDL) and phospholipids. Development of CER-001 leverages Catalent’s GPEx technology, which creates stable, high-yielding mammalian cell lines. Applying GPEx technology spans from early feasibility studies, to clinical manufacturing, through to commercial scale production.
 
Catalent performs GPEx programs at its biomanufacturing facility in Madison, WI, which is designed for cGMP production from 10 L up to 1,000 L, and non-GMP production up to 250 L.
 
Dr. Jean-Louis Dasseux, founder and chief executive officer of Cerenis said, “The partnership established with Catalent Biologics has empowered us to resolve a 30 year challenge: the production of a commercially viable HDL mimetic, by generating a proprietary CHO cell line with a high apoA-I expression via secretion meeting the demanding quality standards we require for our clinical study drugs. The Phase III TANGO trial will fully benefit from GPEx technology and we are convinced its application to the production of CER-001 batches will ensure better product safety and product quality. These features are particularly encouraging with regards to CER-001’s filing for future market approval expected in 2018.”
 
“GPEx technology was designed to offer clients and partners advantages over conventional cell line engineering systems, including increased flexibility and higher, more stable yields,” said Mike Riley, vice president and general manager of Catalent Biologics. “We are pleased to have worked with Cerenis to help advance their life-changing therapy into Phase III studies, and this represents another key milestone for our GPEx platform as an enabling technology.”