Fortress Biotech announced its subsidiary Caelum Biosciences has entered a biopharmaceutical manufacturing agreement with Patheon for process development and current good manufacturing practices (cGMP) production of Caelum’s lead therapy CAEL-101.
The agreement will support Phase 2/3 studies of CAEL-101 for the treatment of amyloid light chain amyloidosis, a rare systemic disorder that leads to the buildup of amyloid proteins in and around tissues, nerves and organs, resulting in organ damage and high mortality rates. CAEL-101 is currently being evaluated by study sponsor Columbia University in a Phase 1b study in AL amyloidosis.
“We believe this manufacturing agreement with Patheon will enable continued progression of the CAEL-101 clinical development program. The establishment of this important collaboration, now allows us to plan for our Phase 2/3 program,” Michael Spector, Chief Executive Officer of Caelum, said.
Patheon provides end-to-end, fully integrated services for both drug substances and drug products to help clients accelerate development in the rapidly evolving world of biologics.