Fortress Biotech, Inc.’s 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 II/III studies of CAEL-101 for the treatment of amyloid light chain (“AL”) 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.

Michael Spector, chief executive officer of Caelum, said, “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.”