Fortress builds on Columbia licence

Columbia University today licensed a therapeutic treatment that could tackle the rare organ disease amyloid light chain (AL) amyloidosis to US-based biopharmaceutical developer Fortress Biotech.

The licence for Columbia’s CAEL-101 antibody has been allocated to Caelum Biosciences, a newly created subsidiary of Fortress to commercialise the therapy.

Fortress has appointed Michael Spector, founder of US-based drug developer North Creek Pharmaceuticals, to run Caelum as chief executive.

AL amyloidosis is a potentially fatal disorder in which malformed proteins produced by bone marrow plasma cells threaten to cause organ failure. Treatment usually involves chemotherapy to damage the plasma cells, however CAEL-101 also attempts to destroy any remaining proteins.

CAEL-101 is based on research by Alan Solomon, a retired specialist in amyloidosis who had practised at University of Tennessee’s Graduate School of Medicine. Columbia University Medical Centre is the only institution to have developed a treatment based on the antibody.

Preliminary results from phase 1a/1b trials suggested 67% of amyloidosis patients improved with CAEL-101. The trial will finish in the first half of 2017, ahead of a wider phase 2 study scheduled for 2018.

Alan Solomon said: “Our anti-amyloid monoclonal antibody 11-1F4, now designated CAEL-101, has demonstrated its ability to bind to amyloid and promote dissolution in mice bearing human AL amyloid tumours.

“Most importantly, CAEL-101 injection has been shown to specifically bind to the amyloid and not to normal tissue in patients with AL amyloidosis.

“We hope that this anti-amyloid immunotherapy, in combination with anti-plasma cell chemotherapy, will benefit patients with this fatal disease.”