Patheon to manufacture amyloidosis antibody treatment for Caelum

By Flora Southey

- Last updated on GMT

Caelum Biosciences has selected Patheon to make its lead antibody CAEL-101 to treat orphan disease amyloid light-chain (AL) amyloidosis.

Contract development and manufacturing organisation (CDMO) Patheon will carry out the good manufacturing practices (cGMP) clinical testing of Fortress Biotech subsidiary Caelum’s lead therapy.

“The establishment of this important collaboration now allows us to plan for our Phase II/III programme,” ​said Caelum CEO Michael Spector.

CAEL-101 is currently being tested in a Phase Ib​ study by Columbia University, but with Patheon on board the firm says it can now plan for Phase II/III trials.

Amyloid light chain (AL) amyloidosis

Amyloidosis is a rare disease with the most common type, light-chain (AL) amyloidosis, estimated​ to affect five to 12 people per million per year.

The disease causes an increase of amyloid proteins in and around tissues, nerves and organs, which can lead to organ damage and fatality.

Caelum’s fibril‐reactive monoclonal antibody (mAb) candidate CAEL-101 received two orphan drug designations from the US Food and Drug Administration (FDA) earlier this year as a therapeutic agent for patients with AL amyloidosis, and as a radio‐imaging agent in amyloidosis.

Patheon – which is set to be acquired​ by life sciences firm Thermo Fisher – has been building up its biologics manufacturing services, especially at a small to mid-volume scale, since it entered the sector in 2014 through a $2.65bn (€2.36bn) merger with DSM’s pharmaceutical product business.

Patheon was unavailable for comment at the time of going to press.

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