MorphoSys AG has announced that its collaborator Novartis has initiated a phase 2/3 clinical trial in sporadic inclusion body myositis (sIBM) patients with the HuCAL-derived antibody bimagrumab (BYM338).
The event triggered a clinical milestone payment to MorphoSys. Further financial details were not disclosed.
Bimagrumab (BYM338) is a novel, fully human monoclonal antibody developed to treat pathological muscle loss and weakness.
Bimagrumab was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with MorphoSys, whose HuCAL library was used to identify the antibody.
Bimagrumab binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. Bimagrumab stimulates muscle growth by blocking signaling from these inhibitory molecules.
Novartis received FDA breakthrough therapy designation for bimagrumab for sporadic inclusion body myositis in August 2013. In addition to being developed in sIBM, bimagrumab is in clinical development for chronic obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia and in mechanically ventilated patients.
"Our pipeline of both partner and proprietary antibody drugs represents the main value driver for MorphoSys and we are therefore delighted to see one of the most exciting and innovative HuCAL-based antibody programs advance into the next stage of clinical development. Bimagrumab is the second HuCAL antibody to enter pivotal studies," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG.
MorphoSys's clinical pipeline now comprises 21 programs. Of these, 17 are programs that were initiated by partners, of which two are in Phase 3 development eight are in Phase 2 and seven are in Phase 1.
From the company's proprietary portfolio, MOR202, which is being co-developed with Celgene, is in a phase 1/2a trial for multiple myeloma. MOR208 is currently being evaluated in two phase 2 trials in B-ALL and NHL.
MOR103, partnered with GSK, has concluded a phase 1b/2a trial in rheumatoid arthritis, and is currently being evaluated in a phase 1b trial in multiple sclerosis.