Otilimab (MOR103/GSK3196165)

Otilimab (MOR103/GSK3196165) is a fully human HuCAL antibody directed against GM-CSF out-licensed to GSK in clinical development for inflammatory diseases.

Otilimab (MOR103/GSK3196165) is an investigational fully human HuCAL antibody directed against the granulocyte-macrophage colony-stimulating factor (GM-CSF). MorphoSys discovered and advanced Otilimab into clinical development, initially in rheumatoid arthritis and multiple sclerosis, and fully out-licensed it to GSK in June 2013. GSK is now developing the antibody in the area of inflammatory diseases including phase 2 clinical studies in rheumatoid arthritis (RA). Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies.


Proposed mode of Action

GM-CSF stimulates stem cells to produce granulocytes and other macrophages and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like rheumatoid arthritis leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction.
GM-CSF levels are significantly elevated in several inflammatory disorders and in the joints of rheumatoid arthritis patients. The HuCAL antibody MOR103 has demonstrated its apotential to reduce GM-CSF induced proliferation and activation of inflammatory cells and to intervene in several pathophysiological pathways in pre-clinical models of RA.

The figure depicts the suggested mechanism of action of Otilimab (MOR103/GSK3196165)

The therapeutic field

Rheumatoid arthritis

Rheumatoid arthritis (RA) is a chronic, disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. The disease affects approximately four to six million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium, where they cause inflammation.
Rheumatoid arthritis is an autoimmune disease characterized by inflammation of the joints, bone and cartilage erosion, and joint deformity. Additionally, the condition manifests itself in multiple joints in the body. Although the disease primarily affects the joints, it can also affect other organs, including the skin, eyes, lungs, heart, and blood vessels. Despite the many advances in both the understanding and the treatment of the disease, it remains largely incurable, and its causes are still unknown. The disease can lead to premature mortality, disability, and decreased quality of life.




Clinical Studies

As the compound has been fully out-licensed to GSK in 2013, they are responsible for the further clinical development of Otilimab (MOR103/GSK3196165).

In mid-2019, GSK announced the start of a phase 3 program in rheumatoid arthritis (RA) called ContRAst. It comprises three pivotal studies and a long-term extension study and evaluates the antibody in patients with moderate to severe RA.


Licensing agreement with GSK

MorphoSys and GSK entered into a global agreement to develop and commercialize Otilimab in June 2013. Under the terms of the agreement, GSK has assumed responsibility for all development and commercialization of the compound. As part of the agreement, MorphoSys received an immediate upfront payment. On achievement of certain development, regulatory, commercial and sale-based milestones, MorphoSys would be eligible to receive extra payments, in addition to tiered, double-digit royalties on net sales.