Inebilizumab in Follow-On Indications
Inebilizumab is a humanized monoclonal antibody designed to target and deplete CD19-expressing B cells. The byproduct of these B cells, called plasmablasts, comprise what is called the autoantibody pathway, which may in turn lead to severe autoimmune diseases.
Beyond neuromyelitis optica spectrum disorder or NMOSD, for which UPLIZNA™ (inebilizumab-cdon) recently received U.S. FDA approval, we believe that patients suffering from a wide range of diseases associated with CD19-expressing B cells, could potentially benefit from treatment with inebilizumab. We are advancing clinical studies in the below follow-on indications:
Patients with high levels of alloantibodies waiting for a kidney transplant have a lower chance of getting a matching organ and overall worse clinical outcomes following transplant. More than 6% of the estimated 95,000 patients on the waiting list for a kidney transplant in the U.S. are considered “sensitized,” with an antibodies score of 98% to 100%. We are planning a proof of concept study to explore the potential of inebilizumab, used alone or in combination with VIB4920, to reduce levels of alloantibodies in kidney transplant candidates thereby improving transplant outcomes.
MG is a chronic, rare autoimmune neuromuscular disorder that causes abnormal weakness of skeletal muscles, which are responsible for breathing and moving parts of the body, including the arms and legs. MG, which affects about 56,000 people in the U.S., is caused by autoantibodies against the acetylcholine receptor, muscle specific kinase or other acetylcholine receptor-related proteins in the post-synaptic muscle membrane. As with NMOSD, autoantibodies secreted by plasmablasts and/or plasma cells play a key role and are thought to be directly pathogenic. Patients are currently managed with off-label immunosuppressants or steroids, or with a recently approved treatment.
This group of disorders marked by tumor-like swelling and fibrosis of affected organs, which may be caused by infiltration of CD19-expressing plasma cells that generate IgG4 antibodies. Affected organs may include the pancreas, salivary glands, retroperitoneum and kidneys. Although it is generally thought to be a rare condition, the prevalence is not well defined. A small trial of rituximab has suggested clinical benefits of B cell depletion.