Otlertuzumab

Enzyme inhibitor

This intravenously administered anti-CD37 IgG fusion protein (MW = 107.5 kDa; CAS 1372645-37-8), also known by its code name TRU-016, is intended for the treatment of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL), as well as for autoimmune and inflammatory diseases. Otlertuzumab was created by humanizing SMIP-016, a mouse/human chimeric protein that demonstrates antitumor activity against lymphoid malignancies in preclinical studies, including in human B-cell tumor mouse xenograft models. TRU-016 demonstrates synergistic or additive activity in NHL cells in combination with rituximab, rapamycin, doxorubicin and bendamustine. In a phase I/II clinical trial in refractory or relapsed patients with CLL or small lymphocytic lymphoma, Otlertuzumab is well tolerated, with clinical benefit and a reduced absolute lymphocyte count observed in all cohorts dosed at > 0.1 mg/kg. TRU-016 is a promising therapeutic agent for patients with B-cell lymphoid malignancies, especially patients refractory to standard treatment.