On January 26, 2011 MENTRIK Biotech, LLC reported the successful acquisition of AME-133 (LY2469298), an anti-CD20 monoclonal antibody under development for cancer treatment of B-cell non- Hodgkin’s lymphoma and other indications (Press release, Mentrik Biotech, JAN 26, 2011, View Source [SID:1234513567]). AME-133 is an intravenously administered, fully humanized, fc engineered, high-affinity immunoglobulin G subclass (IgG1) monoclonal antibody for which Phase I clinical development has been completed. The CD20 antigen is a validated target for the treatment of patients with B-cell cancers like lymphoma, chronic lymphocytic leukemia (CLL), and for auto-immune diseases like rheumatoid arthritis (RA). Rituximab (Rituxan), a first-generation human-mouse chimeric antibody has been approved by the FDA for the treatment of non- Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. AME-133 is a fully humanized antibody and has been optimized through protein engineering both for increased affinity for CD20 and increased effector function in antibody-dependent cell-mediated cytotoxicity (ADCC), which may lead to superior efficacy and safety.
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A Phase I/II clinical trial with AME-133 for the treatment of patients with previously treated follicular lymphoma has been completed. Sixty-seven patients were treated with AME-133 in this trial. The results showed that AME- 133 is well tolerated and 375mg/m2 was confirmed as the recommended dose for future trials. "We are very excited about this acquisition. The clinical results to date suggest that AME-133 has the potential to improve therapeutic options for patients with follicular lymphomas," says Dr. Vinay Jain, CEO of MENTRIK Biotech.
MENTRIK acquired full rights to develop AME-133 for all human therapeutic, prophylactic, and diagnostic uses. The company intends to continue the development of AME-133 for the treatment of B-cell lymphomas such as non- Hodgkin’s lymphoma, Hodgkin’s disease, Waldenstrom’s macroglobulinemia, Mantle cell lymphoma, and also chronic lymphocytic leukemia (CLL). In addition, MENTRIK will also investigate the potential clinical benefit of AME-133 for the treatment of auto-immune diseases like rheumatoid arthritis and multiple sclerosis.