On January 28, 2020 Legend Biotech reported that, according to the terms and conditions of an agreement with Janssen Biotech, Inc. (Janssen), the fourth milestone payment has been achieved relating to the U.S. clinical development of the B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, LCAR-B38M (JNJ-68284528 (JNJ-4528)) (Press release, Legend Biotech, JAN 28, 2020, View Source [SID1234555395]).
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"We are pleased to have achieved this milestone, the fourth under the LCAR-B38M collaboration with Janssen," said Yuan Xu, PhD, CEO of Legend Biotech. "JNJ-4528 continues to advance in the clinic and we congratulate the Legend and Janssen teams on continued progress towards bringing this therapy to patients."
In December 2017, Legend and Janssen entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize LCAR-B38M (JNJ-4528) in multiple myeloma. JNJ-4528 identifies the investigational product candidate being studied globally, except in China where the investigational product candidate (with identical CAR) isidentified as LCAR-B38M. Under the agreement, Legend received an upfront payment of $350 million from Janssen, and is entitled to receive additional payments upon achievement of specified development, production performance, regulatory and sales milestones. The companies have entered into a 50/50 cost-sharing/profit-split arrangement, except in Greater China, where Legend and Janssen have a 70/30 cost-sharing/profit-split arrangement. In December 2018, the first clinical milestone in the U.S. was achieved, resulting in a milestone payment from Janssen in 2019. Legend received the second and third milestone payments from Janssen in July 2019.
About CAR-T and BCMA CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells. By targeting BCMA, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.
Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy. Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections. Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available. In 2020, the American Cancer Society projects that 32,270 new cases of multiple myeloma and 12,830 deaths will occur in the United States.