Researchers reported that in an ongoing early-phase clinical trial in China, 33 out of 35 (94%) patients whose multiple myeloma had relapsed on previous treatments had clinical remission within two months of receiving Legend’s experimental anti-BCMA CAR-T cell product, dubbed LCAR-B38M, and the objective response rate was 100%.
Now J&J wants in, doing a deal with its U.S. and European subsidiaries to develop, manufacture and sell LCAR-B38M; it’s already been accepted for review by the China Food and Drug Administration (CFDA) and in “the planning phase of clinical studies in the United States for multiple myeloma,” according to the U.S. giant’s statement.
It will be competing with the likes of Bluebird Bio and Juno to get the next-gen therapy on the market for this disease, and comes in the same year that the first CAR-T therapies from Novartis and Gilead/Kite saw approval.
Under the deal, Legend gives Janssen, J&J’s biotech unit, a worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with the Legend team. Janssen will record worldwide net trade sales, except for sales made in Greater China. The companies have entered into a 50-50 cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30-70 cost-sharing/profit-split arrangement. The biotech gains $350 million straightaway, with biobucks and royalties coming down the line, although details on exact figures were not shared.
“Despite significant advances, multiple myeloma remains an incurable disease for most patients, creating the need for additional, highly active options,” said Peter Lebowitz, M.D., Ph.D., global therapeutic area head, oncology, Janssen Research & Development. “LCAR-B38M provides an innovative approach with the potential to transform the treatment of myeloma. We look forward to collaborating with the pioneering scientific team at Legend and applying our expertise to the development of this cell therapy, with the goal of building regimens aiming for a cure.”