- Johnson & Johnson has bought itself a foothold in the accelerating CAR-T field, paying $350 million upfront through its subsidiary Janssen Biotech Inc. to gain access to a cancer cell therapy candidate developed by a previously little-known Chinese company called Legend Biotech.
- Based in Nanjing, China, Legend Biotech wowed cancer researchers in June with an impressive late-breaking presentation of its anti-BCMA CAR-T therapy at the annual meeting of the American Society for Clinical Oncology (ASCO).
- Under the licensing deal announced Thursday, Janssen and Legend will equally split development costs and any future profits of the CAR-T candidate in multiple myeloma — excepting Greater China, where the Legend will take a 70% share. In addition to the upfront cash, Legend also stands to receive further, unspecified payments if certain development, regulatory and sales milestones are hit.
This year's ASCO showcased the potential of CAR-T to move beyond targeting of CD19 in B-cell malignancies, with clinical data presented by Legend and bluebird bio Inc. offering early validation of BCMA as a target in multiple myeloma.
bluebird built on that momentum earlier this month, unveiling updated results for its bb2121 candidate which showed strong complete response rates. Not to be outdone, Legend has now parlayed its own ASCO success into a $350 million deal with J&J.
Legend's candidate, dubbed LCAR-B38M, is currently under review by the China Food and Drug Administration and clinical studies are planned in the U.S.
"Clearly [J&J] will initiate studies in the U.S., however, we think it will be at least a year behind [bluebird] given it will need to establish manufacturing in the U.S. for clinical studies," wrote Jefferies analyst Biren Amin in a Dec. 21 note. "We also think [J&J]'s moves reflect a growing interest that BCMA is a very attractive target for treating multiple myeloma."
Data presented by Legend at ASCO showed treatment with LCAR-B38M resulted in clinical remissions in 33 out of 35 multiple myeloma patients within two months of infusion of CAR-T cells. Among the 19 patients who had four months of follow-up, 14 experienced stringent complete responses.
Notably, no patients experienced neurological side effects, which commonly afflict individuals treated with CAR-T therapies. Cytokine release syndrome, another adverse event associated with CAR-T, was reported in 85% of patients, but only two cases were rated severe.
The data remains early, and only comes from a Phase 1 study conducted in China. As Jefferies' Amin notes, Janssen will need to replicate those findings in the U.S. Other studies of CAR-T therapies in lymphoma and leukemia have found some patients relapse after an initial response, which might also occur in multiple myeloma.
Still, Janssen saw enough to merit a sizable upfront payment and a commitment to fund 50% of the costs of develop for LCAR-B38M outside of China.
Janssen has already built a strong franchise in multiple myeloma through its partnership with Danish Genmab A/S on Darzalex (daratumumab). CAR-T could become another avenue for the company to further advance its blood cancer business.
A statement from Janssen's Mathai Mammen, global head of science & development, reflected this, calling CAR-T an "important future therapeutic modality of Janssen."