J&J hustles Legend’s promising BCMA CAR-T into PhI/II trial, winning an FDA green light to begin recruiting patients
After spending $350 million in cash to lay its hands on rights to Nanjing-based Legend Biotech’s promising BCMA CAR-T LCAR-B38M (JNJ-68284528), the pharma giant will now hustle it into an FDA-approved Phase Ib/II trial for multiple myeloma with an eye to snagging an accelerated OK.
The drug — under review in China — emerged from left field a year ago at ASCO, turning heads with extremely promising data that execs at rival bluebird bio dissed as a likely outcome of the patient population that was selected for the small study. J&J, though, went a long way to validating the program with its collaboration deal, helping make this one of the most closely-followed drugs in the industry pipeline, alongside bb2121 from bluebird and Celgene.
J&J’s Peter F. Lebowitz reaffirmed the company’s plan to prioritize this one, saying that “we are committed to rapidly advancing JNJ-68284528, and we are pleased to initiate a global clinical development program” for the drug.
Investigators for J&J will focus on safety and dosing in the first leg of this new study, expected to get underway in the second half of the year, which starts soon. Then they will shift to a look at the overall response rate to peg hard data on its efficacy.
BCMA — or B cell Maturation Antigen— has become a hot target in the booming I/O world, as developers turn to it as the second most popular field that now accounts for 753 cell therapy development programs, with 404 CAR-Ts —an overall increase of 87% in 6 months.
Legend, though, has stood out from the crowd, and J&J paid close attention. Researchers for the company reported last summer that among 35 relapsed, drug-resistant patients, 33 — 94% — demonstrated clinical remission ranging from a complete to a partial response. There was a 100% objective response rate, according to investigators.
“This milestone demonstrates tremendous progress, achieved within six months of establishing our development partnership with Janssen, and reflects the productive and collaborative relationship formed between the teams at both organizations that are working to bring this program forward swiftly,” said Yuan Xu, the CEO of Legend Biotech.