As Legend Biotech and Johnson & Johnson's multiple myeloma cell therapy prospect nears the FDA finish line, the companies are moving to carve out a manufacturing foothold in Europe.
Through a joint investment with J&J’s Janssen unit, Legend has drawn up plans for a new cell therapy facility in Belgium, which the partners will use to boost global production capacity for their multiple myeloma drug cilta-cel, plus other cell therapies, Legend said in a release.
The move comes just a few months after Legend and J&J completed their rolling FDA submission for the CAR-T therapy, which is up for a decision on November 29 after scoring a priority review tag in May.
If cleared, cilta-cel would be forced to play catch up with Bristol Myers Squibb and bluebird bio’s multiple myeloma cell therapy ide-cel, now dubbed Abecma, which became the first CAR-T approved for the disease in late March.
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The new Belgian plant, expected to come online by 2023, marks Legend’s first manufacturing foray into Europe. The company also operates a pair of clinical and commercial-scale factories in New Jersey, plus a plant in China. It also boasts R&D operations in China, Ireland and the U.S., its website says.
Legend didn’t name the size of its investment and offered little in the way of factory specs. The company didn’t immediately respond to Fierce Pharma’s request for comment.
For its part, Janssen is headquartered in Beerse, Belgium, and runs R&D, manufacturing, distribution and clinical pharmacology sites in the country, where it says it employs more than 5,000. By setting up shop there, Legend hopes to “tap into the area’s vast talent pool” and make use of the country’s “strong” life sciences ecosystem, Liz Gosen, senior vice president of global technical operations at Legend, said in a statement.
Despite trailing BMS and bluebird to the market, cilta-cel is poised to put up a fight, analysts noted earlier this year. “We think around 8-9 months difference in the timing of market arrival does not offer much first-mover advantage for [BMS/bluebird bio’s] ide-cel given its inferior clinical profile to cilta-cel,” analysts at Jefferies wrote to clients in April.
At the annual meeting of the American Society of Hematology in December, investigators presented data showing that Legend and J&J's CAR-T drug banished multiple myeloma in two-thirds of patients and shrank tumors in 97%. And in a data update at the American Society of Clinical Oncology earlier this year, cilta-cel posted an overall response rate of 98% and yielded a “stringent” complete response in 80% of patients after a median follow-up period of 18 months. The drug achieved an 18-month progression-free survival rate of 66%.
Legend, which spun out of Genscript Biotech, made a splash last year with a massive $424 million initial public offering, landing the no. 2 spot on Fierce Biotech’s list of 2020’s top biotech IPOs.