Legend looks to Belgium plant opening as CAR-T expansions loom

A facility in Ghent, Belgium will begin clinical supply for an expected increase in patients gaining access to CAR-T therapy Carvykti, says Legend Biotech.

For the third quarter 2023, J&J and Legend Biotech codeveloped therapy Carvykti (ciltacabtagene autoleucel; ciltacel) pulled in $152 million in net sales – up 30% over the previous quarter and 176% year-on-year. Of this, Legend earned $76 million in collaboration revenue from the sale of the chimeric antigen receptor (CAR) T-cell therapy and $20 million in license revenue.

Speaking on its financials last week, Legend CEO Ying Huang said the future of Carvykti – approved in the US in March 2022 – is bright, with the firm having “made considerable strides in enhancing [its] manufacturing capabilities and lowering [its] out-of-spec rate.”

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He added Legend and J&J are continuing to invest in manufacturing capacity as more patients gain access to the product, which is expected as ongoing trials look to bring approval for Carvykti as an earlier line of treatment and in other indications.

Specifically, the firms’ CARTITUDE-4 Phase III study is comparing Carvkykti with the current standard-of-care for multiple myeloma; CARTITUDE-5 is assessing Carvykti in patients with newly diagnosed multiple myeloma (NDMM) not intended for transplant; and CARTITUDE-6 – the first patient having been enrolled in Spain last month – is a Phase III study for frontline patients.

The bulk of Carvykti manufacturing comes from J&J’s Raritan, New Jersey site. J&J/Legend brought Novartis onboard earlier this year as a contract manufacturer of Carvykti to supplement internal production. But with increased patients expected to raise demand further, more capacity will be needed to be brought online.

As such, a codeveloped J&J/Legend manufacturing facility in Ghent, Belgium will begin clinical production of Carvykti after receiving a license from the local regulators.

“Our plan is to start clinical production by end of this year in Belgium for certain clinical trials,” said Huang. “And then about mid-year, next year in 2024, we’re planning to seek regulatory approval for our Obelisc [bio-accelerator park], Ghent facility to start produce commercial Carvykti.

“Initially, we’re planning to supply only the European market. So at this point, we would not need FDA approval. In the future, in the case where we do have excess capacity that we could use from the Ghent facilities, then we plan to come back and ask FDA approval.”

And beyond this, Legend/J&J could expand the contract with Novartis, Huang hinted. “We could also use additional capacity from our CDMO to satisfy that demand for CARTITUDE-6 production.”

The results came days after a separate deal with Novartis was struck, to codevelop Legend’s Phase I candidate LB2102 and other CAR-T cell therapies targeting delta-like ligand protein 3 (DLL3) using Novartis’ cell therapy platform T-Charge.