Legend Bio and Novartis have signed an out-license deal to develop and manufacture Legend’s chimeric antigen receptor (CAR-T) therapies, including LB2102.
The agreement aims to advance Legend’s recently initiated Phase I candidate LB2102 and other CAR-T cell therapies targeting delta-like ligand protein 3 (DLL3), using Novartis’ cell therapy platform T-Charge.
Novartis will pay the New-Jersey-based biotech $100 million upfront, and Legend will be eligible to receive up to $1.01 billion in clinical, regulatory, and commercial milestone payments and tiered royalties.
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“The License Agreement grants Novartis the exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, and Novartis may apply its T-Charge platform to their manufacture. Under the License Agreement, Legend Biotech will conduct a Phase I clinical trial for LB2102 in the U.S. Novartis will conduct all other development for the licensed products, a spokesperson for Legend Biotech told BioProcess Insider.
T-Charge platform is a manufacturing platform designed to preserve T-cell stemness and allow CAR-T cells to expand, primarily in vivo. The platform, “stands to cut down the autologous manufacturing time by reducing the need for extensive culture time outside the body, and it results in T-cells with greater proliferative potential, as well as fewer exhausted T-cells,” the firm says.
“LB2102 would be the first application of T-Charge by Novartis to a cell therapy candidate for solid tumors,” the spokesperson added.
LB2102 is an investigational therapy targeting small cell lung cancer and large cell neuroendocrine carcinoma treatment. In 2022, it was cleared as an investigational new drug in application by U.S. Food and Drug Administration (FDA). Later, in 2023, the candidate was given orphan drug designation, a status conferred to drugs or biologics that are intended to treat, diagnose or prevent rare diseases and conditions.
This is not the first time Novartis has worked with Legend. In March 2023, the firm entered a three-year contract to produce the CAR-T therapy Carvykti (ciltacabtagene autoleucel; ciltacel) for Legend and its fellow Big Pharma partner J&J, as a third-party manufacturer. The deal took effect on April 12 2023, with a tech transfer taking place allowing Novartis to perform the process for production of Carvykti to supplement Legend and J&J’s own manufacturing capabilities.
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