Novartis shells out $100 million upfront in CAR-T pact with Legend
13 Nov 2023
Phase 1Cell TherapyLicense out/inImmunotherapyPhase 2
Novartis has struck a licensing deal to advance some of Legend Biotech's experimental CAR T-cell therapies targeting DLL3, including its autologous CAR-T candidate LB2102. As part of the deal announced Monday, Novartis will pay Legend $100 million upfront, and has committed to additional milestone payments of up to $1.01 billion upon the achievement of certain clinical, regulatory and commercial targets.
A first-in-human Phase I study of LB2102 began in July for the treatment of extensive-stage small-cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma. "We believe LB2102 has an innovative CAR design and armour mechanism that increases its anti-tumour activity," commented Legend's chief scientific officer Guowei Fang, highlighting preclinical evidence that suggests an autologous CAR-T could offer up a differentiated approach for SCLC patients. The Phase I trial of LB2102 has an estimated enrollment of 41 participants and is expected to read out in 2028.
Better proliferative potential
The new licensing deal grants Novartis exclusive worldwide rights to Legend's DLL3-targeting CAR-T therapies, and allows the Swiss drugmaker to apply its T-Charge platform to their manufacture. The platform is designed to preserve T-cell stemness, or the ability to self-renew and mature, resulting in a product that contains greater proliferative potential and fewer exhausted T-cells. With this technology, the expansion of CAR T-cells occurs primarily in vivo, thus eliminating the need for an extended culture time outside of the body, Novartis says. LB2102 would be the first application of T-Charge by Novartis to a cell therapy candidate targeting solid tumours.
Under the agreement, Legend will conduct the Phase I trial for LB2102 in the US, while Novartis takes on all other development for licensed products. Aside from the upfront and potential milestone payments, Legend would also be eligible for tiered royalties on any commercialised products down the road.
Novartis is currently developing the CD19-directed CAR-T rapcabtagene autoleucel, also known as YTB323, for lupus nephritis and first-line high-risk large B-cell lymphoma in Phase II, as well as for adult acute lymphoblastic leukaemia in a Phase I trial. The company is also working on PHE885, another T-Charge manufactured CAR-T cell therapy, this time directed against BCMA for patients with relapse/refractory multiple myeloma.
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