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Legend, Novartis Ink Licensing Deal for DLL3-Targeted Cell Therapies

NEW YORK – Legend Biotech on Monday said Novartis acquired exclusive rights to develop, manufacture, and commercialize certain cell therapies targeting DLL3, including its autologous CAR T-cell therapy candidate LB2102.

Under the terms of the agreement, Novartis may apply its T-Charge platform to the manufacture of the cell therapies. T-Charge is designed to preserve T-cell stemness and facilitate expansion of the cells in vivo while reducing extensive culture time outside the body. LB2102 would represent the first application of the T-Charge platform to a cell therapy candidate targeting solid tumors.

Novartis will pay Legend up to $100 million in an upfront payment and up to $1.01 billion in clinical, regulatory, and commercial milestone payments and tiered royalties.

The Somerset, New Jersey-based company is studying LB2102 in a Phase I trial in patients with extensive-stage small cell lung cancer or large cell neuroendocrine lung cancer. In the first part of the trial, investigators will assess the safety and tolerability of LB2102 and identify a recommended expansion dose. In the second, expansion stage of the trial, they will further characterize safety and tolerability of the drug and establish a recommended dose for Phase II studies. Secondary outcome measures of the trial will include preliminary efficacy, immunogenicity, and pharmacokinetics of LB2102.