Legend Enters Exclusive, Global License Agreement with Novartis for Certain CAR-T Therapies

Rare Daily Staff

Legend Biotech Ireland entered into an exclusive, global license agreement with Novartis Pharma for certain Legend Biotech CAR-T cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102.

The agreement grants Novartis exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, and Novartis may apply its T-Charge platform to their manufacture.

Under the terms of the agreement, Legend Biotech will receive a $100 million upfront payment and will be eligible to receive up to $1.01 billion in clinical, regulatory, and commercial milestone payments and tiered royalties. Legend Biotech will conduct a phase 1 clinical trial for LB2102 in the United States and Novartis will conduct all other development for the licensed products.

Legend Biotech is initiating clinical development of LB2102 for the treatment of extensive stage small cell lung cancer and large cell neuroendocrine carcinoma after the U.S. Food and Drug Administration cleared its investigational new drug application in 2022. In 2023, the FDA granted the product candidate Orphan Drug designation.

The Novartis T-Charge platform is a next-generation CAR-T cell therapy manufacturing platform designed to preserve T cell stemness and facilitate CAR-T cell expansion primarily in vivo. The T-Charge platform is designed to reduce the need for extensive culture time outside the body and results in T cells with greater proliferative potential, as well as fewer exhausted T cells. LB2102 would be the first application of T-Charge by Novartis to a cell therapy candidate targeting solid tumors.

“We believe LB2102 has an innovative CAR design and armor mechanism that increases its anti-tumor activity,” said Guowei Fang, chief scientific officer and head of Business Development at Legend Biotech. “The preclinical evidence shows that an autologous CAR-T could be a differentiated treatment option for patients with small cell lung cancer.”

Photo: Guowei Fang, chief scientific officer and head of Business Development at Legend Biotech