Novartis and Legend Biotech Sign Exclusive License Agreement for CAR-T Therapies

On Nov. 13, 2023, Legend Biotech, a biotechnology company, announced that its wholly owned subsidiary, Legend Biotech Ireland, entered into an exclusive, global license agreement with Novartis for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies targeting Delta-like ligand protein 3 (DLL3). The deal includes Legend Biotech’s autologous CAR-T cell therapy candidate, LB2102 (NCT05680922).

Under 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 as well as tiered royalties. Novartis will be granted exclusive worldwide rights to develop, manufacture, and commercialize these cell therapies.

Novartis may also apply its T-Charge CAR-T cell therapy platform to the manufacture of these candidates. The platform is a next-generation CAR-T cell therapy manufacturing platform designed to preserve T cell stemness. It also facilitates CAR-T cell expansion primarily in vivo. The 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. If applied to the manufacture of LB2102, this would be the first application of the T-Charge platform to a cell therapy candidate targeting solid tumors, according to a company press release.

Legend Biotech will conduct a Phase I clinical trial for LB2102 in the United States, and Novartis will conduct all other development for the licensed products. Clinical development for LB2102 starts with treatment of extensive stage small cell lung cancer and large cell neuroendocrine carcinoma following FDA’s clearance of the therapeutic’s investigational new drug application in 2022. In 2023, FDA granted the candidate orphan drug designation.

“We believe LB2102 has an innovative CAR design and armor mechanism that increases its anti-tumor activity. The preclinical evidence shows that an autologous CAR-T could be a differentiated treatment option for patients with small cell lung cancer,” said Guowei Fang, chief scientific officer and head of Business Development, Legend Biotech, in the press release. “We are excited that a major pharmaceutical company with deep roots in oncology and cell therapy has chosen to further this product candidate in the clinic. We are delighted that a combination of our unique candidate design in LB2102 with the T-Charge platform may potentially offer transformative benefits to small cell lung cancer patients.”

Source: Legend Biotech