Legend Biotech Announces Exclusive, Global License Agreement For Certain CAR-T Therapies Targeting DLL3

• The deal with Novartis seeks to advance Legend Biotech’s autologous CAR-T cell therapy candidate, LB2102, and other potential CAR-T cell therapies targeting Delta-like ligand protein 3 (DLL3), using the Novartis next-generation T-Charge CAR-T cell therapy platform
• Legend Biotech will receive a $100M upfront payment and will be eligible to receive potential milestone payments plus tiered royalties on net sales

Legend Biotech Corporation (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Legend Biotech Ireland Limited, a wholly owned subsidiary of Legend Biotech, has entered into an exclusive, global license agreement (License Agreement) with Novartis Pharma AG for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102 (NCT05680922).^[i] 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.

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 (FDA) cleared its investigational new drug application in 2022. In 2023, the FDA granted the product candidate Orphan Drug Designation, a status conferred to drugs or biologics that are intended to treat, diagnose or prevent rare diseases and conditions.^[ii],[iii]

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.^[iv] 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. 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 of Legend Biotech. “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.”

Under the License Agreement, Legend Biotech will conduct a Phase 1 clinical trial for LB2102 in the U.S. Novartis will conduct all other development for the licensed products.

Under the terms of the License Agreement, Legend Biotech will receive a $100M upfront payment and will be eligible to receive up to $1.01B in clinical, regulatory and commercial milestone payments and tiered royalties. Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

^[i] ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05680922. Last accessed Nov 2023.

^[ii] Legend Biotech Announces FDA Clearance of IND Application for LB2102 in Extensive Stage Small Cell Lung Cancer. Available at: Legend Biotech Announces FDA Clearance of IND Application for LB2102 in Extensive Stage Small Cell Lung Cancer – Legend Biotech. Accessed Nov 2023.

^[iii] FDA.gov. Designating an Orphan Product: Drugs and Biological Products. Available at: Designating an Orphan Product: Drugs and Biological Products | FDA. Last accessed Nov 2023.

^[iv] Cancer Discov. 2023 Sep 6;13(9):1982-1997. doi: 10.1158/2159-8290.CD-22-1276. A Novel Autologous CAR-T Therapy, YTB323, with Preserved T-cell Stemness Shows Enhanced CAR T-cell Efficacy in Preclinical and Early Clinical Development