Legend Biotech Corporation (NASDAQ: LEGN) has recently announced a significant development - its wholly-owned subsidiary, Legend Biotech Ireland Limited, has entered into an exclusive global license agreement with Novartis Pharma AG. This agreement covers specific Legend Biotech chimeric antigen receptor T-cell (CAR-T) therapies targeting DLL3, including the autologous CAR-T cell therapy candidate LB2102 (NCT05680922). Novartis has gained exclusive global rights for the development, manufacturing, and commercialization of these cell therapies, with the option to utilize its T-Charge™ platform in their production.

The clinical development of LB2102 for treating extensive stage small cell lung cancer and large cell neuroendocrine carcinoma has commenced after receiving clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug application in 2022. LB2102 was granted Orphan Drug Designation by the FDA in 2023, recognizing its potential to address rare diseases and conditions.

Novartis' T-Charge platform is a next-generation CAR-T cell therapy manufacturing approach designed to preserve T cell stemness and facilitate in vivo CAR-T cell expansion. This innovative platform aims to reduce the need for extended culture time outside the body, resulting in T cells with enhanced proliferative potential and fewer exhausted T cells. LB2102 marks the first application of Novartis' T-Charge platform to a cell therapy candidate targeting solid tumors.

Guowei Fang, Chief Scientific Officer and Head of Business Development at Legend Biotech, expressed confidence in LB2102's innovative CAR design and armor mechanism, which enhances its anti-tumor activity. The collaboration with Novartis, a major pharmaceutical company with expertise in oncology and cell therapy, signifies a significant step forward in advancing this promising product candidate for small cell lung cancer patients.

According to the terms of the License Agreement, Legend Biotech will lead a Phase 1 clinical trial for LB2102 in the U.S., while Novartis will oversee all other development aspects for the licensed products. Legend Biotech stands to receive a substantial upfront payment of $100 million, along with the potential for up to $1.01 billion in milestone payments related to clinical, regulatory, and commercial achievements, in addition to tiered royalties. The completion of the transaction is contingent upon obtaining necessary consents or approvals, including compliance with the Hart-Scott-Rodino Antitrust Improvements Act of 1976 waiting period.

 

Source: businesswire.com

Report Abuse