China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets in Legend’s CAR-T pipeline targeting DLL3, including LB2102, which is currently in a Phase I study in the US for extensive-stage small-cell lung cancer (ES-SCLC).
Financial Terms and Milestones
Under the terms of the agreement, Legend will receive an upfront payment of USD 100 million, with the potential to earn up to USD 1.01 billion in milestone payments and tiered royalties on future sales. This partnership underscores the significant potential of Legend’s CAR-T pipeline and the company’s growing global footprint in the field of immuno-oncology.
Novartis’ T-Charge Platform and Manufacturing Innovation
Novartis plans to apply its innovative T-Charge platform to the manufacturing of candidates acquired from Legend. This platform significantly reduces the traditional manufacturing process associated with autologous CAR-Ts, allowing the CAR-T cell expansion process to occur primarily within the patient’s body rather than in a lab. This innovation reduces the time required to collect, engineer, and reinfuse a patient’s T-cells from the current 2-3 weeks to approximately 7 days. Novartis has stated that the shorter lab cultivation period results in improved ‘T cell stemness’, leading to greater proliferative potential and fewer exhausted T cells, which translates to better efficacy in patients. This confidence in the T-Charge platform has led Novartis to focus on autologous rather than allogeneic (off-the-shelf) CAR-T therapies.
Legend’s LB2102 and Novartis’ CAR-T Pipeline
Legend’s LB2102, which is slated for the T-Charge treatment, received US FDA IND approval in 2022 and orphan drug designation (ODD) earlier this year, entering a Phase I study in March. Novartis itself has two in-house “T-Charge” candidates in the clinic: the Phase I stage CD19-targeted rapcabtagene autoleucel (YTB323) and the BCMA-targeted PHE885 in Phase II for multiple myeloma. While these targets are more suited to hematological malignancies, Legend’s DLL3-targeted candidates are unique in their focus on solid tumors, potentially offering a more lucrative market if successful.
Pioneering CAR-T Therapies
Both Novartis and Legend are pioneers in the CAR-T field. Novartis was responsible for the first-ever CAR-T therapy to gain market approval, the CD19-targeted Kymriah (tisagenlecleucel), originally developed at the University of Pennsylvania. Legend is responsible for Carvykti (ciltacabtagene autoleucel), the world’s second BCMA-targeted CAR-T, co-developed globally in partnership with Johnson & Johnson under a 2017 deal.- Flcube.com
