Lyell Immunopharma, Inc.

We are a late-stage clinical cell therapy company focused on developing next-generation autologous chimeric antigen receptor (CAR) T-cell product candidates for cancer patients. Our aim is to fully leverage the curative potential of cell therapy for patients with blood cancers (hematologic malignancies) and solid tumors. We achieve this by creating T-cell therapies designed to produce long-lasting clinical responses. Our CAR T-cell product candidates begin by identifying promising cancer targets. We then engineer a patient's own immune cells with our enhancements, including CAR constructs, technologies, and manufacturing protocols, to give T cells stronger cancer-killing abilities. For blood cancers, we are developing therapies intended to provide significantly better outcomes than currently approved, first-generation CD19 CAR T-cell products. Our main product candidate, rondecabtagene autoleucel (ronde-cel, also known as LYL314), is a CAR T-cell therapy that targets both CD19 and CD20. It is designed to increase complete response rates and extend the duration of response compared to approved CD19-targeted CAR T-cell therapies. Ronde-cel uses an 'OR' logic gate to target B cells expressing either CD19 or CD20 with full potency. Its manufacturing process enriches for CD62L-positive cells, creating more naïve and central memory CAR T cells with enhanced stem-like features and anti-tumor activity. We are currently conducting a pivotal single-arm clinical trial (PiNACLE) for ronde-cel in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving third-line or later treatment (3L+). We have also started patient dosing in a Phase 3 randomized controlled head-to-head CAR T-cell therapy trial (PiNACLE-H2H) for LBCL patients receiving second-line treatment (2L), where patients are randomized to receive either ronde-cel or the investigator's choice of axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel).