Lyell Immunopharma, Inc., a clinical-stage cell therapy company, develops chimeric antigen receptor (CAR) T-cell product candidates for patients with hematologic malignancies and solid tumors. The company’s lead product candidate include rondecabtagene autoleucel, an autologous dual-targeting CD19/CD20 CAR T-cell therapy in development, which is in pivotal PiNACLE trial in the 3L+ setting and in a Phase 1/2 clinical trial in the 2L setting, as well as a second pivotal trial, PiNACLE-H2H, which is a Phase 3 head-to-head CAR T cell therapy randomized controlled trial of ronde-cel for LBCL in the 2L setting for the treatment of large B-cell lymphoma; and LYL273, a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration, and cancer cell killing in the hostile solid tumor microenvironment, which is in Phase 1 clinical trial for the treatment of refractory metastatic colorectal cancer. The company develops therapies using various approaches, such as c-Jun overexpression and NR4A3 gene knockout, to endow functional resistance to exhaustion; Epi-R to generate population of stem-like T cells with reduced exhaustion and improved proliferation and antitumor activity; and CD62L positive enrichment to generate CAR T cells with enhanced antitumor activity. Lyell Immunopharma, Inc. was incorporated in 2018 and is headquartered in South San Francisco, California.
Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2026
Lyell reported a Q2 net loss of $44.8 million, ending the quarter with $228.0 million in cash and marketable securities, which management expects to fund operations into Q3 2027.
The PiNACLE pivotal trial of ronde-cel remains on track for pivotal data in mid-2027 and a BLA submission in the second half of 2027, with updated safety data showing no Grade ≥ 3 CRS and a 97% manufacturing success rate.
For the LYL273 program in colorectal cancer, the implementation of gastrointestinal prophylaxis reduced Grade ≥ 2 diarrhea or colitis from 55% to 10%, and the trial has been amended to a Phase 1/2 design with an FDA meeting expected in the second half of 2026.