On September 10, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported successful completion of the planned technology transfer for LYL273, a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, to its LyFE Manufacturing Center (LyFE) in Bothell, Washington, following review by the U.S. Food and Drug Administration (FDA). LyFE is implementing an improved manufacturing process and updated analytical methods to enhance manufacturing performance and increase capacity. The Phase 1/2 clinical trial of LYL273 in patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) continues to enroll patients with the goal of determining the recommended Phase 2 dose and optimized safety management plan. Additional clinical data from the trial and a planned End-of-Phase 1 meeting with the FDA are now expected in 2027.
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"The LYL273 Phase 1/2 clinical trial continues to build momentum. We are activating additional clinical sites for the expansion phase of the trial, with strong interest in the study across our group of highly experienced investigators," said Lynn Seely, MD, President and Chief Executive Officer of Lyell. "LYL273 has already generated encouraging clinical activity data in patients with metastatic colorectal cancer. We are now focused on determining the recommended Phase 2 dose and optimizing the safety management plan, including with results from patients treated with LYL273 manufactured at LyFE. We look forward to sharing additional clinical data and bringing a more complete data package to the FDA as we plan for our End-of-Phase 1 meeting in 2027."
About LYL273
LYL273 is a guanylyl cyclase C (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. CARABiNER (NCT05319314) is an ongoing Phase 1/2 dose-escalation, dose-expansion trial of LYL273 in the United States in patients with R/R mCRC. Lyell announced in June 2026 safety data from the trial demonstrating that gastrointestinal prophylaxis consisting of infliximab, vedolizumab and budesonide reduced Grade ≥ 2 diarrhea/colitis from 55%
without prophylaxis to 10% with prophylaxis. Enrollment in the trial is continuing with dose escalation to determine the recommended Phase 2 dose, including with data from the improved LyFE manufacturing process and analytical methods, as well as to optimize the prophylaxis and safety management plan to calibrate immune suppression.
(Press release, Lyell Immunopharma, SEP 10, 2026, View Source [SID1234670721])