Lyell Immunopharma (NASDAQ: LYEL) announced it has completed the manufacturing transfer of LYL273 to its facility in Bothell, Washington, following review by the U.S. Food and Drug Administration.
The transfer moves production of the guanylyl cyclase C-targeted CAR T-cell candidate to the LyFE Manufacturing Center, where the company says commercial launch capability is already in place. Lyell said it expects the center to have the capacity to produce more than 1,200 CAR T-cell doses annually, and that the technology transfer includes an improved manufacturing process and updated analytical methods intended to enhance both performance and output.
LYL273 is being evaluated in patients with relapsed or refractory metastatic colorectal cancer. It is engineered with CD19 CAR expression and controlled cytokine release, features the company says are designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in solid tumors.
The candidate is being studied under the ongoing Phase 1/2 CARABiNER trial, which is actively enrolling patients and expanding to additional clinical sites. The trial’s goals include determining the recommended Phase 2 dose and refining an optimized safety management plan for the therapy.
In June 2026, Lyell reported safety data showing that gastrointestinal prophylaxis using infliximab, vedolizumab and budesonide lowered the rate of Grade 2 or higher diarrhea or colitis from 55% without prophylaxis to 10% with it. The company has indicated that additional clinical data from the CARABiNER trial — including results from patients treated with LYL273 manufactured at the LyFE facility — are expected in 2027, alongside an End-of-Phase 1 meeting with the FDA.
President and CEO Lynn Seely said the company is now focused on determining the recommended Phase 2 dose and optimizing the safety management plan, incorporating data from patients who received the drug produced at LyFE.
