Lyell completes LYL273 manufacturing transfer, pushes back Phase 1/2 data timeline
Lyell now expects additional clinical data and its End-of-Phase 1 FDA meeting for the colorectal cancer CAR T candidate in 2027, not sooner.
Lyell Immunopharma announced on September 10, 2026 that it had completed the planned technology transfer for LYL273, a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, to its LyFE Manufacturing Center in Bothell, Washington, following review by the FDA1. The company said LyFE is implementing an improved manufacturing process and updated analytical methods to enhance manufacturing performance and increase capacity1.
The ongoing Phase 1/2 trial, known as CARABiNER, continues to enroll patients with the goal of determining the recommended Phase 2 dose and optimized safety management plan1. Lyell said additional clinical data from the trial and a planned End-of-Phase 1 meeting with the FDA are now expected in 20271.
The trial, registered as NCT05319314, is an ongoing Phase 1/2 dose-escalation, dose-expansion trial of LYL273 in the United States in patients with relapsed/refractory metastatic colorectal cancer1. In June 2026, Lyell had reported safety data showing that gastrointestinal prophylaxis consisting of infliximab, vedolizumab and budesonide reduced Grade ≥2 diarrhea/colitis from 55% without prophylaxis to 10% with prophylaxis1. The company said enrollment 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 suppression1.
Lyell also noted its manufacturing facility has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year1.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.