Lyell will soon initiate a phase 1 trial of LYL845 with initial data expected in 2024.
The FDA has cleared Lyell Immunopharma’s investigational new drug application (IND) for LYL845, a tumor-infiltrating lymphocyte (TIL) therapy to treat relapsed/refractory melanoma.
“Advancing LYL845 into the clinic represents steady progression of our mission to develop T-cell therapies that can outlast and eradicate solid tumors,” Liz Homans, chief executive officer, Lyell, said in a statement. “Our goal is to develop LYL845 as an effective TIL therapy for patients with solid tumor cancers such as melanoma, as well as for indications where TIL therapy has not yet been widely effective such as non-small cell lung and colorectal cancer.”
LYL845 is enhanced with Lyell’s proprietary Epi-R reprogramming technology which creates polyclonal T cell populations with properties of durable stemness and improved function.Lyell will soon initiate a phase 1 trial for patients with relapsed/refractory melanoma with plans to expand into non-small cell lung cancer and colorectal cancer. Screening will begin in the coming months and initial data are expected in 2024.
“We have developed our epigenetic reprogramming technology to produce T-cell populations with more favorable attributes than those generated by standard manufacturing approaches,” Rick Klausner, MD, chair, Board of Directors, Lyell, added to the statement. “LYL845 T cells are highly polyclonal and exhibit qualities of durable stemness that have been linked with the anti-tumor functionality and improved outcomes in previous TIL clinical trials, and we look forward to clinically evaluating LYL845 and the role of these qualities in cell therapy for solid tumors."
The open-label, dose-escalation, phase 1 trial will determine safety, tolerability, and a recommended phase 2 dose of LYL845. Secondary objectives will measure response rates, duration of response, progression free survival and overall survival. Another exploratory measure of T-cell stemness biomarkers will also be assessed.
Lyell’s Epi-R platform has demonstrated its ability to create polyclonal populations of T cells in preclinical studies. Cells produced demonstrated properties of durable stemness and antitumor activity.
“While TILs have previously shown clinical benefit in patients with melanoma and limited other solid tumors, we believe that TIL with properties of durable stemness and increased polyclonality are needed for adoptive cell therapies to have curative potential,” said Tina Albertson, MD, PhD, chief medical officer and head of development of Lyell.