Business
Lyell Immunopharma Announces FDA Clearance of its IND for LYL797, a CAR T-Cell Therapy Incorporating Novel Reprogramming Technologies for Solid Tumors
Expects to begin screening patients for the Phase 1 clinical trial by the end of the first quarter; initial data presentation expected in 2023ROR1-targeted
About this update from Lyell Immunopharma, Inc.
[{"type":"text","content":"Expects to begin screening patients for the Phase 1 clinical trial by the end of the first quarter; initial data presentation expected in 2023ROR1-targeted CAR T-cell therapy designed to overcome T-cell exhaustion and promote durable stemness incorporates Lyell’s novel genetic and epigenetic reprogramming technologies, Gen-R™ and Epi-R™LYL797 targets ROR1, a highly expressed cell surface antigen present on many aggressive solid tumors SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for LYL797, Lyell’s first therapeutic candidate incorporating T-cell reprogramming technologies for the treatment of solid tumors. LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors. LYL797 incorporates two Lyell technologies designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with the properties of durable stemness. Durable stemness is the quality that enables T cells to self-renew, proliferate and persist, and create daughter cells with anti-tumor functionality. Lyell expects to begin screening patients with relapsed/refractory triple-negative breast cancer (TNBC) who have failed at least two lines of therapy by the end of the first quarter for the Phase 1 dose escalation phase of the trial and plans to expand the trial to include patients with non-small cell lung cancer (NSCLC) when a recommended dose is determined. “Lyell is applying our understanding of T-cell biology to address what we believe are the primary barriers to consistently effective cell therapies for difficult to treat solid tumors,” said Liz Homans, Chief Executive Officer of Lyell. “Submission and clearance of our first IND is an important milestone for Lyell, and we remain on track to generate data for LYL797 in 2022 and plan to s...