Lyell Immunopharma Inc. (NASDAQ: LYEL) has announced that the US FDA has approved an investigational new drug application to commence the first phase clinical study for LYL132, an experimental T-cell receptor therapy for patients with solid tumors showing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that Lyell is developing in partnership with GSK.
LYL132 is a next-gen upgrade letetresgene autoleucel
LYL132 is a possible next-generation upgrade to letetresgene autoleucel (lete-cel), a GSK TCR treatment targeting NY-ESO-1 that is now in pivotal clinical development. It combines Lyell’s epigenetic reprogramming tech, Epi-R. NY-ESO-1, a cellular antigen found on many malignant solid tumors, has been clinically validated. Lyell’s Epi-R technique aims to overcome a major hurdle to effective Adoptive Cell Therapy (ACT) by producing populations of T cells with lasting stemness features. Thanks to their enduring stemness qualities, t cells with anti-tumor characteristics can proliferate, survive, and self-renew.
CEO Lyell Liz Homans said, “Clearance of the second IND incorporating Lyell’s novel reprogramming technologies is another important milestone for Lyell, especially coming within a month of FDA clearance of an IND for LYL797, our lead CAR program. We are eager to start multiple clinical trials that utilize our technologies to assess the potential benefits for patients with solid tumor cancers.”
Lyell to submit two additional INDs this year
The company is on track to submit two additional INDs at the end of 2022. A very exciting and important milestone for Lyell and cancer medication research is clinically testing the possible benefits of reprogrammed T cells designed to exhibit qualities of lasting stemness in a validated target
Board of Directors Chair Rick Klausner said, “We believe lack of durable stemness is a major barrier to successful ACT in solid tumors and expect our Epi-R technology platform will offer a path forward to better outcomes for patients.”
LYL132 will be tested in individuals with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma in a first phase trial. GSK will undertake the first phase trial, while Lyell will produce LYL132 in its LyFE Manufacturing Center.
