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FDA Approves Lyell Immunopharma's IND For LYL845; Shares Up 8%

Shares of Lyell Immunopharma (LYEL) gained over 8% after the clinical-stage biotech company announced that the U.S. Food and Drug Adminstration has cleared its Investigational New Drug application to initiate a Phase 1 clinical trial for LYL845.

LYL845 is an investigational tumor infiltrating lymphocyte (TIL) therapy enhanced with Lyell's Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.

In preclinical studies, Epi-R creates polyclonal populations of T cells that demonstrate properties of durable stemness and anti-tumor functionality. Durable stemness is the quality that enables T cells to self-renew, proliferate, persist and generate differentiated effector cell progeny.

LYL845 is Lyell's first TIL product candidate and second wholly owned product candidate to receive IND clearance within the past year. Patient screening for the Phase 1 trial is set to begin over the coming months, and initial clinical data is expected in 2024.

"Advancing LYL845 into the clinic represents steady progression of our mission to develop T-cell therapies that can outlast and eradicate solid tumors," said Liz Homans, chief executive officer of Lyell. "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."

LYEL closed Thursday's trading at $8.09, up $0.16 or 2.02%, on the Nasdaq. The stock further gained $0.71 or 8.78% in the after-hours trading.

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