Lyell Receives FDA Orphan Drug Designation For LYL845

(RTTNews) - Lyell Immunopharma, Inc. (LYEL) on Friday announced that it had received an Orphan Drug Designation from the FDA for its LYL845 program.

The product is designed to treat patients with stage IIB-IV melanoma and is an investigational tumor-infiltrating lymphocyte (TIL) product candidate that has been enhanced with Lyell's Epi-R manufacturing protocols.

Currently, it is being studied in a Phase 1 clinical trial for patients with relapsed or refractory metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).

The primary objective of the trial is to determine the safety, tolerability, and recommended phase 2 dose range of LYL845.

The initial data from LYL845's ongoing Phase 1 clinical trial are expected to be available in 2024.