Lyell Immunopharma, Inc. (NASDAQ: LYEL) has made significant strides, sparking positive market momentum after the recent announcement of the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to LYL845 for treating patients with stage IIB-IV melanoma.
LYL845, an investigational tumor infiltrating lymphocyte (TIL) product candidate, is set apart by its enhancement with Lyell’s Epi-R manufacturing protocols. The compound is currently undergoing a Phase 1 clinical trial focusing on patients with relapsed or refractory metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
The primary goal of this trial is to assess the safety, tolerability, and determine a recommended phase 2 dose range of LYL845. Simultaneously, the secondary objective is to evaluate antitumor activity based on response rates, duration of response, progression-free survival, and overall survival. Anticipated initial data from Lyell’s ongoing Phase 1 clinical trial is expected to be unveiled in 2024.
Dr. Lynn Seely, President, and CEO of Lyell stated, “There remains a high unmet medical need for patients with advanced melanoma, and we believe LYL845 has the potential for differentiated potency and durability needed to deliver better outcomes for patients… We are pleased to have received Orphan Drug Designation for LYL845 in advanced melanoma and look forward to presenting initial clinical data from this program next year.”
The market has responded with enthusiasm, driving LYEL shares up by 4.11% in premarket trading to $2.28 as of the latest check on Friday.