Lyell Immunopharma, Inc. (NASDAQ:LYEL) shares are trading higher after the company announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to LYL845 for the treatment of patients with stage IIB-IV melanoma.

LYL845 is an investigational tumor infiltrating lymphocyte (TIL) product candidate that is enhanced with Lyell's Epi-R manufacturing protocols.

It is currently being investigated in a Phase 1 clinical trial in 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 safety, tolerability and a recommended phase 2 dose range of LYL845. 

The secondary objective is to determine antitumor activity as evaluated by response rates, duration of response, progression-free survival and overall survival. 

Initial data from Lyell's ongoing Phase 1 clinical trial are expected in 2024.

"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...," said Lynn Seely, M.D., Lyell's President and CEO. 

"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."

Price Action: LYEL shares are trading higher by 4.11% in the premarket to $2.28 on the last check Friday.