Why Lyell Immunopharma Shares Are Rising Today
Why Lyell Immunopharma Shares Are Rising Today
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.
Lyell Immunopharma, Inc. 纳斯达克股票代码：LYEL）股价走高，此前该公司宣布美国食品药品监督管理局（FDA）授予 LYL845 孤儿药称号，用于治疗 IIB-IV 期黑色素瘤患者。
LYL845 is an investigational tumor infiltrating lymphocyte (TIL) product candidate that is enhanced with Lyell's Epi-R manufacturing protocols.
LYL845 是一种在研肿瘤浸润淋巴细胞 (TIL) 候选产品，Lyell 的 Epi-R 制造协议对其进行了增强。
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).
目前正在一项针对复发或难治性转移或局部晚期黑色素瘤、非小细胞肺癌 (NSCLC) 和结直肠癌 (CRC) 患者的1期临床试验中对其进行研究。
The primary objective of the trial is to determine safety, tolerability and a recommended phase 2 dose range of LYL845.
该试验的主要目的是确定 LYL845 的安全性、耐受性和 2 期推荐剂量范围。
The secondary objective is to determine antitumor activity as evaluated by response rates, duration of response, progression-free survival and overall survival.
次要目标是根据反应率、缓解持续时间、无进展存活率和总存活率来确定抗肿瘤活性。
Initial data from Lyell's ongoing Phase 1 clinical trial are expected in 2024.
莱尔正在进行的1期临床试验的初步数据预计将于2024年公布。
"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.
莱尔总裁兼首席执行官林恩·西利医学博士说：“晚期黑色素瘤患者的医疗需求仍有很大的未得到满足，我们相信 LYL845 有可能实现差异化的效力和耐久性，为患者带来更好的疗效...”
"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."
“我们很高兴获得治疗晚期黑色素瘤的 LYL845 孤儿药称号，并期待明年公布该计划的初步临床数据。”
Price Action: LYEL shares are trading higher by 4.11% in the premarket to $2.28 on the last check Friday.
价格走势： LYEL股价在盘前交易中上涨4.11％，至周五最后一张支票的2.28美元。