Legend Biotech Corporation (NASDAQ:LEGN) told investors that the US regulator, the Food and Drug Administration (FDA), had green-lighted its investigational new drug (IND) application for the treatment of small cell lung cancer (SCLC).
It means the clinical development can now proceed on LB2102, an investigational, antigen receptor T-cell (CAR-T) therapy, in a bid to treat adults with extensive stage SCLC.
The latter is the leading cause of cancer deaths, contributing to 25% of all cancer-related deaths in the US each year.
"Lung cancer is a debilitating disease that often spreads quickly. On average, only seven percent of patients with SCLC are alive five years after receiving their diagnosis," said Lida Pacaud, the vice-president (VP) of clinical development at Legend Biotech, in a statement.
"We are eagerly awaiting the start of this Phase 1 trial, and we hope that the study will provide much needed insight into the potential of this investigational CAR-T therapy."
The Phase 1, first-in-human, open-label clinical study is designed to evaluate the safety and preliminary efficacy of LB2102 in people with extensive stage SCLC and patients with large cell neuroendocrine carcinoma (LCNEC), as well as to determine the recommended dose for a Phase 2 trial.
New Jersey-headquartered Legend Biotech is a global company, which says it is dedicated to treating, and one day curing, life-threatening diseases. It has a market cap of over US$8.5 billion.
From its three R&D sites around the world, it uses innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide.
Contact the author at giles@proactiveinvestors.com