Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, ON June 3, 2022 announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate LB1908 in a Phase 1 clinical trial in the United States. LB1908 is an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy selectively targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with relapsed or refractory gastric, esophageal (including gastro-esophageal junction) or pancreatic cancers. Claudin18.2 is a tight junction protein commonly expressed in patients with these cancer subtypes.
The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy. Study will have dose escalation and dose expansion phases. Patients enrolled in the study must sufficiently express Claudin 18.2.
A Phase 1 investigator-initiated trial evaluating LB1908 for advanced gastric cancers is also ongoing in China (NCT04467853).
“Treatment options for patients with esophageal, stomach and pancreatic cancers have improved in the last ten years, but patients in the advanced stages still face poor prognoses worldwide. Thousands of people have no symptoms until their cancers have moved into late phases and at that point, surgery is no longer an option,” said Lida Pacaud, M.D., Vice-President of Clinical Development. “Based on prevailing research, we are optimistic that a CAR-T therapy targeting Claudin 18.2 can be integrated in future treatment strategies for those with relapsed or refractory gastrointestinal cancers. We look forward to the start of the trial.”