LigaChem Biosciences cleared a key regulatory hurdle for testing its experimental cancer treatment in the US, marking the company’s first step toward the competitive antibody-drug market.
The Korean biotech received FDA approval for Phase 1 trials of LNCB74, developed in partnership with NextCure. The treatment combines NextCure’s antibody targeting the B7H4 protein with LigaChem’s antibody-drug conjugate platform.
The trial, scheduled to begin in early 2024, will initially focus on patients with advanced solid tumors, particularly breast cancer and gynecologic cancers. The study will proceed in two stages: a dose-escalation phase followed by dose-expansion testing.
While preclinical data presented at a recent immunotherapy conference showed tumor remission at low doses in animal studies, the treatment still faces significant hurdles before potential commercialization. The company claims LNCB74 demonstrated better efficacy and safety compared to competing drugs in tests using patient-derived cancer cells.
The global antibody-drug conjugate market is increasingly crowded, with major pharmaceutical companies investing heavily in similar technologies. LigaChem will need to show meaningful clinical benefits to differentiate its treatment from existing options.
