FDA Approves Liga-Chem Bio’s IND for Novel ADC Cancer Therapy
Promising Preclinical Data; Patient Dosing Set to Begin Early Next Year
Liga-Chem BioSciences announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for LNCB74, an antibody-drug conjugate (ADC) being developed as a treatment for solid tumors.
Liga-Chem Bio is co-developing LNCB74 with antibody research specialist NextCure. The candidate combines an antibody targeting the B7H4 protein, commonly overexpressed in cancer cells, with Liga-Chem Bio’s proprietary ADC platform. The therapy is expected to treat various solid tumors, including breast, ovarian, and endometrial cancers.
Following the IND approval, the two companies plan to initiate clinical trials early next year. Phase 1 trials will include a dose-escalation study (Phase 1a) to determine safe dosing levels, followed by a dose-expansion study (Phase 1b) to evaluate the therapeutic dosage and confirm indications. NextCure will lead the clinical trials in collaboration with Liga-Chem Bio’s U.S. subsidiary, ACB, and its clinical experts.
Preclinical studies demonstrated LNCB74’s potential, showing complete tumor eradication even at low doses. In particular, animal studies using patient-derived cancer cells highlighted superior anti-tumor efficacy and safety compared to other ADCs targeting B7H4.
Liga-Chem Bio stated, “The outstanding preclinical results affirm LNCB74’s potential as a best-in-class drug. With this IND approval, we anticipate initiating first-in-human dosing early next year, marking a significant step toward global development.”