FDA Approves IND Application for NextCure's B7-H4-Targeting ADC, LNCB74, for Solid Tumors

Key Insights

• The FDA has accepted NextCure's IND application for LNCB74, an antibody-drug conjugate (ADC) targeting B7-H4, paving the way for Phase 1 clinical trials.
• LNCB74, co-developed with LigaChem Biosciences, aims to treat multiple cancers, including breast, ovarian, and endometrial cancers, by targeting B7-H4 overexpressed in cancer cells.
• Preclinical data demonstrated LNCB74's potential with complete tumor eradication at low doses and superior anti-tumor efficacy compared to other B7-H4-targeting ADCs.

The U.S. Food and Drug Administration (FDA) has accepted NextCure's Investigational New Drug (IND) application for LNCB74, an antibody-drug conjugate (ADC) targeting B7-H4, marking a significant step toward clinical development for multiple cancers. This decision allows NextCure to initiate Phase 1 clinical trials to evaluate LNCB74 as a therapeutic for treating various solid tumors.

LNCB74: A Novel Approach to Targeting B7-H4

LNCB74 is being co-developed by NextCure and LigaChem Biosciences. It combines an antibody that targets the B7-H4 protein, which is commonly overexpressed in cancer cells, with LigaChem Bio’s proprietary ADC platform. The therapy is designed to address cancers such as breast, ovarian, and endometrial cancers, where B7-H4 expression is prevalent.

Michael Richman, NextCure's president and CEO, stated, "Acceptance of the IND application for LNCB74 represents an important milestone for NextCure as we focus our resources on advancing our ADC program. We believe LNCB74 has the potential to transform treatment for patients and we look forward to advancing LNCB74 into clinical development."

Clinical Trial Plans

Following the IND approval, NextCure and LigaChem Biosciences plan to initiate Phase 1 clinical trials early next year. The trials will consist of 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 LigaChem Bio’s U.S. subsidiary, ACB, and its clinical experts.

Promising Preclinical Results

Preclinical studies have demonstrated LNCB74’s potential, showing complete tumor eradication even at low doses. Animal studies using patient-derived cancer cells highlighted superior anti-tumor efficacy and safety compared to other ADCs targeting B7-H4.

LigaChem 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."