Ligachem Bio Receives FDA Approval to Add High-Dose Cohort to LNCB74 Phase 1 Clinical Trial

Ligachem Bioscience (Ligachem Bio) announced on November 5 (local time in the United States) that it has received FDA approval to add a high-dose cohort to the global Phase 1 clinical trial of "LNCB74 (B7-H4 ADC)," which is being co-developed with its antibody partner, NextCure. This information was released through NextCure's third-quarter report disclosure on November 5.

LNCB74 is a B7-H4 ADC that Ligachem Bio and NextCure are co-developing. It is an anti-cancer therapy that combines an antibody targeting the B7-H4 protein, which is overexpressed specifically in cancer cells and developed by NextCure, with Ligachem Bio's next-generation ADC (antibody-drug conjugate) platform and an MMAE payload. The global Phase 1 clinical trial is underway with a primary indication for various solid tumors, including breast cancer and gynecological cancers (such as ovarian and endometrial cancer), which have high unmet medical needs.

This cohort expansion approval is significant in that the FDA has approved a higher dose compared to competing B7-H4 ADCs using the MMAE payload. This is seen as evidence of the superior safety profile of Ligachem Bio's ADC platform applied to LNCB74. In fact, previous clinical results from several ADCs at the clinical stage that use Ligachem Bio's ADC platform, such as HER2 ADC (LCB14) and ROR1 ADC (LCB71), have demonstrated outstanding tolerability and efficacy within ADCs using the same payload class. The fact that the FDA has approved the highest dose among B7-H4 ADCs with MMAE payload for LNCB74 is also viewed positively.

Currently, LNCB74 is undergoing Part 1 of the Phase 1 clinical trial, which is a dose escalation study to evaluate the safety, tolerability, and initial anti-tumor activity of LNCB74. At the 2025 ASCO, NextCure presented a poster outlining the Phase 1 clinical trial design for LNCB74, stating that the dose escalation study would be conducted in four dose cohorts ranging from 0.5 mg/kg to 2.4 mg/kg. However, with this latest FDA approval, the study will be expanded to include additional high-dose cohorts.

Meanwhile, proof-of-concept data demonstrating the initial efficacy of the ongoing global Phase 1 clinical trial of LNCB74 is scheduled to be released in the first half of next year.