Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical are advancing clinical trials of BH3120, a novel immunotherapy co-developed by the two companies. The drug, which leverages Hanmi's proprietary Pentambody dual antibody platform, is designed to simultaneously target PD-L1 on cancer cells and 4-1BB on immune cells. Recent updates on the Phase 1 clinical trial were presented at the Society for Immunotherapy of Cancer (SITC) conference, held in Houston, USA.
BH3120: A Dual-Targeting Immunotherapy
BH3120's mechanism of action involves acting as a bridge, facilitating immune cells' recognition and killing of tumor cells. Preclinical studies have indicated robust anticancer efficacy and a unique decoupling of immune activity between the tumor microenvironment (TME) and normal tissues, potentially addressing safety challenges associated with other 4-1BB-targeting antibody candidates.
Phase 1 Clinical Trial Progress
The ongoing global Phase 1 clinical trial is evaluating the safety and tolerability of BH3120 as a monotherapy in patients with advanced or metastatic solid tumors. According to Hanmi, the trial has progressed smoothly through cohort 3 (1 mg/kg) of the dose escalation phase, with no dose-limiting toxicities (DLT) or grade 3 or higher adverse drug reactions observed to date. This suggests a promising safety profile for BH3120 in early clinical development.
Dr. Dong-wan Kim, lead investigator for the phase 1 clinical trial of BH3120, stated, "The phase 1 clinical trial of BH3120 is a critical step in verifying the potential of this next-generation immunotherapy. We are optimistic about achieving positive outcomes." He also expressed hope that further research will establish BH3120 as an effective and safe treatment option for various cancer types, reducing the side effects often associated with current immunotherapies.
Combination Therapy with KEYTRUDA
In addition to the monotherapy trial, Hanmi is also conducting a Phase 1 trial to assess the safety and efficacy of BH3120 in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced or metastatic solid tumors. Approvals from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) have been obtained to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA. Full-scale clinical development is expected to commence early next year, with Hanmi serving as the lead sponsor and MSD supplying KEYTRUDA for the trial.
Young Su Noh, Director of Hanmi's ONCO Clinical Team, emphasized, "The BH3120 trial represents a milestone as Hanmi's first global clinical research project utilizing our proprietary Pentambody dual antibody platform in immuno-oncology, a field at the forefront of cancer treatment innovation." He further stated the company's commitment to advancing a next-generation immunotherapy that overcomes the limitations of existing treatments and enhances therapeutic efficacy.
