Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical are progressing clinical trials for BH3120, a next-generation cancer immunotherapy co-developed by the two companies. The latest updates on the clinical trial were presented at the Society for Immunotherapy of Cancer (SITC) conference.
BH3120 is based on Hanmi's Pentambody, a dual antibody platform. The drug is designed to simultaneously bind to PD-L1 on cancer cells and 4-1BB on immune cells. This mechanism facilitates the recognition and killing of tumor cells by immune cells.
Phase 1 Trial Progress
A global Phase 1 clinical trial is currently underway in South Korea and the United States to evaluate the safety and tolerability of BH3120 as a monotherapy in patients with advanced or metastatic solid tumors. The trial has progressed 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 thus far.
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 would 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 to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA® were obtained from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) in September. Hanmi will serve as the lead sponsor and conduct the clinical trial, while MSD will supply KEYTRUDA® for the trial.
Differentiated Mechanism of Action
Preclinical studies of BH3120 have demonstrated robust anticancer efficacy alongside a unique decoupling of immune activity between the tumor microenvironment (TME) and normal tissues. This distinct mechanism is expected to make BH3120 an effective and safer anticancer therapy. Other 4-1BB-targeting antibody candidates have faced anticancer efficacy or safety challenges.
Young Su Noh, Director of Hanmi's ONCO Clinical Team, stated, "The BH3120 trial represents a milestone as Hanmi's first global clinical research project utilizing our proprietary Pentambody dual antibody platform in immuno-oncology." He added, "We are committed to advancing a next-generation immunotherapy that overcomes the limitations of existing treatments and enhances therapeutic efficacy."
