Hanmi Pharmaceutical, Beijing Hanmi progress cancer therapy BH3120 with promising trial results

Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical are making significant strides in the development of BH3120, a next-generation cancer immunotherapy. Updates on the innovative treatment were shared at the Society for Immunotherapy of Cancer (SITC) conference, held in Houston, Texas, from November 6 to 10.

BH3120, developed using Hanmi’s proprietary Pentambody platform, represents a breakthrough in immuno-oncology. This dual-antibody therapy targets PD-L1 on cancer cells and 4-1BB on immune cells, working as a “bridge” to enhance immune cell recognition and destruction of tumors. Unlike earlier 4-1BB-targeting candidates, which faced efficacy and safety concerns, BH3120’s preclinical studies reveal its unique ability to separate immune activity in the tumor microenvironment from normal tissues, potentially offering a safer and more effective treatment.

Promising findings in phase 1 clinical trials

The global Phase 1 clinical trial for BH3120 is ongoing in South Korea and the United States, focusing on evaluating its safety and tolerability in patients with advanced or metastatic solid tumors. Thus far, the dose-escalation phase has progressed smoothly, with no dose-limiting toxicities or severe adverse reactions reported in the third cohort (1 mg/kg).

Dr. Dong-wan Kim of the Seoul National University Hospital Clinical Trials Center noted that the trials are a pivotal step in demonstrating BH3120’s potential. While emphasizing the drug’s promising early results, he expressed optimism that continued research could solidify its role as a safer and more effective alternative to current immunotherapy treatments.

Exploring synergy with KEYTRUDA

Beyond its monotherapy trials, BH3120 is also being tested in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), to evaluate the potential for enhanced anticancer efficacy. This Phase 1 trial follows approvals in September from the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration to expand the study.

Hanmi Pharmaceutical will lead the trial while MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA) provides KEYTRUDA for the research. Full-scale clinical development for this combination therapy is expected to begin in early 2024.

A milestone in immuno-oncology innovation

Young Su Noh, director of Hanmi’s ONCO Clinical Team, described BH3120 as a milestone for the company, marking its first global clinical project utilizing the Pentambody platform. He reiterated Hanmi’s commitment to overcoming limitations in existing cancer treatments and improving therapeutic efficacy through innovation.

With a robust preclinical profile and promising early clinical data, BH3120 has the potential to redefine immunotherapy for advanced cancers, offering a safer, more targeted approach to treatment.