- Hanmi Pharmaceutical presents promising progress in BH3120, an innovative immunotherapy, at the SITC 2024 conference, demonstrating early clinical success.
- The ongoing Phase 1 trial of BH3120 shows no severe adverse reactions, with further trials planned to evaluate its combination with KEYTRUDA for advanced cancers.
Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical unveiled the latest clinical trial updates for their pioneering immunotherapy, BH3120, at the Society for Immunotherapy of Cancer (SITC) conference, held in Houston, Texas, from November 6 to 10. The innovative therapy, built on Hanmi’s proprietary "Pentambody" platform, has drawn significant attention for its potential to revolutionize cancer treatment.
BH3120 is a dual-targeting antibody therapy designed to combat cancer by binding to PD-L1 on tumor cells and 4-1BB on immune cells. This dual action enables the therapy to enhance immune response while sparing normal tissues, addressing a common challenge faced by similar therapies.
Preclinical studies indicate that BH3120 achieves potent anticancer efficacy through a novel mechanism that separates immune activation in tumor microenvironments from normal tissues, potentially offering a safer alternative to existing treatments.
The therapy is currently in a global Phase 1 clinical trial across South Korea and the United States, focusing on patients with advanced or metastatic solid tumors. To date, no dose-limiting toxicities (DLT) or severe adverse reactions have been observed during the dose escalation phase, which has progressed to cohort 3 (1 mg/kg).
Dr. Dong-wan Kim, lead investigator of the trial and director of Seoul National University Hospital’s Clinical Trials Center, shared his optimism:
“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 added,
"We hope 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.”
In addition to monotherapy trials, Hanmi is exploring the combination of BH3120 with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), to enhance therapeutic outcomes. Regulatory approvals for this combined study were obtained from both South Korean and U.S. authorities in September, with full-scale clinical development slated to begin next year.
Edited by Harshajit Sarmah
