2 hours Ago By Kim Min-jee
Hanmi Pharmaceutical announced on November 25 that it presented the research findings and clinical progress of its next-generation immuno-oncology drug, BH3120, in a poster session at the Society for Immunotherapy of Cancer (SITC) conference held in Houston, USA from November 6 to 10. BH3120 is an anticancer drug utilizing the “Pentambody” dual antibody platform technology, which allows a single antibody to simultaneously bind to two different targets. This enables targeted cancer therapy that specifically attacks cancer cells while also activating immune cells for immunotherapy.
The design of BH3120 targets PD-L1 on the surface of cancer cells and 4-1BB on the surface of immune cells, serving as a "bridge" that helps immune cells easily recognize tumor cells and induce cell death. Previous antibody candidates targeting 4-1BB faced limitations in terms of anticancer efficacy and safety, but BH3120 has shown excellent anticancer efficacy through various preclinical studies, along with a clear decoupling phenomenon of immune activation between the tumor microenvironment (TME) and normal tissues, proving its potential as an effective and safe anticancer agent. At the SITC conference, Hanmi Pharmaceutical introduced the background, design, and current status of the clinical research for BH3120, which is currently being evaluated for safety and tolerability in patients with advanced or metastatic solid tumors in a global Phase 1 trial being conducted in South Korea and the United States.
The Phase 1 trial is progressing smoothly through Cohort 3 of the dose escalation part (1mpk), and to date, no dose-limiting toxicities (DLT) or serious adverse drug reactions have been observed. Kim Dong-wan, the principal investigator of the Phase 1 trial at Seoul National University Hospital's Clinical Trial Center and a professor in the Department of Hematology and Oncology, stated, "The Phase 1 study of BH3120 is a crucial process to verify the innovative potential of the next-generation immuno-oncology drug. The trial is proceeding smoothly, and we anticipate positive results.
We hope that future research will establish it as an effective and safe treatment option across various types of cancer while minimizing the side effects of existing immunotherapies.” In addition to the monotherapy, evaluations of safety and efficacy in combination with MSD's immune checkpoint inhibitor Keytruda (pembrolizumab) are also planned. Hanmi Pharmaceutical received approval in September from both the Korean Ministry of Food and Drug Safety and the U.
S. Food and Drug Administration (FDA) to amend the clinical trial plan (IND) to assess the combination of BH3120 and Keytruda for patients with advanced or metastatic solid tumors, with plans to commence full-scale clinical development in early next year. Hanmi will oversee the clinical trial as the sponsor, and MSD will provide Keytruda for free for the study.
Noh Young-soo, director of Hanmi's ONCO clinical team, remarked, “The BH3120 clinical trial is significant as it represents Hanmi's first global clinical research project utilizing our unique dual antibody platform technology, Pentambody, in the field of immuno-oncology, which is changing the paradigm of cancer treatment. We will do our utmost to overcome the limitations of existing therapies and achieve breakthrough improvements in treatment efficacy with the development of this next-generation immuno-oncology drug.” Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
, a subsidiary of Merck & Co., Inc., based in Rahway, New Jersey, USA.
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