Hanmi Pharmaceutical's Bispecific Antibody Immuno-Oncology Drug Demonstrates Early Efficacy and Safety in Global Clinical Trials

Presentation at the European Society for Medical Oncology Immuno-Oncology Conference

BH3120, a next-generation immuno-oncology innovative drug jointly developed by Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical, has demonstrated early efficacy in a Phase 1 combination clinical trial with Keytruda (ingredient: pembrolizumab).

Senior Researcher Sungjoong Kim of Hanmi Pharmaceutical's ONCO Clinical Team explained the poster detailing the clinical progress of the next-generation immuno-oncology drug BH3120 at the European Society for Medical Oncology Immuno-Oncology Conference held in London, UK, on the 11th of last month (local time). Hanmi Pharmaceutical

Hanmi Pharmaceutical announced on January 13 that it presented the clinical progress of BH3120 in a poster session at the European Society for Medical Oncology Immuno-Oncology Conference held in London, UK, from December 10 to 12 (local time).

BH3120 is an anti-cancer drug that utilizes the "Pentambody" bispecific antibody platform technology, which enables a single antibody to simultaneously bind to two different targets. This allows for both targeted anti-cancer therapy that attacks only cancer cells and immunotherapy that activates immune cells at the same time.

It is designed to simultaneously target PD-L1 on the surface of cancer cells and 4-1BB on immune cells, serving as a "bridge" that helps immune cells more easily recognize tumor cells and induce cell death. In particular, beyond its anti-cancer efficacy, it has demonstrated a distinct decoupling of immune activation between the tumor microenvironment (TME) and normal tissues, proving the potential for developing effective and safe anti-cancer drugs.

These preclinical research results have been consistently confirmed in subsequent studies. Beijing Hanmi Pharmaceutical presented the results of various non-clinical studies aimed at further elucidating the mechanism of action in vivo at the American Association for Cancer Research (AACR 2025) held in April last year.

Currently, global Phase 1 clinical trials evaluating the safety and tolerability of the Keytruda combination therapy are underway in both Korea and the United States. The dose escalation part of Phase 1, for both the monotherapy and combination therapy groups, is proceeding smoothly as planned, and no dose-limiting toxicity (DLT) has been observed, reaffirming the clinical safety of the drug.

Additionally, early anti-tumor activity has been observed in some patients who failed standard therapies, providing accumulating clinical evidence supporting the therapeutic potential of BH3120 for patients who have not responded to existing immuno-oncology treatments.

Noh Youngsoo, Director of Hanmi Pharmaceutical's ONCO Clinical Team, stated, "This is Hanmi's first global clinical research project utilizing our proprietary bispecific antibody platform technology, Pentambody, and it holds significant strategic value. Our goal is to overcome the limitations of existing treatments and to develop next-generation immuno-oncology drugs that deliver innovative improvements in therapeutic efficacy."