Hanmi Pharm has taken the first step toward clinical trials of BH3120, a double-antibody anticancer drug candidate it is developing as its next-generation pipeline.

According to the Ministry of Food and Drug Safety (MFDS), Hanmi received approval for a phase 1 clinical trial of BH3120 on Friday. Hanmi plans to confirm the safety and efficacy of BH3120 in patients with advanced or metastatic solid tumors. Only Seoul National University Hospital has registered for it so far.

BH3120 is an immunotherapy candidate developed by the R&D Center of Hanmi Pharm Group's subsidiary in China, Beijing Hanmi Pharm. BH3120 is a bispecific antibody that targets PD-L1 and 4-1BB based on Hanmi Pharm's bispecific antibody platform “Pentambody.”

The phase 1 trial will be conducted as a global clinical trial. In April, Hanmi Pharma and Beijing Hanmi Pharm submitted a phase 1 IND (Investigational New Drug Application) for BH3120 to the U.S. Food and Drug Administration. The phase 1 study has yet to be listed on Clinical Trials, a clinical trial information site of the National Institutes of Health (NIH).

Hanmi Pharm and Beijing Hanmi Pharm disclosed the nonclinical results of BH3120 in a poster presentation at the American Association for Cancer Research (AACR) 2022 in April last year. At this year's AACR, the companies said they had confirmed excellent safety in primate studies.

According to the AACR presentation, BH3120 is a bispecific immunoglobulin G (IgG) antibody with differently designed binding affinities to PD-L1 and 4-1BB, demonstrating superior anticancer activity in a dose-dependent manner when administered alone and a strong synergistic effect when combined with a PD-1 inhibitor, resulting in the disappearance of cancerous tissue.

In cancer tissues with PD-L1 overexpression, the immune response by 4-1BB activation is expressed, whereas in normal tissues with low PD-L1 expression, the immune activity signal is hardly observed, showing a clear decoupling of immune activity between cancer and normal tissues.

Based on these characteristics of BH3120, Hanmi Pharm and Beijing Hanmi Pharm expect to confirm a balanced profile between safety and anticancer effectiveness by minimizing hepatotoxicity and other systemic side effects, which have been recognized as toxic in the field of 4-1BB-activated antibodies.

The Hanmi Pharm Group, which celebrated its 50th anniversary this year, is strengthening its commitment to developing its new drugs through R&D. The group has recently begun to improve its affiliates by establishing mid- and long-term strategies and reorganizing leadership, announcing an ambition to reach 5 trillion won ($3.8 billion) in total sales in 2032.