Hanmi Pharm Receives Phase 1 Clinical Approval for 'BH3120' Applying Bispecific Antibody Technology 'Fantambody'

Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical have begun clinical trials for the next-generation immuno-oncology drug 'BH3120,' which applies the independently developed bispecific antibody technology 'Pentambody.'

Exterior view of Hanmi Pharmaceutical Research Center in Dongtan, Hwaseong-si, Gyeonggi Province
[Photo by Hanmi Pharmaceutical]

Hanmi Pharmaceutical announced on the 22nd that it recently received approval from the Ministry of Food and Drug Safety for the domestic Phase 1 clinical trial plan (IND) of the next-generation immuno-oncology drug ‘BH3120 (PD-L1/4-1BB BsAb).’ Earlier, in May, Hanmi Pharmaceutical also obtained IND approval from the U.S. Food and Drug Administration (FDA) for the same substance.

BH3120 is a new drug candidate applying the bispecific antibody platform technology ‘Pentambody,’ where a single antibody simultaneously binds to two different targets. This allows for the advantage of simultaneously performing immuno-oncology treatment that activates immune cells and targeted cancer therapy that attacks only cancer cells. BH3120 is an immunoglobulin G (IgG)-type bispecific antibody designed with different binding characteristics for each target, PD-L1 and 4-1BB. The difference in binding affinity, designed based on various studies, is said to induce differentiation in efficacy and safety.

While the 4-1BB single antibody under development has limitations in efficacy or safety, BH3120 is designed with a bispecific antibody mechanism targeting not only 4-1BB but also PD-L1 located on the surface of cancer cells. It acts specifically in the tumor microenvironment (TME) to exhibit a strong anti-tumor effect by activating immune cell functions within the cancer tissue. Hanmi Pharmaceutical added that, besides the effect as a monotherapy, a powerful synergistic effect was confirmed when combined with PD-1 inhibitors, resulting in the complete disappearance of cancer tissue. Regarding safety, no toxicity or immune-related adverse effects were observed in safety studies on primates, and a superior safety profile was confirmed compared to competing products of the same class currently under development.

At the American Association for Cancer Research (AACR) held in April, Hanmi Pharmaceutical presented research results showing a clear decoupling phenomenon of immune activation between cancer tissue and normal tissue, demonstrating the possibility of developing new immuno-oncology drugs that minimize the side effects of existing immuno-oncology therapies. Based on these preclinical research results, Hanmi Pharmaceutical plans to simultaneously initiate global Phase 1 clinical trials in Korea and the United States within this year.

A Hanmi Pharmaceutical official said, “BH3120 is the first project to conduct global clinical research using the Pentambody platform technology,” adding, “Pentambody, following Hanmi’s proprietary platform technology ‘LAPSCOVERY,’ is expected to continuously create solid future value for Hanmi.”

This content was produced with the assistance of AI translation services.