서울 송파구 방이동 한미약품 본사 (사진 = 연합뉴스)

 

[Alpha Biz=(Chicago) Reporter Kim Jisun] Hanmi Pharmaceutical Group has launched clinical trials of its new drug platform technology "Pentambody" in earnest, challenging it to enter the U.S. market.

According to the pharmaceutical industry on the 25th, Hanmi Pharmaceutical has recently applied to the US Food and Drug Administration (FDA) for a phase 1 clinical trial plan for 'BH3120', an anti-cancer drug candidate with pentambody. It is expected that clinical trials will be possible by the end of this year through the FDA screening process.

BH3120 is a double antibody anticancer drug candidate that targets '4-1BB' and 'PD-L1' at the same time. Stimulating 4-1BB, an active receptor for T-immune cells, can boost the anticancer action of immune cells, while antibodies targeting only 4-1BB have been observed to have side effects such as liver toxicity. However, BH3120 can minimize side effects by boosting the immune response by 4-1BB activation in cancer tissues with overexpressed protein PD-L1 on the cancer cell surface.

This differentiation of BH3120 as an anticancer drug came from the platform technology Pentambody applied to the new drug. Pentambody is a next-generation dual antibody platform technology that can simultaneously combine one antibody to two different targets and allows both immunotherapy and target chemotherapy at the same time. In particular, it has structural characteristics similar to natural immunoglobulin G (lgG), so it has excellent immunogenicity and stability, and has the advantage of high production efficiency.

Hanmi Pharm is said to have applied for a phase 1 clinical trial plan to the FDA shortly after announcing BH3120's findings at the American Cancer Research Society (AACR 2023) in Orlando, Florida, on the 17th.

 

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