- 파이프라인
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한미약품은 축적된 연구 개발 기술력을 바탕으로 항암, 대사성, 심혈관 · 신장계, 희귀질환 치료제 분야에서
다양한 혁신신약을 개발하고 있습니다.
주요 파이프라인 소개
한미약품과 인류의 건강을 위한 창조와 혁신 그리고 도전 정신을 함께 할 파트너사를 찾습니다.
HM16390 (LAPSIL-2 analog)
OVERVIEW
HM16390 is a long-acting interleukin-2 (IL-2) analog chemically conjugated with constant region of human immunoglobulin G4 (IgG4 Fc) via flexible non-peptidyl linker (LAPSCOVERY).
Currently, novel IL-2 analogs are being developed by the two different strategies. Some analogs with the reduced affinity to IL-2Rα could reduce adverse events such as vesicular leak syndrome (VLS), but have low anti-tumor efficacy. The other strategy is to intensify affinity to IL-2Rβ and eliminate IL-2Rα affinity. In this case IL-2 analog shows potent anti-tumor efficacy, but it has potential safety concern such as cytokine release syndrome (CRS) by attenuated regulatory T cells.
HM16390 has the modified rhIL-2 analog which shows both a powerful anti-tumor efficacy by the preferential binding to IL-2 Rβ and an improved safety profile by the balanced IL-2Rα binding affinity. The optimal affinity ratio was determined through the evaluation of various IL-2 analogs which have different IL-2R binding profiles.
In nonclinical studies, HM16390 showed the remarkable anti-tumor efficacy in the various syngeneic models and elicited synergistic action when administered with the immune check point inhibitor (ICI) by modulating tumor-microenvironment.
It is being developed for both the treatment of solid tumors and the combination with other immune-oncology drugs, such as ICIs.
The GLP toxicology study will be initiated in 1Q 2023.
Currently, novel IL-2 analogs are being developed by the two different strategies. Some analogs with the reduced affinity to IL-2Rα could reduce adverse events such as vesicular leak syndrome (VLS), but have low anti-tumor efficacy. The other strategy is to intensify affinity to IL-2Rβ and eliminate IL-2Rα affinity. In this case IL-2 analog shows potent anti-tumor efficacy, but it has potential safety concern such as cytokine release syndrome (CRS) by attenuated regulatory T cells.
HM16390 has the modified rhIL-2 analog which shows both a powerful anti-tumor efficacy by the preferential binding to IL-2 Rβ and an improved safety profile by the balanced IL-2Rα binding affinity. The optimal affinity ratio was determined through the evaluation of various IL-2 analogs which have different IL-2R binding profiles.
In nonclinical studies, HM16390 showed the remarkable anti-tumor efficacy in the various syngeneic models and elicited synergistic action when administered with the immune check point inhibitor (ICI) by modulating tumor-microenvironment.
It is being developed for both the treatment of solid tumors and the combination with other immune-oncology drugs, such as ICIs.
The GLP toxicology study will be initiated in 1Q 2023.
IL-2 agonism
Once-per-treatment
cycle injection
CLINICAL DEVELOPMENT
A phase 1/2 IND submission is planned in 1Q 2024.