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Oruka Therapeutics宣布在歐洲皮膚病學和性病學學院議會上關於ORKA-001的臨床前數據


皮下(SQ)給藥後非人靈長類動物(NHP)的半衰期為30.3天,靜脈(IV)給藥後為33.8天


在多個臨床前試驗中展示出與risankizumab具有相似結合親和力和表位的等效效力
MENLO PARk, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. ("Oruka") (NASDAQ:ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV).
ORKA-001 has an NHP half-life of 30.3 days following SQ administration and 33.8 days following IV administration, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. Projections of ORKA-001 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every six months, while a human half-life of approximately 75 days could enable once-yearly dosing. The NHP half-life observed for ORKA-001 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs. In addition, the extended half-life of ORKA-001 could result in higher antibody exposures than risankizumab, which could lead to greater efficacy.

ORKA-001與risankizumab結合到一個相似的表位,並表現出類似親和力,在各種體外測試中具有等效的效能。ORKA-001以低於五皮摩爾的親和力結合IL-23p19。基於冷凍電子顯微結構分析,ORKA-001與risankizumab結合到一個幾乎完全相同的表位。在細胞系和原代細胞中評估過四種不同的測試中,ORKA-001在IL-23拮抗方面也具有相當的功能效能。這些發現支持ORKA-001具有經過驗證的作用機制,並進一步降低了其開發路徑的風險。
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