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康方生物-B(09926.HK):CD47單抗(AK117)完成I期爬坡,並獲批開展聯合阿扎胞苷治療急性髓系白血病臨牀研究
格隆匯 07-13 06:09

格隆匯7月13日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的腫瘤免疫治療新藥二代CD47單克隆抗體(研發代號:AK117)已完成澳洲I期劑量爬坡試驗。AK117在各個劑量爬坡隊列受試者(0.3毫克╱千克至45毫克╱千克每週一次給藥(“QW”))中均未發生劑量限制性毒性(“DLT”)和未出現有臨牀意義的貧血,各隊列受試者對藥物耐受性良好,無需使用低劑量預激給藥。

同時,AK117獲得中國家藥品監督管理局(“NMPA”)批准,開展聯合阿扎胞苷治療急性髓系白血病(“AML”)的Ib/II期臨牀研究。AK117作為二代CD47單抗,其安全性較一代CD47單抗有顯著提升,AK117聯合阿扎胞苷治療AML有望在同類藥物中獲得更佳表現。此前AK117在骨髓增生異常綜合徵(“MDS”)的研究中已經體現出其安全性優勢,且大多數MDS患者在接受AK117治療後都初步觀察到血液學指標改善。截止目前,AK117在實體瘤及血液瘤的研究均已經開展臨牀並實現患者給藥。

AML是一組造血幹細胞克隆性增殖異常的高度異質性疾病,是成人急性白血病中最常見的類型。CD47在多種腫瘤細胞表面高表達,包括實體瘤和血液瘤,且與不良預後相關。CD47阻斷後可以刺激巨噬細胞對腫瘤細胞的吞噬功能,且可促進適應性免疫反應。臨牀前研究數據顯示,CD47單抗聯合阿扎胞苷後可進一步誘導細胞表面鈣網蛋白的內源性表達,從而進一步加強巨噬細胞對腫瘤的吞噬作用。同時,有臨牀數據顯示CD47單抗聯合阿扎胞苷治療初治不適合接受化療的AML受試者較阿扎胞苷單藥的療效有顯著的提升,且安全耐受性良好。

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