康方生物-B(09926.HK)：CD47單抗(AK117)獲批開展治療中高危骨髓增生異常綜合症(MDS)的I/II期臨牀研究
格隆匯5月18日丨康方生物-B(09926.HK)發佈公吿，公司自主研發的新型腫瘤免疫治療新藥CD47單克隆抗體（研發代號：AK117），獲得中國國家藥品監督管理局（NMPA）批准開展治療中高危骨髓增生異常綜合症（MDS）的I/II期臨牀研究。
AK117是公司自主研發的新一代CD47單克隆抗體，此前公佈的數據顯示出具有優越的安全性。目前已經完成30毫克/千克每週一次給藥（QW）的劑量爬坡，45毫克/千克QW劑量受試者給藥正在進行中。AK117在各個劑量爬坡的隊列受試者中均未發生藥物相關的貧血劑量限制性毒性（DLT），各隊列受試者對藥物耐受性良好。受試者外周血T細胞的CD47受體佔有率（RO）在3毫克/千克隊列就已經達到並維持在100%。
據悉，AK117已於2020年在中國和海外開展治療晚期實體瘤和淋巴瘤患者的劑量遞增和劑量擴展I期臨牀研究。公司計劃於2021年美國臨牀腫瘤學會年會（ASCO2021）發佈AK117治療晚期或轉移性實體瘤的安全性研究成果。
MDS是一類起源於造血幹細胞的異質性髓系克隆性疾病，表現為無效造血、難治性血細胞減少、高風險向急性髓系白血病（AML）轉化。隨着全球人口老齡化，MDS的治療存在巨大未滿足臨牀需求。相關臨牀研究顯示，CD47單抗聯合治療MDS存在有效性和安全性方面的優勢潛力。AK117作為新一代CD47單抗，有望在同類藥物中獲得更佳表現。
AK117是公司自主研發的新一代人源化IgG4mAb，AK117可與腫瘤細胞上表達的CD47結合，阻斷CD47與其受體SIRPα（在吞噬細胞上表達）的相互作用，增強吞噬細胞對腫瘤細胞的吞噬活性，從而抑制腫瘤生長。臨牀前研究也顯示，AK117在保留抗腫瘤活性的同時，消除了紅細胞凝集作用，並顯着降低其介導的巨噬細胞對紅細胞吞噬活性，區別於其他抗CD47抗體藥物，AK117具有不引起紅細胞聚集的差異化特徵。並且AK117介導巨噬細胞對紅細胞吞噬的活性顯着弱於對腫瘤細胞的吞噬。同時，相較於其他CD47抗體所表現出的明顯貧血症狀，AK117在食蟹猴中僅出現輕微的紅細胞變化，並且未觀察到對血小板的毒性作用。
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