博安生物第二代廣譜中和抗體對Omicron等多種新冠病毒變異株有效
近日,由綠葉製藥集團控股子公司博安生物自主研發的治療新冠病毒肺炎(COVID-19)的第二代廣譜中和抗體——BA7208取得重要進展:通過基於假病毒的中和活性評估,BA7208對於11種病毒變異均保持較高中和活性,其中對Omicron亞型變異株BA.1和BA.2的IC50值達到2-5 ng/mL。此外,BA7208對新出現的BA.3、BA.4、BA.5和BA.2.12.1亦能保持高中和活性。
自新冠肺炎疫情爆發以來,全球範圍內已相繼出現Alpha、Beta、Delta、Omicron等多種變異毒株。其中,Omicron是當下全球主要流行的新冠病毒變異株,也是國內本土新冠肺炎傳播的主要變異株。儘管已有多款疫苗、治療藥物投入使用,但病毒的不斷變異加強其傳染性和逃逸能力,使疫苗的保護及治療藥物的療效受到影響。面對新冠病毒的持續肆虐,迅速開發出具有“廣譜效應”的、可廣泛中和當前及未來可能出現的變異株的下一代中和抗體藥物顯得尤為迫切。
博安生物憑藉自有的全人抗體轉基因小鼠及噬菌體展示技術平台,通過序貫免疫和序貫篩查,甄選出若干潛在廣譜中和抗體。這些抗體避開了嚴重急性呼吸系統綜合徵冠狀病毒2(SARS-CoV-2)表面刺突蛋白受體結構域(RBD)中的大多數突變敏感位點,可以廣泛有效地中和SARS-CoV-2各種變體,且對未來變體失去中和活性的風險較低,BA7208便是其中之一。
目前已完成的體外假病毒中和試驗數據顯示:BA7208對於包括Alpha(B.1.1.7)、Beta(B.1.351)、Delta(B.1.617.2)、Gamma(P.1)、Lambda(C.37)、Omicron(B.1.1.529)等11種病毒變異均保持較高的中和活性,其中對Omicron亞型變異株BA.1和BA.2的IC50值達到2-5ng/mL。新出現的變異株BA.3與BA.2的RBD具有完全相同氨基酸序列,BA.4和BA.5相比BA.2在RBD上增加了3個突變L452R、F486V、R493Q,BA.2.12.1相比BA.2在RBD上增加了1個突變L452Q,這些RBD突變或在之前檢測的11個毒株上出現過、或遠離BA7208結合區域,因此可判斷BA7208依然對新出現的BA.3、BA.4、BA.5和BA.2.12.1保持高中和活性。此外,BA7208還在小鼠體內表現出較長的半衰期。該在研藥物有望成為應對新冠病毒變異株的有力武器。
新冠中和抗體具有預防與治療的雙重作用,其特異性和安全性均優於小分子藥物和血漿療法。博安生物作為國內首批研發新冠抗體的創新生物藥企之一,自疫情爆發以來全力投入新冠治療藥物的研究與開發中。除了BA7208,公司自研的另一個新冠中和抗體候選藥物——LY-CovMab也在中國處於II期臨牀試驗階段。
博安生物研發總裁兼首席運營官竇昌林博士表示:“BA7208是我們繼LY-CovMab之後開發的又一新冠治療候選藥物。自疫情爆發以來,我們與病毒賽跑,迅速佈局新冠中和抗體的研究。期待通過我們的專業力量,加快推動這些藥物的開發,更好地助力抗擊疫情、服務人類健康。”
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