君實生物(01877.HK)抗TIGIT單抗注射液臨牀試驗申請獲得FDA受理
格隆匯1月28日丨君實生物(01877.HK)發佈公吿,近日,公司子公司TopAlliance Biosciencies, Inc.(以下簡稱“拓普艾萊”)向美國食品藥品監督管理局(FDA)提交了特異性抗TIGIT單克隆抗體注射液(項目代號“TAB006/JS006”)用於治療晚期惡性腫瘤的臨牀試驗申請並獲得受理。公司將在獲得FDA的正式批准後於美國開展TAB006/JS006的臨牀試驗。
TAB006/JS006是公司自主研發的特異性抗TIGIT單克隆抗體注射液。臨牀前研究結果表明,TAB006/JS006可特異性阻斷TIGIT-PVR抑制通路,刺激殺傷性免疫細胞活化,分泌腫瘤殺傷性因子。
TIGIT(T cell immunoglobulin and ITIM domain,T細胞免疫球蛋白和TIIM結構域)是新興的NK細胞和T細胞共有的抑制性受體,可與腫瘤細胞上高表達的PVR受體相互結合,介導免疫反應的抑制信號,從而直接抑制NK細胞和T細胞對腫瘤細胞的殺傷作用,效果類似於PD-1對T細胞的抑制作用。多項臨牀前的試驗結果顯示抗TIGIT抗體與抗PD-1/PD-L1抗體可發揮協同抗腫瘤作用。兩者結合是一種有前途的抗癌治療策略,有望增加患者對免疫治療的反應,擴大可能受益人羣的範圍。目前,國內外尚無同類靶點產品獲批上市。
據悉,TAB006/JS006注射液的臨牀試驗申請於2020年11月獲得國家藥品監督管理局受理,並已於2021年1月獲得國家藥監局批准,公司將按照相關規定在國內開展臨牀試驗。
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