科倫藥業(002422.SZ)：KL340399注射液瘤內注射治療晚期實體瘤獲批臨牀試驗
格隆匯6月15日丨科倫藥業(002422.SZ)公佈，公司近日獲悉，公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的新一代小分子STING激動劑(KL340399注射液)獲得國家藥品監督管理局(NMPA)簽發新的臨牀試驗通知書。
審評結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2022年4月8日受理的KL340399注射液瘤內注射治療晚期實體瘤申請符合藥品註冊的有關要求，同意按照提交的方案開展瘤內注射給藥的臨牀試驗。
KL340399注射液為公司自主研發的非環二核苷酸(non-CDN)類小分子化合物，是具有全新結構、體內外藥效活性顯著、結構穩定且可兼顧瘤內給藥及系統給藥的新一代STING激動劑。此前已獲批靜脈輸注給藥治療晚期實體瘤適應症，
並已開展臨牀研究。此次獲批適應症為可經瘤內注射給藥的淺表或可通過醫學影像儀器輔助給藥的局部晚期、復發或轉移性實體瘤。
STING全稱干擾素基因刺激蛋白(stimulator of interferon genes)，是一種跨膜蛋白，是固有免疫信號通路中重要的接頭蛋白，具有識別病毒和細菌感染以及啟動機體固有防禦和免疫反應的作用。激活STING通路可誘導I型干擾素和其他促炎因子的表達和分泌，激活固有免疫應答，促進抗腫瘤免疫響應，達到治療腫瘤的目的。STING激動劑的瘤內注射給藥相對靜脈注射給藥具有療效和安全性的潛在優勢。瘤內注射引起的局部炎症反應可以激發腫瘤部位的先天性免疫，併產生遠隔效應，起到全身殺傷腫瘤細胞的作用，且瘤內給藥全身暴露量較低，可以有效減少全身系統性炎症反應的風險。在臨牀應用方面，對於體積較大、位置淺表和難以切除部位的腫瘤，瘤內給藥可以提高腫瘤組織中藥物濃度，減少全身暴露量，有利於實現局部更好的抑瘤療效和減少全身不良反應。
截至公吿披露日，暫無同靶點藥物獲批上市。臨牀研發進展最快的是默克開發的MK-1454，處於臨牀II期。
非臨牀研究結果顯示，KL340399能與人STING蛋白結合，激活STING信號通路，誘導I型干擾素和抗腫瘤細胞因子表達，在多個荷瘤小鼠模型中表現出呈劑量依賴性顯著抑制腫瘤生長，且具有與PD-L1抗體聯用增效的潛質。在安全性評價中顯示整體耐受性良好。
四川科倫博泰生物醫藥股份有限公司將按照國家藥品監督管理局簽發的臨牀試驗通知書的要求，組織實施KL340399注射液瘤內注射給藥的臨牀試驗。
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