復宏漢霖(02696.HK)：HLX301於澳大利亞用於局部晚期或轉移性實體瘤治療的1期臨牀研究完成首例患者給藥
格隆匯2月14日丨復宏漢霖(02696.HK)宣佈，近日，公司自主開發的HLX301(重組人源抗PD-L1與抗TIGIT雙特異性抗體注射液)("HLX301")於澳大利亞用於局部晚期或轉移性實體瘤治療的1期臨牀研究完成首例患者給藥。
公吿稱，本研究是一項在既往標準治療失敗、不耐受或無合適標準治療的局部晚期或轉移性實體瘤患者中開展的，旨在評估雙特異性抗體HLX301的安全性、耐受性、藥代動力學及初步抗腫瘤療效的開放、多中心、劑量探索、首次人體1期臨牀試驗。合格的受試者將接受每兩週靜脈輸注單藥HLX301的治療。1a期為劑量遞增階段，主要終點為評估HLX301的安全性、劑量限制毒性(DLT)，並確定最大耐受劑量(MTD)。次要終點包括藥代動力學、藥效動力學和免疫原性。1b期為劑量拓展階段，主要終點為2期臨牀試驗推薦劑量(RP2D)。次要終點包括客觀緩解率(ORR)、疾病控制率(DCR)和持續緩解時間(DOR)。
據悉，HLX301為公司自主開發的創新型抗PD-L1和抗TIGIT雙特異性抗體，擬用於多種晚期實體瘤治療。其TIGIT結合域來源於公司人源化羊駝重鏈可變區單域抗體(VHH)噬菌體展示庫篩選出的對TIGIT具有高親和力、高特異性的VHH片段。TIGIT(T cell immunoglobulin and ITIM domain，T細胞免疫球蛋白和ITIM結構域)是一種抑制性受體，主要由自然殺傷(NK)細胞、活化的CD8+ T和CD4+ T細胞以及調節性T細胞(Treg)表達。TIGIT與主要表達於抗原提呈細胞(APC)或腫瘤細胞表面的配體CD155(PVR)結合，從而直接抑制NK細胞和T細胞對腫瘤細胞的殺傷作用。阻斷TIGIT與PVR結合而產生的免疫抑制，可以解除T細胞及NK細胞的抑制和耗竭，進而促進T細胞及NK細胞介導的抗腫瘤效應。研究表明，TIGIT阻斷劑具有治療多種晚期腫瘤的前景，包括非小細胞肺癌、胃癌、黑色素瘤、多發性骨髓瘤等。PD-1/PD-L1信號通路在腫瘤免疫中具有重要作用，同時阻斷TIGIT/PVR和PD-1/PD-L1信號通路優於單獨阻斷任一通路，可增強抗腫瘤活性。
臨牀前研究結果表明，雙特異性抗體HLX301可與人PD-L1和TIGIT特異性結合並阻斷PD-1/PD-L1和TIGIT/PVR結合而切斷PD-1和TIGIT下游負向信號，可抑制腫瘤的生長，且耐受性、安全性良好。2021年11月，HLX301獲批於澳大利亞開展用於局部晚期或轉移性實體瘤的臨牀試驗。
截至公吿日，於全球範圍內尚無靶向PD-L1和TIGIT的雙特異性抗體上市。
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