復宏漢霖(02696.HK)：HLX301用於晚期腫瘤治療臨牀試驗申請獲國家藥監局批准
格隆匯3月17日丨復宏漢霖(02696.HK)公吿，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）用於晚期腫瘤治療的臨牀試驗申請(IND)獲國家藥品監督管理局（NMPA）批准。公司擬於條件具備後於中國境內（不包括港澳台地區）開展該項目的1期臨牀研究。2022年2月，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。
HLX301為公司自主開發的創新型抗PD-L1和抗TIGIT雙特異性抗體，擬用於多種晚期腫瘤治療。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。截至本公吿日，於全球範圍內尚無靶向PD-L1和抗TIGIT的雙特異性抗體上市。
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