三生國健(688336.SH)：雙特異抗體注射用SSGJ-705獲得藥物臨牀試驗批准通知書
格隆匯9月29日丨三生國健(688336.SH)公佈，近日，公司雙特異抗體注射用SSGJ-705收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》，並將於近期開展I期臨牀試驗。注射用SSGJ-705已於2021年6月獲得美國食品藥品管理局的IND。
公司研發的抗 HER2x抗PD1雙特異抗體(SSGJ-705)是一種同時針對HER2和PD1的雙特異性抗體(以下簡稱“BsAb”)，將HER2靶向治療與免疫檢查點PD1阻斷相結合，從而更有效地治療HER2陽性實體瘤。BsAb療法相比單抗而言，具備直接抗腫瘤和免疫激活雙重協同效應，是一種新穎的、具有潛力的治療晚期轉移性HER2陽性癌症的療法，有望為HER2陽性實體瘤提供更優的解決方案。
免疫檢查點阻斷療法，包括抗PD1/PDL1抗體，在多種癌症中都已表現出明顯的臨牀效益，但其有效率通常僅限於20%-30%的患者，並且大多數患者隨着時間的推移對治療產生耐藥。在浸潤性乳腺癌患者中，大約20%-25%的病例具有人表皮生長因子受體2(HER2/neu)腫瘤基因過度表達，與更具侵襲性的疾病和更不良的預後有關。抗HER2抗體是目前治療HER2過表達癌症的主要方法之一，但大部分患者會復發或產生耐藥。
SSGJ-705相關研究結果已於近日在核心期刊ActaPharmacologicaSinica發表。研究表明，SSGJ-705與人類HER2和PD1有很高的親和力，同時具有HER2抑制和PD1的阻斷活性，並在體外和動物模型體內均表現出強大的抗腫瘤活性。
SSGJ-705能夠通過多種協同作用機制發揮其強大的抗腫瘤活性，包括：(1)阻斷HER2信號傳導通路，直接抑制HER2陽性腫瘤細胞生長；(2)阻斷PD1/PDL1結合，激活腫瘤微環境中的T細胞；(3)抗體依賴的細胞毒性作用(ADCC效應)有效地殺死HER2陽性腫瘤細胞，而對T細胞沒有影響；(4)通過同時結合HER2和PD1將T細胞定向到腫瘤細胞，產生T細胞和腫瘤細胞直接交聯(Tcellengager)，以一種與抗原呈遞無關的方式誘導直接殺傷腫瘤細胞；(5)通過形成PD1免疫突觸進一步增強T細胞的激活及其腫瘤細胞殺傷活性。
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