永泰生物-B(06978.HK)：遞交RC19D2的新藥臨牀試驗溝通會議申請
格隆匯2月3日丨永泰生物-B(06978.HK)公佈，公司近期已就公司的RC19D2注射液產品向中華人民共和國國家藥品監督管理局藥品審評中心遞交新藥臨牀試驗溝通會議申請。RC19D2(原稱CAR-T–19-D2及CAR-T–19-DNR)為針對免疫抑制分子TGF－β，其為用於治療患有復發難治瀰漫性大B細胞淋巴瘤(“DLBCL”)的患者的注射液。該注射液的目標為解決嵌合抗原受體T細胞(“CAR-T細胞”)對實體瘤治療的持久性不夠、治療效果欠佳及預防腫瘤復發的痛點。
有關RC19D2的資料：CAR-T細胞乃經過基因工程改造以產生人工T細胞受體及嵌合抗原受體，經過工程改造的受體使T細胞被賦予新能力，可以細胞表面的特定蛋白質為目標。CAR-T細胞對患有復發難治性淋巴瘤的患者療效顯著。儘管如此，若干部分患者的CAR-T細胞療效仍然很差，部分原因是，與大多數其他惡性實體瘤一樣，淋巴瘤的機制可逃避免疫系統的攻擊。
RC19D2注射液的功能成分為經基因改造表達抗CD19嵌合抗原受體與拮抗TGF-β下游信號通路的蛋白的T細胞。在所有階段的B細胞發展中，CD19在B細胞表面廣泛表達。此外，由於B細胞及其前體細胞突變導致的疾病，如B細胞淋巴瘤和急性B淋巴細胞白血病中，絕大多數腫瘤細胞同樣表達CD19，使得CD19成為治療這些腫瘤的靶標之一。嵌合抗原受體技術通過鏈接抗CD19的單鏈抗體、蛋白跨膜結構域、共刺激分子結構域等，避免了自身免疫細胞無法識別人體CD19蛋白、腫瘤細胞對免疫細胞的抑制、第二信使通路信號不足等問題，使得經過改造的T細胞可以直接識別CD19分子並殺傷攜帶靶標的細胞，從而達成對腫瘤治療的目的。同時，同步轉錄翻譯表達細胞內部拮抗TGF-β下游信號通路的蛋白，具有阻遏腫瘤微環境中存在TGF－β所導致的免疫抑制效應的潛力，防止RD19D2細胞免疫殺傷能力的削弱與耗竭，從而進一步提高治療效果。
基於目前的研發進展，公司預期於2022年獲得RC19D2注射液的臨牀試驗批覆。
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