遠大醫藥(00512.HK)：美國FDA批准COVID-19疫苗項目CORVax12進行I期臨牀試驗
格隆匯 11 月 3日丨遠大醫藥(00512.HK)發佈公告，集團在腫瘤免疫領域及DNA技術研發平台OncoSec Medical Incorporated (NASDAQ:ONCS) (OncoSec，為集團的一間聯營公司)與Providence Cancer Institute(“Providence”)合作開發，針對新型冠狀病毒病COVID19的DNA疫苗CORVax12獲得美國食品和藥物管理局(FDA)的新藥臨牀試驗申請(IND)批准並啟動研究者發起的I期臨牀試驗。該疫苗是目前唯一使用免疫刺激劑來促進對SARS-CoV-2病毒免疫反應的DNA疫苗，旨在作為預防性疫苗預防COVID-19。
CORVax12疫苗結合了OncoSec專有的TAVOTM電穿孔基因遞送技術平台和美國國家過敏和傳染病研究所(NIAID)授權針對COVID-19病毒的可編碼DNA穩定三聚物SARS-CoV-2刺突蛋白(S蛋白)，體現了TAVOTM技術平台的優勢和可擴展性。通過電轉方式引入S蛋白和白介素12(IL-12)編碼序列，誘導人體免疫系統產生能夠結合SARS-CoV-2的中和抗體，該疫苗的IL-12可有效限制T細胞衰竭，促使體內T細胞產生更強的抗病毒反應，使接受CORVax12疫苗的受試者可能產生更強的抗病毒T細胞應答，從而達到更好的疫苗免疫應答。
根據臨牀試驗方案，Providence將組織開展CORVax12針對COVID-19的開放性I期臨牀研究以評估可編碼S蛋白的序列單獨使用或與IL-12聯合使用的安全性和免疫原性。
CORVax12疫苗的研發將進一步優化TAVOTM平台對現有疫苗和候選疫苗的免疫反應，評估IL-12加入S蛋白能否促進疫苗免疫應答且優於單獨使用S蛋白，並建立對後續COVID-19病毒變種的免疫驅動。
根據於2019年10月，由公司直接全資擁有附屬公司弘年發展有限公司與OncoSec訂立的授權協議，集團擁有OncoSec所有開發項目於中國及三十八個亞洲其他地區的獨家商業化權利，而集團將會根據臨牀研究進展情況適時啟動項目的國內引進工作。
作為集團在腫瘤免疫治療領域和DNA技術研發平台，OncoSec其他在研項目進展順利，其核心產品TAVOTM與KEYTRUDA®(可瑞達，通用名：pembrolizumab，帕博利珠單抗)聯合治療抗PD-1檢查點耐藥轉移性黑色素瘤的最新的臨牀試驗數據顯示客觀緩解率(ORR)為41%，並計劃向FDA申請加速審批流程。其餘TAVOTM聯合治療三陰乳腺癌、鱗狀細胞癌等其他項目的臨牀試驗亦在同步有序推進。
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