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海普瑞(09989.HK):OREGOVOMAB 3期臨牀試驗完成首例患者給藥
格隆匯 11-10 16:45

格隆匯11月10日丨海普瑞(09989.HK)公告,於2020年11月10日,OncoQuest Pharmaceuticals Inc.(前稱為Dual Industrial Co., Ltd.,是一家於KOSDAQ上市的公司,股份代號:078590.KQ)的子公司OncoQuest Pharma USA, Inc.宣佈,其免疫治療候選藥物Oregovomab的3期臨牀試驗已經在美國完成首例患者給藥。這項全球關鍵性試驗預計將招募來自17個國家140個臨牀站點的602名患者。

名為FLORA-5的3期臨牀試驗為一項雙盲、安慰劑對照、多中心的臨牀研究,用於對比Oregovomab與安慰劑的安全性及療效,結合標準六週期化療方案(紫杉醇和卡鉑)的特定週期給藥,聯合最佳減積手術切除,用於治療新診斷的晚期上皮性卵巢癌、輸卵管癌或腹膜癌患者。本試驗的輔助組和新輔助組的主要和次要終點分別為無進展生存期及總生存期。

FLORA-5試驗正在與Gynecologic Oncology Group Foundation及IQVIA(一個臨牀研究機構)合作進行。大中華的臨牀試驗與深圳昂瑞生物醫藥技術有限公司(公司子公司,其為Oregovomab於大中華的商業化許可持有人)合作進行。

於本公告日期,公司對OncoQuest Inc.(一家加拿大私人生物技術公司)約37.8%的股份擁有權益。OncoQuest Inc.與OncoQuest Pharmaceuticals正在完成一項涉及OncoQuest Inc.所有原大中華免疫資產的資產轉讓交易。於該交易完成後,OncoQuest Inc.將以普通股及可轉換債券的形式持有OncoQuest Pharmaceuticals約50.7%的股權。

據悉,OncoQuest Pharmaceuticals是一家韓國生物製藥公司,專注於癌症免疫療法的開發及商業化。OncoQuest Pharmaceuticals的科技平台包括一系列針對CA-125、MUC1、PSA和Her2/neu的腫瘤抗原特異性單克隆免疫球蛋白。該技術平台正通過一項於2020年4月宣佈的資產轉讓交易從OncoQuest Inc.收購。OncoQuest Pharmaceuticals正在探索這些抗體作為間接免疫劑聯合其他免疫調節藥物或藥物組合的治療潛力,以解決腫瘤學中尚未滿足的醫療需求。

OncoQuest Pharmaceuticals的主要候選產品為Oregovomab,一種抗CA-125抗體,用於治療卵巢癌。除了現時在第一線卵巢癌的3期試驗外,這種候選藥物目前正於複發性卵巢癌復發環境中的多個2期臨牀試驗中進行研究。OncoQuest Pharmaceuticals的抗MUC1抗體項目已完成針對乳腺癌患者的1期臨牀試驗,該項目的開發由與本公司合資企業OncoVentCo. Ltd.牽頭。OncoQuest Pharmaceuticals的下一代單克隆抗體乃基於加州大學洛杉磯分校、史丹福大學及Advanced Immune Therapeutics, Inc.授權的免疫球蛋白E技術。該等抗原特異性單克隆IgE抗體目前正處於臨牀前開發中。

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