科倫博泰生物-B(06990.HK)主要產品A400(EP0031)獲美國食品藥品監督管理局批准開啟2期試驗
格隆匯5月3日丨科倫博泰生物-B(06990.HK)公吿，公司的主要產品A400(EP0031)(在轉染過程中重排(RET)小分子激酶抑制劑項目，亦稱為KL590586或EP0031)獲得了美國食品藥品監督管理局(FDA)批准進入2期臨牀開發。
A400(EP0031)是第二代選擇性RET抑制劑(SRI)，對常見的RET基因融合和突變具有廣泛活性。於2021年3月，公司向總部位於英國的國際藥物研發公司Ellipses Pharma Limited("Ellipses")授予一項在大中華區、朝鮮、韓國、新加坡、馬來西亞及泰國外的所有國家開發、製造及商業化A400(EP0031)的獨家、付特許權使用費、可轉授的許可。
於2022年6月，A400(EP0031)已獲得FDA批准的新藥臨牀研究申請，進行一項針對RET基因改變的惡性腫瘤患者的1/2期試驗。於2023年11月，A400(EP0031)獲FDA授予孤兒藥資格認定，用於治療RET融合陽性實體瘤。於2024年3月，A400(EP0031)獲得了FDA授予的快速通道資格認定，用於治療RET融合陽性非小細胞肺癌(NSCLC)。
在臨牀前研究中，A400(EP0031)在體外和體內對主要RET激酶表現出良好的抑制活性。A400(EP0031)在動物模型中也表現出良好的血腦屏障穿透性。於2023年美國臨牀腫瘤學會(ASCO)年會上分享的有關A400(EP0031)的數據顯示，根據其正在進行的1/2期試驗結果，A400(EP0031)在晚期RET+實體瘤患者中表現出良好的抗腫瘤療效，尤其是在一線及二線以上晚期RET+NSCLC中的ORR分別為80.8%及69.7%。據報道，該兩種情況中的DCR均超過96%。
根據ASCO網站發佈的信息，Ellipses將在於2024年6月3日(當地時間)舉行的2024年ASCO年會上呈報在從未採用過SRI或曾接受過治療的晚期RET變異的NSCLC及其他腫瘤的患者中開展的A400(EP0031)1期劑量爬坡及擴展研究中所得臨牀數據。
目前，公司正在中國開展A400(EP0031)針對RET陽性NSCLC的關鍵臨牀研究。
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