基石藥業-B(02616.HK)在2021年第33屆國際分子靶標與癌症治療大會上公佈CS5001(ROR1ADC)研究數據
格隆匯10月8日丨基石藥業-B(02616.HK)宣佈潛在全球同類最佳藥物CS5001(靶向受體酪氨酸激酶樣孤兒受體1(receptor tyrosine kinase-like orphan receptor 1, “ROR1”抗體偶聯藥物(“ADC”))的臨牀前研究數據入選2021年第33屆國際分子靶標與癌症治療大會(AACR-NCIEORTC International Conference on Molecular Targets and Cancer Therapeutics)重磅研究摘要(late-breaking abstract, “LBA”)並通過海報形式展示研究結果(Poster ID: LBA008)。結果表明：CS5001在多種表達ROR1的細胞系展現出了較強的選擇性細胞毒性，並在異種移植小鼠模型中顯示出顯著的體內抗腫瘤活性。在一組癌症細胞系中，ROR1的表達似乎可以預測對CS5001的敏感性。數據顯示，CS5001是一款有望在ROR1高表達的血液腫瘤和惡性實體瘤中都具有精準治療潛力的候選藥物。
基石藥業首席科學官謝毅釗博士表示：“ROR1是一個非常有潛力的藥物靶點，在多種實體瘤和血液惡性腫瘤中都具有差異化的高度表達，而在成人健康組織中並不表達。這意味着ROR1有望成為像PD-1/L1一樣具有廣譜抗癌潛力的新藥靶點。此次公佈的CS5001在臨牀前藥理學和藥效學方面的數據令人鼓舞，表明了CS5001在治療多種血液疾病和惡性實體腫瘤領域的精準醫學的潛力。我們預計將在今年年底前提交臨牀試驗申請(“IND”)，隨後啟動臨牀試驗。”
目前，CS5001已完成IND申報所需的臨牀前研究，其具有獨特的設計，該連接子(linker)與使用腫瘤特異激活的PBD前毒素載荷(payload)相結合。CS5001只有在到達腫瘤後，其連接子被切割釋放PBD前毒素，繼而PBD前毒素在腫瘤細胞內被激活，從而殺死腫瘤細胞。這種連接子加PBD前毒素的“雙控”機制有效地解決了與傳統PBD載荷有關的典型毒性問題，擁有更好的安全性。此外，CS5001利用定向偶聯技術獲得精準的藥物抗體比率(“DAR”)，便於實現均質生產及大規模生產。
2020年10月，基石藥業與LegoChem Biosciences, Inc.(“LCB”)就CS5001的開發和商業化達成授權協議。根據協議條款，基石藥業獲得獨家授權，主導CS5001在韓國以外的全球其他地區的開發和商業化。該研究由基石藥業、LCB公司以及韓國ABL Bio公司共同完成。
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