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針對晚期實體瘤 來凱醫藥(2105.HK)又一款自主研發新藥LAE120(USP1抑制劑)獲FDA臨牀試驗批準
格隆匯 03-03 08:41

• 一款新型、強效USP1變構抑制劑,LAE120在多種腫瘤模型中展現出良好的抗腫瘤活性

• 應用最新人工智能模型輔助工具,極大加速來凱研發進程

• 另一款抗腫瘤潛在藥物LAE118(一種PI3Kα突變選擇性抑制劑)亦進入IND-enabling階段

2025年3月3日,中國上海 —— 來凱醫藥(2105.HK)宣佈,美國食品藥品監督管理局(FDA)已批準其自主研發的LAE120,一種強效、高選擇性USP1抑制劑的新藥臨牀試驗申請(IND),用於治療晚期實體瘤患者。

LAE120是一款新型、強效的USP1變構抑制劑,在同源重組缺陷腫瘤中顯示出單藥療效以及與PARP抑制劑聯用的抗腫瘤活性。其獨特的化學結構與目前已公開的USP1抑制劑具有差異性,可誘導USP1蛋白髮生構象變化。在臨牀前研究中,LAE120在MDA-MB-436和K562等多種腫瘤模型中展現出良好的抗腫瘤活性,並且在與PARP抑制劑聯用的動物實驗中顯示出協同效應.。在GLP長毒實驗中,LAE120體現出良好的安全窗口。來凱正在積極開展外部合作以加快LAE120臨牀開發進展。

來凱醫藥首席科學官顧祥巨博士表示,憑藉雄厚的科研底蘊及開創性的方法,通過藥化、生物和人工智能藥物發現團隊密切合作,公司已經形成了鮮明的自主創新特色,不斷將實驗室早研藥品推向臨牀。值得一提的是,來凱科學家們充分利用了最新的AI人工智能模型輔助工具,極大地加速了項目的研發進程。"我們期望儘快將候選新藥帶給廣大患者。"

早研管線齊頭並進

目前來凱實驗室中,目前有多個臨牀前項目正全力推進。除LAE120,來凱自主研發的另一款抗腫瘤潛在藥物LAE118(PI3Kα突變選擇性抑制劑)也進入了IND支持性研究(IND-enabling)階段。PI3Kα突變在乳腺癌、結直腸癌、肺癌、子宮內膜癌和其它癌症患者中較爲常見,目前已獲批的PI3Kα 抑制劑可抑制野生型,對突變型沒有選擇性,因而耐受性較差,且易產生耐藥性。

作爲一種新型變構抑制劑,LAE118對各類PI3Kα突變型都有很好的活性及選擇性,在動物實驗中比同類藥品療效更強、安全性更高,具同類最佳(best in class)的潛力。來凱此前已在2024年12月的聖安東尼奧乳腺癌研討會(San Antonio Breast Cancer Symposium, SABCS)上展示了LAE118的臨牀前研究數據,預計將在2025年第四季度提交IND申請。

戰略合作加速全球化佈局

"非常自豪來凱又一款早期研發項目獲批IND,體現了來凱在新藥研發領域的實力。我們將持續深耕肥胖、腫瘤、肝纖維化三大優勢領域,推進並豐富產品管線。"來凱醫藥首席執行官呂向陽博士表示,"2024年11月,集團與禮來(NYSE:LLY)達成臨牀合作協議,共同加速LAE102治療肥胖症的全球臨牀開發。未來,我們計劃與全球領先的藥企建立戰略合作,加快候選藥物的臨牀開發及商業化進程,爲全球患者提供變革性療法。"

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