首個雙重抑制劑MRANK-106獲FDA批准進入臨床試驗




雙重WEE1/YES1激酶抑制劑MRANK-106獲得FDA IND批准,MindRank在首創腫瘤學管道中取得重要進展

2025年3月7日,杭州,中國及倫敦 — 致力於臨床階段的人工智能(AI)驅動藥物發現公司MindRank今日宣布,美國食品藥品監督管理局(FDA)已批准該公司的新藥研究(IND)申請,針對MRANK-106這一首創的口服雙重WEE1和YES1激酶抑制劑,用於治療胰腺癌、小細胞肺癌、卵巢癌、乳腺癌及結直腸癌。

根據廣泛的前臨床研究,MRANK-106與其他正在開發的WEE1抑制劑相比,具有以下特點:

– 同時針對WEE1和YES1激酶,提供協同的抗腫瘤效果
– 在各種癌症模型中作為單一藥物及聯合療法的卓越療效
– 在組織和腫瘤中的分佈優於血漿(選擇性為10到120倍),減少WEE1的目標相關血液毒性
– 與單靶WEE1抑制劑相比,安全性窗口有所改善

計劃於2025年啟動的第一期臨床試驗將評估MRANK-106在晚期或轉移性實體腫瘤患者中的安全性、耐受性、藥代動力學及初步抗腫瘤活性。

依靠MindRank尖端的AI驅動藥物發現平台Molecule Pro™及其專有知識圖譜平台PharmKG™,該公司迅速將MRANK-106從前臨床候選確認(PCC)推進至IND批准。作為MindRank首個正式提名的首創候選藥物,MRANK-106標誌著公司在追求突破性療法方面的重要里程碑。

MindRank創始人兼首席執行官劉正明博士表示:「FDA對MRANK-106的IND批准對MindRank來說是一個重要的里程碑,驗證了我們AI驅動的藥物發現方法的潛力。作為公司繼GLP-1計劃之後的第二個臨床階段管道,MRANK-106展示了我們Molecule Pro™平台在設計針對難治性目標的創新療法方面的多樣性和可重複性。通過同時針對WEE1和YES1激酶,MRANK-106在多種難以治療的癌症中顯示出卓越的前臨床療效,我們期待在患者中評估其潛力。」

關於MRANK-106

MRANK-106是一種新型的口服雙重WEE1和YES1激酶抑制劑,通過MindRank的專有AI平台發現。MRANK-106展現了強大的抗腫瘤活性、良好的藥代動力學(PK)特徵及良好的安全性。該化合物通過協同靶向兩種參與DNA損傷反應和癌細胞增殖的關鍵蛋白,克服了單靶DNA損傷修復抑制劑的局限性。

前臨床數據顯示,MRANK-106在胰腺癌、小細胞肺癌、卵巢癌、乳腺癌和結直腸癌模型中均展現出強勁的療效。MRANK-106的卓越前臨床療效和安全性特徵顯示其在多種具有重大未滿足醫療需求的癌症適應症中具備最佳類別的潛力。

關於MindRank

MindRank是一家人工智能(AI)驅動的藥物發現公司。通過利用其專有的AI平台(PharmKG™、Molecule Dance™和Molecule Pro™),該公司旨在顯著加快藥物發現過程,並交付具有差異化和臨床益處的小分子藥物。主要資產MDR-001,一種AI設計的口服GLP-1RA小分子,已進入第二期臨床研究。

這一消息不僅展示了MindRank在腫瘤學領域的創新能力,也反映出AI技術在藥物研發中的潛力。隨著MRANK-106的臨床試驗即將展開,未來的結果將可能改變目前對多種癌症的治療策略。這也提醒我們,隨著科技的進步,傳統的藥物研發模式可能會被更高效、更具針對性的策略所取代,這對於醫療行業來說是一次重要的變革機會。

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