本期看點

1. 靶向Clever-1的單克隆抗體bexmarilimab與標準治療（SoC）聯用治療初治高危骨髓增生異常綜合征（HR-MDS）患者的早期臨床試驗結果亮眼，客觀緩解率（ORR）達100%。

2. 口服靶向抗癌化合物ibrilatazar聯合化療治療III/IV期鱗狀非小細胞肺癌（SQ-NSCLC）患者的1/2a期臨床試驗結果積極，與歷史對照相比，聯合治療組的中位總生存期（OS）接近翻倍（22.5個月對比11.3個月）。

3. Kymera Therapeutics公司的口服STAT6降解劑KT-621在一項1期研究的所有≥50 mg的多劑量遞增（MAD）組中表現積極，患者血液與皮膚中的目標蛋白均達成完全降解。

Bexmarilimab：公布1期聯合治療試驗數據

Faron Pharmaceuticals公司宣布，其靶向Clever-1的單克隆抗體bexmarilimab的一項1期研究結果已發表在《柳葉刀-血液學》（

Lancet Haematology

此次公布的結果顯示，bexmarilimab聯合阿扎胞苷在初治和低甲基化藥物（HMA）治療失敗的HR-MDS患者中的ORR分別為100%和89%。HMA治療失敗的MDS患者的估計中位OS為13.4個月，r/r AML患者為8.1個月。兩名HMA治療失敗的MDS患者在治療后接受了造血干細胞移植（HSCT）。此外，治療后患者的骨髓免疫生物標志物較基線水平提升了近3倍。在67%的HMA治療失敗的MDS患者中觀察到HLA-DR分子增加，進一步支持bexmarilimab的作用機制。安全性方面，bexmarilimab聯合治療的耐受性良好，未觀察到劑量限制性毒性。大多數治療伴發不良事件（TEAE）為輕度至中度，僅6%與bexmarilimab相關。

Ibrilatazar（ABTL0812）：公布1/2a期聯合治療試驗數據

AbilityPharma公司宣布，其評估ibrilatazar（ABTL0812）聯合化療（紫杉醇/卡鉑）治療III/IV期鱗狀非小細胞肺癌患者的1/2a期臨床試驗ENDOLUNG的數據已發表在

Lung Cancer

此次公布的結果顯示，與歷史對照相比，ibrilatazar聯合化療在所有療效終點均顯示出改善，包括：ibrilatazar聯合治療組的總緩解率為52%，歷史對照為31.7%；ibrilatazar聯合治療組的中位無進展生存期（PFS）為6.2個月，歷史對照為4.2個月；ibrilatazar聯合治療組的中位OS為22.5個月，歷史對照為11.3個月。安全性方面，ibrilatazar聯合化療表現出良好的安全性。在紫杉醇/卡鉑基礎上加入ibrilatazar的安全性與歷史對照中紫杉醇/卡鉑單獨使用時的安全性一致，并未帶來除紫杉醇/卡鉑本身已知不良事件之外的顯著新增安全性風險。

KT-621：公布1期臨床試驗數據

Kymera Therapeutics公司公布其潛在“first-in-class”口服STAT6降解劑KT-621在1期健康受試者研究中的積極結果。數據顯示，KT-621在每日一次口服給藥下，于所有高于1.5 mg劑量水平中實現了超過90%的平均血液STAT6降解；在所有≥50 mg的MAD組中，更在血液與皮膚中均達成完全降解。此外，KT-621對Th2炎癥相關生物標志物TARC和Eotaxin-3的中位降低幅度分別高達37%與63%，表現優于或相當于現有獲批藥物。

KT-621在本項試驗中展現出優異的安全性，未觀察到嚴重不良事件或與治療相關的不良事件，整體耐受性與安慰劑無明顯差異。Kymera公司指出，KT-621的臨床表現已顯著優于其預設的產品特征目標，進一步驗證了其“生物制品口服化”開發策略的可行性。當前，KT-621正在中重度特應性皮炎（AD）患者中開展1b期BroADen試驗，預計將在2025年第四季度公布數據，并計劃分別于2025年第四季度與2026年第一季度啟動針對AD與哮喘的兩項2b期臨床研究。

ISB 2001：公布1期臨床試驗的新數據

Ichnos Glenmark Innovation公司公布了其三特異性抗體ISB 2001用于治療復發/難治性多發性骨髓瘤（RRMM）的1期研究的新數據。ISB 2001同時靶向多發性骨髓瘤（MM）細胞上的BCMA和CD38，以及T細胞上的CD3，旨在增加對MM細胞的特異性結合，同時最大限度地減少脫靶效應。

此次公布的結果顯示，在經過大量治療的患者群體中，7個活性劑量（≥50 μg/kg）組患者的持續總緩解率為79%，完全緩解/嚴格完全緩解（CR/sCR）率為30%。所有接受治療的患者的總緩解率為74%，包括2例接受較低劑量治療的患者。安全性方面，ISB 2001具有良好的安全性，大多數患者在數據截止時仍在接受治療。

EBC-129：公布1期臨床試驗的新數據

新加坡實驗藥物研發中心（EDDC）公布了其在研抗體偶聯藥物（ADC）EBC-129的一項1期臨床試驗的新數據。EBC-129靶向CEACAM5和CEACAM6上保守的腫瘤特異性N256糖基化位點，這兩種蛋白在腫瘤發生和轉移中起關鍵作用。該ADC的毒性有效載荷是微管蛋白抑制劑MMAE，該藥物已在其他上市的ADC中被廣泛測試并獲批用于臨床，且已顯示出與PD-1抑制劑之間的協同作用。

此次公布的結果顯示，EBC-129在21名此前接受過大量治療的胰腺導管腺癌（PDAC）患者中顯示出積極的總緩解率和延長的無進展生存期，包括那些之前接受過SoC（通常含有紫杉烷類藥物）的患者。在接受1.8 mg/kg和2.2 mg/kg劑量治療的患者中，總緩解率分別為25%和20%，疾病控制率（DCR）達87.5%和63.6%，中位PFS分別為19周和12周。EBC-129在迄今為止接受治療的58例患者中顯示出可控的安全性，觀察到的主要治療相關不良事件（TRAE）為無并發癥的中性粒細胞減少和輸液相關反應。

IMC-002：公布1期聯合治療試驗的中期數據

ImmuneOncia Therapeutics公司公布了其下一代CD47靶向抗體IMC-002與lenvatinib聯用治療晚期肝細胞癌（HCC）患者的1b期臨床試驗的中期結果。IMC-002是一款全人源化IgG4單克隆抗體，通過阻斷CD47-SIRPα相互作用，促進巨噬細胞對腫瘤細胞的吞噬作用。該抗體療法可以在保證高療效的同時最大限度地減少與紅細胞的結合并避免血液學毒性。

此次公布的結果顯示，IMC-002表現出良好的安全性特征，未報告中性粒細胞減少或血小板減少，96%的不良事件為1/2級。在療效可評估的10名患者中，有3名達到部分緩解（PR），DCR達80%，中位PFS為8.3個月。兩名患者的治療時間已超過一年，提示該療法可能帶來持久的臨床獲益。

參考資料（可上下滑動查看）

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[30] AbilityPharma’s IBRILATAZAR (ABTL0812) doubles overall survival in patients with squamous non-small cell lung cancer. Retrieved June 5, 2025 from https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma%E2%80%99s-ibrilatazar-(abtl0812)-doubles-overall-survival-in-patients-with-squamous-non-small-cell-lung-cancer

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