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1. 下一代CD47阻斷療法evorpacept聯用標準化療方案治療復發或難治性B細胞非霍奇金淋巴瘤（R/R B-NHL）的早期臨床試驗結果亮眼，80%患者獲得完全緩解（CR），兩年總生存（OS）率為84%。

2. T細胞激活劑invikafusp alfa的1/2期臨床試驗結果積極，在腫瘤突變負荷高（TMB-H），對PD-1/PD-L1耐藥且接受過大量前期治療的難治性患者中的疾病控制率（DCR）為67%。

3. D ectin-2靶向抗體 BDC-3042在1期臨床試驗中展現積極抗腫瘤作用，在17例患有6種不同類型腫瘤的患者中，80%（12/15）的可評估患者達到了疾病穩定（SD）或更好的狀態。

Evorpacept（ALX148）：公布1/2期聯合治療試驗數據

ALX Oncology公司公布了其CD47抑制劑evorpacept與標準治療方案利妥昔單抗和來那度胺（R2）聯用的1/2期由研究者發起的臨床試驗（IST）的積極數據，該試驗針對復發或難治性B細胞非霍奇金淋巴瘤患者。Evorpacept是一種下一代CD47阻斷療法，它將高親和性CD47結合結構域與經特殊處理的Fc結構域相結合，因此無法激活Fc受體，有望降低CD47靶向抗體因激活Fc受體可能產生的毒副作用。此外，與其它抗CD47抗體相比，evorpacept的分子量更小，更容易滲透到實體瘤中，從而提高療效。

此次試驗共納入20例惰性（18例）和侵襲性（2例）R/R B-NHL患者，所有患者均曾接受過抗CD20單抗治療。在中位隨訪28個月后，聯合治療組患者的兩年無進展生存（PFS）率為69%，兩年OS率為84%。16例患者（80%）達到CR，最佳總緩解率（ORR）為90%。18例接受evorpacept聯用R2方案的惰性NHL患者的CR率為83%，高于歷史上在僅使用R2方案的類似患者中觀察到的34%的CR率。此外，治療期間觀察到T細胞和抗腫瘤巨噬細胞顯著增加。安全性方面，該聯合治療方案耐受性良好，未出現劑量限制性毒性。

Invikafusp alfa（STAR0602）：公布1/2期臨床試驗數據

Marengo Therapeutics公司將公布其潛在“first-in-class”T細胞激活劑invikafusp alfa的1/2期臨床試驗更新結果。Invikafusp alfa是一款雙特異性融合蛋白，它不但可以與T細胞受體的Vβ鏈結合，還可以激活另一條T細胞共刺激信號通路，促進特定效應Vβ T細胞的擴增，從而增強抗腫瘤免疫反應。

摘要結果顯示，在腫瘤突變負荷高（TMB-H），對PD-1/PD-L1耐藥且接受過大量前期治療的難治性患者中，優化劑量的invikafusp alfa在9名可評估療效的患者中達到67%的DCR，其中兩名患者獲得確認部分緩解（PR），一名患者緩解持續時間超過12個月。此外，研究發現CD8陽性、Vβ T細胞的劑量依賴性、選擇性擴增，在2期臨床推薦劑量下最高擴增600%。擴增的Vβ T細胞表現出記憶表型并表達細胞毒性效應分子。基于初步臨床及臨床前結果，美國FDA已授予invikafusp alfa治療TMB-H結直腸癌的快速通道資格。

BDC-3042：公布1期臨床試驗數據

Bolt Biotherapeutics公司公布了其抗體療法BDC-3042的1期劑量遞增研究結果。BDC-3042是一種靶向dectin-2的激動劑抗體，dectin-2是一種由腫瘤相關巨噬細胞（TAM）表達的免疫激活受體。作為C型凝集素受體，dectin-2在病原體識別及誘導保護性免疫反應中發揮著關鍵作用。

截至2025年4月7日的數據，BDC-3042在10 mg/kg每兩周一次的劑量下表現出良好的耐受性，未出現劑量限制性毒性或藥物相關嚴重不良事件。同時，該藥物顯示出明確的生物學活性，促炎細胞因子和趨化因子水平呈劑量依賴性升高。BDC-3042展現出潛在的抗腫瘤活性，80%的可評估患者（12/15）的最佳緩解為SD或更好，所有3例非小細胞肺癌患者均實現≥12周的SD，包括1例未確認的PR。

Tovecimig（CTX-009）：研究者發起的臨床試驗完成首例患者給藥

Compass Therapeutics公司宣布，其靶向DLL4和VEGF-A的雙特異性抗體tovecimig（CTX-009）用于一線治療膽道癌（BTC）的IST研究已完成首例患者給藥。Tovecimig通過同時阻斷促血管生成的DLL4和VEGF-A信號通路發揮抗腫瘤作用。臨床前及早期臨床數據顯示，其在結直腸癌、胃癌、膽管癌、胰腺癌和非小細胞肺癌等多種實體瘤中具有活性。在既往接受過多種治療且對已獲批抗VEGF療法產生耐藥的晚期癌癥患者群體中，已觀察到接受tovecimig單藥治療的患者獲得了PR。

VS-7375：IND申請獲得FDA許可

Verastem Oncology公司宣布，美國FDA已批準其口服KRAS G12D（ON/OFF）抑制劑VS-7375的IND申請，公司預計將于2025年年中啟動一項1/2a期臨床研究，并計劃在晚期實體瘤（如胰腺癌、結直腸癌和非小細胞肺癌）中開展多個擴展隊列試驗，包括聯合療法評估。VS-7375由Verastem Oncology與勁方醫藥合作開發，是一款口服高活性、高選擇性小分子KRAS G12D（ON/OFF）抑制劑，通過非共價形式結合KRAS G12D蛋白，抑制其與下游效應蛋白結合，從而在細胞中破壞KRAS G12D對下游通路的持續活化，最終高效抑制腫瘤細胞增殖。

參考資料（可上下滑動查看）

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[6] AP Biosciences Doses First Patient in Phase 1/2 Clinical Trials of AP402 for HER2+ Cancer Patients. Retrieved April 25, 2025, from https://www.globenewswire.com/news-release/2025/04/22/3065502/0/en/AP-Biosciences-Doses-First-Patient-in-Phase-1-2-Clinical-Trials-of-AP402-for-HER2-Cancer-Patients.html

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[14] Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025. Retrieved April 25, 2025, from https://www.globenewswire.com/news-release/2025/04/25/3068520/0/en/Bolt-Biotherapeutics-Presents-Results-from-the-Phase-1-Dose-Escalation-Clinical-Study-of-BDC-3042-at-AACR-Annual-Meeting-2025.html

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