潛在“first-in-class”的抗癌雙特異性ADC；創新免疫檢查點抑制劑三聯療法獲積極數據…… | 一周盤點

本期看點

1. SystImmune公司與百時美施貴寶（Bristol Myers Squi bb） 潛在“first-in-class”的抗癌雙特異性抗體偶聯藥物（ADC）iza-bren（BL-B01D1）的早期臨床試驗的積極結果。

2. Ciforadenant與ipilimumab和nivolumab的免疫檢查點抑制劑三聯療法的1b/2期臨床試驗獲積極中期數據，與單獨使用ipilimumab和nivolumab的歷史數據相比有所改善。

Iza-bren（BL-B01D1）：公布1期臨床試驗數據

SystImmune公司與百時美施貴寶公布其全球1期研究US-Lung-101的安全性和有效性數據。該研究評估了ADC療法iza-bren在多種腫瘤患者中的療效與安全性。Iza-bren是一款潛在“first-in-class”的EGFR/HER3靶向雙特異性ADC。該療法的雙重作用機制可阻斷EGFR和/或HER3信號，抑制癌細胞增殖與存活，同時在抗體介導的內化后釋放Topo1i有效載荷，引發細胞毒性反應，最終導致癌細胞死亡。Iza-bren已獲美國FDA授予突破性療法認定，用于既往接受過治療的

EGFR

截至2025年7月23日，iza-bren在多種高度預處理的實體瘤患者中，包括

EGFR

EGFR

Ciforadenant：公布1b/2期臨床試驗的中期數據

Corvus Pharmaceuticals公司宣布，其候選藥物ciforadenant用于治療轉移性腎細胞癌（RCC）患者的1b/2期臨床試驗取得了積極的中期數據。Ciforadenant是一種在研口服小分子免疫檢查點抑制劑。此前，ciforadenant已被證明可以阻斷腫瘤中髓系細胞的免疫抑制作用。臨床前研究結果顯示，ciforadenant與抗PD-1和抗CTLA-4抗體聯合使用具有協同作用。

截至2025年5月的數據，ciforadenant與ipilimumab和nivolumab的三藥聯合療法是可行且耐受性良好的。在年齡中位數為61.5歲的患者群體中（其中82%為預后較差或中等的患者），治療的深度緩解率達到了34%，與單獨使用ipilimumab和nivolumab的歷史數據相比有所改善。客觀緩解率（ORR）為46%，包括2例完全緩解和21例部分緩解；中位PFS為11.04個月。

mRNA-4359：公布1/2期臨床試驗的初步數據

Moderna公司宣布，其癌癥疫苗mRNA-4359聯合PD-1抑制劑pembrolizumab，用于治療免疫檢查點抑制劑耐藥或復發（CPI-R/R）黑色素瘤患者的1/2期臨床研究獲得積極初步結果。mRNA-4359是一種在研的免疫逃逸靶向癌癥抗原療法，可編碼PD-L1與IDO1兩種常見免疫逃逸通路的表位，以誘導抗原特異性T細胞反應，從而直接殺傷腫瘤細胞并清除免疫抑制細胞。

研究納入29例曾接受至少一種免疫檢查點抑制劑治療的CPI-R/R黑色素瘤患者。結果顯示，在所有可評估患者中，ORR為24%，疾病控制率（DCR）為60%。在PD-L1陽性（TPS≥1%）且可評估疾病的患者中，ORR達67%（6/9），治療成功誘導了外周抗原特異性T細胞反應及新型T細胞受體克隆。研究中尚未達到中位緩解持續時間（DOR），提示該疫苗的療效持久。mRNA-4359目前已進入該1/2期研究的臨床2期部分。

參考資料：

[1] Vasa Therapeutics Receives FDA IND Clearance to Advance Novel Small Molecule VS-041 for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF). Retrieved October 17, 2025, from https://www.prnewswire.com/news-releases/vasa-therapeutics-receives-fda-ind-clearance-to-advance-novel-small-molecule-vs-041-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-hfpef-302581657.html

[2] Hinge Bio Announces FDA Clearance of Investigational New Drug Application for HB2198, a Novel B cell-Depleting Agent, for Patients with Systemic Lupus Erythematosus and Lupus Nephritis. Retrieved October 17, 2025, from https://www.globenewswire.com/news-release/2025/10/13/3165493/0/en/Hinge-Bio-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-HB2198-a-Novel-B-cell-Depleting-Agent-for-Patients-with-Systemic-Lupus-Erythematosus-and-Lupus-Nephrit.html

[3] Moderna Presents Promising Early Data for Its Investigational Cancer Antigen Therapy at the 2025 European Society for Medical Oncology Congress. Retrieved October 14, 2025 from https://feeds.issuerdirect.com/news-release.html?newsid=5823943357532273&symbol=MRNA

[4] Tr1X Announces FDA Clearance of IND Application for TRX319, a First-in-Class Allogeneic CAR-Tr1 Treg Cell Therapy for Progressive Multiple Sclerosis, and $50 Million in Additional Financing. Retrieved October 17, 2025, from https://www.globenewswire.com/news-release/2025/10/14/3166144/0/en/Tr1X-Announces-FDA-Clearance-of-IND-Application-for-TRX319-a-First-in-Class-Allogeneic-CAR-Tr1-Treg-Cell-Therapy-for-Progressive-Multiple-Sclerosis-and-50-Million-in-Additional-Fin.html

[5] TransCode Therapeutics presents preliminary data from its completed Phase 1a study with TTX-MC138 in metastatic disease at ESMO. Retrieved October 17, 2025, from https://www.prnewswire.com/news-releases/transcode-therapeutics-presents-preliminary-data-from-its-completed-phase-1a-study-with-ttx-mc138-in-metastatic-disease-at-esmo-302582916.html

[6] Corventum Announces IND Clearance for CVT-130, a First-in-Class Small Molecule for the Prevention of Anthracycline Cardiotoxicity. Retrieved October 17, 2025, from https://www.corventum.com/Corventum-Press-Release-IND-Acceptance.pdf

[7] Tagworks Pharmaceuticals Announces CTA Authorization and Initiation of Phase 0/1 Clinical Trial for TGW211, a Radiopharmaceutical for the Treatment of HER2+ Tumors. Retrieved October 17, 2025, from https://www.prnewswire.com/news-releases/tagworks-pharmaceuticals-announces-cta-authorization-and-initiation-of-phase-01-clinical-trial-for-tgw211-a-radiopharmaceutical-for-the-treatment-of-her2-tumors-302584061.html

[8] AB Science provides intitial Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia. Retrieved October 17, 2025, from https://www.globenewswire.com/news-release/2025/10/16/3168256/0/en/AB-Science-provides-intitial-Phase-1-data-for-the-combination-of-AB8939-with-venetoclax-for-the-treatment-of-refractory-or-relapsed-acute-myeloid-leukemia.html

[9] Corvus Pharmaceuticals Announces Presentation of Interim Data from the Phase 1b/2 Clinical Trial of Ciforadenant for Patients with Metastatic Renal Cell Cancer at the European Society for Medical Oncology (ESMO) Congress 2025. Retrieved October 17, 2025, from https://www.globenewswire.com/news-release/2025/10/17/3168712/0/en/Corvus-Pharmaceuticals-Announces-Presentation-of-Interim-Data-from-the-Phase-1b-2-Clinical-Trial-of-Ciforadenant-for-Patients-with-Metastatic-Renal-Cell-Cancer-at-the-European-Soci.html

[10] SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren, an EGFR x HER3 Bispecific Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors at ESMO 2025. Retrieved October 17, 2025, from https://www.prnewswire.com/news-releases/systimmune-inc-and-bristol-myers-squibb-announce-first-global-phase-i-results-of-iza-bren-an-egfr-x-her3-bispecific-antibody-drug-conjugate-in-patients-with-advanced-solid-tumors-at-esmo-2025-302586896.html

[11] Artios Announces Phase 1/2a Data for DNA Polymerase Theta Inhibitor ART6043 at ESMO Congress 2025. Retrieved October 17, 2025, from https://www.globenewswire.com/news-release/2025/10/17/3168732/0/en/Artios-Announces-Phase-1-2a-Data-for-DNA-Polymerase-Theta-Inhibitor-ART6043-at-ESMO-Congress-2025.html

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