Ozekibart(Ozekibart) - 药物靶点：DR5_在研适应症：软骨肉瘤，大肠腺癌，尤文肉瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体、VHH-Fc

别名

INBRX 109、INBRX-109、JCT-205

靶点

DR5

作用方式

激动剂

作用机制

DR5激动剂(肿瘤坏死因子受体超家族成员10B激动剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病其他疾病+ [1]

在研适应症

软骨肉瘤大肠腺癌尤文肉瘤+ [1]

非在研适应症-

原研机构

Sanofi AATD, Inc.Inhibrx Biosciences, Inc.

在研机构

Inhibrx Biosciences, Inc.

非在研机构

权益机构

Inhibrx Biosciences, Inc.

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)无进展

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

Sequence Code 656084092H

来源: *****

关联

2

项与 Ozekibart 相关的临床试验

NCT04950075

/ Active, not recruiting临床2期

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

开始日期2021-09-23

申办/合作机构

Inhibrx Biosciences, Inc.

NCT03715933

/ Recruiting临床1期

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

开始日期2018-10-08

申办/合作机构

Inhibrx Biosciences, Inc.

100 项与 Ozekibart 相关的临床结果

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100 项与 Ozekibart 相关的转化医学

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100 项与 Ozekibart 相关的专利（医药）

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3

项与 Ozekibart 相关的文献（医药）

2026-11-01·BIOCHIMICA ET BIOPHYSICA ACTA-REVIEWS ON CANCER

Molecular landscape of chondrosarcoma: From tumor biology to therapeutic vulnerabilities

Review

作者: Pozzuoli, Assunta ; Ruggieri, Pietro ; Belluzzi, Elisa ; Angelini, Andrea ; Trovarelli, Giulia

Chondrosarcoma (CS) is the second most common primary malignant bone tumor and comprises a heterogeneous group of cartilage-producing neoplasms with distinct histopathological, molecular, and clinical features. Surgery remains the cornerstone of treatment, whereas intrinsic resistance to conventional chemotherapy and radiotherapy limits therapeutic options for patients with unresectable or metastatic disease. This narrative review critically examines the molecular, genetic, epigenetic, metabolic, and microenvironmental mechanisms underlying CS development, progression, and treatment resistance and evaluates their translational implications. CS subtypes are associated with characteristic molecular alterations, including IDH1/2 mutations in central conventional CS, EXT1/2 disruption in secondary peripheral CS, and HEY1::NCOA2 fusion in mesenchymal CS. Additional alterations involving TP53, CDKN2A/RB1, and the TERT promoter contribute to disease progression. These events interact with dysregulated signaling pathways, metabolic and epigenetic reprogramming, hypoxia, extracellular-matrix remodeling, bone remodeling, and heterogeneous immune states. This biological complexity has prompted the investigation of mutant-IDH inhibitors, death receptor agonists, antiangiogenic and multitarget kinase inhibitors, immune-checkpoint blockade, and therapies targeting cell-cycle, epigenetic, metabolic, and microenvironmental dependencies. Nevertheless, most approaches have produced limited or predominantly cytostatic activity. Ozekibart has provided a positive randomized signal, with improved progression-free survival in conventional CS, whereas mutant-IDH1 inhibitors can achieve durable disease stabilization in selected patients but rarely induce objective responses. Future progress requires subtype-specific trials, assessment of pretreatment tumor growth kinetics, pharmacodynamic confirmation of target inhibition, and prospective integration of genomic, epigenetic, metabolic, and immune biomarkers.

2025-04-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Recent Advances in Succinate Dehydrogenase Deficient Gastrointestinal Stromal Tumor Systemic Therapies

Review

作者: Van Galen, Joseph ; Dedousis, Demitrios ; Gadra, Elyse ; von Mehren, Margaret

OPINION STATEMENT:

Gastrointestinal stromal tumors (GIST) are the most common gastrointestinal soft tissue sarcomas, with an incidence of about 15 cases per million person-years. Approximately 15% of GIST develop due to succinate dehydrogenase deficiency (SDH-Def), and such tumors do not respond well to the tyrosine kinase inhibitors (TKIs) used to treat other GIST. Due to its indolent nature SDH-Def GIST can often be surveilled if asymptomatic. In our current practice we typically treat advanced symptomatic SDH-Def GIST with the anti-angiogenic TKIs, sequentially treating with sunitinib, regorafenib and pazopanib. This practice is based on limited data. This systematic review provides an update on new data (12/21/2021 to 9/26/2024) for systemic treatment of SDH-Def GIST, both with agents generally used to treat other GIST subtypes and with agents approved in other malignancies. Olverembatinib and rogaratinib have shown promising activity in pre-clinical models and small SDH-Def GIST cohorts. Other agents whose benefits are explored here include the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab and temozolomide, whether as monotherapy or in combination with INBRX-109 (a pro-apoptotic antibody) or olaparib. Additional research into TKI agents with anti-vascular endothelial growth factor receptor (VEGFR) and anti-fibroblast growth factor receptor (FGFR) activity in this clinical setting is needed. Patients with SDH-Def will benefit more broadly from ongoing explorations of treatments with alternative mechanisms of action, especially those that exploit cellular pathways involved in SDH-Def GIST tumorigenesis.

2025-03-01·Oncology and Therapy

Advancing Systemic Therapy in Chondrosarcoma: New Horizons

Article

作者: Duffaud, Florence ; Jones, Robin L ; Li, Ka Hou C ; Gulia, Ashish

The systemic treatment landscape for advanced and metastatic chondrosarcoma, a malignancy with limited responsiveness to conventional therapies, has always been notoriously challenging. While standard chemotherapy offers minimal benefits, certain subtypes, such as mesenchymal and dedifferentiated chondrosarcomas, have shown some response to systemic therapies initially developed for other sarcomas. Investigational strategies are focusing on molecular targets, including mutations in the isocitrate dehydrogenase gene (IDH), signaling pathways, such as hedgehog and death receptor 5 (DR5) and immune modulation. IDH mutations, notably found in conventional and dedifferentiated chondrosarcomas, have prompted the evaluation of IDH inhibitors, which have demonstrated promising efficacy in preclinical and early clinical trials, despite limited data in chondrosarcoma. Additionally, the hedgehog pathway, implicated in chondrosarcoma progression, has been targeted with inhibitors, although clinical translation has shown mixed results. Immunotherapy, including programmed cell death 1 (PD-1) checkpoint inhibitors and chimeric antigen receptor-T (CAR-T) cells, is also being investigated but faces challenges due to the immunosuppressive tumour microenvironment. Among new approaches, DR5 agonists such as INBRX-109 have shown single-agent efficacy, with minimal toxicity, opening possibilities for use in combination therapies to improve outcomes. Given the heterogenous and treatment-resistant nature of chondrosarcoma, we highlight the need for multi-omics and genetic profiling to guide personalized, combination therapies that target multiple carcinogenic pathways. The integration of multi-targeted approaches could enhance efficacy, address tumour heterogeneity, and overcome resistance, presenting a hopeful direction for systemic therapy in this challenging cancer. The investigation of combination regimens with IDH inhibitors, immunotherapy and DR5 agonists hold promise for transforming the management of advanced chondrosarcoma.

122

项与 Ozekibart 相关的新闻（医药）

2026-10-19

·手机新浪网

INBX收跌0.04%，成交额1399.82万美元

10月20日，INBX（INBX）收跌0.04%，报89.79美元，成交额1399.82万美元，市值13.21亿美元。行情数据• 开盘价：90.43美元• 最高价：92.98美元• 最低价：88.21美元• 成交量：15.61万股• 换手率：1.06%• 52周最高：155.29美元• 52周最低：28.16美元最新财务表现公司最新财报显示，净亏损3665万美元，上年同期净亏损2865.4万美元。公司简介英希布瑞克斯生物科学公司是一家临床阶段的生物制药公司，拥有一系列利用专有模块化蛋白质工程平台开发的新型生物治疗候选药物。其临床治疗候选药物管线包括INBRX - 109和INBRX - 106，这两种药物均采用多价形式，其精确的价态可以以靶点为中心进行优化，以介导被认为最合适的激动剂功能。该公司成立于2024年1月8日，总部位于加利福尼亚州拉霍亚。

财报

2026-10-16

·手机新浪网

INBX收跌0.74%，成交额1303.27万美元

10月17日，INBX（INBX）收跌0.74%，报89.83美元，成交额1303.27万美元，市值13.22亿美元。行情数据• 开盘价：89.83美元• 最高价：90.72美元• 最低价：87.72美元• 成交量：14.6万股• 换手率：0.99%• 52周最高：155.29美元• 52周最低：28.16美元最新财务表现公司最新财报显示，净亏损3665万美元，上年同期净亏损2865.4万美元。公司简介英希布瑞克斯生物科学公司是一家临床阶段的生物制药公司，拥有一系列利用专有模块化蛋白质工程平台开发的新型生物治疗候选药物。其临床治疗候选药物管线包括INBRX - 109和INBRX - 106，这两种药物均采用多价形式，其精确的价态可以以靶点为中心进行优化，以介导被认为最合适的激动剂功能。该公司成立于2024年1月8日，总部位于加利福尼亚州拉霍亚。

2026-10-14

·PRNewswire

Inhibrx Announces Participation in Upcoming Scientific Conferences

SAN DIEGO, Oct. 13, 2026 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, today announced it will be presenting at the following upcoming scientific conferences: 2026 European Society for Medical Oncology (ESMO) Congress October 25 th , 2026 – Madrid, Spain Title: HexAgon-HN: a phase 2/3 study of the hexavalent OX40 agonist ordastobart (INBRX-106) in combination with pembrolizumab as first-line treatment (1L tx) of PD-L1–high recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)—phase 2 primary analysis Format: Oral Presentation Lead Author: Jong Chul Park Date and Time: Sunday, October 25th, 2026; 8:30-10:00 AM CET 2026 Musculoskeletal Tumor Society (MSTS) Annual Meeting October 29 th , 2026 – Miami, Florida Title: The Tetravalent Death Receptor 5 (DR5) Agonist Ozekibart (INBRX-109) in Conventional Chondrosarcoma: Secondary Efficacy Endpoints from the Randomized, Registrational, Phase 2 ChonDRAgon study Format: Oral Presentation Lead Author: Robin Jones Date and Time: Thursday, October 29th, 2026; 2:50-3:40 PM EST 2026 Connective Tissue Oncology Society (CTOS) Annual Meeting November 19 th – 20 th , 2026 – Seoul, South Korea Title: Tetravalent Death Receptor 5 Agonist Ozekibart (INBRX-109) in Conventional Chondrosarcoma: Subgroup Analysis and Updated Progression-Free Survival (PFS) from the Randomized, Phase 2 ChonDRAgon Study Lead Author: Sant Chawla Format: Oral Presentation Date and Time: Friday, November 20th, 2026; 11:00 AM-12:30 PM KST Title: Phase 1/2 Study of the Tetravalent Death Receptor 5 (DR5) Agonist Ozekibart (INBRX-109) Combined with Irinotecan (I) and Temozolomide (T) in Adolescents and Adults with Ewing Sarcoma (EWS) Lead Author: Varun Monga Format: Poster Presentation Date and Time: Thursday, November 19th, 2026; 5:30-6:30 PM KST The presentations and poster will be accessible through a link on the investors' section of Inhibrx's website at , upon commencement of each event. About Inhibrx Biosciences, Inc. Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and ordastobart (INBRX-106), both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. For more information, please visit . Investor and Media Contact: Kelly Deck, CFO [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

临床2期并购

100 项与 Ozekibart 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12458	-	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
软骨肉瘤	申请上市	美国	Inhibrx Biosciences, Inc.	2026-06-15
大肠腺癌	临床1期	美国	Inhibrx Biosciences, Inc.	2018-10-08
大肠腺癌	临床1期	法国	Inhibrx Biosciences, Inc.	2018-10-08
大肠腺癌	临床1期	意大利	Inhibrx Biosciences, Inc.	2018-10-08
大肠腺癌	临床1期	荷兰	Inhibrx Biosciences, Inc.	2018-10-08
大肠腺癌	临床1期	西班牙	Inhibrx Biosciences, Inc.	2018-10-08
大肠腺癌	临床1期	英国	Inhibrx Biosciences, Inc.	2018-10-08
尤文肉瘤	临床1期	美国	Inhibrx Biosciences, Inc.	2018-10-08
尤文肉瘤	临床1期	法国	Inhibrx Biosciences, Inc.	2018-10-08
尤文肉瘤	临床1期	意大利	Inhibrx Biosciences, Inc.	2018-10-08

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03715933 (INBRX-109, ASCO2026)	临床1期	晚期结直肠腺癌	44	Ozekibart + FOLFIRI	遞範壓製醖憲窪鑰構製(襯齋製鏇衊遞艱壓憲觸) = the most common AEs (in > 25% of patients) were anemia (any grade, 36.4%; grade ≥3, 9.1%), diarrhea (34.1%; 9.1%), nausea (31.8%; 0%), fatigue (27.3%; 2.3%), and alopecia (27.3%; 0%). Increased alanine aminotransferase was the only grade ≥3 hepatotoxicity event and occurred in 1 patient. 築餘鑰製夢壓淵醖廠餘 (網願蓋淵簾糧構鹽壓醖 )	积极	2026-05-29
NCT04950075 (ChonDRAgon, PRNewswire) 人工标引	临床2/3期	软骨肉瘤	206	Ozekibart	艱廠繭鏇構願餘淵餘醖(憲憲衊製鹽簾簾願簾鹹) = 鏇餘淵構餘鹹觸網糧衊製衊顧鏇觸窪窪觸鑰製 (鬱鹹鹹鏇繭膚獵壓衊構 ) 达到更多	积极	2025-10-23
NCT04950075 (ChonDRAgon, PRNewswire) 人工标引	临床2/3期	软骨肉瘤	206	Placebo	艱廠繭鏇構願餘淵餘醖(憲憲衊製鹽簾簾願簾鹹) = 積積糧廠夢積艱齋遞顧製衊顧鏇觸窪窪觸鑰製 (鬱鹹鹹鏇繭膚獵壓衊構 ) 达到更多	积极	2025-10-23
NCT03715933 (PRNewswire) 人工标引	临床1/2期	结直肠癌 \| 尤文肉瘤末线 \| 三线	51	Ozekibart + FOLFIRI (Colorectal Cancer)	憲蓋製膚艱鏇製醖襯製(蓋鏇製艱齋廠齋夢顧觸) = Group1: The most common TEAEs included anemia, diarrhea, nausea, and fatigue, with the majority being low-grade. Group2: The most common adverse events were diarrhea, nausea, anemia, and fatigue. 鏇鏇願廠鹹餘齋壓餘遞 (願繭積夢願餘觸壓繭夢 )	积极	2025-10-23
NCT03715933 (PRNewswire) 人工标引	临床1/2期	结直肠癌 \| 尤文肉瘤末线 \| 三线	51	Ozekibart + Irinotecan + Temozolomide (Ewing Sarcoma)		积极	2025-10-23
NCT03715933 (ASCO_GI2025)	临床1期	大肠腺癌二线	13	Ozekibart 1 mg/kg + FOLFIRI	廠鏇夢鹹觸網構選繭顧(願鹽獵顧鏇壓醖製壓醖) = Ozekibart-related adverse events (AEs) were reported in 85% of pts (grade ≥3, 31%) and led to ozekibart interruption in 3 pts and discontinuation in 1 pt 憲糧餘夢選鹽壓鹹網網 (願襯糧繭積鬱繭願糧襯 ) 更多	积极	2025-01-23
NCT03715933 (PRNewswire) 人工标引	临床1期	尤文肉瘤	13	INBRX-109+Irinotecan+Temozolomide	鏇積製齋範築築鏇膚範(願觸淵壓襯願廠構餘餘) = 鏇遞壓鹹膚醖範鬱襯積齋餘願膚簾鬱餘襯製繭 (繭遞淵選膚築蓋鑰淵膚 ) 更多	积极	2023-11-02
NCT03715933 (Pubmed \| Clin Cancer Res)	临床1期	软骨肉瘤 IDH1/IDH2-mutant	-	INBRX-109 3 mg/kg	齋膚艱淵築廠廠廠範廠(簾築構糧構壓範鬱餘鑰) = <4 months 夢鏇鹽齋積獵願憲築鹽 (鬱觸廠膚願淵夢範簾鹽 ) 更多	-	2023-08-15
NCT03715933 (Corporate Publications) 人工标引	临床1期	软骨肉瘤	33	INBRX-109	蓋壓廠糧築積願夢網築(簾網糧鏇襯觸築選廠窪) = increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. 窪鏇顧壓範夢夢憲艱築 (願憲選獵構鑰衊顧襯選 )	积极	2022-11-16
NCT04950075 (ASCO2022)	临床2期	软骨肉瘤	201	INBRX-109	窪願網鑰繭衊鬱蓋窪製(憲繭淵窪廠鏇積積窪築) = 築窪淵簾廠艱襯觸艱願淵鏇憲憲積鹹構願鑰齋 (淵觸築觸顧製鹽艱鹽鏇 )	-	2022-06-02
NCT04950075 (ASCO2022)	临床2期	软骨肉瘤	201	Placebo	窪願網鑰繭衊鬱蓋窪製(憲繭淵窪廠鏇積積窪築) = 製憲鑰選廠簾鹹鏇艱醖淵鏇憲憲積鹹構願鑰齋 (淵觸築觸顧製鹽艱鹽鏇 )	-	2022-06-02