主要目的：评价BI-1206在第一阶段的安全性导入部分的安全性、耐受性；评价BI-1206与利妥昔单抗联合治疗复发性或难治性的惰性B细胞非霍奇金淋巴瘤（NHL）的安全性和耐受性；通过确立BI-1206的最大耐受剂量（MTD）（以静脉输注[IV]方式按周次给药，连续4周，与利妥昔单抗联合用药）来选择推荐的Ⅱ期剂量（RP2D）。如果药代动力学（PK）和药效学（PD）数据表明当前剂量为与国外临床研究17-BI-1206-02可比的最佳治疗剂量，则可在达到临床研究17-BI-1206-02获得的MTD之前，由队列审查委员会（CRC）决定暂停剂量递增，并基于PK和PD数据确定RP2D。

开始日期2022-07-25

申办/合作机构

凯信远达医药（中国）有限公司

NCT04219254

/ Recruiting临床1/2期

A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Previously Treated With Anti-PD-1 or Anti-PD-L1 Antibodies (KEYNOTE-A04)

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies

开始日期2020-06-29

申办/合作机构

BioInvent International AB

[+1]

NCT03571568

/ Recruiting临床1/2期

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

开始日期2018-05-16

申办/合作机构

BioInvent International AB

100 项与 BI-1206 相关的临床结果

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100 项与 BI-1206 相关的转化医学

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100 项与 BI-1206 相关的专利（医药）

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项与 BI-1206 相关的文献（医药）

2022-12-01·Journal of hematology & oncology

Targeting FcγRIIB by antagonistic antibody BI-1206 improves the efficacy of rituximab-based therapies in aggressive mantle cell lymphoma

Letter

作者: Huang, Shengjian ; Wang, Michael ; Zhang, Rongjia ; Karlsson, Ingrid ; Teige, Ingrid ; Nie, Lei ; Kovacek, Mathilda ; Jordan, Alexa ; Frendéus, Björn ; Liu, Yang ; Li, Yijing ; Jiang, Vivian Changying ; Cai, Qingsong ; Che, Yuxuan ; Leeming, Angela ; Chen, Zhihong ; Mårtensson, Linda ; McIntosh, Joseph

Abstract:

Inevitable relapses remain as the major therapeutic challenge in patients with mantle cell lymphoma (MCL) despite FDA approval of multiple targeted therapies and immunotherapies. Fc gamma receptors (FcγRs) play important roles in regulating antibody-mediated immunity. FcγRIIB, the unique immune-checkpoint inhibitory member of the FcγR family, has been implicated in immune cell desensitization and tumor cell resistance to the anti-CD20 antibody rituximab and other antibody-mediated immunotherapies; however, little is known about its expression and its immune-modulatory function in patients with aggressive MCL, especially those with multi-resistance. In this study, we found that FcγRIIB was ubiquitously expressed in both MCL cell lines and primary patient samples. FcγRIIB expression is significantly higher in CAR T-relapsed patient samples (p < 0.0001) compared to ibrutinib/rituximab-naïve, sensitive or resistant samples. Rituximab-induced CD20 internalization in JeKo-1 cells was completely blocked by concurrent treatment with BI-1206, a recombinant human monoclonal antibody targeting FcγRIIB. Combinational therapies with rituximab-ibrutinib, rituximab-venetoclax and rituximab-CHOP also induced CD20 internalization which was again effectively blocked by BI-1206. BI-1206 significantly enhanced the in vivo anti-MCL efficacy of rituximab-ibrutinib (p = 0.05) and rituximab-venetoclax (p = 0.02), but not the rituximab-CHOP combination in JeKo-1 cell line-derived xenograft models. In patient-derived xenograft (PDX) models, BI-1206, as a single agent, showed high potency (p < 0.0001, compared to vehicle control) in one aggressive PDX model that is resistant to both ibrutinib and venetoclax but sensitive to the combination of rituximab and lenalidomide (the preclinical mimetic of R2 therapy). BI-1206 sensitized the efficacy of rituximab monotherapy in a PDX model with triple resistance to rituximab, ibrutinib and CAR T-therapies (p = 0.030). Moreover, BI-1206 significantly enhanced the efficacy of the rituximab-venetoclax combination (p < 0.05), which led to long-term tumor remission in 25% of mice. Altogether, these data support that targeting this new immune-checkpoint blockade enhances the therapeutic activity of rituximab-based regimens in aggressive MCL models with multi-resistance.

Graphical Abstract:

2020-09-01·Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc4区 · 农林科学

Preparation, identification, and functional analysis of monoclonal antibodies against atypical porcine pestivirus NS3 protein

4区 · 农林科学

Article

作者: Yang, Wenting ; Huang, Jingling ; Chen, Jianing ; Yan, Miaomiao ; Liu, Guangliang

Atypical porcine pestivirus (APPV) had been detected in many countries. However, to date, a commercial detection kit is not available because of a lack of specific monoclonal antibodies (mAbs) to APPV. We generated 7 mAbs targeting the NS3 protein of APPV. Isotyping results indicated that all of these mAbs are IgG1 with a kappa light chain. We analyzed the epitopes recognized by mAbs 2B6, 6G11, 8D1, 8D3, and 8F12, which recognized the same linear epitope (GRIKSAYSDE); the 6H3 and 7E10 mAbs recognized 2 different conformational epitopes. Applications of these antibodies were verified by ELISA, western blot, indirect immunofluorescence assay, and flow cytometry. The antibodies were functionally workable for these immunoassays except for 8F12, which could not be used in flow cytometry.

2016-09-01·Experimental parasitology4区 · 医学

Insights into the biological features of the antigenic determinants recognized by four monoclonal antibodies in redia and adult stages of the liver fluke Fasciola hepatica

4区 · 医学

Article

作者: Mosqueda, Maryani ; Hernández, Hilda ; Sánchez, Jorge ; Rodríguez, Suanel Y ; Marcet, Ricardo ; Alfonso, Carlos ; Sarracent, Jorge ; Otero, Oscar ; Capó, Virginia ; Alba, Annia

Fasciola hepatica is a digenean trematode which infects a wide variety of domestic animals and also humans. Previous studies have demonstrated that four monoclonal antibodies (Mabs) against the total extract of F. hepatica redia (named as 1E4, 6G11, 4E5 and 4G11) also recognized the excretion - secretion antigens (ES Ag) of adult parasites, which is a biologically-relevant mixture of molecules with functional roles during infection and immune evasion on definitive hosts. In the present report we describe the partial characterization of the epitopes recognized by these Mabs by heat treatment, mercaptoethanol reduction, pronase proteolysis and sodium peryodate oxidation, which suggested their predominant protein and conformational nature. Also, a comparative study using immunodetection assays on crude extracts and on histological sections of both rediae and adults of F. hepatica were performed to explore the expression pattern of the antigenic determinants in these developmental stages. From these experiments it was found that the Mabs reacted most likely with the same proteins of approximately 64 and 105 kDa present on both rediae and adult's extracts. However, the 1E4, 6G11 and 4E5 Mabs also recognized other molecules of the total extract of F. hepatica adults, a fact that constitutes an evidence of the antigenic variation between both stages and points at a certain biological relevance of the recognized antigenic determinants. Immunolocalization studies on histological sections revealed that all Mabs reacted with the tegument of F. hepatica in both rediae and adults stages, while the epitopes recognized by 1E4, 6G11 and 4E5 antibodies were also preferentially localized in the intestinal caeca and in different organs of the reproductive system of adult specimens. The immunogenicity of these antigenic determinants, their conserved status among different stages of the life cycle of F. hepatica and their presence in both tegument and ES Ag of adult parasites, are suitable features that suggest their potential use for developing an epitope-based vaccine for fasciolosis control.

项与 BI-1206 相关的新闻（医药）

2025-08-30

·casipharma.com.cn

CASI制药公布2025年第二季度财务业绩

2025年8月29日，CASI制药公布了截至2025年6月30日的季度财务业绩报告。 CASI首席执行官David Cory表示：“我们正全力推进潜在同类最佳（best-in-class）抗CD38单抗CID-103的临床开发。近期我们宣布，CID-103用于治疗活动性及慢性活动性肾移植抗体介导的排斥反应（AMR）的临床试验申请（IND）已获美国食品药品监督管理局（FDA）批准。同时， CID-103治疗成人慢性免疫性血小板减少症（ITP）的I/II期剂量递增研究也在积极开展患者招募与给药。我们将持续推进CID-103的临床开发，并适时披露项目进展。” 业务进展核心管线进展及预期里程碑 • CID-103治疗免疫性血小板减少症（ITP） I/II期剂量递增研究进行中 • CID-103治疗肾移植抗体介导的排斥反应（AMR） IND已获FDA批准计划于2025年第三季度启动I期临床研究公司动态 • 任命David Cory为首席执行官，并担任公司董事会成员 • 与Kaixin Pharmaceuticals Inc.达成最终《股权及资产转让协议》中国资产剥离交易 2025年5月12日，公司宣布与何为无博士全资控股的开曼实体Kaixin Pharmaceuticals Inc.(“Kaixin Pharmaceuticals”)及公司在中国的两家全资子公司（“目标公司”）达成最终《股权及资产转让协议》。根据协议约定，公司将向Kaixin Pharmaceuticals转让目标公司100%股权（“目标股权”），以及BI-1206（大中华地区）、CID-103（亚洲，日本除外）和塞替派（中国内地，不含港澳台地区）相关产品（“目标管线产品”）的全部许可权、经销权、供货协议及附属权益。总交易对价2000万美元，其中包括承担公司不超过2000万美元的债务（“本次交易”）。本次交易完成须满足若干惯例交割条件，包括解除因公司与Juventas Cell Therapy Ltd.法律纠纷导致的目标股权司法冻结。相关仲裁程序仍在进行中。根据交易安排，公司和Kaixin Pharmaceuticals计划与相关许可方签署权益转让协议，以完成目标管线产品相关权益的转让，预计将与目标股权交割同步完成。交易完成后，公司将保留CID-103（日本及非亚洲地区）、EVOMELA®、FOLOTYN®、CNCT19及CB-5339的相关权益。公司认为，此次交易是CASI发展进程中的重要转折点，标志着公司正持续聚焦核心战略方向，灵活应对市场环境变化。公司将集中资源推进CID-103的临床开发，持续造福患者、创造股东价值。 2025年第二季度财务业绩 2025年第二季度收入为420万美元，较2024年同期的400万美元增长5%。 2025年第二季度营业成本为210万美元，较2024年同期的190万美元增长11%。 2025年第二季度研发费用为170万美元，较2024年同期的130万美元增长31%，主要因CID-103项目的开发投入增加，以支持公司向器官移植排斥反应及自身免疫性疾病领域的战略转型。 2025年第二季度管理与行政开支为610万美元，与2024年同期的590万美元基本持平。 2025年第二季度销售和营销费用为500万美元，较2024年同期的440万美元增长14%，主要因应对美法仑仿制药竞争加剧而加强营销推广力度。 2025年第二季度，公司应占联营企业净亏损为220万美元，主要源自公司对Precision Autoimmune Therapeutics的股权投资确认了220万美元的投资损失。 2025年第二季度净亏损为1340万美元，而2024年同期为700万美元。截至2025年6月30日，公司持有现金及现金等价物共计670万美元，而2024年底为1,350万美元。更多信息请访问www.casipharmaceuticals.com。

财报临床1期临床申请

2025-06-15

·药明康德

总缓解率达90%的抗癌组合疗法；有望加速肝脏再生的小分子疗法进入临床…… | 一周盘点

本期看点1. 强生（Johnson & Johnson）公司口服menin抑制剂bleximenib联用venetoclax和azacitidine（VEN+AZA）治疗新确诊但不适合强化化疗的急性髓系白血病（AML），在一项早期临床试验中的总缓解率（ORR）达90%，复合完全缓解（cCR）率达75%。2. 布鲁顿酪氨酸激酶（BTK）降解剂bexobrutideg单药治疗复发/难治性慢性淋巴细胞白血病（CLL）和华氏巨球蛋白血症（WM）患者的1a/1b期临床试验结果积极，在两类患者中的客观缓解率均超80%。3. 有望加速和增强肝脏再生过程的小分子疗法HRX-215进入临床试验阶段，其针对因结直肠癌肝转移而接受部分肝切除术的患者开展的1b期临床试验已完成首例患者给药。Bleximenib（JNJ-75276617）：公布1b期临床试验的新数据强生公司公布了其在研药物bleximenib的1b期临床试验的积极数据。Bleximenib是一种口服menin抑制剂，通过阻断menin与KMT2A融合蛋白之间的致癌相互作用，抑制携带KMT2A基因重排或NPM1基因突变的白血病细胞生长。该研究评估了bleximenib联用VEN+AZA在复发/难治性（R/R）AML和新确诊但不适合强化化疗的AML患者中的安全性和有效性。该研究共纳入125名患者，其中52例携带KMT2A重排，73例携带NPM1突变。在推荐的2期剂量（RP2D）下，R/R AML患者的ORR为82%，cCR率为59%。新确诊但不适合强化化疗的AML患者的ORR为90%，cCR率为75%。安全性方面，数据显示分化综合征的发生率低，且无QTc间期延长的心脏安全信号。Bexobrutideg（NX-5948）：公布1a/1b期临床试验的新数据Nurix Therapeutics公司公布了其布BTK降解剂bexobrutideg单药治疗复发/难治性CLL和WM患者的1a/1b期临床试验的新数据。Bexobrutideg是一种口服、可穿越血脑屏障的小分子BTK蛋白降解剂。截至2025年3月12日，中位随访时间为9.0个月，大多数患者仍在接受治疗。在疗效可评估的47名CLL患者中，客观缓解率为80.9%，首次缓解的中位时间为1.9个月。许多患者在更长的时间内经历了缓解加深，多次从病情稳定转变为部分缓解（PR），一名接受治疗两年多的患者经历了完全缓解。中位缓解持续时间尚未达到，有18名患者接受了一年多的治疗。在所有CLL患者群体中观察到缓解，无论既往治疗、基线突变或中枢神经系统（CNS）受累如何。在疗效可评估的19名WM患者中，客观缓解率为84.2%，包括2例非常好的部分缓解（VGPR）、11例PR和3例轻微缓解（MR）患者，3名患者获得疾病稳定（SD）。无论基线时MYD88突变和CXCR4突变的情况如何，患者均观察到缓解。此外，从4周的第一次评估开始就观察到关键疗效指标IgM水平的稳步下降，随后继续加深，3例患者的IgM水平降低超过90%。安全性方面，bexobrutideg耐受性良好，在较长的研究持续时间或更高的剂量下未观察到新的安全信号。Tuspetinib：公布1/2期联合治疗试验的新数据Aptose Biosciences公司公布了其针对新确诊的AML患者开展的1/2期TUSCANY试验的新数据。这些患者接受了不同剂量的tuspabetinib联用标准剂量的venetoclax和azacitidine（TUS+VEN+AZA三联疗法）。该三联疗法正在被开作发为一种安全且不依赖于特定突变的一线治疗方案，用于治疗那些无法接受诱导化疗的新确诊AML患者，这些患者具有多样的突变。此次公布的结果显示，携带不同突变（包括TP53突变/复杂核型、FLT3野生型）的AML患者安全地达到了CR和最小残留病（MRD）阴性。40毫克剂量组（n=4）中有3名患者达到CR且MRD状态为阴性。80毫克剂量组（n=3）中所有3名患者均达到了CR和伴有血液学不完全恢复的完全缓解（CRi）。120毫克剂量组（n=3）的患者仍在接受治疗。安全性方面，该三联疗法的安全性良好，无治疗相关死亡，迄今为止接受治疗的所有10名患者均存活。MP0533：公布1/2a期临床试验数据Molecular Partners公司公布了其四特异性T细胞接合器MP0533用于治疗R/R AML患者的1/2a期临床试验的最新积极数据。MP0533是一种新型多特异性蛋白分子，可同时靶向CD33、CD123、CD70和CD3四个靶点。截至2025年4月14日的数据，队列8中8名可评估的R/R AML患者中，有3人（超过30%）在第一个治疗周期后达到临床缓解，其中包括1例CR和2例伴有部分血液学恢复的完全缓解（CRh）。两名患者的缓解持续时间超过3个月，一名患者仍在接受治疗，缓解已维持超过6个月。安全性方面，MP0533在所有队列中均显示出可接受的安全性特征。SGR-1505：公布1期临床试验的初步数据Schrödinger公司宣布其候选药物SGR-1505在针对复发/难治性B细胞恶性肿瘤患者的1期临床试验中展现出积极的初步数据。SGR-1505是一种口服MALT1抑制剂，靶向NF-κB信号通路中的关键节点MALT1，旨在阻断癌细胞的存活与增殖。在临床前研究中，观察到SGR-1505具有高效性和选择性，并且在临床前模型中作为单一疗法以及与BTK抑制剂和BCL-2抑制剂联用均显示出抗肿瘤活性。截至2025年5月13日，49名患者进行了安全性评估，SGR-1505整体安全且耐受性良好，未出现剂量限制毒性或因治疗伴发不良事件（TEAE）导致的死亡，常见不良事件包括皮疹和疲劳。45名疗效可评估的患者中，ORR为22%，并在多个B细胞肿瘤类型中观察到缓解，包括CLL/小淋巴细胞白血病（SLL）、WM和边缘区淋巴瘤（MZL）。值得注意的是，一些曾接受过BTK和BCL-2抑制剂治疗失败的患者也出现了缓解。目前，该研究正扩展至侵袭性淋巴瘤患者，并观察到1名患者达到PR。HRX-215：1b期临床试验完成首例患者给药HepaRegeniX公司宣布其候选药物HRX-215的1b期临床试验已完成首例患者给药。该试验旨在评估HRX-215在因结直肠癌肝转移而接受部分肝切除术的患者中的安全性和有效性。HRX-215是一种口服的小分子抑制剂，靶向肝脏再生过程中的关键调节因子丝裂原活化蛋白激酶激酶4（MKK4）。通过选择性地抑制MKK4，HRX-215已在临床前模型中被证明可以稳定和保护肝细胞，并加速和增强肝脏再生过程，即使是在受损或患病的肝脏中也同样有效。参考资料（可上下滑动查看）[1] Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/09/3095726/0/en/Metsera-Announces-Positive-Phase-1-Data-of-First-in-Class-Once-Monthly-Amylin-Candidate-MET-233i.html[2] Avidity Biosciences Announces Positive Topline Phase 1/2 FORTITUDE™ Data Demonstrating Consistent Improvement Across Multiple Functional Measures Compared to Placebo in Del-Brax Treated FSHD Participants. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/avidity-biosciences-announces-positive-topline-phase-12-fortitude-data-demonstrating-consistent-improvement-across-multiple-functional-measures-compared-to-placebo-in-del-brax-treated-fshd-participants-302476040.html[3] Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME). Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/eluminex-biosciences-announces-phase-1b-single-ascending-dose-study-results-of-a-novel-pentavalent-trispecific-fusion-antibody-eb-105-in-patients-with-diabetic-macular-edema-dme-302476053.html[4] 큐어버스, 자가면역 ‘S1P1 작용제’ 美 1상 “IND 승인”. Retrieved June 13, 2025, from https://www.biospectator.com/news/view/25347[5] Myosin Therapeutics Receives FDA Clearance to Initiate First-in-Human Trial of MT-125 in Glioblastoma. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/myosin-therapeutics-receives-fda-clearance-to-initiate-first-in-human-trial-of-mt-125-in-glioblastoma-302475329.html[6] Nuevocor Announces FDA Clearance of IND for NVC-001 for LMNA-Related Dilated Cardiomyopathy. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/nuevocor-announces-fda-clearance-of-ind-for-nvc-001-for-lmna-related-dilated-cardiomyopathy-302477505.html[7] Monte Rosa Therapeutics Announces FDA Clearance of IND Application for MRT-8102, a NEK7-Directed Molecular Glue Degrader for the Treatment of Multiple Inflammatory Diseases. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/10/3096463/0/en/Monte-Rosa-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-MRT-8102-a-NEK7-Directed-Molecular-Glue-Degrader-for-the-Treatment-of-Multiple-Inflammatory-Diseases.html[8] HepaRegeniX Doses First Patient in Phase Ib Trial with Small Molecule Inhibitor HRX-215 to Promote Liver Regeneration. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/10/3096394/0/en/HepaRegeniX-Doses-First-Patient-in-Phase-Ib-Trial-with-Small-Molecule-Inhibitor-HRX-215-to-Promote-Liver-Regeneration.html[9] BioInvent Announces Promising Phase 1 Data of BI-1206 in Combination with KEYTRUDA® (pembrolizumab) in Solid Tumors. Retrieved June 13, 2025, from https://www.bioinvent.com/en/press/bioinvent-announces-promising-phase-1-data-bi-1206-combination-keytrudar-pembrolizumab-solid[10] Capsida is initiating the Phase 1/2 study for CAP-003, with the first patient expected to be dosed in the third quarter of this year. Retrieved June 13, 2025, from https://capsida.com/capsida-receives-fda-ind-clearance-for-its-iv-administered-gene-therapy-for-parkinsons-disease-associated-with-gba-mutations/[11] Molecular Partners presents positive data from ongoing Phase 1/2a trial of MP0533 in AML at EHA 2025. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/11/3097923/0/en/Molecular-Partners-presents-positive-data-from-ongoing-Phase-1-2a-trial-of-MP0533-in-AML-at-EHA-2025.html[12] ImmuneWalk Therapeutics Announces Positive Topline Phase 1 SAD Data for Immunology and Inflammation Drug Candidate IW-601. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/11/3097503/0/en/ImmuneWalk-Therapeutics-Announces-Positive-Topline-Phase-1-SAD-Data-for-Immunology-and-Inflammation-Drug-Candidate-IW-601.html[13] Capstan Therapeutics Announces Initiation of Phase 1 Trial of Lead In Vivo CAR-T Therapy, CPTX2309, for Treating Autoimmune Disease. Retrieved June 13, 2025, from https://www.capstantx.com/press-releases/capstan-therapeutics-announces-initiation-of-phase-1-trial-of-lead-in-vivo-car-t-therapy-cptx2309-for-treating-autoimmune-disease/[14] Vanda Pharmaceuticals Announces First Patient Dosed in a Trial Evaluating VCA-894A in Charcot-Marie-Tooth disease Type 2S. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-first-patient-dosed-in-a-trial-evaluating-vca-894a-in-charcot-marie-tooth-disease-type-2s-302477600.html[15] Silence Therapeutics Presents Additional Phase 1 Data Highlighting Promise of Divesiran as the Potential First-in-Class siRNA Treatment for Polycythemia Vera. Retrieved June 13, 2025, from https://silence-therapeutics.com/investors/press-releases/press-releases-details/2025/Silence-Therapeutics-Presents-Additional-Phase-1-Data-Highlighting-Promise-of-Divesiran-as-the-Potential-First-in-Class-siRNA-Treatment-for-Polycythemia-Vera/default.aspx[16] Schrödinger Reports Encouraging Initial Phase 1 Clinical Data for SGR-1505 at EHA Annual Congress. Retrieved June 13, 2025, from https://ir.schrodinger.com/press-releases/news-details/2025/Schrdinger-Reports-Encouraging-Initial-Phase-1-Clinical-Data-for-SGR-1505-at-EHA-Annual-Congress/default.aspx[17] New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia. Retrieved June 13, 2025, from https://www.investor.jnj.com/news/news-details/2025/New-results-for-Johnson--Johnsons-bleximenib-demonstrate-promising-antileukemic-activity-in-combination-with-venetoclax-and-azacitidine-for-acute-myeloid-leukemia/default.aspx[18] Nurix Therapeutics Presents Updated Positive Data Demonstrating Durable, Deepening Responses in Ongoing Clinical Trial of Bexobrutideg (NX-5948) Monotherapy in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Waldenström Macroglobulinemia (WM). Retrieved June 13, 2025, from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-updated-positive-data-demonstrating[19] Angitia Biopharmaceuticals Announces Topline Results from First in Human Study of AGA2115, A Bispecific Antibody for the Treatment of Osteogenesis Imperfecta. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/12/3098209/0/en/Angitia-Biopharmaceuticals-Announces-Topline-Results-from-First-in-Human-Study-of-AGA2115-A-Bispecific-Antibody-for-the-Treatment-of-Osteogenesis-Imperfecta.html[20] Fate Therapeutics Announces Updated Clinical Data for FT819 Off-the-shelf CAR T-cell Product Candidate Demonstrating Durability of Drug-free Remission for Severe Lupus Nephritis at EULAR 2025 Congress. Retrieved June 13, 2025, from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-announces-updated-clinical-data-ft819-shelf#:~:text=All%20three%20patients%20treated%20with%20FT819%20following%20fludarabine-free,in%20drug-free%20Definition%20of%20Remission%20in%20SLE%20%28DORIS%29tients-with-squamous-non-small-cell-lung-cancer免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床2期临床1期临床结果

2025-06-11

·bioinvent.com

BioInvent Announces Promising Phase 1 Data of BI-1206 in Combination with KEYTRUDA® (pembrolizumab) in Solid Tumors

The Phase 1 dose escalation has been completed, and results show encouraging early signs of clinical activity in solid tumors with one complete response, one long-lasting partial response, and 11 patients with stable disease. Based on this promising data, BioInvent plans to initiate Phase 2a expansion cohorts to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) or uveal melanoma, in the front line in combination with KEYTRUDA® (pembrolizumab). Patient enrollment is expected to begin H2 2025. Lund, Sweden – June 11, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced updated, positive Phase 1 data of intravenous (IV) and subcutaneous (SC) BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. Based on the encouraging data, the company intends to expand its investigation of BI-1206 SC in combination with pembrolizumab in earlier lines of treatment, by initiating a Phase 2a study arm with focus on first-line patients with advanced or metastatic NSCLC and uveal melanoma. The Phase 2a study is planned to be initiated during H2 2025. The updated Phase 1 data in heavily pre-treated patients - including several lines of IO agents - show encouraging clinical activity of the combination, with one patient with metastatic cutaneous melanoma experiencing a complete response (CR), one patient with metastatic uveal melanoma achieving a long-lasting partial response (PR) and 11 patients experiencing stable disease (SD) out of a total of 36 evaluable patients. The product was well-tolerated, enabling continued dose expansion exploring the use of higher dose levels. The trial is part of BioInvent’s strategy to transition from IV dosing to SC formulation for BI-1206 allowing slower systemic entry and prolonged time on target to enhance the products therapeutic impact and improve safety and tolerability of the combination. The Phase 1 data in solid tumors corroborate preclinical findings that BI-1206 significantly enhances the effect of anti-PD-1. Based on this evidence, MSD and BioInvent have agreed to further investigate the synergies between BI-1206 and pembrolizumab in earlier lines of treatment. The upcoming Phase 2a study of BI-1206 in combination with pembrolizumab is planned to be performed in treatment-naïve patients with NSCLC and uveal melanoma. “We are highly encouraged by the clinical responses emerging from our solid tumor program which support the broad utility of combining subcutaneous BI-1206 with pembrolizumab in a range of solid tumors,” said Martin Welschof, Chief Executive Officer of BioInvent. “The strong signals we have observed in heavily pre-treated patients support the idea that BI-1206 could be used to improve the activity of pembrolizumab across different tumor types, and we therefore look forward to initiating our Phase 2a study in the high unmet medical need of non-small cell lung cancer.” KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ###About NSCLC and combination treatment with targeting FcyRIIBNSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While checkpoint inhibitors are widely accepted and can produce durable responses in NSCLC, the overall response rate remains low, rarely exceeding 25%. A common resistance mechanism in cancer is the binding and degradation of therapeutic antibodies against PD-1 such as pembrolizumab by FcγRIIB expressing immune cells. Therefore, based on preclinical and early clinical data, the company believes that resistance or lack of response to anti-PD-1 treatment may be overcome by FcγRIIB blockade in particular in subjects who have never been exposed to anti PD-1 agents. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer). BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors (NCT04219254) is ongoing. The concluded Phase 1 dose escalation study in heavily pre-treated patients shows encouraging clinical activity of the combination, including one CR in metastatic melanoma, one PR in uveal melanoma and 11 patients experiencing SD out of a total of 36 evaluable patients. The product was well-tolerated, enabling continued dose expansion exploring the use of higher dose levels. For further details, please refer to the ASCO 2024 poster on the company web site: https://www.bioinvent.com/sites/bioinvent/files/BioInvent_ASCO_Poster_BI-1206_FINAL.pdf. Out of the patients with stable disease as best response, one patient with long-lasting metastatic melanoma, who had previously progressed on nivolumab treatment, remained a stable disease throughout the two-year study duration with BI-1206 and pembrolizumab. The planned Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve patients with NSCLC and uveal melanoma consists of two parts: a signal seeking phase and a dose optimization phase. In the first signal seeking phase, up to 30 NSCLC and 12 uveal melanoma patients will receive fixed doses of BI-1206 and pembrolizumab every 21 days for three treatment cycles. Patients showing clinical benefit by Week 9 can continue therapy for up to 32 additional cycles, while those with disease progression will not proceed further. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

临床1期免疫疗法临床结果临床2期

100 项与 BI-1206 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非霍奇金淋巴瘤	临床2期	英国	凯信远达医药（中国）有限公司	2022-01-30
晚期恶性实体瘤	临床2期	美国	BioInvent International AB	2020-06-29
晚期恶性实体瘤	临床2期	瑞典	BioInvent International AB	2020-06-29
转移性黑色素瘤	临床2期	美国	BioInvent International AB	2020-06-29
转移性黑色素瘤	临床2期	瑞典	BioInvent International AB	2020-06-29
非小细胞肺癌	临床2期	美国	BioInvent International AB	2020-06-29
非小细胞肺癌	临床2期	瑞典	BioInvent International AB	2020-06-29
葡萄膜黑色素瘤	临床2期	美国	BioInvent International AB	2020-06-29
惰性B细胞非霍奇金淋巴瘤	临床2期	美国	BioInvent International AB	2018-05-16
惰性B细胞非霍奇金淋巴瘤	临床2期	巴西	BioInvent International AB	2018-05-16

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临床结果

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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


PS1897 (EHA2025)	临床1期	惰性B细胞非霍奇金淋巴瘤	16	BI-1206 + Rituximab	遞鹹遞遞窪壓衊壓蓋選(齋獵鹹窪鹽獵淵繭艱襯) = decreases of platelet count were observed in 93.8% of subjects treated with BI-1206 + Rituximab 鏇築遞鹹窪衊範顧範鏇 (衊蓋壓艱築餘鹽齋鏇繭 ) 更多	积极	2025-05-14
PB3180 (EHA2025)	N/A	惰性B细胞非霍奇金淋巴瘤 CD32b \| CD20	30	BI-1206 + Rituximab + Acalabrutinib	繭簾鏇遞網壓築願製憲(鹽襯網鹹齋廠膚範鹽繭) = 3 patients had recorded AE related to study medication. Most adverse events were classified as mild or moderate. One subject had Gr3 neutropenia which has been downgraded after 3 days. This was the only Gr3 event recorded. With regards to safety events of interest, one patient had Gr2 thrombocytopenia, resolved to Gr1 within 3 days. No serious adverse events were recorded. 窪築鏇餘齋鑰醖構遞襯 (蓋鏇鑰憲築簾觸醖夢顧 ) 更多	积极	2025-05-14
NCT03571568 (Accesswire) 人工标引	临床1/2期	非霍奇金淋巴瘤	2	BI-1206+Calquence+Rituximab	繭觸簾窪製製襯壓築簾(鹹鹽餘築鏇構願廠積簾) = 壓顧淵鬱築夢糧膚窪夢醖蓋積醖鏇鹽鬱構選膚 (選遞衊構選膚構鏇鏇艱 ) 更多	积极	2025-01-08
NCT03571568 (Company_Website) 人工标引	临床2期	非霍奇金淋巴瘤	2	BI-1206 + rituximab + Calquence	構簾廠餘窪製築膚鏇簾(簾鏇衊糧醖艱鏇獵衊廠) = 廠糧鹹窪鹽醖範構鬱範淵醖鹹構鬱鏇夢廠繭鏇 (製襯壓齋構觸膚遞憲繭 ) 更多	积极	2025-01-08
NCT04219254 (Phase 1/2a clinical trial of BI-1206, ASCO2024)	临床1/2期	晚期恶性实体瘤 CD32b (FcγRIIB)	15	BI-1206 IV	憲淵簾構餘醖願鏇膚餘(鏇餘鏇窪願壓糧獵鏇壓) = The most frequent related adverse events were infusion-related reactions, thrombocytopenia and elevated liver enzymes. All were transient without any clinical consequences, and adequate pre-medication with corticosteroids or split dose administration reduced the risk and/or intensity of these events. 廠餘獵淵簾範積鹽繭糧 (醖鑰蓋鬱築觸淵艱鹽艱 ) 更多	积极	2024-05-24
EHA2024 人工标引	临床1/2期	惰性B细胞非霍奇金淋巴瘤 CD32B (FCGRIIB)	-	BI-1206 Irituximab	網齋製齋範構膚壓鏇積(製鏇餘夢鑰構製餘網遞) = the most frequent related treatment-emergent adverse events after BI-1206 IV wasthrombocytopenia and elevated transaminases. Thrombocytopenia ≥G3 occurred in 4 out of 10 subjectswithout premedication and 6 out of 13 subjects with premedication. No associated bleeding occurred. Allevents were resolved with a median duration of 5 days. Elevated liver enzymes ≥G3 occurred in 4 out of 10subjects without premedication and 3 out of 13 subjects with premedication. Events were resolved with amedian duration of 4 days without any clinical complication. 觸顧憲簾襯築憲壓壓積 (鹹網壓鏇膚鑰鏇顧衊齋 ) 更多	积极	2024-05-14
EHA2024 人工标引	临床1/2期	惰性B细胞非霍奇金淋巴瘤 CD32B (FCGRIIB)	-	BI-1206 +rituximab (SC)		积极	2024-05-14
CTR20220706 (Company_Website) 人工标引	临床1期	难治性惰性非霍奇金淋巴瘤 \| 复发性惰性非霍奇金淋巴瘤 \| 非霍奇金淋巴瘤	8	BI-1206	夢襯網夢鏇鬱顧鏇壓鏇(醖蓋網鹽鹽範夢製築蓋) = 簾蓋製選築構觸製網鹹衊顧鬱糧壓壓觸襯蓋糧 (淵膚鹹願遞衊廠鹹鏇廠 ) 更多	积极	2024-03-05
NCT02933320 (CTgov)	临床1/2期	慢性淋巴细胞白血病 \| 巨球蛋白血症 \| B细胞恶性肿瘤	14	BI-1206 single agent dose escalation phase (Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase)	選簾築簾獵艱窪糧鹹膚 = 襯艱鹽鹽製襯選膚鏇遞壓壓鬱繭簾製製網夢衊 (鹹製遞艱構廠窪構襯鏇, 襯夢簾選構積膚範鏇鹹 ~ 夢餘鏇鏇選範鹹醖憲鑰) 更多	-	2021-07-08
NCT02933320 (CTgov)	临床1/2期	慢性淋巴细胞白血病 \| 巨球蛋白血症 \| B细胞恶性肿瘤	14	BI-1206+rituximab (Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase)	選簾築簾獵艱窪糧鹹膚 = 糧遞網網衊壓醖廠顧獵壓壓鬱繭簾製製網夢衊 (鹹製遞艱構廠窪構襯鏇, 築廠憲簾醖憲遞壓選齋 ~ 艱窪襯憲構鏇範願網淵) 更多	-	2021-07-08