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

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

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 ; Karlsson, Ingrid ; Zhang, Rongjia ; Teige, Ingrid ; Nie, Lei ; Kovacek, Mathilda ; Frendéus, Björn ; Jordan, Alexa ; 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: Hernández, Hilda ; Mosqueda, Maryani ; Sánchez, Jorge ; Rodríguez, Suanel Y ; Marcet, Ricardo ; Alfonso, Carlos ; Sarracent, Jorge ; Otero, Oscar ; Alba, Annia ; Capó, Virginia

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）

2026-03-31

·bioinvent.com

BioInvent International AB publishes Annual Report 2025

Lund, Sweden – March 31, 2026 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immunomodulatory antibodies for cancer immunotherapy, today announced that the Annual Report for 2025 has been published. The Annual Report is attached to this press release in pdf format and is available on the company’s website www.bioinvent.com. BioInvent’s key achievements in 2025 centered on advancing the lead programs BI-1808 and BI-1206 into mid-stage clinical development, presenting encouraging data at major scientific meetings, and strengthening the financial and strategic position. “During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier stage programs to maximize the probability of success and near-term value creation. This portfolio optimization reflects a disciplined approach to development and partnering, aligning investment with the strongest clinical signals and upcoming milestones. In summary, 2025 was a year of clinical validation and strategic consolidation. We advanced our most promising programs into Phase 2a, delivered encouraging data, and controlled our financial position through disciplined portfolio management and royalty monetization.” – Martin Welschof, CEO of BioInvent. KEY EVENTS IN 2025• (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025• (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025• Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma• Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL)• (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximaband Calquence® for the treatment of NHL• BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency• (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025• Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced• (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million• FDA Fast Track Designation received for BI-1808 for the treatment of CTCL• BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL (R)= Regulatory event In line with the information in the Year-end report for 2025 issued end of February 2026, it is the Board of Directors’ and the CEO’s assessment that the company is, based on ongoing projects, financed into the latter part of Q1 2027. The Board of Directors and the CEO continuously evaluate various options to finance the company’s activities, but since no such financing has been secured at the time of signing of the annual report, this indicates an uncertainty. However, the Board of Directors and the CEO assess that there are good possibilities for future financing solutions. See page 35 and 69 of the annual report. EXPECTED KEY CATALYSTS 2026 The priorities for 2026 are clear: complete the ovarian cancer cohort expansion with BI-1808 and report data in H2 2026; continue to optimize BI-1808 development for CTCL; and progress BI-1206 in NHL as datasets mature and partnering opportunities develop. By the second half of this year, we expect to have the first data from the BI-1206 Phase 2a study in first-line NSCLC. Mid-2026:• First combination data for BI-1808 and pembrolizumab for the treatment of cutaneous T-cell lymphoma (CTCL), as well as additional CTCL monotherapy data• Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin’s lymphoma (NHL)H2 2026:• Additional Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors• First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients. 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 drug candidates in 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. This information is information that BioInvent International is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-03-31 11:45 CEST.

临床结果孤儿药免疫疗法临床2期快速通道

2026-02-26

·bioinvent.com

BioInvent International AB: Year-end report January 1 – December 31, 2025

“During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier programs to maximize the probability of success and near-term value creation.”- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025 (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025 Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL) Phase 1 data of the company’s second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and Calquence® for the treatment of NHL BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025 Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer FDA Fast Track Designation received for BI-1808 for the treatment of CTCL BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025• Net sales SEK 3.0 (21.4) million• Profit/loss after tax SEK -125.8 (-116.9) million• Profit/loss after tax per share before and after dilution SEK –1.91 (-1.78)• Cash flow from operating activities SEK-90.6 (-98.3) million January – December 2025• Net sales SEK 226.5 (44.7) million• Profit/loss after tax SEK -332.9 (-429.4) million• Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53)• Cash flow from operating activities SEK -247.8 (-380.5) million• Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company’s website under Financial reports. INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025BioInvent’s CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English.When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at https://bioinvent.events.inderes.com/q4-report-2025. If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference.https://events.inderes.com/bioinvent/q4-report-2025/dial-in. The conference call will be made available on the company website after the call. 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 drug candidates in 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

临床结果孤儿药免疫疗法临床2期临床1期

2026-02-26

·BioSpace

BioInvent International AB: Year-End Report January 1 - December 31, 2025

LUND, SE / ACCESS Newswire / February 26, 2026 / BioInvent International (STO:BINV) - "During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier programs to maximize the probability of success and near-term value creation."- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (R) Promising early Phase 2a monotherapy data for the company's lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025 (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin's Lymphoma (NHL) presented at ASH 2025 Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and Calquence® for the treatment of NHL BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025 Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer FDA Fast Track Designation received for BI-1808 for the treatment of CTCL BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025 • Net sales SEK 3.0 (21.4) million • Profit/loss after tax SEK -125.8 (-116.9) million • Profit/loss after tax per share before and after dilution SEK -1.91 (-1.78) • Cash flow from operating activities SEK-90.6 (-98.3) million January - December 2025 • Net sales SEK 226.5 (44.7) million • Profit/loss after tax SEK -332.9 (-429.4) million • Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53) • Cash flow from operating activities SEK -247.8 (-380.5) million • Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at . If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference. . The conference call will be made available on the company website after the call. About BioInvent BioInvent 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 drug candidates in 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 . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 Attachments BioInvent Q4, 2025 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床结果孤儿药临床2期免疫疗法临床1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	德国	BioInvent International AB	2020-06-29
晚期恶性实体瘤	临床2期	波兰	BioInvent International AB	2020-06-29
晚期恶性实体瘤	临床2期	罗马尼亚	BioInvent International AB	2020-06-29
晚期恶性实体瘤	临床2期	西班牙	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
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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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	蓋糧鏇鹹選壓齋膚鬱遞(壓糧範襯衊窪鑰夢簾壓) = decreases of platelet count were observed in 93.8% of subjects treated with BI-1206 + Rituximab 淵衊廠壓艱鬱願選構鹽 (壓簾窪鏇網鹽觸鏇壓窪 ) 更多	积极	2025-05-14
EHA2025	N/A	惰性B细胞非霍奇金淋巴瘤 CD32b \| CD20	30	BI-1206 + Rituximab + Acalabrutinib	齋鏇鏇夢願艱願鹽窪選(鑰糧廠簾夢獵醖鑰築憲) = 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. 糧襯築選觸醖糧積夢鹹 (艱繭鹽簾窪遞鹹鏇積觸 ) 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	餘壓蓋網範築齋獵醖範(構繭淵廠廠鬱積積窪觸) = 夢鑰鑰鹹網醖齋醖網網艱衊鹽糧製淵鏇構鏇築 (鑰製願繭構鏇餘製積糧 ) 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	網艱願構憲艱觸襯醖窪(鹽構鏇簾範獵醖齋餘蓋) = 遞選網網遞窪衊網齋衊淵糧繭簾鹽觸築製壓網 (繭鏇鹽選齋網憲廠範範 ) 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	選膚繭網範遞壓餘餘襯(網簾構壓衊夢壓願衊簾) = 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. 鬱獵製簾網簾積鏇淵窪 (築範繭簾醖簾艱遞鑰醖 ) 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	簾鹽遞獵廠鹹蓋鹽鏇積(獵構鏇餘築選衊壓鬱簾) = 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. 選觸獵襯觸糧築獵衊鹹 (製製壓願齋顧膚憲顧製 ) 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	蓋膚製遞蓋選繭夢壓衊(衊遞簾鹽衊顧餘顧蓋選) = 範選鏇積觸淵築襯齋鹽衊網範鑰網範襯鑰鹹選 (窪獵繭鑰鑰壓壓餘鹽壓 ) 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)	艱艱構憲膚鹹築鏇壓窪 = 淵衊簾淵憲廠醖艱艱選憲餘選醖憲鑰觸夢醖衊 (醖積夢製獵壓夢艱願窪, 鹹願襯齋範願觸膚顧範 ~ 製遞憲網糧齋網顧窪製) 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)	艱艱構憲膚鹹築鏇壓窪 = 鹽遞齋蓋願範繭顧襯窪憲餘選醖憲鑰觸夢醖衊 (醖積夢製獵壓夢艱願窪, 醖簾鹹壓簾淵選膚獵膚 ~ 夢淵網繭築艱襯選鹹繭) 更多	-	2021-07-08