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 ; Kovacek, Mathilda ; Nie, Lei ; 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:

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

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.

2012-10-01·Hybridoma (2005)

A Monoclonal Antibody Against F1-F0 ATP Synthase Beta Subunit

Article

作者: Yuan, Jun ; Fang, Sui ; Ling, Sumei ; Zhuang, Zhenhong ; Wang, Shihua ; Zhang, Cheng

As a transmembrane enzyme, ATP synthase plays an important role in energy metabolism of organ tissues, as well as in tumors. In this study we generated a monoclonal antibody, 6G11, to the catalytic subunit of F1-F0 ATP synthase (ATP5B). The SDS-PAGE result demonstrated that the hybridoma clone had a molecular weight of 50 and 27 kDa components that could be the heavy and light chains of the monoclonal antibody, respectively. Chromosome analysis of the hybridoma clone proved that they had 98 to 102 chromosomal numbers that were the sum of the SP2/0 and spleen cells. Western blot assay revealed that the hybridoma clone reacted specifically with the ATP synthase beta subunit, but not with other proteins. In addition, the subclass of the hybridoma clone was identified as IgG1 by capture ELISA. Furthermore, it demonstrated that the antibody retained stability after half a year. These results indicated that the hybridoma clone 6G11 was a monoclonal antibody with significant stability and special reactivity to ATP5B antigen.

项与 BI-1206 相关的新闻（医药）

2026-06-11

·BioSpace

BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026)

BioInvent will host an in-person KOL lunch briefing (11:45 a.m. - 2:00 p.m. CEST / 5:45 - 8:00 a.m. EDT) in conjunction with EHA 2026 Congress today (virtual event link here ) 83% ORR across all evaluable patients in the total non-Hodgkin's lymphoma (NHL) population (n=23) 81% objective response rate (ORR) and 44% complete response rate (CRR) in relapsed/refractory follicular lymphoma (FL), on par with the recently approved tafasitamab+R2 (rituximab + Revlimid) combination Markedly lower rate of serious adverse events (14%) versus tafasitamab+R2 (34%), obinutuzumab+zanubrutinib (35%), rituximab+lenalidomide "R2" (29-32%), and epcoritamab+R2 (56%) Only 3% TEAE (treatment emergent adverse events)-related treatment discontinuation, compared to 7%-19% across R2-based standard-of-care regimens Acalabrutinib (Calquence ® ) with BI-1206 + rituximab boosted efficacy without increasing toxicity LUND, SE / ACCESS Newswire / June 11, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced new clinical data from the BI-1206 triplet combination in relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL) to be presented in a poster at the 31 st European Hematology Association (EHA2026) Congress, taking place June 11-14, 2026 in Stockholm, Sweden. The poster summarizes key efficacy, safety, and mechanistic data from the ongoing Phase 1/2 study ( NCT03571568 ) evaluating BI-1206 in combination with rituximab and Calquence ® (acalabrutinib) in patients with relapsed or refractory NHL, including follicular lymphoma. BI-1206 directly targets FcγRIIB-mediated rituximab internalization, a major driver of resistance to CD20-directed therapy, while leveraging BTK inhibition with acalabrutinib to enhance anti-tumor activity. "These EHA data reinforce our conviction that BI-1206 has the potential to meaningfully change the treatment landscape for patients with relapsed or refractory follicular lymphoma," said Martin Welschof, Chief Executive Officer of BioInvent. "An 81% response rate that matches or exceeds recently approved combinations - coupled with a safety pro is markedly more favorable than the widely used R2-based regimens - is exactly the kind of differentiated clinical pro set out to build. BI-1206 is now the cornerstone of our NHL strategy, and we look forward to advancing this program toward pivotal development as we work to bring a compelling new option to patients who urgently need it." Overview of data included in the poster at EHA 2026 The BI-1206 triplet exhibits an ORR and safety pro with established clinical benchmarks, including standard-of-care (SOC) R2 therapy and the recently approved tafasitamab+R2 combination, underscoring its potential as a highly competitive therapeutic option in R/R FL. As of data cut-off May 6, 2026, the triplet of BI-1206 + rituximab + acalabrutinib delivered an 83% objective response rate (ORR) in the total population (n=23 evaluable), with 11 complete responses (CR) and 8 partial responses (PR). In the follicular lymphoma (FL) subset (n=16), ORR was 81% and complete response rate (CRR) was 44%. All remaining patients exhibited stable disease as best response, giving a disease control rate (DCR) of 100%. The cohort has been completely enrolled, though response assessment has not yet occurred for all patients; as the majority of patients are still on treatment, any PFS (progression-free survival) calculation is yet premature. The regimen showed a very favorable tolerability profile, with treatment-related serious adverse events observed in only 4 (14%) patients and discontinuation due to a drug-related adverse event in 1 patient. Grade 3+ treatment-related adverse events observed in only 31% of patients, versus 54-84% for comparator regimens. Poster presentation details Title: Targeting resistance to rituximab through FcγRIIB (CD32B) blockade: BI-1206 + rituximab + acalabrutinib shows powerful activity in R/R NHL Presenter: Dr. Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Brazil Session Date/Time: Friday, June 12, 6:45 pm-7:45 pm CEST (12:45 pm-1:45 pm EDT) Location: EHA2026 Congress, Stockholm The poster will be posted to the Scientific Publications section of the company website ( ) when the presentation has occurred. About the BI-1206 Phase 2a part of the study The triple combination arm in the ongoing Phase 2a part of the study (NCT03571568) combines the subcutaneous formulation of BI-1206 with rituximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approximately 30 patients) has been completed in Spain, Germany, USA, and Brazil. BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence ® (acalabrutinib) for the combination arm. About BI-1206 FcγRIIB is overexpressed in several forms of NHL and its overexpression has been associated with poor prognosis in difficult-to-treat subtypes, including mantle cell lymphoma. FcγRIIB-mediated internalization of rituximab is a well-established driver of resistance to CD20-directed therapy. By blocking this receptor on tumor cells, BI-1206 is designed to restore and enhance rituximab activity in combination regimens. The clinical rationale for the BI-1206 triplet is supported by the ROSEWOOD trial (Zinzani et al., JCO 2023), which showed that adding the BTK inhibitor zanubrutinib to the Fc-engineered anti-CD20 antibody obinutuzumab - which has reduced but not absent FcγRIIB-mediated internalization - increased ORR from 45% to 69% and median PFS from 10.4 to 28 months in R/R FL. By contrast, acalabrutinib added to standard rituximab yielded only 31% ORR and a median PFS of 8.3 months (Strati et al., Br J Haem 2024), despite similar BTK kinase profiles for the two inhibitors. These data point to improved CD20 targeting - not BTK inhibition per se - as the key driver of superior outcomes. Because BI-1206 directly targets FcγRIIB-mediated internalization, combining it with rituximab and acalabrutinib offers a mechanistically distinct approach to overcoming rituximab resistance. The 81% ORR observed in the EHA 2026 data, substantially exceeding the 31% seen with acalabrutinib plus rituximab alone, is consistent with this hypothesis. BI-1206 is evaluated in two separate clinical Phase 1/2a programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL), a type of blood cancer. Both programs show encouraging clinical activity along with good tolerability. 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 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. Attachments BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026) SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床结果临床2期上市批准免疫疗法临床1期

2026-06-01

·BioSpace

BioInvent to Host a KOL Event in Stockholm on June 11, 2026, to Discuss Updated BI-1206 & BI-1808 Data in Hematology

LUND, SE / ACCESS Newswire / June 1, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced that it will host an in-person and virtual key opinion leader (KOL) event at GT30, Grev Turegatan 30 in Stockholm on Thursday, June 11, 2026 at 11:45 AM CEST. The event will feature Guilherme Perini MD, PhD (Hospital Israelita Albert Einstein), and Stefan K. Barta, MD, MS (Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania) who will join company management to discuss the treatment landscape, unmet need, and future outlook in non-Hodgkin's lymphoma (NHL) and cutaneous T-cell lymphoma (CTCL). To register for the in-person event, click here . RSVP June 4, 2026. The event will highlight the clinical progress and commercial potential of BioInvent's lead programs in hematology, BI-1206 and BI-1808. Presentations will include new insights into BI-1206's ability to overcome resistance to rituximab through FcγRIIB blockade, including encouraging activity observed in the triple combination with rituximab and Calquence® (acalabrutinib) in patients with relapsed or refractory NHL. In addition, the session will feature BI-1808, a novel anti-TNFR2 immunotherapy, highlighting data from the Phase 2a study in patients with advanced CTCL. Patients in these cohorts received BI-1808 as monotherapy or in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab). Early clinical findings demonstrating meaningful and sustained responses, alongside evidence of immune activation, support its potential as both a monotherapy and combination treatment. Agenda (CEST) 11:45am | BioInvent's BI-1206 & BI-1808 opportunities in hematology | Martin Welschof, CEO 11:50am | NHL treatment landscape, medical need and future outlook | Guilherme Perini, MD, PhD 12:05pm | BI-1206 in NHL: Targeting the Resistance to Rituximab through FcγRIIB Blockade: BI-1206 + Rituximab + Acalabrutinib Shows Powerful Activity in R/R NHL | Andres McAllister, CMO 12:20pm | BI-1206: Market opportunity in NHL | Sylvie Ryckebusch, CBO 12:30pm | Q&A BI-1206 in NHL | All 12:45pm | Coffee break | - 1:00pm | CTCL treatment landscape, medical need and future outlook | Stefan Barta, MD, MS 1:15pm | BI-1808: A Novel Immunotherapy Approach in CTCL: TNFR2 Blockade Shows Durable and Meaningful Responses | Andres McAllister, CMO 1:30pm | BI-1808: Market opportunity in CTCL | Sylvie Ryckebusch, CBO 1:40pm | Q&A BI-1808 in CTCL | All 1:55pm | Closing remarks | Martin Welschof, CEO The event will be conducted in English and a live webcast will be available here . A replay of the webcast will be made available on BioInvent's website following the event. This event is the second in a two-part KOL series. The first event, held on May 27, 2026, focused on BI-1808 for the treatment of ovarian cancer. About Guilherme Perini, MD, PhD Dr. Guilherme Perini is a board-certified hematologist in Brazil, with a focus on lymphoid malignancies. He is the current Director of the Department of Excellence in Lymphoid Malignancies at Hospital Israelita Albert Einstein in São Paulo, Brazil. He is also the Head of Oncology Research at ARO - Academic Research Organization, at Einstein. Dr. Perini is currently the principal investigator in more than 20 clinical trials in lymphoma and chronic lymphocytic leukemia (CLL). About Stefan K. Barta, MD, MS Stefan K. Barta, MD, MS is Associate Professor of Medicine (Hematology-Oncology) directing the T-cell lymphoma program at the University of Pennsylvania and serve as the Executive Officer of the NCI-sponsored Consortium for Advancing Management and Prevention of Cancer in People with HIV (AMC). Additionally, he is an active member of the AMC Lymphoma Working group and the ECOG Lymphoma Core Committee. Dr. Barta is a recognized expert in T-cell lymphomas, including cutaneous T-cell lymphoma (CTCL), and has served as lead author and principal investigator on multiple clinical studies evaluating novel immunotherapies for hematologic malignancies. About the BI-1206 Phase 2a part of the study The triple combination arm in the ongoing Phase 2a part of the study ( NCT03571568 ) combines the subcutaneous formulation of BI-1206 with rituximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approximately 30 patients) has been completed in Spain, Germany, USA, and Brazil. BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence ® (acalabrutinib) for the combination arm. About BI-1206 FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab and acalabrutinib in the treatment of several forms of NHL. The drug candidate is evaluated in two separate clinical Phase 1/2a programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL), a type of blood cancer. Both programs show encouraging clinical activity along with good tolerability. About the BI-1808 Phase 2a Study ThisPhase 2a trial ( NCT04752826 ) is designed to assess the safety and tolerability of BI-1808 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its pharmacokinetics and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS). The modified Severity-Weighted Assessment Tool (mSWAT) was used to assess disease activity. About BI-1808 The anti-TNFR2 antibody BI-1808 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is a first-in-class drug candidate in clinical development for the treatment of T-cell lymphoma and solid tumors. A manuscript detailing the mechanisms of action of the BI-1808 and differentiated BI-1910 anti-TNFR2 antibodies is available on BioRxiv.com , an open-access online repository for yet unpublished research manuscripts (preprints). Both anti-TNFR antibodies show potent anti-tumor efficacy across multiple syngeneic mouse tumor models, can effectively be combined with anti-PD-1, and trigger CD8+ T cell antitumor immunity, albeit by different mechanisms; BI-1808 is a ligand-blocking FcyR-engaging antibody that depletes immunosuppressive Treg cells and reprograms myeloid cells. BI-1910 is a pure agonist antibody that directly co-stimulates T and NK cells through partially FcyR-independent mechanisms. 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 to Host a KOL Event in Stockholm on June 11, 2026, to Discuss Updated BI-1206 & BI-1808 Data in Hematology SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床2期免疫疗法引进/卖出

2026-05-20

·BioSpace

BioInvent to Host Virtual KOL Event to Discuss BI-1808 for the Treatment of Ovarian Cancer, on May 27, 2026

LUND, SE / ACCESS Newswire / May 20, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune‑modulatory antibodies, today announced that it will host a virtual key opinion leader (KOL) event on Wednesday, May 27, 2026 at 8:00 AM EDT / 2:00 PM CEST featuring Dmitriy Zamarin MD, PhD (Tisch Cancer Center, Icahn School of Medicine at Mount Sinai), who will join company management to discuss the unmet need and current treatment landscape for ovarian cancer. To register, click here . The event will provide an overview of BI-1808, which has shown highly encouraging clinical activity both as single agent as well as in combination with pembrolizumab. Earlier disclosed interim data from 21 evaluable patients treated with BI-1808 plus pembrolizumab demonstrated an overall response rate (ORR) approximately three times higher than historically reported for pembrolizumab alone in heavily pretreated ovarian cancer patients. Agenda 08:00 am | BioInvent, Poised for Growth | Martin Welschof, CEO 08:05 am | Ovarian Cancer Treatment Landscape, Medical Need and Future Treatment of Ovarian Cancer | Dmitriy Zamarin, MD, PhD 08:25 am | BI-1808's Differentiated Mechanism of Action | Björn Frendéus, CSO 08:30 am | BI-1808 in Ovarian Cancer | Andres McAllister, CMO 08:50 am | Translational Data: Dynamics of Responses | Björn Frendéus, CSO 09:05 am | Market Opportunity for BI-1808 | Sylvie Ryckebusch, CBO 09:15 am | Final Remarks | Martin Welschof, CEO 09:20 am | Live Q&A Session | All presenters The webcast will be conducted in English and broadcast live. A replay of the webcast and presentation materials will be made available on BioInvent's website following the event. This event is the first in a two-part KOL series. A second event taking place on June 11th will focus on BI-1206 and BI-1808 for the treatment of non-Hodgkin's lymphoma and cutaneous T-cell lymphoma, respectively. About Dmitriy Zamarin MD, PhD Dmitriy Zamarin MD, PhD is Professor of Oncology, Section Head of Gynecologic Medical Oncology, and co-director of Center of Excellence for Gynecologic Cancers at the Tisch Cancer Center at Icahn School of Medicine at Mount Sinai. Dr. Zamarin obtained his MD and PhD degrees from the Mount Sinai School of Medicine. He completed residency in Internal Medicine at the Mount Sinai Hospital and fellowship in Hematology/Oncology at the Memorial Sloan Kettering Cancer Center. He spent a decade as a faculty and Translational Research Director in Gynecologic Medical Oncology at the Memorial Sloan Kettering Cancer Center before transitioning to his current role in September of 2023. Dr. Zamarin has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials exploring novel immunotherapy combinations in gynecologic cancers and other solid tumors and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee (NRG is a prominent national cooperative group funded by the National Cancer Institute (NCI) that conducts clinical trials for cancer treatments). In the laboratory, his research is focused on understanding of the mechanisms by which gynecologic cancers are recognized by the immune system and on identification of biomarkers predictive of response and resistance to immunotherapy. His laboratory uses experimental models to explore the mechanisms of tumor-immune system interactions and to develop novel therapeutics, with particular focus on oncolytic viruses, vaccines, and targeted therapies. Dr. Zamarin has received awards and funding from multiple organizations including Damon Runyon Foundation, Ovarian Cancer Research Alliance, Department of Defense, and the National Cancer Institute and is an elected member of the American Society for Clinical Investigation. About the BI-1808 Phase 2a Study This Phase 2a trial (NCT04752826) is designed to assess the safety and tolerability of BI-1808 as a single agent (Part A), in combination with pembrolizumab (Part B) and in a triple combination with pembrolizumab and paclitaxel (Part C). The study aims to characterize safety, pharmacokinetics and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST. About BI-1808 The anti-TNFR2 antibody BI-1808 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is a first-in-class drug candidate in clinical development for the treatment of T-cell lymphoma and solid tumors. A manuscript detailing the mechanisms of action of the BI-1808 and differentiated BI-1910 anti-TNFR2 antibodies is available on BioRxiv.com , an open-access online repository for yet unpublished research manuscripts (preprints). Both anti-TNFR2 antibodies show potent anti-tumor efficacy across multiple syngeneic mouse tumor models, can effectively be combined with anti-PD-1, and trigger CD8+ T cell antitumor immunity, albeit by different mechanisms; BI-1808 is a ligand-blocking FcgR-engaging antibody that depletes immunosuppressive Treg cells and reprograms myeloid cells. BI-1910 is a pure agonist antibody that directly co-stimulates T and NK cells through partially FcgR-independent mechanisms. 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 to Host Virtual KOL Event to Discuss BI-1808 for the Treatment of Ovarian Cancer, on May 27, 2026 SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床2期免疫疗法

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
转移性非小细胞肺癌	临床2期	美国	BioInvent International AB	2020-06-29
转移性非小细胞肺癌	临床2期	德国	BioInvent International AB	2020-06-29
转移性非小细胞肺癌	临床2期	波兰	BioInvent International AB	2020-06-29

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临床结果

适应症

分期

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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


EHA2026	临床1期	非霍奇金淋巴瘤	23	BI-1206 + rituximab + acalabrutinib	餘築餘窪獵製構繭繭鹹(膚願糧壓醖顧構遞鬱觸) = 2 patients with IRR related to rituximab 鬱顧襯獵築糧繭範製蓋 (餘選鹽窪窪鏇繭夢鏇醖 ) 更多	积极	2026-05-12
EHA2026	临床1期	非霍奇金淋巴瘤	23	BI-1206 + rituximab + acalabrutinib (FL subset)		积极	2026-05-12
PS1897 (EHA2025)	临床1期	惰性B细胞非霍奇金淋巴瘤	16	BI-1206 + Rituximab	遞鹹網獵淵鬱觸鹽選鑰(積襯鹽壓醖鬱齋艱襯繭) = decreases of platelet count were observed in 93.8% of subjects treated with BI-1206 + Rituximab 壓夢襯願衊鑰鬱艱選顧 (襯衊獵觸繭憲積膚觸願 ) 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	窪艱範鹹選襯顧範製獵(艱選遞範窪鹽夢鬱蓋醖) = 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. 鬱鏇醖網網鑰獵蓋構範 (鏇鏇積鑰鏇窪艱製淵簾 ) 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	壓願繭艱夢鏇淵齋築築(選選廠餘廠醖選繭鑰鹽) = 範夢廠壓廠積網糧膚膚網網夢糧糧繭願艱顧憲 (鑰積淵顧襯遞遞製艱膚 ) 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	膚齋淵壓憲鏇遞窪繭鬱(構窪遞願艱構鑰醖膚膚) = 繭願鏇膚繭餘遞醖餘醖淵鏇鬱簾願製糧繭鹽鏇 (選願壓構繭衊窪獵積構 ) 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	築醖廠築鹽繭範窪襯夢(憲鹽襯顧蓋餘構鑰鹽觸) = 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. 製齋範積鏇築夢簾顧憲 (築餘糧蓋觸壓構廠蓋餘 ) 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	膚觸觸艱蓋壓選網衊餘(繭鏇憲夢淵選膚積糧齋) = 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. 鬱鏇憲蓋繭糧襯餘獵夢 (鬱蓋選鹹繭築醖築願鬱 ) 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	積鑰鹹餘鹹襯鬱觸淵繭(蓋簾願觸壓鹽簾觸網網) = 襯網製鹹蓋襯憲憲鹽鏇蓋壓醖淵範願廠顧憲積 (築糧構觸衊鏇遞構願鑰 ) 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)	積構繭蓋餘鹽製簾蓋淵 = 鹽鏇壓築築顧範餘獵壓積夢鑰範廠願醖襯糧膚 (構範願淵觸獵餘鬱衊蓋, 醖網鑰淵顧鏇繭鹽遞繭 ~ 糧淵築餘觸夢夢鹽壓廠) 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)	積構繭蓋餘鹽製簾蓋淵 = 膚願淵簾糧糧壓願夢廠積夢鑰範廠願醖襯糧膚 (構範願淵觸獵餘鬱衊蓋, 鑰壓網衊獵鏇鬱衊製齋 ~ 範鬱網廠鏇糧廠壓廠鏇) 更多	-	2021-07-08