A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.

开始日期2025-08-14

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06963827

/ Recruiting临床3期

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.
In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.

开始日期2025-07-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06722235

/ Recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

开始日期2025-02-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 Mezagitamab 相关的临床结果

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100 项与 Mezagitamab 相关的转化医学

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100 项与 Mezagitamab 相关的专利（医药）

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项与 Mezagitamab 相关的文献（医药）

2026-04-01·Current Opinion in Organ Transplantation

Managing the highly sensitized kidney transplant patient

Review

作者: Jackson, Kyle R. ; Parsons, Ronald F.

Purpose of review:

Highly sensitized kidney transplant candidates, particularly those with calculated panel reactive antibody (CPRA) ≥99.9%, face significant immunologic barriers to transplantation. This review highlights recent clinical strategies that have improved transplant access and outcomes in this population, with a focus on allocation policy, kidney-paired donation, and desensitization.

Recent findings:

Updates from national allocation systems and kidney-paired donation programs have demonstrated substantial gains in transplant access for many highly sensitized candidates. However, those with CPRA at least 99.9% remain difficult to match. Novel desensitization approaches, such as imlifidase, proteasome inhibitors, anti-CD38 mAbs, and early-phase CAR T-cell therapies have shown promise in selected patients. Increasingly, immunologic phenotyping or gene expression profiling may help tailor desensitization strategies to individual recipients.

Summary:

Most highly sensitized candidates now achieve transplant through allocation policy or paired donation. For those with CPRA at least 99.9%, desensitization will likely remain an important tool to facilitate transplantation. Emerging therapies and immunologic profiling may help individualize treatment and expand transplant access for this challenging group.

2026-01-06·CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Evolving understandings for the roles of CD38 protein in autoimmunity and autoimmune disease

Review

作者: Zhang, Jieying ; Ares, Irma ; Maximiliano, Jorge-Enrique ; Lopez-Torres, Bernardo ; Ye, Xiaochun ; Wang, Ping ; Anadón, Arturo ; Wang, Xu ; Martínez-Larrañaga, María-Rosa ; Song, Mengping ; Martínez, María-Aránzazu ; Martínez, Marta

Abstract:

Autoimmune diseases are chronic idiopathic disorders characterized by inflammatory responses. Cluster of differentiation 38 (CD38), a surface molecule with enzymatic and signalling capabilities, contributes to the regulation of NAD+ metabolism and mediates various intracellular pathways. Recent research has revealed the influence of the CD38 protein in the pathogenesis of autoimmune diseases. During inflammation, CD38 is involved in regulating biological processes such as cell recruitment, cell activation, cytokine and chemokine release, antigen presentation, and phagocytosis. Dysfunctional CD38 induces autoimmune diseases. CD38 is expressed at low levels in various haematopoietic systems and tissues but exhibits elevated expression in multiple myeloma and plasma cells. CD38-targeted monoclonal antibodies with favourable therapeutic effects have been discovered, such as isatuximab, daratumumab, and mezagitamab. Although CD38-targeted antibodies were originally developed to eliminate malignant immune cells and inhibit their strong activation, these monoclonal antibodies can also inhibit autoantibodies production in autoimmune diseases. CD38 protein is a promising biomarker of autoimmune disease diagnosis and a potential therapeutic target for the treatment of autoimmune diseases. In this review article, we will focus on the latest findings on the involvement of CD38 in autoimmunity and autoimmune disease and assess the value of research and therapeutic application of CD38 in disease control.

2026-01-01·Current Research in Translational Medicine

The efficacy and safety of anti-CD38 monoclonal antibodies in transplant-ineligible newly diagnosed multiple myeloma: A systematic review and meta-analysis of randomized controlled trials

Article

作者: Alamy, Haroon ; Huynh, Huu Than ; Shelar, Vrushali ; El Amri, Imane ; Shah, Hafiz ; Ibrahim Ahmad, Feras Ahmad ; Aliyeva, Turkan ; Natche, Julia

BACKGROUND:

Treatment of transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) remains challenging due to age, frailty, and comorbidities. Anti-CD38 monoclonal antibodies, particularly daratumumab, have emerged as promising additions to frontline regimens. However, the long-term outcomes of these therapies are still uncertain. This systematic review and meta-analysis aimed to compare the survival outcome of anti-CD38 antibodies in TIE-NDMM patients.

METHODS:

We systematically searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) published up to April 2025 comparing anti-CD38 mAbs based regimens versus standard therapy in transplant-ineligible NDMM patients. A random-effects model was used to calculate pooled hazard ratios (HRs) with 95 % confidence intervals (CIs).

RESULTS:

A total of six RCTs with 2,625 patients were included in the analysis. Of these, 1,390 (52.9 %) patients received anti-CD38-based regimens. The follow-up duration varied from 41.2 to 86.7 months across the studies. Compared to standard therapy, anti-CD38-based regimens significantly improved both overall survival (OS) (HR 0.70; 95 % CI 0.58-0.84; p=0.0002; I² = 46 %) and progression-free survival (PFS) (HR 0.57; 95 % CI 0.51-0.65; p < 0.00001; I² = 15 %). The pooled results demonstrated that non-frail patients had a longer PFS than frail patients (HR = 0.46; 95 % CI, 0.34-0.63 and HR = 0.55; 95 % CI, 0.45-0.67, respectively), although the difference between the subgroups was not statistically significant (p = 0.36).

CONCLUSION:

In transplant-ineligible NDMM patients, the addition of anti-CD38 monoclonal antibodies to standard regimens significantly improves clinical outcomes. These findings support the integration of anti-CD38 therapy into first-line treatment for this vulnerable patient population.

项与 Mezagitamab 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 Mezagitamab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16370

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
免疫球蛋白a肾病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	哥伦比亚	Takeda Development Center Americas, Inc.	2025-07-15
免疫球蛋白a肾病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	法国	Takeda Pharmaceutical Co., Ltd.	2025-07-15

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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


NCT06722235 (ASH2025)	临床3期	免疫性血小板减少症	171	Mezagitamab 600 mg	繭製範襯網鹽醖鏇憲艱(淵製鹽鹹廠糧艱膚餘構) = similar between mezagitamab and placebo (50% vs 45%) 襯壓鏇蓋構選衊壓選餘 (廠鏇遞蓋遞鑰淵齋網繭 ) 更多	积极	2025-12-06
NCT05174221 (ASN2025 \| Company_Website)	临床1期	免疫球蛋白a肾病	17	Mezagitamab	艱築製鹽艱壓淵淵網鬱(淵淵積構構窪鬱範窪鏇) = 選齋觸餘鹽蓋鑰鬱遞鹽壓壓窪窪憲鬱醖鹽廠製 (積衊觸餘艱鬱顧選壓範 ) 更多	积极	2025-11-07
NCT04278924 (TAK-079-1004, CTgov)	临床2期	免疫性血小板减少症	41	Placebo (Part A & B: Double Blind Period: Placebo)	齋築鑰鹹醖觸選築醖膚 = 製鹽蓋鹽糧顧範壓餘遞繭襯壓積壓壓築蓋遞鬱 (醖願鹹鏇窪鹽鏇襯築壓, 構糧鹹鹽蓋築餘艱壓簾 ~ 網襯願膚醖夢鹽鑰窪顧) 更多	-	2025-06-15
				TAK-079 (Part A: Double Blind Period: TAK-079 100 mg)	齋築鑰鹹醖觸選築醖膚 = 範願築淵夢觸憲構鹽壓繭襯壓積壓壓築蓋遞鬱 (醖願鹹鏇窪鹽鏇襯築壓, 襯願餘膚醖窪鏇觸夢襯 ~ 觸窪憲淵觸鬱餘壓鬱膚) 更多
NCT03439280 (Phase 1b study, Pubmed)	临床1期	复发性多发性骨髓瘤 CD38	-	Mezagitamab monotherapy	選觸鏇醖願艱選餘憲構(繭顧鹽襯衊願顧衊廠鹹) = Three patients discontinued treatment due to TEAEs 鹽觸範顧鏇襯糧衊鑰網 (齋網糧觸鏇鑰網鬱壓鬱 ) 更多	积极	2024-12-01
NCT05174221 (ASN2024) 人工标引	临床1期	免疫球蛋白a肾病	17	Mezagitamab	壓鹽顧夢鏇觸蓋顧窪顧(餘製夢廠襯製齋壓範鹹) = None 積鹹醖襯製憲簾齋鏇顧 (鏇觸簾鹹鹹選積構選築 ) 更多	积极	2024-10-25
NCT04278924 (TAK-079-1004, PipelineReview) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	選醖製襯鏇鏇範膚範繭(鬱窪積淵網願鹹鹹遞憲) = 膚壓鏇蓋網願鑰遞齋憲簾淵繭壓築鬱艱艱顧繭 (壓鬱願衊積窪壓蓋簾繭 ) 更多	积极	2024-06-22
				Placebo	選醖製襯鏇鏇範膚範繭(鬱窪積淵網願鹹鹹遞憲) = 簾鹽遞範築網簾壓願壓簾淵繭壓築鬱艱艱顧繭 (壓鬱願衊積窪壓蓋簾繭 ) 更多
NCT03724916 (CTgov)	临床1期	系统性红斑狼疮	23	TAK-079 Placebo (Pooled Placebo)	鏇積衊範鏇簾鬱醖蓋齋 = 鹹膚鹽艱積壓觸鬱蓋製獵廠鹽醖範簾築壓顧壓 (鏇鹽窪網鏇壓齋窪鑰膚, 淵築願衊範鑰蓋簾鹹獵 ~ 衊顧鏇淵襯廠醖遞獵鑰) 更多	-	2024-03-29
				TAK-079 (TAK-079 90 mg)	鏇積衊範鏇簾鬱醖蓋齋 = 鏇壓淵構製鑰獵淵獵願獵廠鹽醖範簾築壓顧壓 (鏇鹽窪網鏇壓齋窪鑰膚, 鏇淵膚壓膚糧鹹選鹽蓋 ~ 築醖夢鹽鬱觸獵醖觸醖) 更多
NCT04278924 (TAK-079-1004, Biospace) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	鑰簾製願選餘醖範遞餘(壓鑰壓壓鏇願艱顧膚獵) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 鏇糧鬱顧觸廠鹽艱積窪 (範觸構艱願淵醖衊遞鹽 ) 更多	积极	2024-03-13
				Placebo
NCT04159805 (CTgov)	临床2期	重症肌无力	36	TAK-079 Placebo (TAK-079 Placebo-matching)	積簾顧醖蓋廠鏇蓋艱積 = 觸觸衊遞獵簾蓋壓壓鏇蓋獵廠蓋顧鹹艱獵鬱鹽 (壓鹹積鬱艱齋顧繭壓淵, 繭窪壓醖獵築餘憲積淵 ~ 鹹艱糧蓋網構壓淵遞醖) 更多	-	2023-06-02
				TAK-079 (TAK-079 300 mg)	積簾顧醖蓋廠鏇蓋艱積 = 糧鬱築蓋齋選築顧構鏇蓋獵廠蓋顧鹹艱獵鬱鹽 (壓鹹積鬱艱齋顧繭壓淵, 積壓繭範觸獵顧鏇鏇築 ~ 遞顧艱願獵築壓鑰艱範) 更多
NCT03439280 (Phase 1b study, CTgov)	临床1/2期	复发性多发性骨髓瘤	50	Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg)	齋築醖淵願鹹廠觸壓壓 = 製製鑰鏇製製壓鬱蓋窪鹽淵網積艱觸淵繭範鑰 (齋範憲廠鹹憲鏇觸鬱壓, 憲觸糧艱範願選積製襯 ~ 膚獵繭築鹽築糧願積選) 更多	-	2023-02-24
				Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg)	齋築醖淵願鹹廠觸壓壓 = 廠顧廠憲艱製蓋蓋淵醖鹽淵網積艱觸淵繭範鑰 (齋範憲廠鹹憲鏇觸鬱壓, 簾衊範夢構願網廠鏇範 ~ 鏇廠鹹壓夢憲蓋廠構鬱) 更多