[Translation] A Phase II, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of TAK-079 in patients with persistent/chronic primary immune thrombocytopenia

主要目的主要目的是评价TAK-079在持续性/慢性原发性免疫性血小板减少症(ITP)患者中的安全性和耐受性次要目的：次要目的是评估TAK-079对持续性/慢性原发性ITP患者血小板计数的影响探索性目的： 1. 确定TAK-079的PK 2. 确定TAK-079的药效学特征 3. 探索血小板应答的持久性 4. 确定TAK-079对血小板相关抗体水平和亚型的影响 5. 需要补救治疗的患者频率和比例 6. 使用ITP出血评分进行出血评估 7. 确定治疗对健康相关生活质量的影响 8. 探索疫苗诱导的保护性抗体 9. 探索TAK-079重复给药对抗药物抗体（ADA）和疾病活动度的探索性生物标志物的影响

[Translation]

Primary Objectives The primary objective is to evaluate the safety and tolerability of TAK-079 in patients with persistent/chronic primary immune thrombocytopenia (ITP) Secondary Objectives: The secondary objective is to evaluate the effect of TAK-079 on platelet counts in patients with persistent/chronic primary ITP Exploratory Objectives: 1. Determine the PK of TAK-079 2. Determine the pharmacodynamic profile of TAK-079 3. Explore the durability of platelet responses 4. Determine the effect of TAK-079 on platelet-associated antibody levels and subtypes 5. Frequency and proportion of patients requiring rescue therapy 6. Bleeding assessment using the ITP Bleeding Score 7. Determine the effect of treatment on health-related quality of life 8. Explore vaccine-induced protective antibodies 9. Explore the effect of repeated dosing of TAK-079 on anti-drug antibodies (ADA) and exploratory biomarkers of disease activity

Start Date31 May 2023

Sponsor / Collaborator

Takeda (China) International Trading Co. Ltd.

[+2]

CTR20222215 / Active, not recruitingPhase 1

一项在原发性IgA 肾病患者中评价Mezagitamab（TAK-079）联合稳定背景治疗的安全性、耐受性、药代动力学和有效性的Ib 期、多中心、开放性研究

[Translation] A Phase Ib, multicenter, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of mezagitamab (TAK-079) in combination with stable background therapy in patients with primary IgA nephropathy

主要目的: 评价Mezagitamab 在接受稳定背景治疗的原发性IgAN 患者中的安全性和耐受性。次要目的：确定Mezagitamab 的PK， PD 特征，对蛋白尿的影响和免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of mezagitamab in patients with primary IgAN receiving stable background therapy. Secondary objectives: To determine the PK, PD characteristics, effect on proteinuria and immunogenicity of mezagitamab.

Start Date18 Dec 2022

Sponsor / Collaborator

Takeda Development Center Americas, Inc.

[+2]

NCT05174221 / Active, not recruitingPhase 1

A Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy

This study will have two parts. The main aims are to:
check the side effects from mezagitamab.
check for long-term side effects from mezagitamab.
Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period.
Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.

Start Date09 Nov 2022

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Mezagitamab

100 Translational Medicine associated with Mezagitamab

100 Patents (Medical) associated with Mezagitamab

Literatures (Medical) associated with Mezagitamab

22 Sep 2024·British journal of haematology

A CD38/CD3xCD28 trispecific T-cell engager as a potentially active agent in multiple myeloma patients relapsed and/or refractory to anti-CD38 monoclonal antibodies.

Article

Author: Zabaleta, Aintzane ; Blanco, Laura ; Wang, Hongfang ; Rodriguez-Otero, Paula ; San-Miguel, Jesús ; Van de Velde, Helgi ; Bisht, Kamlesh ; Paiva, Bruno ; Kim, Peter S ; Tamariz-Amador, Luis-Esteban ; Lasa, Marta ; Martín-Sánchez, Esperanza

There is accumulating evidence of BCMA and GPRC5D loss after treatment with T-cell redirecting therapies in patients with relapsed/refractory multiple myeloma (RRMM). While complete CD38 loss is not observed upon relapses after treatment with anti-CD38 monoclonal antibodies (mAb), there is downregulation of surface CD38 expression and decreased number and function of NK cells, which renders these patients resistant to retreatment with anti-CD38 mAb. Here, we provide preclinical evidence that RRMM patients previously exposed to anti-CD38 mAb could benefit from T-cell-based immunotherapy that depend less on CD38 antigen density and NK-cell activity, such as the novel CD38/CD3xCD28 trispecific T-cell engager, SAR442257.

01 Sep 2024·Oncology and Therapy

From Triple- to Penta-Exposed Multiple Myeloma: A Real-World Study in a Medicare Population

Article

Author: Rodriguez Lorenc, Karen ; Moynahan, Aaron ; Delea, Thomas E ; Sabater Anaya, Natalia ; Song, Xue ; Ge, Wenzhen ; Kroog, Glenn S ; Ma, Qiufei

INTRODUCTIONTreatment of multiple myeloma (MM) has been transformed by novel therapies, including CD38 monoclonal antibodies (mAbs), immunomodulatory drugs (IMiDs), and proteasome inhibitors (PIs), resulting in increasing numbers of patients who are triple-class exposed (TCE; exposed to ≥ 1 drug in each class). Many patients are penta-exposed (PE; ≥ 2 IMiDs, ≥ 2 PIs, and a CD38 mAb), some are triple-class refractory (TCR), and some are PE and TCR (PE-TCR). Data on real-world outcomes in elderly patients with MM across this spectrum of exposure are limited.METHODSData from the Medicare Chronic Conditions Warehouse Database from November 2006-December 2020 were used to examine cohorts of TCE, TCR, PE, and PE-TCR patients. Outcomes were assessed from the start of the index line of therapy (LOT), defined as the first LOT after becoming TCE or PE.RESULTSA total of 2830 TCE, 1371 TCR, 1121 PE, and 774 PE-TCR patients were identified. Pomalidomide was the most frequently used medication for the index LOT in all cohorts (32.6% [PE-TCR] to 43.3% [TCR]). The most frequently used regimens for the index LOT were pomalidomide plus daratumumab for TCE (17.2%) and PE (7.0%), pomalidomide plus carfilzomib for TCR (10.3%), and pomalidomide plus elotuzumab for PE-TCR (7.4%). Median time to discontinuation (TTD) ranged from 4.2 (PE-TCR) to 6.9 (TCE) months, and overall survival (OS) ranged from 13.0 (TCR) to 15.9 (PE) months. Healthcare resource utilization (HRU) was lowest for TCE and highest for PE-TCR patients. Mean monthly healthcare costs (HCC) ranged from $23,091 (TCE) to $24,412 (PE-TCR). MM medications represented 66.2% (PE-TCR) to 72.8% (TCE) of costs.CONCLUSIONSIn this study across a spectrum of Medicare TCE patients, there was heterogeneity in treatment regimens, suggesting no standard of care. TTD and OS were short, and HRU and HCC were high. These results underscore the potential for new therapies in this population.

01 Aug 2024·Clinical Lymphoma Myeloma and Leukemia

Clinical Significance of Cytomegalovirus Reactivation in Patients With Plasma Cell Dyscrasia Who Were Treated With Anti-CD38 Monoclonal Antibody: A Retrospective Analysis in a Single Institution

Article

Author: Komatsu, Hirokazu ; Nakanishi, Yoko ; Narita, Tomoko ; Iida, Shinsuke ; Ebina, Toru ; Nishitarumizu, Nozomi ; Kondo, Aki ; Ri, Masaki ; Kinoshita, Shiori ; Nakamura, Tomoyuki ; Suzuki, Tomotaka ; Kusumoto, Shigeru ; Marumo, Yoshiaki ; Nakashima, Takahiro ; Matsunaga, Naohiro ; Kato, Yukiyasu

INTRODUCTIONAnti-CD38 monoclonal antibodies (mAbs) have improved the prognosis of patients with plasma cell dyscrasia (PCD), but are also associated with increased infectious adverse events. Cytomegalovirus (CMV) is a common latent pathogen that is reactivated in immunocompromised individuals. Although CMV reactivation has mostly been reported after high-dose chemotherapy followed by stem cell transplantation in patients with PCD, cases of reactivation during anti-CD38 mAb therapy have been reported recently. Due to limited studies, we aimed to determine the frequency and impact of CMV reactivation during anti-CD38 mAb therapy.PATIENTS AND METHODSThis retrospective analysis included 154 consecutive patients with PCD who were treated with anti-CD38 mAbs at a single institution.RESULTSSeventy-six patients were evaluated for CMV reactivation by CMV pp65 antigen testing, and 29 (38%) patients, including nine with newly diagnosed PCD, showed positive results. Patients who tested positive for the CMV pp65 antigen had substantially lower serum albumin levels than those who tested negative. However, the two groups showed no marked difference in the concurrent anti-PCD medications or baseline absolute lymphocyte count. Although most patients showing positive results in the CMV pp65 antigen test had mild or no symptoms, with fever being the most common symptom, some patients developed CMV end-organ disease. In addition, CMV reactivation interfered with the course of anti-PCD treatment in most patients, necessitating dose reductions, delays, and discontinuation of chemotherapy.CONCLUSIONThis study provides an overview of the clinical impact of CMV reactivation in patients with PCD treated with anti-CD38 mAb-containing regimens.

News (Medical) associated with Mezagitamab

23 Oct 2024

·www.prnewswire.com

Anti-CD38 mAb Market to Accelerate Substantially During the Study Period (2020-2034) Owing to a Strong Uptake of DARZALEX in Multiple Myeloma and Expected Entry of anti-CD38 mAbs in Autoimmune Diseases | DelveInsight

The anti-CD38 mAb market is projected to experience substantial growth in the coming years owing to strong uptake of DARZALEX (along with DARZALEX FASPRO), the expected entry of subcutaneous formulation of SARCLISA in Multiple Myeloma. This growth is also driven by a rising number of cancer and autoimmune disorder diagnoses, as well as an increasing number of Anti-CD38 mAbs undergoing clinical trials and seeking approval. LAS VEGAS, Oct. 23, 2024 /PRNewswire/ -- DelveInsight's Anti-CD38 mAb Market Insights report includes a comprehensive understanding of current treatment practices, emerging anti-CD38 mAb, market share of individual therapies, and current and forecasted anti-CD38 mAb market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Anti-CD38 mAb Market Report As per DelveInsight's analysis, the total market size of anti-CD38 mAb in the 7MM is expected to surge significantly by 2034. Multiple Myeloma is the only indication for which anti-CD38 therapies, Johnson&Johnson's (J&J) DARZALEX and Sanofi's SARCLISA have been approved until now. Around 50% of DARZALEX usage comes from second-line treatment in Multiple Myeloma. Additionally, in the frontline multiple myeloma clinical trials, DARZALEX has emerged triumphant, surpassing all expectations and solidifying its position as the gold standard of therapy. Its unparalleled effectiveness and exceptional safety profile have exceeded rivals' predictions and soon positioned DARZALEX to dominate the multiple myeloma market. The filing submission of SARCLISA subcutaneous in 3L R/R MM (IRAKLIA) is anticipated in 2025 and beyond. Somehow, SARCLISA is way behind DARZALEX in terms of market expansion, and DARZALEX has also got an early mover advantage of over 4 years. Multiple Myeloma is the leading indication, other emerging indications with commercial opportunity include Systemic Lupus Erythematosus (SLE), Chronic Kidney Disease (CKD), and IgA Nephropathy Leading emerging anti-CD38 mAb companies such as Takeda Pharmaceuticals, HI-Bio, Genmab, CASI Pharmaceuticals, and others are developing novel anti-CD38 mAb that can be available in the market in the coming years. Some of the key anti-CD38 mAb in the pipeline include Mezagitamab (TAK-079), Felzartamab, GEN3014, CID-103 , and others. In June 2024, data from the IMROZ Phase III study by Sanofi demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed transplant-ineligible multiple myeloma. In May 2024, Biogen and Human Immunology Biosciences (HI-Bio), announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for USD 1.15 billion upfront and up to USD 650 million in potential milestone payments. Discover which therapies are expected to grab the anti-CD38 mAb market share @ Anti-CD38 mAb Market Report Anti-CD38 mAb Market Dynamics The market for anti-CD38 mAbs has undergone significant growth and transformation in recent years, driven primarily by the increasing prevalence of multiple myeloma and the d emand for more effective treatment options. The market dynamics are further influenced by ongoing research into the broader application of anti-CD38 mAbs beyond multiple myeloma. There is growing interest in exploring their efficacy in other CD38-expressing malignancies, such as chronic lymphocytic leukemia and certain solid tumors. Additionally, research into combination therapies, where anti-CD38 mAbs are paired with immune checkpoint inhibitors, CAR-T cells, or other novel agents, is expanding the horizon for these treatments. Such advancements are likely to further propel the market, attracting substantial investment and fueling innovation. However, challenges such as biosimilar competition, pricing pressures, and the need for differentiation in a crowded market pose potential hurdles. The entrance of biosimilars could reduce costs but also threaten market share for existing products. Companies must navigate these challenges through strategic pricing, market access strategies, and continuous innovation to maintain their competitive edge. The anti-CD38 mAb market is poised for continued expansion, with a promising pipeline of new therapies and combinations on the horizon, making it a dynamic and evolving sector within oncology. Anti-CD38 mAb Treatment Market Monoclonal antibodies targeting CD38 are crucial in the treatment of newly diagnosed and refractory multiple myeloma. Currently, DARZALEX and SARCLISA are the two approved anti-CD38 therapies. SARCLISA is a prescription medication used to treat multiple myeloma in adults. It is administered alongside pomalidomide and dexamethasone for patients who have undergone at least two previous treatments, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is used with carfilzomib and dexamethasone for patients who have received one to three prior therapies that were either ineffective or have stopped working. In March 2020, the US FDA approved SARCLISA in combination with pomalidomide and dexamethasone for multiple myeloma patients who had at least two prior therapies, including lenalidomide and a proteasome inhibitor. Later, in May 2020, the European Commission approved SARCLISA. By March 2021, the US FDA also approved SARCLISA with carfilzomib and dexamethasone for those with relapsed or refractory multiple myeloma who had received one to three previous treatments. DARZALEX is an innovative monoclonal antibody that the US FDA approved for treating multiple myeloma in patients with at least one prior treatment. It works by inducing tumor cell death through several mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis. In November 2015, the FDA granted DARZALEX accelerated approval as a monotherapy for multiple myeloma patients who had undergone at least three prior treatments. By November 2016, it was also approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who had received at least one prior therapy. From 2015 to 2021, DARZALEX gained further approvals for use in various drug combinations. Their effectiveness in managing multiple myeloma and plasma cell disorders has been confirmed by numerous Phase III clinical trials. Moreover, CD38-targeted therapies are being explored for other conditions such as primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematologic cancers. Learn more about the FDA-approved anti-CD38 mAb @ Anti-CD38 mAb Drugs Key Emerging Anti-CD38 mAb and Companies Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Mezagitamab is a fully human IgG1 monoclonal antibody that targets CD38 and is being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, the FDA granted Fast Track designation and Orphan Drug status to mezagitamab for idiopathic thrombocytopenic purpura (ITP). Takeda also revealed plans to begin a global Phase III trial for mezagitamab in ITP later in 2024. The drug is currently in Phase II of clinical development. HI-Bio's leading candidate, felzartamab, is a fully human anti-CD38 monoclonal antibody. Clinical studies have demonstrated its ability to selectively target and deplete CD38+ cells, including plasma cells and NK cells, potentially enabling broader therapeutic applications and enhanced clinical outcomes across various immune-mediated diseases. Felzartamab has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for primary membranous nephropathy and also received Orphan Drug Designation for treating antibody-mediated kidney transplant recipients. Phase II trials have been completed for primary membranous nephropathy and antibody-mediated transplant rejection, with ongoing studies in IgA nephropathy. HI-Bio intends to progress each of these indications to Phase III. The anticipated launch of these emerging therapies are poised to transform the anti-CD38 mAb market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anti-CD38 mAb market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about anti-CD38 mAb clinical trials, visit @ Anti-CD38 mAb Treatment Drugs Anti-CD38 mAb Overview Anti-CD38 monoclonal antibodies (mAbs) are a class of therapeutic agents that target CD38, a surface protein widely expressed on plasma cells, including malignant ones in multiple myeloma. By binding to CD38, these mAbs can induce direct cytotoxicity, promote antibody-dependent cellular cytotoxicity (ADCC), and facilitate complement-dependent cytotoxicity (CDC) to destroy the targeted cells. Beyond their role in multiple myeloma, anti-CD38 mAbs are being explored for their potential in treating other hematologic malignancies and autoimmune diseases. CD38 is not only a marker for plasma cells but also involved in processes like calcium signaling and NAD+ metabolism, which are crucial for cell survival and proliferation. By targeting CD38, these antibodies can modulate the immune microenvironment, making them a promising tool for both oncology and immunology. The ongoing research is focused on optimizing their efficacy, managing resistance, and exploring their use in combination with other immunotherapies to enhance patient outcomes. Anti-CD38 mAb Epidemiology Segmentation Epidemiology assessed for multiple myeloma showed that the United States, in 2023, accounted for 36,800 incident cases of multiple myeloma. The anti-CD38 mAb market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Indication for Anti-CD38 mAb Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication Total Treatable Cases of Selected Indications for Anti-CD38 mAb Scope of the Anti-CD38 mAb Market Report Anti-CD38 mAb Therapeutic Assessment: Anti-CD38 mAb current marketed and emerging therapies Anti-CD38 mAb Market Dynamics: Conjoint Analysis of Emerging Anti-CD38 mAb Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Anti-CD38 mAb Market Access and Reimbursement Discover more about anti-CD38 mAb in development @ Anti-CD38 mAb Clinical Trials Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insight, Epidemiology and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including Janssen, Pharmacyclics, Novartis, Incyte Corporation, Gracell Biotechnology, SpringWorks Therapeutics, Sana Biotechnology, Cytovia Therapeutics, Pfizer, MorphoSys, Biokine Therapeutics, Arcellx, Rapa Therapeutics, iTeos Therapeutics, Sorrento Therapeutics, CARsgen, Ascentage Pharma, Cartesian Therapeutics, Bristol-Myers Squibb, Juno Therapeutics, Nanjing IASO Biotherapeutics, Arch Oncology, Oncoceutics, TeneoBio, Nerviano Medical Sciences, among others. Relapse/Refractory Multiple Myeloma Market Relapse/Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R multiple myeloma companies, including NexImmune, Amgen, AbbVie, Allogene Therapeutics, Precision Biosciences, Takeda Oncology, ORIC Pharmaceuticals, Ionis Pharmaceuticals, Cellectis S.A., YZY Biopharma, Janssen Research & Development, Bristol Myers Squibb, Lava Therapeutics, Prelude Therapeutics, among others. Relapse/Refractory Multiple Myeloma Pipeline Relapse/Refractory Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key R/R multiple myeloma companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugFast TrackPhase 3Immunotherapy

28 Jun 2024

·www.fiercepharma.com

Fierce Pharma Asia—Daiichi, Merck's FDA rejection; Wegovy's expansion; Takeda CEO's hunt for China deals

The FDA's rejection of Daiichi and Merck's HER3 ADC, Wegovy's approval in China, and Takeda CEO's appetite for more deals with Chinese biotechs made our news this week. The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight loss star Wegovy secured approval in China. After two large licensing deals, Takeda's CEO is open to more partnerships with Chinese biotechs. And more. 1. Daiichi's lung cancer ADC rejected by FDA in blow to first project under Merck partnership Daiichi Sankyo’s Merck-partnered HER3 antibody-drug conjugate, patritumab deruxtecan, was rejected by the FDA because of third-party manufacturing issues. The drug is one of three ADC programs featured as part of a $4 billion upfront deal between the two companies, and it would have been Merck’s first ADC launch. The partners are working with the contractor and the FDA to address the problems. 2. Novo Nordisk wins approval in China for GLP-1 obesity drug Wegovy China has approved Novo Nordisk’s Wegovy as a weight loss treatment for people with a body mass index of at least 30 or between 27 and 30 with one weight-related risk factor. However, the drug will be unlikely to get national reimbursement after China’s medical insurance authority in an April Q&A ruled out the inclusion of any anti-obesity drugs, along with seven other therapeutic categories, in the national insurance scheme. 3. Takeda keeps looking for China biotech partnerships, CEO says (Bloomberg) Since last year, Takeda has signed major deals with Chinese biotechs Hutchmed and Ascentage Pharma. Now, CEO Christophe Weber told Bloomberg the Japanese pharma “should remain very open of potential partnerships with Chinese biotech.” He also said that the draft BIOSECURE Act would have no impact on Takeda as the company’s manufacturing in China is for the Chinese market. 4. Takeda's anti-CD38 antibody on track for phase 3 after boosting platelet count in bleeding disorder Although Takeda has decided to wind down mezagitamab in myasthenia gravis and systemic lupus erythematosus, it’s still advancing the anti-CD38 antibody in primary immune thrombocytopenia. Latest data from 41 patients in a phase 2b trial showed that the drug improved platelet response compared with placebo across all three doses with what Takeda viewed as a favorable safety profile. 5. Sumitomo Pharma's new CEO weighs layoffs in Japan after sharp sales drop, US job cuts: report Sumitomo Pharma’s new CEO Toru Kimura, who just officially took the helm this week, is weighing a restructuring that could be implemented “as soon as this fiscal year,” he told Nikkei Asia. The reorg would follow a recent layoff round affecting 400 U.S. staffers. Recent revenue declines give the company “no choice but to take further measures, including offering early retirement,” he told the publication. 6. Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval The FDA has endorsed Dizal Pharma’s plan to file its China-approved sunvozertinib in the U.S. for an accelerated approval in previously treated EGFR exon 20 insertion-mutated non-small cell lung cancer, its CEO said. That’s despite the FDA’s recent full approval for Johnson & Johnson’s bispecific antibody Rybrevant in the same indication. The agency clearly sees the need for alternative or better therapies, Dizal’s CEO explained. 7. SK Bioscience begins 'globalization' push, paying $244M for majority stake in contract manufacturer IDT Biologika SK Bioscience has acquired a 60% stake in Germany’s IDT Biologika for 339 billion South Korean won ($244 million) as part of the company’s global expansion push. IDT ranks among the world’s top 10 firms in vaccine production. The transaction enables SK to expand its footprint geographically as well as in new treatment areas such as anti-cancer viruses and cell and gene therapy, SK said. Other News of Note: 8. FDA slams Dr. Reddy's plants in India with a pair of Form 483s 9. Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's 10. Fosun Pharma offers $690M to take biotech subsidiary Henlius private (Reuters) 11. GenScript's ProBio arm debuts new gene therapy production plant in NJ 12. Terns' ex-MASH drug cuts fat, not muscle or food intake, in GLP-1 combo in mice 13. Glenmark recalls 114 batches of low potassium drug in the US over potentially deadly hyperkalemia risk

Drug ApprovalClinical ResultPhase 2VaccinePhase 3

27 Jun 2024

·pmlive.com

Takeda’s mezagitamab shows promise in immune thrombocytopenia

Takeda has announced promising mid-stage results for mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP). The phase 2b results were presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis and the company plans to initiate a global phase 3 trial in the second half of 2024. Affecting approximately four in every 100,000 people every year, ITP is a rare, immunoglobulin (IgG)-mediated autoimmune disease characterised by a low platelet count and tiny blood cells responsible for preventing or stopping bleeding. The TAK-079-1004 trial has been evaluating once-weekly 100mg, 300mg and 600mg subcutaneous mezagitamab versus placebo for eight weeks in patients with chronic or persistent primary ITP, followed by over eight weeks of safety follow-up. The fully human IgG1 monoclonal antibody therapy with high affinity for CD38 expressing cells is designed to deliver rapid and sustained improvement in platelet response and to restore platelet counts to functional levels. Results demonstrated that treatment with mezagitamab significantly improved platelet response across all three dose levels tested, compared to placebo, as well as a rapid and sustained increase in platelet counts that persisted eight weeks after the final dose. In addition, more than 81% of patients treated with mezagitamab dose of 600mg achieved a complete platelet response, while nearly 91% achieved a meaningful platelet response and 100% demonstrated haemostatic platelet response. Furthermore, mezagitamab had a favourable safety and tolerability profile in patients with ITP, with no new safety signals reported and a safety profile consistent with previous studies. The therapy previously received Orphan Drug Designation and Fast Track Designation for the treatment of chronic/persistent ITP from the US Food and Drug Administration, which has not yet been approved for use. Obi Umeh, vice president, franchise global programme leader, Takeda, commented: “Based on these results, we plan to initiate a phase 3 study of mezagitamab in ITP in the second half of 2024, further underscoring our goal to develop transformative treatments in therapeutic areas with high unmet patient needs.” Last year, Takeda announced positive phase 3 results of its enzyme replacement therapy, TAK-755, in congenital thrombotic thrombocytopenic purpura, an ultra-rare, chronic and debilitating blood clotting disorder.

Clinical ResultOrphan DrugPhase 3Fast TrackImmunotherapy

100 Deals associated with Mezagitamab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Thrombocytopenia	Phase 2	BG	Spera Pharma, Inc.Startup	09 Nov 2020
Thrombocytopenia	Phase 2	BG	Takeda Development Center Americas, Inc.	09 Nov 2020
Thrombocytopenia	Phase 2	GR	Spera Pharma, Inc.Startup	09 Nov 2020
Myasthenia Gravis	Phase 1	CA	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Myasthenia Gravis	Phase 1	US	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Myasthenia Gravis	Phase 1	RS	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Myasthenia Gravis	Phase 1	ES	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Myasthenia Gravis	Phase 1	IT	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Myasthenia Gravis	Phase 1	PL	Takeda Pharmaceutical Co., Ltd.	14 Jan 2020
Relapse multiple myeloma	Phase 1	US	Millennium Pharmaceuticals, Inc.	20 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04278924 (TAK-079-1004, PipelineReview) Manual	Phase 2	Purpura, Thrombocytopenic, Idiopathic	-	Mezagitamab	(ghhzsxabae) = lmhtqhiqph norbxzweci (edlrbztovp ) View more	Positive	22 Jun 2024
				Placebo	(ghhzsxabae) = bogyauakcd norbxzweci (edlrbztovp ) View more
NCT03724916 (CTgov)	Phase 1	Systemic Lupus Erythematosus	23	TAK-079 Placebo (Pooled Placebo)	prfiygredh(wfkbbyycsd) = huqffdglaf qoafhfteje (xfvfrhtzio, vagdeimdzz - wkxoqnmaon) View more	-	29 Mar 2024
				TAK-079 (TAK-079 90 mg)	prfiygredh(wfkbbyycsd) = kziomliuxo qoafhfteje (xfvfrhtzio, vkigbnftqd - dqsnzguvnp) View more
NCT04278924 (TAK-079-1004, Biospace) Manual	Phase 2	Purpura, Thrombocytopenic, Idiopathic	-	Mezagitamab	(esrrltepsd) = Mezagitamab has been generally safe and well tolerated across all three cohorts. chvnqhwbof (cilxhzcstj ) View more	Positive	13 Mar 2024
				Placebo
SITC2023	Not Applicable	-	-	Anti-CD38 mAb	nlmkogsryt(rbiekmaalz) = egeynkksgh ksnssgubkm (bznwybycml )	-	02 Nov 2023
NCT04159805 (CTgov)	Phase 2	Myasthenia Gravis	36	TAK-079 Placebo (TAK-079 Placebo-matching)	vdbigfhwdj(hszaupvcmx) = yxiiksnjdg yvfeyvgkzz (wrmuwpqvuv, svsasfylxh - evpvltchfv) View more	-	02 Jun 2023
				TAK-079 (TAK-079 300 mg)	vdbigfhwdj(hszaupvcmx) = xwuxzwydgs yvfeyvgkzz (wrmuwpqvuv, bprbljgfym - ppzcuilywo) View more
ASCO2023	Not Applicable	Multiple Myeloma	4,980	Anti-CD38 mAb-based regimens	huufsxtbfm(jhkctvqpiz) = zwpberlgjz aegogkfamj (msghhqrwih )	Negative	31 May 2023
				Control	huufsxtbfm(jhkctvqpiz) = hychnjiftl aegogkfamj (msghhqrwih )
NCT02219256 (Pubmed \| Br J Clin Pharmacol)	Phase 1	-	74	TAK-079	(lsqeigaxzz) = tpxfjihkvw bvvvhpusgq (uajilwphvk, 52) View more	-	01 Jul 2020
NCT03439280 (ASCO2020)	Phase 1/2	Relapse multiple myeloma	34	TAK-079	(eijkcqopuz) = 18% eroccsdrbr (flxbytkbri ) View more	Positive	25 May 2020
NCT03439280 (EHA2020)	Phase 1	Relapse multiple myeloma	34	TAK-079	dhdpnzunxa(eyxuwhuuhh) = Drug related adverse events (AEs), any grade, occurring in at least 10% of patients were: fatigue (21%), anemia (18%), neutropenia (18%), leukopenia (15%). Neutropenia was the only drug related grade 3 AEs in 2 or more patients (n=2); only drug related SAE was 1 Grade 3 diverticulitis. No drug-related grade 4 AEs, AEs leading to study discontinuation, or on-study deaths reported ljqvntlfbs (mlzwfvifpl ) View more	Positive	14 May 2020
ACR2016	Not Applicable	Systemic Lupus Erythematosus CD38 \| CD20 \| CD27 ... View more	-	TAK-079	lmlpuabieb(lthvqwozei) = ucanvovfnu orleqirgcq (ydrpeneell ) View more	Positive	14 Nov 2016

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