mezagitamab (TAK-079) / Takeda, Xoma, BioInvent - LARVOL DELTA

Trial in progress: Study design of a randomized, phase 3 trial evaluating the efficacy and safety of mezagitamab (TAK-079) compared with placebo in adults with chronic primary immune thrombocytopenia (ASH 2025) - P2, P3 | "Use of additional, stable Background ITPtherapy is permitted, including corticosteroids, thrombopoietin receptor agonists, and fostamatinib, as isuse of rescue therapy (corticosteroids, intravenous immunoglobulin, platelet transfusion) whenindicated. Given promising, early-stage results for anti-CD38 treatment in patients who have beendifficult to manage on current therapies, this global study will evaluate the efficacy and safety ofsubcutaneous mezagitamab as a potential novel therapy for patients with ITP who have had aninsufficient response or intolerance to prior therapy."

Clinical • P3 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Safety, Tolerability, and Efficacy of Mezagitamab (TAK-079) as Add-On to Standard-of-Care Therapy in Individuals with Primary IgAN: Week 96 Data from an Open-Label Phase 1b Study (KIDNEY WEEK 2025) - P1 | "Renal function (eGFR) remained stable through Week 96 (mean change from baseline 2.9; 95% CI: −1.8, 7.6; n=12). Conclusion Mezagitamab was generally well-tolerated as an add-on to standard-of-care therapy and led to rapid and sustained reductions in UPCR and stable eGFR through Week 96."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

Takeda Presents New Data Showing Mezagitamab (TAK-079) Sustained Effect on Kidney Function 18 Months After Treatment in Primary IgA Nephropathy (Businesswire) - "The results were presented at the American Society of Nephrology (ASN) Kidney Week 2025....Phase 1b, Open-Label Study Follow Up Shows Stable Kidney Function (eGFR) in Patients Treated with Investigational Mezagitamab Through Week 96 - 18 Months After Last Dose. Rapid Reductions in Proteinuria and Serum Gd-IgA1 Levels Were Sustained Through Week 96. No Serious Adverse Events or Opportunistic Infections Were Observed Through Week 96."

P1 data • IgA Nephropathy

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Anticipated 2025 Partner Events of Note -Takeda (GlobeNewswire) - "First patient dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with IgA Nephropathy."

Trial status • IgA Nephropathy

TAK-079-3001: A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrials.gov) - P3 | N=347 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Phase 1b study of the anti-CD38 antibody mezagitamab in patients with relapsed/refractory multiple myeloma. (PubMed, Blood Neoplasia) - P1/2 | "Fifty patients were enrolled: 44 received mezagitamab monotherapy (dose-escalating cohorts at 45-1200 mg) and 6 received mezagitamab 300 mg in combination with pomalidomide plus dexamethasone. Further development of mezagitamab in myeloma is not planned, but studies are underway in autoimmune conditions. This trial was registered at www.ClinicalTrials.gov as #NCT03439280."

Clinical • Journal • P1 data • Fatigue • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Myeloma • Neutropenia • Oncology

Results from a phase 2 study on mezagitamab for chronic/persistent primary immune thrombocytopenia (ISTH 2025) - "Mean change from baseline ITP-PAQ scale scores showed clinically meaningful improvement in mezagitamab groups but not in placebo (Figure 2). Table or Figure Upload"

P2 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Takeda presents positive results from trial of chronic kidney disease treatment (Pharmafile) - P1b | N=16 | NCT05174221 | Sponsor: Takeda | "Takeda Pharmaceuticals has announced positive results from a proof-of-concept study of mezagitamab (TAK-079) to treat patients with primary immunoglobulin A nephropathy (IgAN), a chronic kidney disease...The data was presented at the European Renal Association Congress on 6 June 2025 in Vienna, Austria. It indicated that at week 48, IgAN patients treated with mezagitamab experienced significant benefits compared to those who received standard-of-care therapy alone. These patients achieved rapid and sustained reductions in both serum IgA and proteinuria, as well as stable renal function. Additionally, no serious adverse side effects or discontinuations were reported."

P1 data • IgA Nephropathy

Safety, Tolerability, and Efficacy of Mezagitamab (TAK-079) as Add-on to Standard of Care Therapy in Individuals with Primary IgA Nephropathy: Results from a Phase 1b Study (ERA 2025) - P1 | "Mezagitamab was generally well tolerated as an add-on to standard of care therapy in IgAN without any opportunistic infections or Grade 3 or higher infections. Rapid and sustained reductions in proteinuria, serum IgA, Gd-IgA1, and IgG were seen while renal function remained stable during the first year of this study."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Pain • Renal Disease • Respiratory Diseases

XOMA Royalty Purchases Mezagitamab Royalty and Milestone Rights Held by BioInvent International for up to USD $30 Million (GlobeNewswire) - "XOMA Royalty Corporation...and BioInvent International AB...announced XOMA Royalty has purchased the future mezagitamab (TAK-079) royalty and milestone interests held by BioInvent for USD $20 million at closing, with a total transaction of up to USD $30 million."

Commercial • Hematological Malignancies • Oncology • Thrombocytopenia

A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrials.gov) - P3 | N=347 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

BioInvent Receives Milestone Payment as Takeda moves mezagitamab into Phase 3 (ACCESSWIRE) - "BioInvent International AB...today announces that it has earned a 1 million USD milestone payment, following Takeda's...initiation of Phase 3 clinical trial of mezagitamab (TAK-079), identified from BioInvent's proprietary n-CoDeR antibody library. The study is evaluating this potential best-in-class anti-CD83 monoclonal antibody for persistent or chronic primary immune thrombocytopenia (ITP)."

Financing • Immune Thrombocytopenic Purpura

Antigen masking indirect antiglobulin test can mitigate the interference of Mezagitamab, a novel anti-CD38 antibody, in serological pre-transfusion testing. (PubMed, Transfus Med) - "All novel anti-CD38 antibodies, such as mezagitamab, have the potential to interfere in serological pre-transfusion testing. While masking only one epitope, DaraEx has so far been an effective mitigation for all clinical anti-CD38 antibodies."

Journal • CNS Disorders • Hematological Malignancies • Multiple Myeloma • Myasthenia Gravis • Oncology

TAK-079-3002: A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=171 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Takeda Delivers Strong Third-Quarter FY2024 Results; Raises Full Year Outlook, Forecasting Revenue and Core Operating Profit Margin Growth (Businesswire) - "Among the multiple late-stage programs presented, the company expects...Phase 3 data readouts in the calendar year 2025 with filings anticipated in FY2025-FY2026 for the following programs and indications: oveporexton (TAK-861) for the treatment of narcolepsy type 1; zasocitinib for the treatment of psoriasis...Moreover, five additional indication filings for late-stage programs are on pace for FY2027-FY2029. zasocitinib for the treatment of psoriatic arthritis; mezagitamab for treatments of immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder, and immunoglobulin A nephropathy (IgAN), a chronic progressive autoimmune mediated kidney disease; fazirsiran for the treatment of alpha-1 antitrypsin deficiency-associated liver disease, and elritercept for the treatment of anemia associated with myelodysplastic syndrome."

Filing • P3 data • Alpha-1 Antitrypsin Deficiency • Anemia • IgA Nephropathy • Immune Thrombocytopenic Purpura • Narcolepsy • Psoriasis • Psoriatic Arthritis

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Feb 2025 ➔ Mar 2026 | Trial primary completion date: Feb 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • Transplantation

Takeda Spotlights High-Value, Late-Stage Pipeline Accelerating the Development of Potential Transformative Treatments for Patients in Multiple Therapeutic Areas (Businesswire) - "Data from...Phase 3 programs is expected to read out in 2025...zasocitinib, an investigational next-generation, highly selective and potent oral allosteric tyrosine kinase 2 (TYK2) inhibitor will deliver Phase 3 results in psoriasis...Filings for these...indications are expected in fiscal years 2025 and 2026. Five additional indication filings for late-stage programs are on pace for fiscal years 2027 through 2029: zasocitinib in psoriatic arthritis; mezagitamab, an investigational anti-CD38 antibody providing rapid, selective and sustained depletion of disease-causing immune cells that could set a new standard for the treatment of immune thrombocytopenia (ITP) and immunoglobulin A neuropathy (IgAN)."

Filing • P3 data • Immune Thrombocytopenic Purpura • Psoriasis • Psoriatic Arthritis

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=171 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Safety, Tolerability, and Efficacy of Mezagitamab (TAK-079) as Add-On to Standard of Care Therapy in Individuals with Primary IgA Nephropathy: Interim Results from an Open-Label Phase 1b Study (KIDNEY WEEK 2024) - P1 | "Mezagitamab was generally well tolerated as an add-on to standard of care therapy. Rapid and sustained reductions in UPCR, serum IgA, and Gd-IgA1 levels were seen with stable eGFR."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Pain • Renal Disease • Respiratory Diseases

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Apr 2024 | Trial primary completion date: Aug 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Safety, tolerability, and efficacy of mezagitamab (TAK-079) in chronic or persistent primary immune thrombocytopenia: Interim results from a phase 2, randomized, double-blind, placebo-controlled study (ISTH 2024) - "Participants (N=41) had a mean disease duration of 10.98 (range:0.3–35.2) years and received a mean of 3.9 (range:1–13) prior ITP treatments. In the prespecified interim analysis, TEAE incidence was similar between mezagitamab-treated and placebo-treated participants. In mezagitamab-treated versus placebo groups, 14.3% versus 0%, 17.9% versus 23.1%, and 14.3% versus 7.7% of participants had TEAEs leading to discontinuation, Grade ≥3 TEAEs, and serious adverse events, respectively."

Clinical • Late-breaking abstract • P2 data • Hematological Disorders • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Takeda Presents Late-Breaking Data from Phase 2b Study of Mezagitamab, Demonstrating Potential to Transform Treatment of Primary Immune Thrombocytopenia (Businesswire) - P2b | N=41 | NCT04278924 | Sponsor: Takeda | "These data (Abstract #LB 01.1) were presented at the oral Late-Breakthrough Session at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH)....The Phase 2b trial results demonstrated that mezagitamab treatment improved platelet response compared to placebo, across all three dose levels of mezagitamab tested....All the different measures of platelet response evaluated were highest among patients treated with the mezagitamab 600mg dose, specifically 81.8% achieved complete platelet response, 90.9% clinically meaningful platelet response, and 100% hemostatic platelet response. Fewer mezagitamab-treated patients compared to placebo had ≥1 disease activity-related bleeding AE (17.9% vs 46.2%, respectively)....'Based on these results, we plan to initiate a Phase 3 study of mezagitamab in ITP in the second half of FY2024'."

Late-breaking abstract • New P3 trial • P2b data • Thrombocytopenia

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Takeda | Phase classification: P1b ➔ P1 | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Combination therapy • Phase classification • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • Transplantation