cizutamig (EMB-06) / EpimAb Biotherap, Candid Therapeutics - LARVOL DELTA

An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting ➔ Recruiting | N=19 ➔ 28 | Trial completion date: Nov 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of Cizutamig for Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase I Study of a Novel BCMA×CD3 Bispecific Antibody Emb-06 in Relapsed or Refractory Multiple Myeloma (ASH 2024) - "Notably, patients experiencing treatment delays of at least 3 months due to adverse events (AEs) still exhibited sustained responses in one patient and deepened responses in two patients (from VGPR to CR and from PR to CR, respectively). Conclusions : In this analysis of full dose escalation study, EMB-06 demonstrated a differentiated safety profile in RRMM patients, with low rates of CRS and no ICANS, and durable efficacy in heavily pre-treated RRMM patients."

P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Hepatitis C • Infectious Disease • Liver Failure • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial

Clinical Study of Cizutamig in Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=47 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Study to evaluate Cizutamig in patients with immunoglobulin A nephropathy (ChiCTR) - P=N/A | N=15 | Recruiting | Sponsor: Peking University First Hospital; Peking University First Hospital

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Phase 1B, Open-label, Multicenter Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, And Preliminary Clinical Actvity of Cizutamig in Systemic Lupus Erythematosus (ChiCTR) - P1 | N=47 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Cizutamig, a BCMA T-cell engager: preclinical to clinical translation of design optimization for the treatment of autoimmune diseases (ACR Convergence 2025) - "A patient with rheumatoid arthritis (RA) refractory to 5 targeted synthetic and biologic DMARDs including rituximab was the first non-oncology patient treated with weekly doses of cizutamig. In vitro, cizutamig showed comparable T cell dependent cytotoxicity of BCMA-expressing cell lines with lower cytokine release compared to benchmark BCMA TCEs (Fig 1)... Cizutamig was designed to mitigate cytokine release while preserving cytotoxicity of BCMA-expressing cells. Preclinical and clinical data demonstrate a differentiated safety profile with signs of clinical activity in RRMM patients and a patient with refractory RA. Further clinical evaluation of cizutamig in autoimmune diseases is being explored."

Preclinical • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Multiple Myeloma • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • CD20 • SDC1

Clinical Study of Cizutamig in Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=47 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial • CNS Disorders • Myasthenia Gravis

A First-In-Human Phase 1 Study of a Novel BCMA×CD3 Bispecific T Cell Engager EMB-06 in Relapsed or Refractory Multiple Myeloma. (PubMed, Am J Hematol) - No abstract available

First-in-human • Journal • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of Cizutamig in Systemic Sclerosis (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1 trial • Immunology • Scleroderma • Systemic Sclerosis

A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy (clinicaltrials.gov) - P1 | N=15 | Enrolling by invitation | Sponsor: Peking University First Hospital

New P1 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients with Generalized Myasthenia Gravis (gMG) (ChiCTR) - P1 | N=44 | Not yet recruiting | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New P1 trial • CNS Disorders • Myasthenia Gravis

Candid Therapeutics Advances Portfolio of Novel T-Cell Engagers into Five Autoimmune Diseases for Clinical Evaluation (Businesswire) - "First patients dosed with cizutamig and CND261: Patients with refractory rheumatoid arthritis and systemic sclerosis have been dosed at therapeutically active doses."

Trial status • Rheumatoid Arthritis • Systemic Sclerosis

CND106, a novel BCMA-directed T-cell engager (TCE), has a differentiated safety profile and potential for development in autoantibody-driven autoimmune diseases (EULAR 2025) - P1/2 | "CND106 (formerly known as EMB-06) is a novel 2 + 2 BCMA×CD3 T-cell engaging bispecific antibody featuring tetravalent binding domains in cis-configuration with high affinity for BCMA and optimized affinity for CD3 to reduce cytokine production while maintaining cytolytic activity... CND106 demonstrates a differentiated safety profile based on preclinical and clinical data. Furthermore, preclinical data support the potential for development of CND106 in autoantibody-driven autoimmune diseases."

Clinical • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Multiple Myeloma • Oncology • Systemic Lupus Erythematosus • IFNG • IL10 • IL2 • IL6 • TNFA

Optimization of a novel 2+2 BCMA x CD3 bispecific antibody for minimized cytokine release and potent efficacy. (PubMed, Mol Cancer Ther) - "The low cytokine release profile of CD3med FIT-Ig was further validated in human PBMC engrafted mice and cynomolgus monkeys. The CD3med FIT-Ig (also known as EMB-06) could offer a differentiated safety profile with effective anti-tumor activity."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma (clinicaltrials.gov) - P1/2 | N=40 | Terminated | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | N=66 ➔ 40 | Trial completion date: Mar 2025 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Aug 2024; Company's resource optimization and product's development change

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=19 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

EpimAb Biotherapeutics Announces Oral Presentation for EMB-06 (CND106) First-in-human (FIH) Phase I Study in Multiple Myeloma at the American Society of Hematology (ASH) 2024 Annual Meeting (GlobeNewswire) - "EpimAb Biotherapeutics...is pleased to announce the acceptance of a late-breaking abstract featuring our novel BCMA targeted T cell engager (TCE) EMB-06 (CND106) as an oral presentation at the American Society of Hematology (ASH) Annual Meeting in San Diego, California to be held between December 7-10, 2024....This presentation will highlight the full Phase I clinical results for EMB-06 (CND106), a novel BCMA targeting TCE designed with an optimized efficacy and safety profile, in relapsed or refractory multiple myeloma patients."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

EpimAb Biotherapeutics and Vignette Bio Announce Strategic Collaboration to Develop EMB-06, a BCMA×CD3 Bispecific Antibody (GlobeNewswire) - "EpimAb Biotherapeutics, Inc...and Vignette Bio, Inc...announced today that EpimAb and Vignette have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06....Under this agreement, EpimAb will grant Vignette the exclusive rights to develop and commercialize EMB-06 outside of Greater China (mainland China, Hong Kong, Macau and Taiwan), while EpimAb shall retain the rights to EMB-06 in Greater China."

Licensing / partnership • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase I Study of a Novel BCMA×CD3 Bispecific Antibody EMB-06 in Relapsed or Refractory Multiple Myeloma (RRMM) (ESMO-IO 2023) - No abstract available

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

A phase I study of a novel BCMA×CD3 bispecific antibody EMB06 in relapsed or refractory multiple myeloma (SITC 2023) - P1/2 | "An initial ORR of 100% has been observed at doses ≥120mg. Updated data will be shared at the meeting."

Late-breaking abstract • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology