First‐in‐human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti‐CD40 monoclonal antibody
Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first‐in‐human, randomized, double‐blind, placebo‐controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscali...
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| Published in | American journal of transplantation Vol. 20; no. 2; pp. 463 - 473 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Limited
01.02.2020
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1600-6135 1600-6143 1600-6143 |
| DOI | 10.1111/ajt.15661 |
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| Abstract | Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first‐in‐human, randomized, double‐blind, placebo‐controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target‐mediated drug disposition resulting in dose‐dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3‐0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154‐induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40‐CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases.
Iscalimab is a promising blocker of the CD40‐CD154 costimulatory pathway with potential use in transplantation and autoimmune diseases. |
|---|---|
| AbstractList | Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first-in-human, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target-mediated drug disposition resulting in dose-dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3-0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154-induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40-CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases. Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first-in-human, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target-mediated drug disposition resulting in dose-dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3-0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154-induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40-CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases.Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first-in-human, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target-mediated drug disposition resulting in dose-dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3-0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154-induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40-CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases. Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first‐in‐human, randomized, double‐blind, placebo‐controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target‐mediated drug disposition resulting in dose‐dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3‐0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154‐induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40‐CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases. Iscalimab is a promising blocker of the CD40‐CD154 costimulatory pathway with potential use in transplantation and autoimmune diseases. Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent. We describe a first‐in‐human, randomized, double‐blind, placebo‐controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of iscalimab in healthy subjects and rheumatoid arthritis patients. Healthy subjects (n = 56) received single doses of intravenous iscalimab (0.03, 0.1, 0.3, 1, or 3 mg/kg), or subcutaneous iscalimab (3 mg/kg), or placebo. Rheumatoid arthritis patients (n = 20) received single doses of intravenous iscalimab (10 or 30 mg/kg) or placebo. Iscalimab exhibited target‐mediated drug disposition resulting in dose‐dependent and nonlinear pharmacokinetics. Complete (≥90%) CD40 receptor occupancy on whole blood B cells was observed at plasma concentrations >0.3‐0.4 µg/mL. In subjects receiving 3 mg/kg iscalimab, antibody responses to keyhole limpet hemocyanin were transiently suppressed. CD40 occupancy by iscalimab prevented ex vivo human rCD154‐induced expression of CD69 on B cells in whole blood. All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events. Iscalimab appears to be a promising blocker of the CD40‐CD154 costimulatory pathway with potential use in transplantation and other autoimmune diseases. |
| Author | Schuler, Roland Avrameas, Alexandre Espié, Pascal Koo, Phillip Chokoté, Edwige Rush, James S. Ristov, Jacinda Verles, Aurelie Rotte, Michael Gergely, Peter Colin, Laurence Dupuy, Cyrielle Mergentaler, Heidi Milojevic, Julie Hernandez‐Illas, Martha Groenewegen, Andrea Auger, Anita Sickert, Denise Tomek, Charles S. He, YanLing |
| Author_xml | – sequence: 1 givenname: Pascal surname: Espié fullname: Espié, Pascal organization: Novartis Institutes for BioMedical Research – sequence: 2 givenname: YanLing surname: He fullname: He, YanLing email: yanling.he@novartis.com organization: Novartis Institutes for BioMedical Research, Inc – sequence: 3 givenname: Phillip surname: Koo fullname: Koo, Phillip organization: Novartis Pharmaceuticals Corporation – sequence: 4 givenname: Denise surname: Sickert fullname: Sickert, Denise organization: Novartis Institutes for BioMedical Research – sequence: 5 givenname: Cyrielle surname: Dupuy fullname: Dupuy, Cyrielle organization: Novartis Institutes for BioMedical Research – sequence: 6 givenname: Edwige surname: Chokoté fullname: Chokoté, Edwige organization: Novartis Institutes for BioMedical Research – sequence: 7 givenname: Roland surname: Schuler fullname: Schuler, Roland organization: Novartis Institutes for BioMedical Research – sequence: 8 givenname: Heidi surname: Mergentaler fullname: Mergentaler, Heidi organization: Novartis Institutes for BioMedical Research – sequence: 9 givenname: Jacinda surname: Ristov fullname: Ristov, Jacinda organization: Novartis Institutes for BioMedical Research – sequence: 10 givenname: Julie surname: Milojevic fullname: Milojevic, Julie organization: Novartis Institutes for BioMedical Research – sequence: 11 givenname: Aurelie surname: Verles fullname: Verles, Aurelie organization: Novartis Institutes for BioMedical Research – sequence: 12 givenname: Andrea surname: Groenewegen fullname: Groenewegen, Andrea organization: Novartis Institutes for BioMedical Research – sequence: 13 givenname: Anita surname: Auger fullname: Auger, Anita organization: Novartis Institutes for BioMedical Research – sequence: 14 givenname: Alexandre surname: Avrameas fullname: Avrameas, Alexandre organization: Novartis Institutes for BioMedical Research – sequence: 15 givenname: Michael surname: Rotte fullname: Rotte, Michael organization: Novartis Institutes for BioMedical Research – sequence: 16 givenname: Laurence surname: Colin fullname: Colin, Laurence organization: Novartis Institutes for BioMedical Research, Inc – sequence: 17 givenname: Charles S. surname: Tomek fullname: Tomek, Charles S. organization: Celerion, Inc – sequence: 18 givenname: Martha surname: Hernandez‐Illas fullname: Hernandez‐Illas, Martha organization: QPS Miami – sequence: 19 givenname: James S. surname: Rush fullname: Rush, James S. organization: Novartis Institutes for BioMedical Research – sequence: 20 givenname: Peter surname: Gergely fullname: Gergely, Peter organization: Novartis Institutes for BioMedical Research |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31647605$$D View this record in MEDLINE/PubMed |
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| Copyright | 2019 The American Society of Transplantation and the American Society of Transplant Surgeons 2019 The American Society of Transplantation and the American Society of Transplant Surgeons. 2020 The American Society of Transplantation and the American Society of Transplant Surgeons |
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| Keywords | clinical trial translational research/science immunosuppressant - fusion proteins and monoclonal antibodies: B cell specific immunosuppression/immune modulation clinical research/practice |
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publication-title: Transplantation. doi: 10.1097/01.tp.0000286058.79448.c7 |
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| SubjectTerms | Adolescent Adult Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - pharmacokinetics Antibodies, Monoclonal - therapeutic use Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - immunology Autoimmune diseases Case-Control Studies CD40 antigen CD40 Antigens - immunology CD40L protein CD69 antigen clinical research/practice clinical trial Double-Blind Method Female Follow-Up Studies Humans immunosuppressant – fusion proteins and monoclonal antibodies: B cell specific immunosuppression/immune modulation Immunosuppressive Agents - adverse effects Immunosuppressive Agents - pharmacokinetics Immunosuppressive Agents - therapeutic use Injections, Intravenous Injections, Subcutaneous Intravenous administration Lymphocytes B Male Middle Aged Monoclonal antibodies Pharmacodynamics Pharmacokinetics Rheumatoid arthritis Safety Thromboembolism translational research/science Transplantation Young Adult |
| Title | First‐in‐human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti‐CD40 monoclonal antibody |
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