Drugs / Cusatuzumab
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04241549 | Mar 2020 → Jul 2021 | acute myeloid leukemia | OncoVerity, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04150887 | Dec 2019 → May 2027 expected | acute myeloid leukemia | OncoVerity, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02759250 | Feb 2015 → Apr 2018 | cancer | argenx | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03030612 | Dec 2016 → Aug 2022 | acute myeloid leukemia, myelodysplastic syndrome | OncoVerity, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01813539 | Feb 2013 → Jul 2020 | neoplasm | OncoVerity, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06384261 | Jul 2024 → Jan 2027 expected | acute myeloid leukemia | OncoVerity, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04264806 | May 2021 → Apr 2022 | chronic myelomonocytic leukemia, myelodysplastic syndrome | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04023526 | Jul 2019 → Aug 2023 overdue | acute myeloid leukemia | OncoVerity, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2023-04-01 | OncoVerity, Inc. | Results Nasopharyngeal carcinoma cells promote regulatory T cell development and suppressive activity via CD70-CD27 interaction oncoverity.com ↗ |
| 2023-01-01 | OncoVerity, Inc. | Results Results from a phase I/II trial of cusatuzumab combined with azacitidine in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy oncoverity.com ↗
Results from a phase I/II trial of cusatuzumab combined with azacitidine in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy |
| 2021-01-07 | argenx | Results argenx Announces 2021 Corporate Priorities and Highlights Recent Achievements Across Immunology Pipeline argenx.com ↗
Additionally, the Company announced interim data from the Phase 2 CULMINATE trial of cusatuzumab in development with Cilag GmbH International, an affiliate of Janssen, and provided financial guidance for 2021. |
| 2020-09-01 | OncoVerity, Inc. | Results Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents oncoverity.com ↗
Hematological responses in the 12 patients enrolled included 8 complete remission, 2 complete remission with incomplete blood count recovery and 2 partial remission with 4 patients achieving minimal residual disease negativity by flow cytometry at <10−3. |
| 2019-12-06 | argenx | Results argenx Announces Receipt of First Milestone Payment under Janssen Collaboration and Provides Data Update from Phase 1 Dose Escalation Trial of Cusatuzumab in Acute Myeloid Leukemia at ASH Annual Meeting argenx.com ↗ |
| 2018-12-02 | argenx | Results argenx Provides Detailed Data from Phase 2 Clinical Trial of Efgartigimod in Immune Thrombocytopenia and Phase 1/2 Clinical Trial of Cusatuzumab in Acute Myeloid Leukemia argenx.com ↗
New cusatuzumab data in AML resulted in a 92% response rate with 10 of 12 patients showing a complete response (CR/CRi) |
| 2018-10-31 | argenx | Results argenx announces new cusatuzumab (ARGX-110) AML data in abstracts published in connection with 60th American Society of Hematology Annual Meeting and Exposition argenx.com ↗
As of the data cut-off on July 16, 2018, the ORR across the 12 patients was 92% (11/12 patients), including 9 patients (82%) with a complete response with or without hematologic recovery (CR/CRi), 1 patient (9%) who reached morphologic leukemia-free status, and 1 (9%) partial response (PR). |
| 2017-12-10 | argenx | Results argenx to provide updates on Phase 1/2 clinical trials of ARGX-110 in Acute Myeloid Leukemia and Cutaneous T-Cell Lymphoma during American Society of Hematology Annual Meeting argenx.com ↗
All six patients showed encouraging signs of clinical activity, including complete remission (3/6), complete remission with incomplete blood count recovery (1/6) and partial response (2/6). |
| 2017-06-13 | argenx | Results argenx presents update on Phase I data from ARGX-110 expansion study in patients with cutaneous T-cell lymphomas at the International Conference of Malignant Lymphoma (ICML) argenx.com ↗
We observed partial response and stable disease, respectively, in three and seven out of 16 patients with highly relapsed/refractory CTCL and confirmed overexpression of CD70. |
| 2016-12-27 | argenx | Results argenx announces publication of seminal data supporting the therapeutic potential of ARGX-110 for acute myeloid leukemia in the Journal of Experimental Medicine argenx.com ↗
Data published by argenx collaborator Prof. Adrian Ochsenbein at the University of Bern, demonstrate that CD70/CD27 is highly expressed on AML blasts and leukemic stem cells in newly diagnosed AML patients, regardless of cytogenetic factors, or the patient’s risk class. |
| 2016-11-30 | argenx | Results argenx to provide updates on ARGX-113 and ARGX-110 during American Society of Hematology Annual Meeting argenx.com ↗
ARGX-110 continues to show a favorable safety and tolerability profile. |
| 2016-06-08 | argenx | Results argenx announces presentation of updated ARGX-110 phase 1 data in TCL at EHA 2016 argenx.com ↗
The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70. |
| 2015-12-03 | argenx | Results argenx to host workshop and webcast announcing topline clinical TCL data and preclinical AML data from ARGX-110 program argenx.com ↗
The data on ARGX-110, a novel anti-CD70 therapeutic antibody, include topline clinical results in T-cell lymphoma (TCL) and preclinical data in acute myelogenous leukemia (AML). |
| 2015-07-29 | argenx | Results arGEN-X and University of Bern enter into license agreement to develop ARGX-110-based combination therapies for treatment-resistant cancers argenx.com ↗
Ongoing preclinical work has demonstrated the potential use of ARGX-110 to overcome imatinib resistance in chronic myelogenous leukemia (CML), data which are published today in the leading journalScience Translational Medicine. |
| 2015-06-17 | argenx | Results Preliminary Phase I results of ARGX-110 in patients with T-cell lymphomas presented at ICML argenx.com ↗
Breda, the Netherlands/Ghent, Belgium– arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, today presented preliminary results from an ongoing Phase I study of ARGX-110 in patients with T-cell lymphoma at the 13th International Conference on Malignant Lymphoma (Lugano, Switzerland; 17-20 June, 2015) in the ‘Novel Agents’ session. |
| 2014-12-07 | argenx | Results arGEN-X Reports Preclinical Data on ARGX-110 in Chronic Myelogenous Leukemia Model argenx.com ↗
The data show that co-treatment of ARGX-110, the Company’s anti-CD70 therapeutic antibody, and imatinib, a first-line BCR/ABL-specific tyrosine kinase inhibitor (TKI), eradicates the disease-initiating CML stem cells, a cell population often resistant to TKI therapy. |
| 2014-11-02 | argenx | Regulatory arGEN-X Submits Investigational New Drug Application to Evaluate ARGX-110 in Waldenström’s Macroglobulinemia argenx.com ↗
announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b/2 trial of ARGX-110 in patients with relapsed or refractory Waldenström’s macroglobulinemia. |
| 2014-05-28 | argenx | Results arGEN-X to present results of Phase 1 study of ARGX-110, a novel anti-CD70 antibody, in patients with advanced cancer at ASCO argenx.com ↗
The study also showed that ARGX-110 has a favorable safety profile and identified a dose that was advanced into a larger safety study in patients with a range of hematological and solid tumors. |
| 2013-12-16 | argenx | Results ARGX-110, a novel anti-CD70 antibody, meets translational development goals in dose escalation part of Phase Ib cancer study argenx.com ↗
The study also showed that ARGX-110 has a favourable safety profile and a dose has been selected to advance into the Phase Ib safety and efficacy expansion cohorts, which will start early in 2014 and are expected to report top-line results approximately 12 months later. |
All press releases naming this drug 34 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cusatuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04023526 ↗ |
| Known as | ARGX-110 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02759250 ↗ |
| Action | Inhibit | “ARGX-110, a defucosylated IgG1 monoclonal antibody (mAb) that selectively targets and neutralizes CD70, the ligand of CD27.” PMID 24492296 ↗ Dec 2013 |
| Modality | Monoclonal antibody | “ARGX-110, a defucosylated IgG1 monoclonal antibody (mAb) that selectively targets and neutralizes CD70, the ligand of CD27.” PMID 24492296 ↗ Dec 2013 |
| Route | Intravenous | “ARGX-110 will be administered as an IV infusion.” NCT01813539 ↗ |
| Target | CD70 | “ARGX-110, a defucosylated IgG1 monoclonal antibody (mAb) that selectively targets and neutralizes CD70, the ligand of CD27.” PMID 24492296 ↗ Dec 2013 |