Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 214 |
| INN | Glenzocimab |
| Status | Clinical |
| Drug code(s) | ACT017 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | Fab |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | GP VI |
| Indications of clinical studies | Heart attack, Acute Ischemic Stroke, COVID-19, thrombotic diseases |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2017 |
| Start of Phase 2 | December 16, 2020 |
| Start of Phase 3 | September 23, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Acticor Biotech |
| Licensee/Partner | None |
| Comments about company or candidate | Oct 2024: Acticor Biotech Repositions Glenzocimab in the Treatment of Myocardial Infarction Aug 2024: Paris Commercial Court opened receivership proceedings on August 6, 2024. The purpose of these proceedings is to enable the Company to assess all options for pursuing the development of its product, glenzocimab, and its search for financing and partners. This procedure also enables the Company, as announced on August 6, 2024, to finance its operations until January 2025. Sep 2023: Acticor plans to consult the EMA and FDA again during 2024 to confirm that the phase 3 design will support registration in both Europe and the United States, projected no later than 2028. May 30, 2023 press release: Anticor has discussed the clinical development plan of glenzocimab in acute ischemic stroke (AIS) with US and EU regulatory agencies and summarised here the outcome: https://uploads-ssl.webflow.com/60ed4d6a6fc45c3a0e3cfb8f/64762965523664c9b52e6abd_Acticor_PR_FDA_EN_vf.pdf NCT05559398 Phase 2/3 study of Glenzocimab for REperfusion in the Setting of Endovascular Therapy for Brain infarctioN: GREEN Study due to start in Oct 2022 has not been updated since Sep 2022. Sep 2022: Acticor Biotech has enrolled the first US subject in the Phase II/III ACTISAVE (NCT05070260) clinical trial of glenzocimab in acute ischemic stroke patients. July 2022: PRIME Designation for Acute Ischemic Stroke NCT05070260 Phase 2/3 in stroke patients started in Sep 2021 recruiting as of April 21, 2023. NCT04659109 Phase 2 in COVID-19 started on Dec 16, 2020. NCT03803007 Phase 1/2 study Acute Ischemic Stroke Interventional Study (not yet recruiting as of June 21, 2019. February 5, 2018 – Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including stroke and other thrombosis disorders like pulmonary embolism, announced today the completion of its phase I clinical trial in healthy volunteers with its drug candidate, ACT017. The study, a randomized, double blind, placebo-controlled single escalating dose, conducted in the clinical research center of QPS (The Netherlands) enrolled 48 subjects in 6 dose level cohorts, with each cohort consisting of 8 subjects: 6 on active and 2 on placebo at subsequent doses of 62,5 – 125 – 250 – 500 – 1 000 and 2 000 mg. |
| Full address of company | Acticor Biotech, Wojo Building, 82, avenue du Maine, 75014 Paris Europe France https://www.acticor-biotech.com/ |
ACT017 is a humanized monoclonal antibody fragment (Fab) directed against a platelet glycoprotein (GPVI) involved in thrombosis.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |