Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 800 |
| INN | Pivekimab sunirine |
| Status | Clinical |
| Drug code(s) | IMGN632 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Alanine-Alanine (Cleavable linker) |
| Ave. DAR | 2; Site-specific (S442C) |
| Conjugated/fused moiety | DNA binding, DGN549 IGN (indolino-benzodiazepine) |
| Discovery method/technology | None |
| Target(s) | CD123 |
| Indications of clinical studies | Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies (single Phase 1 study) |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2017 |
| Start of Phase 2 | March 15, 2023 |
| Start of Phase 3 | |
| 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 | AbbVie |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 2024: Listed as Phase 2 in AbbVie pipeline Feb. 12, 2024: AbbVie announced that it has completed its acquisition of ImmunoGen. The pivotal phase 2 study for Blastic plasmacytoid dendritic cell neoplasm (NCT03386513 CADENZA) is recruiting as of March 15, 2023. Immunogen press release of June 9, 2023 "With enrollment in the R/R cohort complete, ImmunoGen expects to complete enrollment in the pivotal frontline de novo cohort this year and report top-line data in 2024." https://investor.immunogen.com/news-releases/news-release-details/immunogen-presents-updated-findings-cadenza-trial-pivekimab. Aug 2022: Following Discussion with FDA, CADENZA Patients to be Segmented into De Novo and PCHM BPDCN Patients; Aligned with FDA on Efficacy Analysis in De Novo Patients. Immunogen expects to report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end. Feb 2022: Continued the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab, formerly IMGN632) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm Oct 5, 2020: ImmunoGen, Inc. announced that FDA has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). Nov 1 2019 earnings release: ImmunoGen initiated a study in minimal residual disease positive (MRD+) AML patients following frontline induction therapy. The Phase Ib/II study will study both IMGN632 monotherapy as well as IMGN632 combination therapy with Vidaza (azacitidine) and Venclexta (venetoclax). NCT04086264 Phase 1/2 study in AML not yet recruiting as of Sep 11, 2019. As of Aug 2019, ImmunoGen plans to commence enrollment in the IMGN632 combination and single-agent MRD+ Phase 2 cohorts. Nov 2018: The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN632 for the treatment of acute myeloid leukemia. IND filed in mid-September 2017; NCT03386513 Phase 1 study started Jan 4 2018 recruiting as of last record update in June 2019. |
| Full address of company | Waltham, Massachusetts, United States North America United States of America https://www.immunogen.com/ |
Conjugated with Indolino-benzodiazepine compound (sulfonated DGN462)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |