Pivekimab sunirine Clinical ADC

Antibody Information

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

Therapeutic information

Target(s)	CD123
Indications of clinical studies	Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies (single Phase 1 study)
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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/

Description/comment

Conjugated with Indolino-benzodiazepine compound (sulfonated DGN462)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None