Ianalumab Clinical Naked monospecific

Antibody Information

Entry ID	1415
INN	Ianalumab
Status	Clinical
Drug code(s)	VAY736, NOV-5
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Phage display (HuCAL)-derived antibody

Therapeutic information

Target(s)	BAFFR
Indications of clinical studies	Diffuse Cutaneous Systemic Sclerosis, Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus, Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Autoimmune Hepatitis, Systemic Lupus Erythematosus, Pulmonary fibrosis, rheumatoid arthritis, Primary Sjögren's syndrome, Pemphigus Vulgaris, Relapse Remitting Multiple Sclerosis, Leukemia
Primary therapeutic area	Immune-mediated / inflammatory disorders

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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 15, 2012
Start of Phase 2	December 15, 2013
Start of Phase 3	February 28, 2018
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	Novartis Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	Q2 2024 update: Possible submission in 2026 (https://www.novartis.com/sites/novartis_com/files/q2-2024-investor-presentation.pdf) Q2 2023 update: 1L and 2L ITP readouts in 2025 with submission in 2026 Phase 3 studies for Sjogren syndrome (NCT05350072 is recruiting as of March 2023, NCT05349214 is recruiting as of May 2023); Lupus nephritis (NCT05126277); Systemic Lupus Erythematosus (NCT05624749, NCT05639114) are recruiting as of April 2023; Warm Autoimmune Hemolytic Anemia (wAIHA) (NCT05648968) is recruiting as of May 2023; Primary Immune Thrombocytopenia (ITP) (NCT05653349, NCT05653219) are recruiting as of May 2023; and phase 2/3 study for Autoimmune hepatitis (NCT03217422) is recruiting as of September 21, 2022. Fast track for Sjogren Syndrome NCT05648968 Phase 3 in Warm Autoimmune Hemolytic Anemia started in Dec 2022. NCT05350072 and NCT05349214 Phase 3 studies in Sjogren Syndrome started in Aug 2022; NCT05126277 Phase 3 in Lupus Nephritis started in July 2022. Phase 2/3 in Autoimmune Hepatitis still recruiting as of May 2021. Results from NCT02962895 Phase 2B study in Primary sjogren's syndrome expected in H2-2020. NCT03656562 Phase 2 study in lupus started recruiting in Dec 2018. Total of 6 Phase 1/2 or 2 studies listed on clinicaltrials.gov as of Aug 2017. Phase 2/3 NCT03217422 AMBER study in Autoimmune Hepatitis started in Feb 2018.
Full address of company	Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens TNFRSF13C (tumor necrosis factor receptor (TNFR) superfamily member 13C, BAFFR, BAFF-R, BR3, B cell activating factor receptor, CD268)], Homo sapiens monoclonal antibody

Additional information

Anticipated events	Submission readout in 2025, possible submission in 2026
Factor(s) contributing to discontinuation	None