IMVT-1402, HL161ANS Clinical TBD

Antibody Information

Entry ID	811
INN	None
Status	Clinical
Drug code(s)	IMVT-1402, HL161ANS
Brand name	None
mAb sequence source	mAb human
General Molecular Category	TBD
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic rat (OmniRat)

Therapeutic information

Target(s)	FcRn
Indications of clinical studies	Phase 1 in healthy volunteers
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 2 pivotal
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 15, 2023
Start of Phase 2
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	Immunovant Inc.
Licensee/Partner	HanAll Biopharma Co. Ltd.
Comments about company or candidate	Feb 2025 company update: IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiated NCT06727604 Phase 2 in Graves' disease started in Dec 2024. Sep 2024: Pivotal trial of IMVT-1402 in GD expected by December 31, 2024. May 2023: Immunovant received IND clearance for IMVT-1402 from the U.S. Food and Drug Administration (FDA) and initiated a Phase 1 clinical trial of IMVT-1402 in healthy volunteers in New Zealand after approval of the CTA by the regulatory authority, MEDSAFE. The clinical trial will evaluate the safety, tolerability and pharmacodynamic profiles of IMVT-1402, a subcutaneously administered, FcRn inhibitor. In the multiple-ascending dose (MAD) portion of the study, Immunovant plans to evaluate subcutaneous doses of 300 mg and 600 mg, at a concentration of 150 mg/mL vs. placebo. Immunovant anticipates initial results from a Phase 1 trial for HL161ANS, a new FcRn inhibitor (Immunovant project designation: IMVT-1402), in the second half of 2023. Immunovant also plans to evaluate HL161ANS in multiple autoimmune diseases, based on strategic portfolio considerations. Feb 2023: Immunovant plans to initiate a Phase 1 clinical trial for IMVT-1402 in early calendar year 2023 contingent on clearance of its Investigational New Drug (“IND”) application, with initial data results from this Phase 1 trial expected to be available in mid-calendar year 2023. Immunovant expects to have top-line results from the ongoing MG trial in the second half of calendar year 2024 and from the TED program, consisting of two Phase 3 clinical trials, in the first half of calendar year 2025. Sept. 28, 2022: Immunovant, Inc. announced a new anti-FcRn, IMVT-1402, at Roivant’s Investor Day at 11:00am on September 28, 2022.
Full address of company	320 W 37th Street, 6th Floor, New York, NY 10018 North America United States of America https://www.immunovant.com/contact-us

Description/comment

IMVT-1402 is a novel, fully human monoclonal antibody that targets the neonatal fragment crystallizable receptor

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None