DNTH103, ZB005 Clinical Naked monospecific

Antibody Information

Entry ID	564
INN	None
Status	Clinical
Drug code(s)	DNTH103, ZB005
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	Complement C1s
Indications of clinical studies	Multifocal Motor Neuropathy, Generalized Myasthenia Gravis
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)	November 15, 2022
Start of Phase 2	February 15, 2024
Start of Phase 3	February 10, 2025
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	Dianthus Therapeutics
Licensee/Partner	Zenas BioPharma
Comments about company or candidate	NCT06858579 Phase 3 in Chronic Inflammatory Demyelinating Polyneuropathy started in Feb 2025. NCT06537999 Phase 2 in Multifocal Motor Neuropathy started in Sep 2024. July 2024 corrporate presentation focused on DNTH103 (https://investor.dianthustx.com/static-files/f2b9dc4c-b746-47bb-ae09-f9baff2ca3d8) June 2024: FDA clears Phase 2 in multi-focal motor neuropathy to start. Feb. 26, 2024: Dianthus Therapeutics, Inc. announced the initiation of the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis Jan 2024 presentation: On track to initiate multiple Ph. 2 trials in neuromuscular indications starting with generalized Myasthenia Gravis in Q1’24 with top-line results in 2H’25; Ph. 2 trials in CIDP and MMN to be initiated in 2024. November 30, 2022 – Dianthus Therapeutics announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial of its lead monoclonal antibody, DNTH103. Data from this Phase 1 study will provide important information about the safety, tolerability, pharmacokinetics and pharmacodynamics of DNTH103 in healthy adult volunteers across single and multiple ascending dose cohorts, demonstrating potential proof-of-concept to advance DNTH103 into severe autoimmune diseases Zenas holds the development and commercialization rights in greater China (https://www.sec.gov/Archives/edgar/data/1953926/000110465924097538/tm2332800-15_s1a.htm)
Full address of company	Massachusetts, United States North America United States of America https://dianthustx.com/?pag=1&category=3

Description/comment

DNTH103 is a selective inhibitor of the active C1s protein in the complement system’s classical pathway. YTE half-life extension
https://investor.dianthustx.com/static-files/650017e0-0d1c-4701-bc7e-60d48691c252

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None