MIL62 Clinical Naked monospecific

Antibody Information

Entry ID	1007
INN	None
Status	Clinical
Drug code(s)	MIL62
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Systemic Lupus Erythematosus, Primary Membranous Nephropathy, Neuromyelitis Optica Spectrum Disorder, Non-Hodgkin's lymphoma
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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 15, 2019
Start of Phase 2
Start of Phase 3	June 02, 2021
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	Beijing Mabworks Biotech Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	Phase 2/3 and 3 studies for: Neuromyelitis optica spectrum disorder (NCT05314010) is recruiting as of November, 2024; Follicular lymphoma and marginal zone lymphoma (NCT04834024) is recruiting as of November, 2024; Systemic Lupus Erythematosus (NCT05796206) is recruiting as of March 2024; Primary Membranous Nephropathy (NCT05862233) is recruiting as of November, 2024. Phase 2/3 and 3 studies for: Neuromyelitis optica spectrum disorder (NCT05314010) is recruiting as of August 24, 2022; Follicular lymphoma and marginal zone lymphoma (NCT04834024) is recruiting as of November 14, 2022; Systemic Lupus Erythematosus (NCT05796206) is not yet recruiting as of April 3, 2023. Aug 2022: H2 2024 NDA submission is upcoming milestone. Partnered with Jiangsu Hengrui Pharmaceutical Co., Ltd. in 2021, but partnership terminated in 2023. NCT04834024 Phase 3 in follicular lymphoma started in June 2021. NCT04304040 Phase 1/2 study in B-cell lymphoma not yet recruiting when posted on March 11, 2020. NCT04110301 Phase 1 study started in Nov 2019 (https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00281-5/fulltext)
Full address of company	Room 25, Tower 1, HAN'S Plaza, No. 2 Ronghua South Road, Beijing Economic-Technological Development Area Asia China http://www.mab-works.com/en/contactus.html

Description/comment

Humanized glycoengineered type Ⅱ anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region (https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00281-5/fulltext)

Additional information

Anticipated events	Marketing application possible in 2024
Factor(s) contributing to discontinuation	None