BAT1308 Clinical Naked monospecific

Antibody Information

Entry ID	374
INN	None
Status	Clinical
Drug code(s)	BAT1308
Brand name	None
mAb sequence source	mAb humanized
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)	PD-1
Indications of clinical studies	Mismatch repair protein-deficient (dMMR) endometrial carcinoma, Solid tumors
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 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	January 15, 2021
Start of Phase 2	December 13, 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	Bio-Thera Solutions Ltd.
Licensee/Partner	None
Comments about company or candidate	NCT06321068 Phase 2/3 in endometial cancer started in Mar 2024 active not recruiting as of last update in Oct 2024.. NCT06123884 / CTR20232394 Phase 2/3 in cervical cancer started in Dec 2023. NCT05109650 Phase 1 in solid tumors due to start in December 2021. NCT05155722 Phase 1 started in Sep 2020 recruiting as of last update in Jan 2022. Bio-Thera Solutions, Ltd., a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers.
Full address of company	Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China Asia China https://www.bio-thera.com/plus/list.php?tid=67

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None