Tifcemalimab Clinical Naked monospecific

Antibody Information

Entry ID	863
INN	Tifcemalimab
Status	Clinical
Drug code(s)	JS004, TAB004
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	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	BTLA
Indications of clinical studies	Lung cancer, Head and Neck Squamous Cell Carcinoma/Nasopharyngeal Carcinoma, Recurrent/Refractory Malignant Lymphoma, 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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	April 15, 2019
Start of Phase 2
Start of Phase 3	November 15, 2023
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	Shanghai Junshi Bioscience Co Ltd
Licensee/Partner	None
Comments about company or candidate	NCT06170489 / CTR20234002 Phase 3 in Hodgkin's lymphoma started in Dec 2023. NCT06095583 / CTR20233182 Phase 3 in small cell lung cancer started in Nov 2023. June 28, 2023: Shanghai Junshi Biosciences Co., Ltd announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed. Junshi Biosciences will officially initiate the phase 3 clinical study in the near future. NCT05664971 Phase 1/2 in lung cancer due to start in Dec 2022. Phase 1/2 in Head and Neck Squamous Cell Carcinoma and Nasopharyngeal Carcinoma started in May 2021. NCT04477772 Phase 1 in lymphoma not yet recruiting when first posted in July 2020. NCT04137900 Phase 1 started in Oct 2019, In April 2019, the IND of JS004 for treatment of patients with advanced unresectable or metastatic solid tumors (including lymphoma) and patients refractory to prior PD-1 antibody treatment was approved by the U.S. FDA for clinical trial. In October 2019, the first patient has been successfully dosed in the Phase I clinical trial (NCT04137900) conducted in the U.S. Junshi Biosciences announce that the company has received the Clinical Trial Approval in respect of the “recombinant humanized anti-BTLA monoclonal antibody injection” (project code: TAB004/JS004) issued by the National Medical Products Administration (NMPA).
Full address of company	100, Pingjiaqiao Road, Shanghai, China Asia China https://www.junshipharma.com/en/contact-us/

Description/comment

Humanized IgG4κ monoclonal antibody. Target is B and T lymphocyte attenuator (BTLA; CD272) is a member of the CD28 family expressed on activated T cells, B cells, and APCs.
INN was formerly icatolimab.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None