Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| 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 |
| 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 | 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/ |
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.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |