Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1365 |
| INN | None |
| Status | Regulatory review |
| Drug code(s) | TNM002 |
| Brand name | (Pending) |
| mAb sequence source | mAb human |
| 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 |
| Target(s) | Tetanus toxin |
| Indications of clinical studies | Infection with Clostridium bacteria |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | December 31, 2022 |
| 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 | Zhuhai Trinomab Biotechnology Co Ltd. |
| Licensee/Partner | China Medical System Holdings Limited |
| Comments about company or candidate | Dec 2023: TNM002 in review in China https://mp.weixin.qq.com/s/f-C5ScgNqm3j8nAQBRQbMw Jan 13, 2023: Trinomab Biotech has initiated a Phase III Clinical Trial of Its Fully Native Human Monoclonal Antibody (TNM002) in patients at risk after exposure to C. tetani. The phase III clinical trial of TNM002 is carried out in 30 clinical research centers in China. Phase 3 study for Tetanus (NCT05664750) started in Dec 2022 is active not recruiting as of last update in May 2023, and on chinadrugtrials (CTR20223067) it is "in progress, recruitment complete". Aug 2022 LinkedIn post: US FDA has granted Fast Track Designation to our fully native human monoclonal antibody TNM002 for the prophylaxis against tetanus. TNM002, already in late phase II in China. NCT05842798 Phase 1 in healthy volunteers started in Oct 2021 completed in Feb 2022. April 2021: The Board of Directors (the “Directors”) of China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group through its wholly-owned subsidiary signed certain agreements for strategic collaboration with an innovative biopharmaceutical company Trinomab Biotech Co., Ltd. (珠海泰諾麥博生物技術有限公司, the English name is for identification purpose) (“Trinomab” or the “Investment Target”) recently and pursuant to which the Group will make equity investment in and establish a joint venture with Trinomab (the “Collaboration”) Based on the HitmAb® platform, Trinomab has developed more than 20 new native natural fully human monoclonal antibodies, including those against infectious diseases (such as rabies virus, tetanus toxin, cytomegalovirus, respiratory syncytial virus, varicella-zoster virus novel coronavirus, etc.) and cancers, among which, certain antibody products are in the process of rapid industrialization. CXSL2100089 has event date of Mar 2021. NCT04629131 Phase 1 in healthy adults started in Nov 2020 |
| Full address of company | 2F, Building 6C, Zhizao Street, Hongqi Town, Jinwan District, Zhuhai, Guangdong Asia China https://trinomab.com/en-us/list/70.html |
TNM002 (human monoclonal antibody against tetanus toxin). TNM002 is a natural and fully human monoclonal antibody drug developed by Trinomab using its HitmAb technology platform with independent intellectual property rights. Preclinical studies show that TNM002 has strong specificity and affinity
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |