Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1364 |
| INN | None |
| Status | Clinical |
| Drug code(s) | TNM001 |
| Brand name | None |
| 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) | RSV (F glycoprotein) |
| Indications of clinical studies | Healthy preterm and term infants. |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2021 |
| Start of Phase 2 | October 25, 2022 |
| Start of Phase 3 | September 11, 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 | Zhuhai Trinomab Biotechnology Co Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06710925 Phase 3 due to start in Nov 2024. NCT06083623 / CTR20232792 Phase 2/3 in preventing lower respiratory tract infections caused by respiratory syncytial virus in infants under 1 year of age started in Sep 2023 NCT05630573 is a Phase Ib/IIa clinical trial for TNM001 injection is a multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TNM001 injection in healthy Chinese preterm and term infants. The primary objective is to assess the safety and tolerability after injection with a single intramuscular dose of TNM001 in healthy preterm and term infants to provide basis line information for subsequent confirmatory trials. IND application of TNM001 injection was approved by China NMPA in July and US FDA in November of 2021. A randomized, double-blind, placebo-controlled phase I clinical trial is being conducted in healthy adults. At present time, all subjects have been enrolled and are being followed up. Preliminary clinical trial results showed that TNM001 was safe and well tolerated in healthy adults, and no adverse events related to TNM001 were found. |
| 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 |
Recombinant anti-respiratory syncytial virus (RSV) fully human monoclonal antibody TNM001 injection. TNM001 is intended to prevent severe lower respiratory tract disease resulted by pediatric respiratory syncytial virus. The results of preclinical research showed that it had broadly potent neutralizing activity by targeting on the pre-fusion conformation (Pre-F) epitope of RSV fusion protein (F), effectively protected infectious animal model of cotton rats from challenge with RSV, had no apparent side effects in preclinical animal studies, had long half-life, thus providing longer-term protection in humans. https://trinomab.com/en-us/list/95.html
| Anticipated events | Phase 3 pending |
| Factor(s) contributing to discontinuation | None |