On October 24, Trinomab announced that its self-developed recombinant anti-respiratory syncytial virus (RSV) fully human monoclonal antibody TNM001 injection has entered Phase Ib/IIa clinical trial stage in China.
TNM001 injection is the first RSV fully human monoclonal antibody independently developed by Trinomab, to enter the clinical stage in China, which 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.
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.
Current 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 was to evaluate 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.
Dr. Wanmei Wang, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, said: "The Phase I clinical trial of TNM001 injection is progressing well. As a preventive drug for infants and young children, we have paid especially close attention to the safety, tolerability and effectiveness of the drug in infants clinical trial design process. The ongoing Ib/IIa trial is the first time to explore the safety and effectiveness of TNM001 injection in infants and young children, which is essential for the follow-up confirmatory clinical trials of the drug. Now the trail has been launched and we hope that infants in the future we can provide the best alternative medication for the prevention of RSV infection.”
About TNM001
As the most important cause of seasonal lower respiratory tract infections in infants and children, RSV is also an important contributor to neonatal mortality due to viral infections. Based on epidemiology data, during the late fall through early spring of the epidemic season, 80% of lower respiratory tract infection cases among infants and children under 1 year old are caused by RSV infection, and the RSV infection rate of children under 2 years old can reach as high as 99%.
There is no vaccine or specific antiviral drug against RSV infection in China. Palivizumab (Synagis ®), developed by MedImmune, was approved by FDA in 1998 for the prevention of severe lower respiratory tract disease resulted by pediatric respiratory syncytial virus (RSV), but is not yet available in China. Palivizumab requires monthly injections during the epidemic season (5-6 months) of RSV.
TNM001 injection, a fully human monoclonal antibody derived from healthy adults, specifically binds Pre-F on a conservative antigenic epitope and blocks the entry of RSV into host cells, thus blocking the transmission of the virus. In vitro studies showed that TNM001 neutralize various strains of RSV viruses with potency at least 30-fold better than that of the Palivizumab. TNM001 antibody with only one injection is expected to bring protection against RSV infection for an entire epidemic season, making it more competitive in terms of costs and clinical adherence.
About Trinomab
Trinomab Biotech Co., Ltd. is a clinical stage biopharmaceutical company with a global expansion perspective. The company is mainly engaged in R&D of novel fully native human mAb drugs. The core technology of the company is known as the fourth-generation antibody technology HitmAb®, a proprietary technology platform featuring differentiated advantages and high efficiency for the discovery of fully native human mAbs as therapeutics against infectious diseases, autoimmune disorders, malignant tumors and other human diseases.
In addition to TNM001 injection, TNM002 injection (anti-tetanus toxin monoclonal antibody) has also entered the clinical phases. Several more products are about to file the IND, and nearly 10 more projects are under development.Trinomab pharmaceutical campuses in Zhuhai includes about 2500㎡ R&D center and 2500㎡ process development center, and about 23,000 ㎡ GMP antibody production facility equipped with the GE FlexFactory™ production lines and supporting QC laboratories, storage facilities and offices.
