Trinomab announced that its self-developed recombinant anti-respiratory syncytial virus (RSV) fully native human monoclonal antibody TNM001 injection has been successfully approved by NMPA in China and FDA in the U.S., and successfully completed enrollment and dosing of the first subject, thus officially kicking off its phase I clinical trial.
TNM001 injection is a specific antibody against RSV fusion protein in pre-fusion conformation (Pre-F) developed by Trinomab using HitmAb®, a proprietary fourth-generation antibody technology platform, intended against lower respiratory tract diseases caused by RSV infection.
This a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, pharmacokinetic profiles, immunogenicity, as well as preliminary exploration of efficacy of TNM001 in healthy adult subjects, and to provide a basis for the design of subsequent clinical trials in infants and children.
Dr. Wanmei Wang, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, said:
"TNM001 injection is the first RSV fully human monoclonal antibody independently developed in China to enter into the clinical stage, and also one of the few RSV monoclonal antibodies against this target in the world. We will develop a safer, scientific and efficient clinical study plan and work with several centers at home and abroad to accelerate its clinical trial process. ”
"TNM001 injection is the star product of Trinomab, and the results of pre-clinical studies showed that it had a very high neutralizing ability, with a long half-life which can cover the whole RSV epidemic season (May-June). Currently, RSV prophylaxis drugs are far from meeting clinical needs globally; once introduced to the market in the future, TNM001 is will provide the optimal drug option for the prevention of RSV infection in infants and children worldwide", Dr. Huaxin Liao, Chairman & CTO of Trinomab, said.
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. According to statistics, during the virus 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 reaches 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, is able to specifically bind Pre-F and block the entry of RSV into host cells, thus blocking the transmission of the virus. In vitro studies showed that TNM001 had the ability to neutralize RSV viruses on a broad spectrum, with neutralizing activity is better than that of the Palivizumab antibody. The half-life of TNM001 antibody has been extended after being optimized by antibody engineering, thus providing longer-term protection in humans. It is expected to protect for the entire epidemic season with only one injection, making it more competitive in terms of costs and clinical adherence.
About Us
As an innovative biopharmaceutical company at clinical stage with a perspective of global layout, Trinomab Biotech Co., Ltd (Trinomab for short) is mainly engaged in R&D of original fully native human monoclonal antibody new 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 against infectious diseases, autoimmune diseases, malignant tumors and other human diseases.
Currently, the company has several new fully native human mAbs in the process of industrialization, some of which have already entered into the clinical trial stage. Among them, its star product recombinant anti-tetanus toxin (TT) fully native human mAbs TNM002 injection, following its phase I clinical trial in Australia, officially started human bridging trial in Chinese population. In addition, IND applications of recombinant anti-human cytomegalovirus (HCMV) fully human monoclonal antibody, recombinant anti-human nerve growth factor (NGF) fully human monoclonal antibody, and recombinant varicella-zoster virus (VZV) fully human monoclonal antibody in the product pipeline will be applied in succession in 2022.
In April 2021, Trinomab's GMP-compliant production facility (FlexFactory™) at the Zhuhai International Health Park was completed and officially opened. In August 2021, Trinomab completed round A and round A+ financing of nearly RMB 1.1 billion.
