On November 10, 2024, Investigators Meeting was successfully held in Chengdu, China for "A Randomized, Double-Blind, Placebo-Controlled and Parallel-Group Adaptive Phase III Trial to Evaluate the Efficacy and Safety of TNM001 Injection in Preventing Lower Respiratory Tract Infections Caused by Respiratory Syncytial Virus(RSV) in Infants under 1 Year of Age" sponsored by the Zhuhai Trinomab Pharmaceuticals Co., Ltd.(Trinomab）. This marks that the R & D process of TNM001 Injection has entered a new stage. Results of the IIb clinical trial were also announced and particularly noteworthy during the meeting.
This meeting gathered more than 200 investigators from 62 hospitals from 19 provinces/municipalities/autonomous regions across China. Participants engaged in detailed discussions about the preliminary results of the phase IIb trial and the protocols for Phase III trials of TNM001 injection. TNM001 injection as the first fully human monoclonal antibody to RSV is being independently developed for prevention of lower respiratory tract RSV infections caused by Trinomab, to enter the clinical stage in China.
Actively promote: Investigator Meeting for Phase III Clinical Trial
At the meeting, Dr. Huaxin Liao, Chairman and CTO of Trinomab, along with Professor Hanmin Liu from West China Second University Hospital, Sichuan University and Professor Enmei Liu from the Children's Hospital of Chongqing Medical University, delivered remarks on behalf of the sponsor and the team of the trial investigators, respectively. Meeting participants actively engaged in in-depth exchanges and discussions on core issues such as the scientific design of the Phase III clinical trial of TNM001 Injection, as well as some of logistics and compliance of clinical trials in the pediatric field .
The Phase III clinical trial is a crucial step in the R & D process of TNM001 Injection, which will demonstrate the efficacy and safety of the drug in the trial involving in approximately 1500 infants. The convening of this investigators meeting provided an effective platform for communication and opportunity for collaboration among all parties, providing strong support for the high-quality progress of the Phase III clinical trial.
Initial Results: Exciting IIb Clinical Research Results
At this meeting, Trinomab announced the much-anticipated results of the Phase IIb clinical trial of TNM001 Injection.
The results met both the primary and secondary endpoints. TNM001 significantly reduced RSV-induced MALRTI and RSV-associated hospitalizations throughout the 5-month RSV epidemic season.
Notably, the protection rate in the high-risk subgroup (early preterm or moderately preterm infants, and infants with CHD or CLD) was remarkable.
Safety analysis showed the incidence of adverse events (AEs) and serious AEs were comparable between the TNM001 and placebo groups, demonstrating a good safety profile of TNM001.
Dr. Wanmei Wang, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, said:
“The Phase IIb clinical results of TNM001 Injection are exciting. The results met both the primary and secondary endpoints, further validating the great potential of this drug in preventing RSV infection in infants and young children. This positive research outcome lays a solid foundation for the subsequent Phase III confirmatory clinical trial. We will work together with the investigator institutions to promote the conduct of the Phase III clinical trial, thus providing more original domestic new drugs for the prevention of RSV infection in Chinese infants and young children.”
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. The peak age for children for RSV infection is from 1 month to 6 months old, RSV infection rate of children under 2 years old can reach as high as 99%, and about 10% of them will develop severe cases and require hospitalization. Severe cases of RSV infection are manifested by aggravated coughing and wheezing, along with the occurrence of respiratory failure, chest expansion, and intercostal and subcostal retractions, which seriously endanger the life and health of affected children.
The substance of TNM001 injection is the fully native human RSV neutralizing monoclonal antibody, which is the first such an antibody moving into clinical trials from a domestic company. TNM001 injection specifically binds a conservative antigenic epitope on RSV fusion proteins with pre-fusion conformation (Pre-F) and blocks fusion of RSV with host cell membrane, thus blocking RSV entering into cells resulting in neutralizing RSV and preventing RSV infection. Studies has demonstrated that TNM001 not only neutralize wide spectrum of RSV isolates including laboratory-adapted and clinical isolates, but also has high neutralizing potency that is 30-fold better than that of the Palivizumab. In addition, TNM001 has a long half-life, and it is expected that a single dose of injection can provide anti-RSV protection throughout the entire epidemic season.
About Trinomab
Zhuhai Trinomab Pharmaceutical is an innovative biopharmaceutical company with a global expansion perspective. The company is mainly engaged in R&D of innovative 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.
With the mission of “Create Clinical Value” in mind, remarkable progress has been made by Trinomab in recent years. NDA for Siltartoxatug Injection (anti-tetanus toxin monoclonal antibody) has been formally accepted in last December by China NMPA. In addition, TNM001 injection (anti-RSV long-acting monoclonal antibody) has just entered phase III clinical trials, TNM009 injection (anti-NGF monoclonal antibody) and TNM005 injection (anti-VZV monoclonal antibody) have entered in phase I clinical trials last year in China and the United States, respectively. Clinical trial for TNM006 injection (anti-hCMV monoclonal antibody) will be launched in the first half of the next year as the IND has been approved for TNM006 in 2023. In addition, several new products are in preparation of IND filling with additional more antibody projects on the horizon.
