Trinomab TNM006 Injection (hCMV Monoclonal Antibody) Successfully Received IND Approval From NMPA 2023-05-30

Trinomab just announced that the National Medical Products Administration (NMPA) officially granted approval for its self-developed class I antibody new drug TNM006 injection as an Investigational New Drug (IND) for clinical trials. TNM006 injection is a recombinant native human monoclonal antibody against human cytomegalovirus (hCMV), which is intended to prevent cytomegalovirus infection after organ transplantation.


HCMV is a member of the herpesvirus family. The prevalence of human cytomegalovirus infection in adults China is generally high in developing countries and varies in different reports ranging from 70% to 100%.  HCMV is effectively suppressed by the host's immune systems and infections usually present clinically asymptomatic. However, reinfection or reactivation of hCMV in immunocompromised individuals, such as organ transplant recipients, can cause serious complications and even life-threatening situations. HCMV infection is the most common viral infection caused by use of immunosuppressants after organ transplantation. If not prevented, up to 75% of solid organ transplant recipients will develop hCMV infection or reactivation within 3 months after transplantation, resulting in eventually organ transplantation failure or even death. In addition, congenital hCMV infection is the main cause of neurological hearing defects and central nervous system damage in children. Because of the serious health threat of hCMV infection, world-wide effort has been waged for development of prevention and treatment measures against hCMV.


At present, the main drugs used to treat and prevent hCMV reactivation in clinic include small molecule inhibitors and hCMV-specific immunoglobulins. However, drug resistance and side effects of small molecule inhibitors reduce efficiency of the drug treatment and prognosis of patients. HCMV immunoglobulin as a blood-derived product is limited by resource scarcity and batch differences. In addition, because of collection "window period", blood products have risk of transmitting blood-borne pathogens. Compared with specific immunoglobulins, monoclonal antibodies have great advantages in safety, specificity and accessibility.


About TNM006 Injection

TNM006 injection is a recombinant anti-hCMV monoclonal antibody derived from a native human monoclonal antibody isolated by Trinomab’s fourth-generation antibody research and development platform technology and developed independently by Trinomab for prevention of hCMV infection after organ transplantation. Thus, TNM006 injection is expected to have avoided or minimized immunogenicity and immunoreactivity of the antibody compared to antibodies from non-human origins. Its main mechanism of action is to neutralize hCMV by inhibiting the membrane fusion of the virus with host cell membrane through binding specifically to hCMV gB protein.


TNM006 Injection is intended for the prophylaxis and treatment of hCMV infection in immunosuppressed conditions such as organ transplantation. Preclinical pharmacodynamic data of the antibody showed that TNM006 Injection potently neutralize hCMV and has good safety records in animal studies. Phase I clinical trials is expected to be started soon with the main objective of evaluating the safety, tolerability and pharmacokinetics (PK) profile of TNM006 injection.


Dr. Wang Wanmei, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, said:

At present, there is no vaccine or immunoglobulin for the prevention and treatment of hCMV infection in China. TNM006 injection is the first native human monoclonal neutralizing antibody against hCMV in China. In preclinical studies, TNM006 injection has shown excellent safety and specificity. We will vigorously promote the development of clinical trials and bring good news to clinical organ transplantation patients as soon as possible.


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.


With the mission of “Creating Clinical Value”, Trinomab has two products currently in clinical development phases. TNM001 injection (anti-RSV long half-life monoclonal antibody) is currently been in Phase I/IIb clinical trials and will soon enter the confirmatory phase II/III clinical trials this fall. TNM002 injection (anti-tetanus toxin monoclonal antibody) is in phase III clinical trials that has completed the enrollment of more than 600 subjects in April. NDA of TNM002 is expected to be filled in this fall. TNM005 Injection (anti-VZV monoclonal antibody) received IND approval from FDA. IND of TNM009 injection (anti-NGF monoclonal antibody as a pain killer) has recently been approved for clinical trials in China by the National Medical Products Administration (NMPA) in April. Phase I trial of TNM009 will roll out in coming months. In addition, several more products are in preparation of IND filling with additional more antibody projects on the horizon.


[1] Li Z, Tang Y, Tang N, et al. High anti-human cytomegalovirus antibody levels are associated with the progression of essential hypertension and target organ damage in Han Chinese population. PloS one, 2017,12(8): e0181440.

[2] Boppana SB, Pass RF, Britt WJ, et al. Symptomatic congenital cytomegalovirus infection: Neonatal morbidity and mortality. The Pediatric infectious disease journal, 1992, 11(2): 93-98.

[3] Morillo-Gutierrez, B., Waugh, S., Pickering, A., Flood, T., and Emonts, M. (2017). Emerging (val)ganciclovir resistance during treatment of congenital CMV infection: a case report and review of the literature. BMC Pediatr 17,181.