Trinomab just announced that TNM005 injection as an Investigational New Drug (IND) derived from a fully native human monoclonal antibody against varicella-zoster virus (VZV) has recently been officially approved by the US Food and Drug Administration (FDA). The drug is intended forsusceptible individuals including immunocompromised people, pregnant women without evidence of immunity, and some neonates and infants at risk of severe varicella after exposure to VZV.
VZV is mainly transmitted through respiratory tract and close contact. Primary infection of VZV causes varicella resulting in latent VZV infection through rest of life after recovery. Reactivation of latent VZV in the body causes herpes zoster. Varicella is a common disease in children, which is self-limited in healthy children, but it can cause disseminated infection, damage of important organs and even death in newborns, premature infants, women in delivery and special groups with immune deficiency. Herpes Zoster manifests as a cluster of blisters usually distributed band-like along one side of the body accompanied by a severe burning pain. The older the patient is, the more severe the neuralgia is.
Studies have shown that premature infants are at risk of varicella infection at least 6 months after birth, while children under 1 year of age are not eligible for VZV vaccination. At present, VZV-specific immunoglobulins (such as VariZIGTM), which are marketed abroad, are mainly used as passive immune prevention measures for varicella in high-risk groups, which can reduce the probability of VZV infection and reduce the severity of VZV infection. Because immunoglobulin belongs to blood products, it has resource scarcity and batch differences. With the existence of "window period", such products have risk of transmitting blood-borne pathogens, so it is urgent to develop safer and more effective innovative alternatives.
About TNM005 Injection
TNM005 injection presents the first monoclonal antibody product against VZV infection getting into human trials in the world. TNM005 injection is a fully native human antibody with specificity targeting on gH/gL protein that is critically important for VZV getting into host cells. It has high-titers of neutralization activity in cell-based VZV neutralization assays against VZV. Comparison of TNM005 with VariZIGTM in parallel studies showed that the antibody has great potential and advantage in substitution of VariZIGTM for prophylactic treatment against varicella exposure. In addition, preliminary study in VZV-induced herpes zoster animal models showed that the antibody may be used for treatment of herpes zoster caused by VZV infection.
Dr. Huaxin Liao, Chairman and CTO of Trinomab, said:
We are very pleased that TNM005 injection among our first tier products has been approved for clinical trials by FDA. This is the third fully native human monoclonal antibody drug of Trinomab that received IND approval from FDA, representing highly diverse products among Trinomab’s product pipeline and progress being made in our continuous effort in drug research and development. As the world's first fully human monoclonal antibody against VZV, we will make every effort to evaluate this product in clinical trials to ensure its effectiveness and safety in human use for prevention of VZV infection.
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 “Create Clinical Value”, Trinomab has two products currently in clinical development phases. TNM001 injection (anti-RSV long-acting 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 phase III clinical trials with the completion of enrollment of more than 600 subjects in April. NDA of TNM002 is expected to be filled in this fall. 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.
