Trinomab’s TNM009 and TNM005 Injection Entered Phase I Clinical Trial 2023-10-08

Recently, Trinomab announced that phase I clinical trials for both TNM009 injection (anti-nerve growth factor monoclonal antibody) and TNM005 injection (anti-varicella-zoster virus monoclonal antibody) have been officially launched in China and the United States, respectively, as the enrollment and administration of the first subjects have been successfully completed recently. 


The active ingredient of TNM009 injection is a recombinant anti-nerve growth factor (NGF) native human monoclonal antibody, which is intended to be used for the treatment of cancer pain and was approved for clinical trials by NMPA in China in March 2023. The ongoing Phase I clinical trial in China is a randomized, double-blind, placebo-controlled, parallel-group, single-dose, dose-escalation clinical study in healthy adults to evaluate the safety, tolerability, pharmacokinetic profile and immunogenicity of TNM009 injection in healthy adult subjects.


TNM005 injection is the world's first monoclonal antibody against varicella-zoster virus (VZV) to enter the clinical stage, which is intended to be used for the prevention of VZV infection for varicella exposure in high-risk groups, and was approved by FDA for clinical trials in April 2023. The ongoing Phase I clinical trial in the United States is a randomized, double-blind, placebo-controlled, dose-escalation clinical study in healthy adults to evaluate the safety, tolerability, pharmacokinetic profile and immunogenicity of TNM005 injection in healthy adult subjects.


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

"I am very pleased that TNM009 and TNM005 among our core products have entered clinical trials, which further enrich the company's clinical pipeline in the field of pain and infectious diseases. We will spare no effort to promote high-quality clinical trials in China and the world, strive to bring these products to meet the needs in the clinic and market as soon as possible, and provide more and better means of prevention and treatment for patients in needs around the world.”


About TNM009 Injection

Pain is one of the most common and unbearable symptoms in cancer patients, and it obviously decrease the quality of life in cancer patients. Cancer pain can occur at any stage from the early stage to the late stage of cancer. The incidence of pain is about 20% -30% in newly diagnosed cancer patients, and the incidence of pain in advanced stages of cancer approaches 60-80%, of which 1/3 of patients have severe pain. At present, the drug treatment of cancer pain is limited, and the commonly used analgesic drugs have unsatisfactory efficacy or related safety concerns, which limit their long-term clinical application.


Nerve growth factor (NGF) is a pleiotropic cytokine that widely exists in various tissues and organs of the body. In many pathological conditions, NGF is considered to be an important mediator of pain and plays an important role in the transmission of pain signals. The interaction between NGF and its receptor TrkA is an important link in the initiation and maintenance of pain.


TNM009 injection is a fully native human antibody isolated from human and developed by Trinomab as therapeutic antibody drug to reduce pain in cancer patients independently. Its main mechanism is to block the binding of NGF to TrkA receptor resulting in inhibition of NGF-mediated pain signaling pathways to achieve the goal of pain relief. As a native human monoclonal antibody, TNM009 injection has advantage over other monoclonal antibodies originated from non-human animal sources as it has no or minimal immunogenicity.  Immunogenicity could result in adverse effect and ineffective of the medicine while repeated use of anti-pain intervention could aggravate the issue of immunogenicity. The preclinical in vivo efficacy shows that TNM009 injection could significantly relieve cancer pain and chemotherapy-induced neuralgia in animals. In addition, it has been demonstrated that TNM009 had effective analgesic effect and was safe in other neuralgia animal models.


About TNM005 Injection

Varicella-zoster virus (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.


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.


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.


About Trinomab

Zhuhai Trinomab Pharmaceutical 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”, the core products of Trinomab TNM001 injection (anti-RSV long-acting monoclonal antibody) has recently enter the confirmatory phase IIb/III clinical trials. Phase III clinical trials of TNM002 injection (anti-tetanus toxin monoclonal antibody) have been recently completed in enrollment of more than 600 subjects. TNM006 injection (anti-hCMV monoclonal antibody) has been granted approval for clinical trials from the National Medical Products Administration (NMPA) of China, and phase I clinical trials will be carried out soon. In addition, several more products are in preparation of IND filling with additional more antibody projects on the horizon.