Product code
  • TNM001
  • TNM002
  • TNM005
  • TNM006
  • TNM009
  • TNM030
  • TNM039

Respiratory syncytial virus (RSV) refers to a single-negative-stranded RNA virus of the genus Pneumovirus in the family Paramyxoviridae, which is a common viral pathogen of respiratory infections. It can be sporadically distributed or outbreaks within a short time, in a local area or on a broader scale. As the most important cause of seasonal lower respiratory tract infections in infants and children. The peak age for RSV infection is between 2-8 months and almost 90% of children have been infected by the age of 2 years. The primary infection of RSV may cause mild cold-like symptoms like coughing, low-grade fever and wheezing. Most people recover in a week or two. But RSV can sometimes lead to serious conditions including the impaired ability to clear secretions from the airways due to ineffective cough, respiratory muscle weakness and high prevalence of gastro-oesophageal reflux. Without proper treatment, it can also cause decreased activity and respiratory failure.

There is no vaccine or specific antiviral drug against RSV infection in China. Palivizumab (Synagis ®) developed by MedImmune, was approved by the FDA in 1998 for the prevention of congenital heart disease or lung disease in premature infants born at less than 35 weeks, but is not yet available in China.

TNM001 injection, the star product of Trinomab, is the first long-acting fully native human anti-respiratory syncytial virus neutralizing antibody drug independently developed in China. 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. Currently, RSV preventive drugs are far from meeting clinical needs globally. Once introduced to market in the future, TNM001 will provide the optimal drug option for the prevention of RSV infection in infants and children worldwide. 


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM001 Prevention of RSV infection RSV Pre-F protein

Clostridium tetani (clostridium tetani) refers to a pathogenic bacterium that causes tetanus and exists in large numbers in the intestinal tract of humans and animals. It often infects the body and causes disease through traumatic wounds and lacerated wounds in the birth canal of pregnant women after contamination of soil by feces. Tetanus toxin refers to a neuroprotein toxin produced by Bacillus tetani. By blocking the release of inhibitory neurotransmitters, it cuts off the transmission of information between nerves and muscles, causing muscle spasm, cranial nerve paralysis and central nervous system dysfunction. The typical symptoms of tetanus are trismus, opisthotonus, and hyperreflexia.

The passive immune agents currently used in clinical practices for the prevention and treatment of tetanus include “antitoxin TAT” and “hTIG”. However, as an immunoglobulin derived from horse serum, the “antitoxin TAT” is prone to allergic reactions, while the “human” type” is limited in yield with the risk of transmitting known (e.g. AIDS, hepatitis B) or unknown blood-borne infectious diseases.

TNM002 refers to a recombinant anti-tetanus toxin monoclonal antibody developed by Trinomab by leveraging its fully native human monoclonal antibody R&D technology Platform (HitmAb®), and is the first fully human anti-tetanus toxin monoclonal antibody in the world entering the clinical stage, which will be mainly used for the prevention of tetanus after trauma exposure. When commercially available, the antibody drug will provide clinics with a safer and more efficient drug which is suitable for mass production and more accessible.

Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM002 Prevention of tetanus Tetanus toxin

Children infected with varicella-zoster virus (VZV) for the first time may show symptoms as fever, swollen local lymph nodes, and batches of centripetal papules, which is called chickenpox. After recovery from chickenpox, however, the virus latented in the body can cause herpes zoster when the latent virus re-emerges in adulthood when the immunity is low, so it is called varicella-zoster virus.

VZV infection is transmitted through respiratory secretions and can also be transmitted to the fetus through placenta, causing congenital infection and it is highly contagious. The infection rate is significantly higher in newborns, premature infants, women in the period of childbirth, and special populations with immune insufficiency due to receiving immunosuppressive drugs, cytotoxic drugs, or radiotherapy for organ transplantation, malignant blood diseases, malignant tumors, nephrotic syndrome, etc., which may even result in deaths. VZV has a long latency period, and herpes zoster that caused by VZV infection has been a common diease for middle-aged and elderly people. 

As a fully native human anti-varicella-zoster monoclonal antibody developed by Trinomab by leveraging the HitmAb® , TNM005 will provide a novel and highly specific antibody for the prevention and treatment of varicella and herpes zoster. 


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM005 Prevention and treatment of VZV infection VZV gH/gL protein

Human cytomegalovirus (hCMV) is one of the eight major herpes viruses that infect humans, and the proportion of seropositivity is as high as 97% in population in China. It can remain latent for a life time after initial infection, and people with normal immunity usually do not show clinicopathological symptoms, but for people with low immunity, such as organ transplant recipients, it can cause organ damage due to massive virus multiplication. hCMV infection is the most common viral infection that occurs after organ transplantation as a result of the use of immunosuppressive drugs. If no prevention measures are taken, up to 75% of solid organ transplant recipients will develop an hCMV-activated infection within 3 months after transplantation, which can ultimately result in organ transplant failure or even death.

Currently, there are no anti-cytomegalovirus monoclonal antibody drugs available at home and abroad, while specific immune proteins that can effectively reduce the risk of hCMV infection in mother-to-child transmission and organ transplant recipients are mainly derived from the plasma of healthy individuals with high antibody titers, which have the risk of transmitting known or unknown blood-borne infectious diseases, and it has complicated production processes, as well as extremely limited sources and yields. To this end, it is an iterative advancement for the use of high-titer anti-hCMV monoclonal neutralizing antibodies as an alternative to hCMV-specific immunoglobulins.

Trinomab uses the HitmAb® platform to develop a fully native human monoclonal antibody against human cytomegalovirus (hCMV) featuring high specificity, strong neutralization and safety. Moreover, it is a non-blood product which can be produced on a large scale under strict quality control, thus making it more accessible. Once put into market, the product is expected to fill the gap of hCMV monoclonal antibodies at home and abroad, bringing patients an effective and safe means of prevention and treatment. 


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM006 hCMV infection (prevention) human cytomegalovirus

NGF (nerve growth factor) refers to a pleiotropic cytokine that is widely present in all organisms and organs of human body. It is currently considered to be an important mediator of pain, and the interaction of NGF with its receptor TrkA is an important link in the initiation and maintenance of pain, therefore playing an important function in pain signaling. Numerous clinical studies have shown that NGF levels are elevated in trauma, inflammation, and chronic pain.

OA (Osteoarthritisis) refers to a slowly developing joint disease typically caused by a disorder of the body's NGF and is the leading cause of disability and pain in the elderly people, second only to cardiovascular disease. However, more than half of patients suffering OA using opioids and NSAIDs fail to achieve an ideal result in pain relief. In addition, pain is one of the most common and intolerable symptoms in cancer patients. The incidence of pain is about 20% -30% in newly diagnosed cancer patients, and theincidence of pain in advanced stages of cancer approaches 60-80%, of which 1/3 of patients have severe pain.

TNM009 refers to a NGF-targeted fully human monoclonal antibody that neutralizes NGF in vivo, thereby blocking the NGF/TrkA signaling pathway and achieving pain relief. It has also demonstrated its efficacy in some animal models and in the study of pharmacodynamics both in vivo and in vitro. 


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM009 cancer pain, joint pain NGF

Staphylococcus aureus (SA) refers to a major human pathogenic bacterium whose pathogenicity depends mainly on the toxins and invasive enzymes it produces, while Hlα toxin is also the most widely expressed of all SA toxins, with almost all SAs carrying the Hlα gene. Staphylococcus aureus (SA) can cause local septic infection, as well as pneumonia, and even systemic infections such as sepsis etc. SA exotoxin can also cause such systemic lethal infections as food poisoning, scald-like skin syndrome and toxic shock syndrome, with an infection death rate as high as 20%, and a mortality rate up to 50% for bacteraemia caused by SA. Methicillin-resistant staphylococcus aureus (MRSA) infection has been regarded as one of the three most challenging infectious diseases worldwide, with the other two being hepatitis B and AIDS.

Trinomab has developed multiple strains of fully human Hlα toxin monoclonal antibodies against SA infection by leveraging HitmAb®, which are selected and matured in the human immune tolerance environment and applied as drugs to minimize the immunogenicity of the antibody drugs. Once put into the market, it will provide a new treatment option for patients infected with SA, thus improving the survival rate of patients. At the same time, the fully native human anti-Hlα toxin monoclonal drug, as a non-antibiotic drug, is a response to the new measures for the treatment of infections advocated by WHO as a counter measure to the spread of superbugs caused by the improper use of antibiotics, thus contributing to the prevention and control of "superbugs” worldwide.

 


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM030 Bacterial infectious shock Hla toxin

Rabies refers to a zoonotic disease caused by Rabies Virus, with clinical symptoms of mania and fear of water, and has an almost 100% mortality rate once it develops. Once the human body is bitten by an animal carrying rabies virus, the virus may be latent locally or move slowly toward the central nervous system. When the virus reaches the central nervous system (CNS), it will multiply rapidly and prolifically, causing acute encephalomyelitis and eventually death due to loss of cardiopulmonary function.

The rabies vaccine cannot not block rabies virus completely but takes 7-14 days. For rabies post-exposure prophylaxis (PEP), rabies immunoglobulin (RIG) can rapidly trigger passive immune protection, but RIG is costly, of uncontrolled quality and carries the risk of transmission of other infectious diseases. In 2018, The World Health Organization (WHO) issued recommendations to use more standardized and quality-controlled anti-rabies virus monoclonal products as an alternative to RIG.

® TNM039 is a fully native human anti-rabies virus monoclonal antibody developed by Trinomab by leveraging the HitmAb®. Since it was selected and matured in a human immune tolerance environment, this antibody is expected to overcome disadvantages including lack of sources, unstable quality control, and the risk of other infectious diseases that exist in rabies immunoglobulin, and will provide patients with effectiveness and safety as much as possible in clinical practices.


Product code Indications Target Pre-clinical IND phase I phase 2 phase 3 NDA Registration
TNM039 Rabies prevention Rabies virus