Trinomab TNM002 Injection Obtained FDA Fast-Track Designation 2022-08-24

TNM002 Injection being developed for prophylaxis against tetanus by Trinomab Biotech Co. in Zhuhai, China has been granted fast-track designation from the US Food and Drug Administration (FDA) on August 23, 2022. The active ingredient of TNM002 injection is a recombinant anti-tetanus toxin human monoclonal antibody (mAb). In March this year, TNM002 injection was also designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) in China.


The FDA fast-track designation granted for TNM002 means it meets the criteria for a process to facilitate the development, expedite the review and fill an unmet clinical need with the purpose to get important new drugs like TNM002 to the patient earlier. According to the existing policy, drugs approved for fast-track can maintain close contact with FDA at every stage of the development process, including consultation and communication on issues related to drug development plans, clinical trial design and the use of biomarkers. Next, Trinomab is expected to apply for accelerated approval and priority review, which means that the development speed of TNM002 injection in the United States will be further accelerated.


“Exposure to tetanus toxin, a neuron toxin, secreted by Clostridium tetani causes tetanus. To prevent tetanus for people at risk after exposure to Clostridium tetani as results of tetanus-prone injury, antitoxin treatment is needed. TNM002 is an anti-tetanus toxin neutralizing human monoclonal antibody being developed by Trinomab and is the first anti-tetanus toxin monoclonal antibody entering the clinical stage in the world. Fast-track designation to TNM002 granted by FDA will no doubly facilitate the development and eventual approval of TNM002 as an effective new drug in substitution of TAT and HTIG for prevention of tetanus, which provides a strong guarantee for human tetanus prevention.” said Dr. Wang Wanmei, Chief Medical Officer (CMO) of Trinomab.


About tetanus and TNM002

The passive immune agents currently used in clinical practices for the prevention and treatment of tetanus include tetanus antitoxin (TAT) and human tetanus immunoglobulin (HTIG). However, as an immunoglobulin derived from horse serum, TAT is prone to allergic reactions (5% -30% allergic reaction rate) and thus banned in developed world such as Europe and the United States. HTIG has little allergic reaction but it is limited in yields with the risk of transmitting known (e.g. AIDS, hepatitis B) and/or unknown blood-borne infectious diseases. Meanwhile, plasma supply shortage along with other factors limit “HTIG” production and clinical use. Thus, use of TAT is still dominated in low income and populous countries or regions such as China, India, Southeast Asia and Africa.


TNM002 is an anti-tetanus toxin neutralizing native human mAb generated by using Trinomab’s proprietary platform technology (HitmAb®) from a human volunteer who acquired immunity through tetanus vaccination. Early clinical data indicated that TNM002 injection was safe and well tolerated, and with extremely high capability to neutralize tetanus toxin. TNM002 injection is scheduled for phase III clinical trials in China by the end of this year.


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 as therapeutics against infectious diseases, autoimmune disorders, malignant tumors and other human diseases.