At the American College of Emergency Physicians (ACEP) annual meeting, held from September 29 to October 2, 2024, in Las Vegas, USA, Zhuhai Trinomab Pharmaceuticals Co., Ltd. (Trinomab) made a notable appearance by an oral presentation to announce the results of a phase III trial of its innovative new drug, Siltartoxatug Injection, a recombinant native human anti-tetanus monoclonal antibody. The drug garnered significant attention as a first-in class recombinant monoclonal antibody as passive immunization therapeutics for prevention of tetanus, leading to its selection for an oral presentation at the conference.
The ACEP annual meeting is the largest, most influential, and prestigious emergency medicine conference in the world, aims to promote the development of high-level, high-quality emergency medicine and highlight the essential role of emergency physicians. Each year, thousands of emergency medicine professionals from around the globe participate in the conference.
Siltartoxatug Injection is the world's first recombinant anti-tetanus toxin monoclonal antibody for prophylaxis against tetanus. As the leading product among the first-tier products in pipeline of Trinomab, siltartoxatug stands out as with its scientific innovation and superior efficacy over HTIG. Acceptance as an oral presentation at this international conference underscores the medical community's strong interest in learning of results from phase III clinical trial of siltartoxatug.
ACEP Conference Presentation
At the ACEP conference, Liu Si, Deputy Director of Emergency Department at the Peking University First Hospital and representative of the investigators in the siltartoxatug Phase III clinical trial team, showcased the study titled as " A Recombinant Native Human Anti-Tetanus Monoclonal Antibody Versus Human Tetanus Immunoglobulin for Passive Immunization Against Tetanus A Double-Blind, Randomized, Phase 3 Trial."
The trail results demonstrated that siltartoxatug provides protective levels of anti-tetanus neutralizing antibodies more rapidly, achieves higher serum antibody levels, and sustains protective levels for a longer duration compared to Human Tetanus Immunoglobulin (HTIG) as the current standard of care. Compared to HTIG as polyclonal antibodies, Siltartoxatug as a monoclonal antibody may have less inhibitory effect on the induction of antibody response when co-administered with tetanus vaccine, compared to HTIG. Siltartoxatug is well-tolerated, with a safety profile comparable to HTIG. Therefore, siltartoxatug has great advantages to substitute equine tetanus antitoxin and HTIG as a standardized, more accessible, safer and more effective first-line tetanus passive immunization therapy.
Dr. Wanmei Wang, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, said:
“The Phase III and related clinical trials of siltartoxatug demonstrate that the drug can significantly elevate the serum levels of anti-tetanus neutralizing antibodies above the protective threshold within 12 hours, achieving a rapid onset of action. Furthermore, duration maintaining serum protective antibody levels exceeds 105 days. Siltartoxatug with the well-defined mechanism of action and superior efficiency provides a new alternative modality for passive immunization against tetanus.
We are looking forward to the eventual approval from Chinese authority for moving Siltartoxatug Injection to the market, which will contribute to significantly improving the current standard care for tetanus prophylaxis. Siltartoxatug is expected to open a new chapter in supporting tetanus prevention worldwide.”
About Siltartoxatug Injection
Tetanus is an extremely serious and potentially fatal disease. Without medical intervention, the mortality rate for severe cases is almost 100%. Even with aggressive comprehensive treatment, the global mortality rate remains between 30% to 50%. Passive immunization currently used in clinical practices for the prevention and treatment of tetanus includes equine tetanus antitoxin (TAT), Equine Anti-Tetanus（F(ab')2）and human tetanus immunoglobulin (HTIG).
TAT and F (ab')2 are prone to cause allergic reactions. The main clinical manifestations are anaphylactic shock and serum sickness, and "skin test" is needed before clinical use. Desensitization approach has to be applied for patients with positive skin test. During desensitization injection process, there is still a probability of allergic reactions and anaphylactic shock. In 1991, WHO removed TAT from WHO Model List of Essential Medicines, developed countries have banded the clinical use of TAT. However, in China, there are 40 to 70 million doses of TAT prescribed.
HTIG as plasma-derived products pose significant safety concerns, such as the risk of transmitting known- and unknown-pathogens despite rigorous testing in the manufacture process. In China, the preventive dose of HTIG is 250 International Units (IU), and in 2020, more than 6 million doses of HTIG were prescribed.
Thus, it is highly warranted to develop a safe and highly effective therapeutic monoclonal (mAb) to substitute TAT and HTIG for prevention and treatment of tetanus infection. Siltartoxatug Injection is an anti-tetanus toxin native human monoclonal antibody drug developed through Trinomab’s proprietary HitmAb® technology platform. Siltartoxatug Injection is administered by intramuscular injection for emergency prevention of post-traumatic tetanus. Based on its obvious clinical advantages in terms of safety, effectiveness and accessibility compared with the existing treatment methods, Siltartoxatug Injection has been granted the “Breakthrough” designation from the China NMPA in March 2022, and “Fast-track designation from USA FDA in August of the same year. New Drug Application (NDA) for Siltartoxatug injection has been formally accepted by China NMPA in December 2023 and has then been awarded with the priority review process by the administration.
About Trinomab
Zhuhai Trinomab Pharmaceutical is an innovative biopharmaceutical company with a global expansion perspective. The company is mainly engaged in R&D of innovative 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.
With the mission of “Create Clinical Value” in mind, remarkable progress has been made by Trinomab in recent years. NDA for Siltartoxatug Injection (anti-tetanus toxin monoclonal antibody) has been formally accepted in last December by China NMPA. TNM001 injection (anti-RSV long-acting monoclonal antibody) has just entered phase III clinical trials recently. TNM009 injection (anti-NGF monoclonal antibody) and TNM005 injection (anti-VZV monoclonal antibody) have entered in phase I clinical trials last year in China and the United States, respectively. Clinical trial for TNM006 injection (anti-hCMV monoclonal antibody) will be launched in the first half of the next year as the IND has been approved for TNM006 in 2023. In addition, several new products are in preparation of IND filling with additional more antibody projects on the horizon.
