RSV (Respiratory syncytial virus, respiratory syncytial virus) is a member of the pneumovirus subfamily of the Paramyxoviridae family. The virus is a common viral pathogen of respiratory tract infections. It can be distributed or erupted, local epidemic and widespread epidemic. It is a common and frequently-occurring disease in humans, especially for infants and young children. Caused millions of children hospitalized due to pneumonia and other pulmonary dysfunction, causing 160,000 children to die from RSV infection. Almost all children under the age of 2 have had respiratory syncytial virus infection. Since infection with respiratory syncytial virus does not produce life-long immunity, repeated infections often occur.
After half a century of research and development, there are no safe and effective RSV vaccine products on the market. Palivizumab is a humanized monoclonal anti-RSV neutralizing antibody. The drug was approved by the FDA in 1998 to prevent congenital heart disease or lung disease in preterm infants under 35 weeks, and is currently the only prophylactic agent for respiratory syncytial virus, reducing nearly half of the hospitalized cases. In June 2010, AstraZeneca (AZ)’s R&D product RSV monoclonal antibody Motavizumab was rejected by regulators in the clinical phase III due to safety issues.
It once again reminded us that safety is always the first factor in drug development.
The second-generation anti-RSV monoclonal antibody product MEDI8897, which is expected to reduce the frequency of infection in the quarter, is in the IIb clinical trial.
Due to the iteration and development of antibody technology, the fourth generation of natural all-Human antibodies (HAMP) technology currently represented by HitmAb® technology is beginning to show its advantages. The monoclonal antibody developed by Trinomab Biotechnology Co., Ltd. of Zhuhai, China, is a truly natural fully human monoclonal antibody. Not only is the antibody sequence 100% human, but the antibody heavy chain and light chain are natural native paired combinations. Moreover, its affinity and specificity are matured through the selection of the human immune tolerance environment, which minimizes the possibility of immunogenicity. There is no doubt that the natural all-human antibody in its R & D starting line, greatly reducing the risk of research and development and investment, significantly increased the rate of finished drugs.
The company has developed a variety of natural, fully human monoclonal antibodies against infectious diseases, such as rabies virus antibodies, tetanus toxin antibodies, HBV antibodies, MRSA antibodies, hCMV antibodies, VZV antibodies, and the like.
RSV is fused to the host cell by a fusion protein on the surface of the virus during infection. Analysis of the crystal structure revealed that the pre-fusion conformation of the fusion protein is the most vulnerable to the virus. Therefore, designing a fusion protein that can maintain the pre-fusion conformation as a vaccine will be an important key to the development of RSV vaccine design. Fusion of the pre-conformation is undoubtedly an important target for antibody therapy. Antibodies against the pre-fusion conformation of the RSV fusion protein will have more pronounced efficacy than current clinically used Palivizumab.
The discovery of the pre-fusion conformation of the RSV fusion protein was a breakthrough in the vaccine field in 2013 as judged by Science. More recently, Trinomab Biotechnology Co., Ltd. of Zhuhai identified several strains of neutralizing antibodies capable of binding to RSV fusion proteins from several tens of anti-RSV natural, fully human monoclonal antibodies isolated. Two of them could recognize RSV fusion protein in the pre-fusion conformation and neutralize RSV with high efficiency. The neutralizing potency was more than 80 times higher than that of currently marketed RSV antibody palinizumab, Synagis, indicating the high efficiency of this antibody.
The industrialization of this antibody can not only prevent the syncytial virus infection, but also have the therapeutic effect on already infected people, showing great social and economic benefits.