Recently，Synermore announces the innovative drug SYN023, a human rabies immunoglobulin antibody drug, has finished the phase I & Phase IIa clinical trials study in the US, and now Synermore is preparing Phase IIb clinical trials in the US and Phase I+II bridging clinical study in China. The drug is hoped to be approved in China in 2021.
SYN023, a mixture of two anti-rabies humanized monoclonal IgG1κ antibodies, which bind to distinct and non-overlapping antigenic sites on the rabies virus glycoprotein, neutralize rabies virus and make rabies virus reduce or lose its infection activity to nerve cells. The proposed indication for SYN023 is the post-exposure prophylaxis of category III and partly category II of rabies virus exposure, in conjunction with rabies vaccine. Due to rabies vaccine usually takes 7-10 days to induce the body to produce the necessary amount of protective antibodies, and SYN023 can provide passive immunization supplementation to the rabies vaccine at the early stage after rabies virus exposure without affecting the active immunity of rabies vaccine.
“SYN023 has been proved that it can neutralize 15 contemporary clinical isolates of rabies viruses collected in China, and 35 predominant strains from North America and global.” said Eric I Tsao, founder and Chief Executive Officer of Synermore. “SYN023 is the first global recombinant humanized rabies mixed monoclonal antibody with proprietary intellectual property rights. It was certified as an ‘orphan drug’ by the US FDA in 2015”.
Rabies Active immunity & Passive immunity
Rabies vaccine is an active immunity drug, which needs body's immune system to respond well to it before it can play a neutralizing and protective role. It takes time for the body to produce antibodies after vaccination. It usually takes 7-10 days or even longer to produce enough protective antibodies. It means that if bitten by an animal with high level of rabies virus in the body, it is likely that the body will have no time to produce antibodies or the amount of developed antibodies is not enough to neutralize rabies virus after vaccination, the virus has begun to spread along the nerve, eventually leading to death.
Rabies immune globulin (RIG) is a passive immunity drug. It can immediately neutralize the rabies virus that enters the body without the body's response. The passive administration of RIG is intended to provide an immediate supply of neutralizing antibody to bridge the gap until the production of active immunity in response to vaccine administration. RIG provides a rapid, passive immunity. At present, human rabies immune globulin (HRIG) is mainly used in the rabies passive immunization. Since HRIG is derived from pooled sera of human donors against rabies, there is a limited supply, particularly in endemic areas. There are also issues regarding quality control and the safety of this blood-derived product has been raised. Thus, there is an urgent need for improved approaches to the critical initial treatment period of the current prophylaxis regimen.
Rabies monoclonal antibody is also a passive immunity drug, and it has a similar or better neutralization effect compare with immune globulin. In recent years, developing monoclonal antibodies against rabies virus instead of traditional human immunoglobulin and immune antiserum products is an important direction of international research in this field. WHO also strongly recommends the replacement of rabies immunoglobulin with a combination of monoclonal antibodies to solve the problem of insufficient supply of rabies immunoglobulin.
Synermore Biologics (Suzhou) Co. Ltd. (“Synermore”) is located in beautiful BioBay of Suzhou Industrial Park, and committed to developing and commercializing innovative and biosimilar monoclonal antibodies in the fields of oncology, infectious diseases, and immune disorders. Eric I Tsao, the founder and Chief Executive Officer of Synermore, has over 25 years of experience in biopharmaceutical R & D and manufacturing. Synermore strictly implements the European and American cGMP standards, and file IND or NDA in both China and international. In June 2018, Syneromre was awarded as a Unicorn Breeding Enterprise by Suzhou Industrial Park. So far, 3 varieties have obtained Chinese Clinical Trial Permission and 4 varieties are being carried out Phase I and II clinical trials in the United States and Australia. SYN023 is expected to become the first recombinant humanized rabies mixed monoclonal antibody to be approved and marketed in the world, filling the gap in the global treatment market.