brincidofovir SyB V-1901: injection
SyB V-1901 (injection) (generic name: brincidofovir, BCV) has a new mechanism of action as a lipid conjugate of cidofovir (CDV). CDV is an antiviral drug already approved and marketed in the United States and the European Union, but unapproved in Japan. BCV is expected to be an effective treatment against a wide spectrum of dsDNA virus infections (cytomegalovirus, adenovirus, Epstein-Barr virus, herpes virus, BK virus, papillomavirus and smallpox virus including monkeypox, etc.), with superior features such as high activity antiviral effect in comparison with CDV and other antiviral drugs. Due to the breakthrough nature of the BCV molecule, in which a specific length of lipid chain is attached to the CDV, BCV is converted into a molecule that acts directly within the cell, thereby dramatically increasing the efficiency of cellular uptake and showing a high antiviral activity. Moreover, BCV is expected to be a highly active antimultiviral agent that can reduce the risk of nephrotoxicity or myelosuppression, which are serious side effects of other antiviral drugs including CDV.
In September 2019, SymBio entered into a license agreement with Chimerix for the exclusive worldwide rights to develop, market, and manufacture BCV for all diseases except orthopoxviruses (such as smallpox and monkeypox). In September 2022, Chimerix announced the completion of the process of transferring the rights to BCV to Emergent BioSolutions (headquartered in Maryland, U.S.). There is no impact on the exclusive worldwide development, manufacturing and marketing rights for all indications except orthopoxvirus diseases.
Currently, SymBio is pursuing business development to become a global specialty pharmaceutical company by 2030, and to maximize the value of the business, a Phase II clinical trial is underway for patients with adenovirus infection after hematopoietic stem cell transplantation, and in addition, in May 2022, a Phase II clinical trial for patients with BK virus infection after kidney transplantation will In addition, in May 2022, a Phase II clinical trial was initiated for patients with post-kidney transplant BK virus infection.
In addition to its high antiviral activity, BCV is also expected to have anti-tumor effects. We are currently conducting collaborative studies with the National Cancer Center of Singapore, the University of California, San Francisco, and other institutions to confirm its anti-cancer activity and to identify synergistic effects when combined with its antiviral activity. With regard to multiple sclerosis, an intractable disease that has recently been proven to be associated with the EB virus, SymBio entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), to examine BCV's efficacy against EB virus in the treatment of multiple sclerosis and to obtain information needed to conduct future clinical trials.