SmartPharm Approach: Gene MAbs™ for Coronavirus
SmartPharm is applying our non-viral gene therapy platform to develop an effective preventive treatment for SARS-CoV-2. We are using DNA designed to produce in the muscle of the person who receives the gene a monoclonal antibody (“Gene Mab™”) that could be protective against the SARS-CoV-2 virus. To do this, we are utilizing a novel DNA vector with low immunogenicity, durable expression potential and cost-effective manufacturing up to millions of doses. We are coupling this type of DNA vector with a delivery system that significantly enhances DNA expression in the muscle and is also capable of high-volume, economic production. Coupled together, these represent a way to generate protective mAbs in many people to provide “pop-up immunity” in this population against COVID-19 regardless of their immune status or their infection status.
The first step in developing a Gene MAb™ against SARS-CoV-2 is to determine a mAb sequence that possesses both a high binding affinity to the coronavirus (so it stays attached to the virus for a long time) and the ability to neutralize the virus (block it from invading cells or attract immune response against the virus). We have implemented strategic partnerships with a number of organizations to do this, including Sorrento Therapeutics. Sorrento has initiated an accelerated program to identify potent neutralizing antibodies against SARS-CoV-2 that can be used for either treatment or prophylaxis. Based on this collaboration as well as internal work, SmartPharm will define a DNA that can express these antibodies in human skeletal muscle and use a delivery technology designed to allow the DNA to be delivered directly into the muscle. The SmartPharm delivery system is designed to be used with a standard hypodermic needle, the way most vaccines are delivered.
1. Antibodies with significant neutralizing efficacy against SARS-CoV-2 are identified in recovered COVID-19 patients. 2. The antibody is sequenced and incorporated into a DNA plasmid. 3. Plasmids are combined with a delivery system for a final formulation of the Gene MAb™ drug. 4. The Gene MAb™ is given to people using a standard hypodermic injection.
After delivery in the muscle, the DNA is designed to produce antibodies in the muscles within a matter of hours. Within a day or two—a much faster time than a typical vaccine—protective levels of antibody could be produced, resulting in what we refer to as “pop up-immunity”: a rapidly-established window of immune protection against the virus.
Antibody production lasts a number of weeks or even months and is effective regardless of what the recipient’s immune system is like or whether they are infected or not. Creating pop-up immunity with Gene MAbs™, which are both cost-effective and scalable for large population protection, introduces a way to quickly mount a protective immune barrier in treated people and reduce the infectivity of the virus in larger populations.