Vyriad to Develop Antibody Test to Determine COVID-19 Protective Immunity

Vyriad has completed the development of a serology test to measure protective immunity against SARS-CoV-2, the novel coronavirus that causes COVID-19. The Vyriad SARS-CoV-2 Neutralizing Antibody Test detects neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. The ability to reliably identify these neutralizing antibodies will be critical to the safe re-opening of work, school and social settings. Vyriad and Regeneron jointly developed the test as part of their existing discovery and development collaboration. The test is expected to be available through major CLIA-certified testing labs by the end of May.

The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The Vyriad SARS-CoV-2 Neutralizing Antibody Test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.

“We believe the ability of our test to accurately identify virus-neutralizing antibodies provides a higher degree of certainty about whether individuals have acquired protective immunity from COVID-19, including in those people who have never had symptoms of COVID-19,” said Stephen Russell, M.D., Ph.D., Chief Executive Officer of Vyriad, a clinical-stage biotechnology company specializing in virus therapies to treat diseases, including cancer. “We believe this is the first commercially scalable test of its kind and could become the gold standard for determining protective immunity, because it detects specifically the antibodies capable of blocking re-infection. Our hope is that this assay will be used to help inform back-to-work decisions for individuals who believe they have been exposed to the virus.”

Since the start of the COVID-19 outbreak in December 2019, experts believe millions of people around the world may have contracted the disease, many with asymptomatic infections or mild infections that go undetected or undiagnosed. People who recover from COVID-19 infection may develop an antibody response to the pathogen, which creates immunological memory and potentially protects them from future exposure to the virus. These antibodies are typically detectable in the blood approximately 14 days after the onset of infection.

“Regeneron is working on multiple fronts to find effective approaches against SARS-CoV-2, including the development of a novel antibody therapeutic that could be used as prevention or treatment for the disease,” said Christos Kyratsous, Ph.D., Vice President of Research, Infectious Diseases and Viral Vector Technology at Regeneron. “We’re encouraged to also be working with our collaborator Vyriad to utilize both companies’ virus engineering capabilities in order to deploy a much-needed testing approach.”

Vyriad has internally validated this assay and is conducting ongoing assay verification studies to continually evaluate assay performance. The assay validation results and methodology have been submitted to the FDA in accordance with regulatory requirements for COVID-19 Emergency Use Authorization.

The test is currently run at Vyriad’s CLIA approved laboratory in Rochester, Minnesota. Vyriad does not engage in patient services and can only accept testing requests from a referring physician or laboratory at this time. It is anticipated that this test will be commercially available through major laboratories within the next few weeks.

Since October 2019, Vyriad has been working exclusively with Regeneron to research and develop vesicular stomatitis virus (VSV)-based oncolytic virus technologies. This collaboration now includes the SARS-CoV-2 Neutralizing Antibody Test, which was developed utilizing the deep scientific expertise of both companies. Regeneron’s proprietary VelociSuite® technologies and Vyriad’s virus engineering capabilities enabled development of this scalable assay in a rapid timeframe.