An antibody candidate from Sorrento has shown complete blockage of infection in early assessments. The company is now pursuing production and regulatory aid.
An investigative antibody for SARS-CoV-2 has reported 100% inhibition of viral infection during an in vitro experiment conducted at a low antibody concentration.
Sorrento Therapeutics announced Friday its anti-SARS-CoV-2 antibody STI-1499 completely neutralized virus infectivity at a very low antibody dose, indicating its candidacy for further assessment and development by the San Diego-based drug maker.
STI-1499 will be the first antibody developed by the company, as it pursues an antibody cocktail product that would potentially shield patients from SARS-CoV-2 coronavirus infection—regardless of viral mutations or failed antibody therapy effectiveness over time.
In response to the coronavirus 2019 (COVID-19) pandemic, Sorrento has been screening billions of collected antibodies in its proprietary G-MAB fully human antibody library to identify eligible candidates for its cocktail product. Approximately one dozen thus far have demonstrated inhibition of the S1 protein’s interaction with human angiotensin-converting enzyme 2 (ACE2).
As this is the receptor used for viral entrance into human cells, these blocking antibodies are among the first assessed candidates for SARS-CoV-2 virus infection inhibition in the in vitro virus infection model.
Sorrento now plans to request priority evaluation and accelerated pathway review from regulators to make a potential therapy available as soon as possible. Their antibody manufacturing facility is capable of producing 200,000-plus doses monthly, and the company intends to produce 1,000,000 doses while seeking US Food and Drug Administration (FDA) approval for any STI-1499 product candidate.
"Our STI-1499 antibody shows exceptional therapeutic potential and could potentially save lives following receipt of necessary regulatory approvals,” Henry Ji, PhD, chairman and chief executive officer of Sorrento, said in a statement. “We at Sorrento are working day and night to complete the steps necessary to get this product candidate approved and available to the waiting public.”