Candidate: COVI-GUARD™ (STI-1499)
Type: Anti-SARS-CoV-2 antibody, the first antibody to be identified as part of COVI-SHIELD™, an antibody “cocktail” therapy being developed by the partners.
Status: Sorrento said August 19 it had filed an IND with the FDA to study COVI-GUARD in hospitalized COVID-19 patients, with plans to launch a Phase I safety trial (NCT04454398). The Phase I trial is expected to be followed by pivotal trials, with a goal of potentially receiving an Emergency Use Authorization (EUA) as early as the end of this year.
The Phase I trial will use doses of up to 200 mg per patient, which according to Sorrento is a much lower dose than currently being tested for other known antibodies in active clinical studies. Sorrento reasons that the potentially higher potency of the antibody may allow for faster scaled manufacturing, and potentially a lower cost per dose as compared to other known antibodies currently being evaluated.
In May, Sorrento founder and CEO Henry Ji, PhD, denied that his company was being “manipulative” and trying to “shamelessly profiteer off the pandemic,” as alleged by Hindenburg Research in a report stating it has taken a short position in shares of the company. Five days earlier, Sorrento saw its share price more than double, rocketing 158% to a closing price of $6.76, after announcing that in preclinical experiments, COVI-GUARD showed 100% inhibition of SARS-CoV-2 virus infection on healthy cells after four days incubation, while a low dose prevented SARS-CoV-2 from infecting healthy cells. “We want to emphasize there is a cure,” Ji told Fox News.
Shares dipped back to a close of $5.70 on May 20. Hindenburg cited Sorrento submitting “shelf registration” paperwork in March seeking the right to sell up to $1 billion in securities. In April, the company agreed to sell $500 million of stock, weeks before its announcement.
“What we are focusing on instead of watching the stock going up or going down, we are focusing on making sure we have the real deal,” Ji said. “You have the antibody that can prevent the virus from infecting healthy cells. That means you will have a real product. If you have a real product, eventually the stock will be reflecting the assets you have.”
Sorrento said COVI-GUARD emerged from billions of antibodies screened in the company’s proprietary G-MAB™ fully human antibody library. Sorrento identified hundreds of antibody candidates that bind the S1 subunit of the SARS-CoV-2 Spike protein, of which about a dozen showed the ability to block the S1 protein’s interaction with human angiotensin-converting enzyme 2 (ACE2). The blocking antibodies were further tested for their ability to inhibit SARS-CoV-2 virus infection in an in vitro SARS-CoV-2 virus infection model, under a preclinical testing agreement with The University of Texas Medical Branch at Galveston announced March 31, 2020.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: