SOUTH SAN FRANCISCO (KPIX) – A Bay Area biotechnology company has discovered a new way to make a COVID-19 treatment by producing an entirely new class of drugs. Soon, the invention will be tested in human clinical trials.
These drugs are called recombinant hyperimmunes. They are polyclonal antibody drugs which are like a xerox of a patient’s immune system: a high tech version of convalescent plasma therapy.
To date, hospitals across the country are treating COVID-19 patients with convalescent plasma. This is plasma taken from those who survived the disease. The hope is that a good dose of antibodies will help the sick fight off the illness.
The problem is that the demand outstrips the supply and some donations from the survivors have weak levels. Each donor may only supply a few doses. The need for plasma therapy has U.S. Surgeon General Jerome Adams issuing a plea.
“If you have recovered from COVID, you can save up to 3 lives by donating your plasma,” urged Dr. Adams.
That’s where GigaGen comes into the picture. The South San Francisco Company may have a solution.
“It’s something completely novel. So we’re excited about this,” said GigaGen CEO David Johnson.
GigaGen has come up with a way to make an antibody therapy without relying on donors
Dr. Johnson noted that with their technology, they can crank out millions of doses from just a few good survivors.
“You don’t have to go back to the same donors over and over,” said Dr. Johnson.
The company takes DNA from the plasma of a COVID survivor, and then using high-end DNA technologies” produces a consistently potent antibody serum that contains thousands of different antibodies.
“It’s 12,500 antibodies. So you can see how this is certainly a much different kind of product than monoclonal antibodies,” explained Dr. Johnson.
GigaGen got its donors from recovered COVID-19 patients who attended Mardi Gras in New Orleans. They screened 50 patients, and found 16 of them to have extraordinarily high quality antibodies.
“Those samples of blood actually become our recombinant product which is now being manufactured for our clinical studies,” said Dr. Johnson.
In a newly published study in bioRXiv, researchers from around the world tested the serum in the lab and in animals, and found it was 100-fold more potent than donated plasma, and that it actually binds to and fights the virus.
The company is in discussions with the U.S. Food and Drug Administration. GigaGen expects human trials to begin early 2021.