FDA Green-Lights Clinical Trial For COVID-19 Coronavirus Treatment That ‘Flattens The Curve’ In Patients

Therapeutics startup Celularity announced Thursday morning that it has received FDA clearance to begin a clinical trial of a proposed stem-cell treatment for COVID-19. The approval of the New Jersey-based company’s IND application enables the company to begin a clinical trial with patients who have the disease.

The company’s therapy, called CYNK-001 for now, uses “Natural Killer” (NK) cells, a form of white blood cells that wage war against cancer and viral infection, derived from placental stem cells. The company’s been developing similar treatments for several years against cancer and Crohn’s disease, several of which are being tested as well.

The idea behind the therapy is that for patients who are starting to show symptoms, or who may be at risk for a more severe form of the disease, can receive an intravenous infusion of NK cells to bolster their immune response to the virus, says founder and CEO Robert Hariri. That’s because the additional NK cells help slow down the viruses’ ability to replicate within the body. It’s an approach he likens to social distancing—slowing the spread of COVID-19 so hospitals don’t get even more overwhelmed—within patients themselves.

“By administering our NK cells to patients, we are acting to ‘flatten the viral titer curve,’ so the patient’s adaptive immune system can get in gear and do the job of clearing the virus,” he says.

Celularity was cofounded by Hariri and X Prize Foundation chair Peter Diamandis in 2016 as a spinout of pharmaceutical company Celgene. About a decade before, the company had found itself in the business of collecting and storing umbilical cord blood from placentas after birth. The undifferentiated stem cells found in that blood offer a universal way to generate NK cells that potentially reduce risk of rejection or other complications.

It’s a strategy that’s earned the company support from investors like Bill Maris at Section 32, Sorrento Therapeutics, and former Apple CEO John Sculley. According to Pitchbook, the company has raised over $327 million in backing to date.

The primary thrust of the company’s therapeutic efforts have been to leverage these treatments against forms of cancer such as myelomas and leukemia. But because NK cells are often involved in protecting the body against viruses, Hariri says he’s always looked to the company one day going after infectious disease.

According to Hariri, it may take only a matter of days to see results from the first clinical trial of COVID-19 patients. That test will involve use of the treatment in a patient group of up to 86 people. If that’s successful, Hariri hopes those results will mean accelerating to a larger trial, and then, if all goes well, out to market.

“This is a very easy product to deploy,” says Hariri. “We’re hopeful that if we get compelling enough data, the agency and the CDC and the NIH will work with us to scale up production.”