A potentially groundbreaking COVID-19 treatment is now in clinical trials at Seattle's Infectious Disease Research Institute (IDRI). Unlike some other treatments being explored, this one uses human cells previously deployed against certain cancers.
The first trial of placenta-derived CYNK-001, being developed in partnership with the New Jersey-based Celularity biotechnology firm, began last week on a patient at the University of California Irvine. Up to 14 patients hospitalized with moderate COVID-19 symptoms will receive three doses of the so-called "Natural Killer" cells -- NK-cells -- over a one-week span at eight testing sites nationwide, followed by a second phase that measures results against a control group receiving the current "best supportive" care.
Those touting the use of NK-cells say they differ from current antiviral medication treatments for COVID-19 -- which are garnering moderately successful results at best -- in that they are produced within the body and shouldn't cause collateral damage to vital organs. NK-cells had previously been safely used in studies for treatment of patients with leukemia and multiple myeloma.
"They are natural to your body; they are innate," said Alan Lew, IDRI's senior clinical trial manager, adding that more than 50 institute employees are engaged full time on the trials. "So, they play a very important role against the various pathogens. So, with the multiple additional NK-cells we're giving into the body, that will hopefully help to cause that immune response to destroy those viruses."
The treatment also differs from proposed COVID-19 vaccines under development in that those require infusing various strains of the virus into the body to build immunity. While vaccines are meant as a preventive treatment, the NK-cells would be used by those who already have COVID-19 in moderate-to-severe forms not yet critical enough to require being placed on a mechanical ventilator.
"Our hope is to give it well in advance so that your body can build that immune response to it," Lew said. "Due to the fact a lot of people are staying home, they're coming in once their symptoms are very severe. They go to the hospital and they realize they've had COVID for a good amount of time and it might be too late. They might need to go on to other treatments."
The trials will gauge the effectiveness of the treatment as well as any adverse patient reactions to the NK-cells.
By mid-May, CYNK-001 was already being used in Food & Drug Administration-approved testing on four critically ill COVID-19 patients who'd failed to respond to other treatments. Two of the four patients had improvements in their respiratory status and the others did not because of what Lew described as "their underlying conditions."
None suffered adverse effects from the treatments.
"It was well tolerated," Lew said. "So, that was a great sign."
Lew said the initial phases of clinical trials should last about six months. After that, he expects the FDA could seek additional testing of larger groups that would last until the fourth quarter of next year -- though preliminary results could become available prior to that.
Celularity first agreed to a seven-figure funding deal for testing with IDRI in March. The FDA approved their application in April, after which testing facilities were set up with partner hospitals in COVID-19 "hot spots" -- two in California, three in New Jersey and others in Arizona, Arkansas and at the Tacoma-based MultiCare Health System.
"We are pleased to have IDRI as our collaborator on what we believe is the first NK cell-based immunotherapy trial targeting COVID-19," Dr. Robert J. Hariri, Celularity's founder, chairman and CEO, said in a news release. "The collaboration enabled a very rapid scale up, allowing us to administer CYNK-001 to the first COVID-19 patients within five weeks of obtaining Investigational New Drug clearance from the FDA."
The testing sites were chosen based on geography -- hoping to cover both coasts and the center of the country -- and proximity to known COVID-19 outbreaks in order to have ample access to testing candidates. IDRI is inviting those who feel they meet the testing inclusion requirements to discuss it with their doctor or contact IDRI through its website to be considered for participation.
