Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19

Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19.

The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost the immune system’s disease-fighting response.

For Celularity, those NK cells are derived from stem cells cultivated from placental tissue, which hospitals typically treat as medical waste.

Backed by the venture investment firm Section 32, and strategic investors including Celgene, now a division of Bristol Myers; United Therapeutics, a biomedical technology developer; Human Longevity, the troubled venture-backed startup founded by genomics J. Craig Venter; and Sorrento Therapeutics, a publicly traded biomedical company; Celularity was pursuing a number of applications of the novel cell therapy, but its initial focus was on cancer treatments.

The real breakthrough for the company, and one of the reasons why it’s attracted so much capital, is that its cell therapies don’t need to be cultivated from a patient donor — a lengthy and expensive process. Celularity is able to produce NK cells and store them, so that they can be ready for transfusion when they’re needed.

With the the FDA’s clearance, Celularity is going to begin a small, 86-person trial to test the efficacy of its CYNK-001 immunotherapy to treat COVID-19 infected adults, the company said.

There are at least two studies underway in China that are also testing whether Natural Killer cells can be used to treat COVID-19.

NK cells are a type of white blood cell that are part of the body’s immune system. Unlike t-cells, which target particular pathogens, NK cells typically work to support the immune system by identifying and destroying cells in the body that appear to be stressed, either from an infection or a mutation.

The therapy seems to be successful in treating certain types of cancer, and the company’s researchers speculate that it can provide similar results in stopping the ability of the novel coronavirus which causes COVID-19 to spread throughout the body.

However, there are some potential roadblocks and risks to pursuing the NK therapy. Chiefly, COVID-19 is deadly in part because it can push the immune system into overdrive. The “cytokine storm” that results from the infection means that the body starts attacking healthy cells in the lungs which leads to organ failure and death. If that’s the case, then boosting the immune response to COVID-19 might be dangerous for patients.

There’s also the possibility that NK cells might not be able to detect which cells are infected with the coronavirus which causes COVID-19, rendering the therapy ineffective.

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” said Celularity’s Chief Scientific Officer, Xiaokui Zhang, in a statement. “These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”