Giuliani-promoted COVID-19 therapy from Celularity nabs FDA speedy trial start

A new trial approval from the FDA adds to the growing arsenal of treatments vying to kill off the SARS-CoV-2 virus. (Pixabay/Thor Deichmann)

A new and unproved COVID-19 cell therapy from a New Jersey biotech has been given a quick trial approval by the FDA, coming just days after President Donald Trump’s personal attorney and former New York City Mayor Rudy Giuliani pushed for the med to be trialed ASAP.

Writing on his Twitter page, which has more than 650,000 followers, Giuliani said in late March: “Our special guest today [Celularity CEO Robert Hariri] on Common Sense describes the process of extracting placenta ”Killer Cells” and their effectiveness in attacking cancer and virally infected cells.

“Trials need to be EXPEDITED.”

It seems he got his wish: Today, New Jersey-based Celularity said it has been given the all-clear from the FDA to start its clinical trial of CYNK-001, its allogeneic, off-the-shelf, cryopreserved natural killer cell therapy to be used in a phase 1/2 study in up to 86 patients with COVID-19.

The Celgene spinoff sees CYNK-001 as the first immunotherapy IND cleared by the FDA to treat COVID-19-infected adults. This comes only a few weeks after it asked the FDA for a clearance to run its test.

“This IND represents a significant step toward a potential treatment of patients infected with COVID-19 virus, which is spreading globally at unanticipated rates,” said Robert Hariri, M.D., Ph.D., founder, chairman and CEO at Celularity.

“With our initial clinical study, we will gain an understanding of the impact CYNK-001 can have on patients recently diagnosed with COVID-19. We are hopeful to contribute to flattening the COVID-19 curve, expanding on the promising early results we’ve seen in our clinical studies in devastating cancers to patients with coronavirus.”

This also comes after the FDA said this week it was looking to hit the gas pedal on new treatments for COVID-19.

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In a podcast with Giuliani last week, Hariri talked about the potential of the treatment, leading Giuliani to also tweet that this “therapy [CYNK-001] has real potential. Let’s hope FDA can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.” Hariri did not criticize the FDA.

CYNK-001 cells derived from the placenta are also currently being investigated as a treatment for acute myeloid leukemia, multiple myeloma and glioblastoma multiforme.

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” added Celularity’s chief scientific officer, Xiaokui Zhang, Ph.D. “CYNK-001 demonstrates a range of biological activities expected of NK cells, including expression of activating receptors such as NKG2D, DNAM-1 and the natural cytotoxicity receptors NKp30, NKp44 and NKp46, which bind to stress ligands and viral antigens on infected cells.

“They also show the expression of cytolytic molecules perforin and granzyme B, which kill recognized infected cells. 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.”

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This comes amid a growing plethora of treatments and vaccines against SARS-CoV-2, the virus causing COVID-19. Many treatments are focused on repurposed antivirals or autoimmune drugs as well as old antibiotic and anti-malaria meds; experimental therapies are working on using recovered patients’ blood for antibodies to the virus, and some are trying RNAi approaches.