April 02, 2020
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FDA clears IND application for natural killer cell-based COVID-19 therapy

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The FDA cleared an investigational new drug application for CYNK-001 for the treatment of adults with COVID-19 infection, according to the agent’s manufacturer.

CYNK-001 (Celularity) is an investigational, cryopreserved, allogeneic natural killer cell therapy derived from placental hematopoietic stem cells.

"This investigational new drug application represents a significant step toward a potential treatment of patients infected with COVID-19 virus, which is spreading globally at unanticipated rates," Robert Hariri, MD, PhD, founder, chairman and CEO of Celularity, said in a company-issued statement.

"With our initial clinical study, we will gain an understanding of the impact CYNK-001 can have on patients recently diagnosed with COVID-19,” Hariri added. “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 FDA clearance will allow Celularity to begin a phase 1/phase 2 clinical trial of its natural killer cell therapy in up to 86 patients with COVID-19. The investigational treatment is believed to be the first immunotherapy to receive this clearance by the FDA for treatment of COVID-19, according to the statement.

"Studies have established that there is robust activation of [natural killer] cells during viral infection regardless of the virus class," Xiaokui Zhang, PhD, chief scientific officer of Celularity, said in the statement.

Zhang said CYNK-001 has demonstrated “a range of biological activities” that would allow its cellular therapy to potentially recognize and kill infected cells.

“These functions suggest that CYNK-001 could provide a benefit to patients with COVID-19 in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells,” he added.

The FDA approved an IND for CYNK-001 in January for the treatment of glioblastoma multiforme, a type of brain cancer, as previously reported by Healio.