Policy & Regulation
Celularity awarded USD750,000 CIRM grant to advance COVID-19 treatment in California
6 August 2020 -

Biotechnology company Celularity reported on Wednesday the receipt of a USD750,000 COVID-19 Project grant from the California Institute for Regenerative Medicine (CIRM) to support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.

In the trial, the University of California Irvine is the first CA site to open for patient enrollment. The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects.

The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability and efficacy of multiple CYNK-001 intravenous (IV) infusions in up to 14 COVID-19 patients in three doses over the course of seven days. The Phase II randomized, open-label, multi-site study will measure the multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints.

NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells, Celularity said.

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