Celularity announced the first patient was dosed in a Phase I/II study of human placental hematopoietic stem cell derived NK cells (CYNK-001) for the treatment of adults with COVID-19 as part of a national clinical trial. The patient was treated at UC Irvine in California, the first CA site to open for patient enrollment with support from a COVID-19 Project grant awarded to Celularity by the California Institute for Regenerative Medicine (CIRM). Participating trial sites include Hackensack University Medical Center and Atlantic Health in New Jersey, MultiCare Health System in Washington State, Banner University Medical Center Phoenix in Arizona, the University of Arkansas in Arkansas, and UC Davis in California.
"Through this collaboration with our partner sites, we were able to rapidly scale and commence what we believe is the first NK cell-based immunotherapy trial targeting COVID-19," said Robert J. Hariri, M.D., Ph.D., Celularity's founder, Chairman and CEO. "We are optimistic that the study's initial findings will demonstrate CYNK-001 as a safe and effective, as well as rapidly deployable and scalable approach to the treatment of COVID-19 patients, giving them the immune cells that are critical in fighting this infection."
The trial will evaluate the safety and clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. 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 COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.
The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.
Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in the U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.
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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. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.
CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are intrinsically safe and versatile and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.
The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 3.6 million confirmed cases and over 250,000 deaths reported to date worldwide.