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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients
Preliminary data from NantKwest collaborators suggests mesenchymal stem cell treatments may benefit COVID-19 patients with acute respiratory distress
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nPreliminary data from NantKwest collaborators suggests mesenchymal stem cell treatments may benefit COVID-19 patients with acute respiratory distress syndrome and cytokine storm\n\n\nTrial anticipated to initiate in Los Angeles area hospitals in Q2\n\n\nProprietary automated “GMP-in-a-Box”, an in-house manufacturing apparatus, enables rapidly scalable, off-the-shelf allogeneic mesenchymal stem cell product BM-Allo.MSC\n\n\n EL SEGUNDO, Calif.--(BUSINESS WIRE)--\nNantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.\n\n\n“There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and ‘cytopathic storm’,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2.”\n\n\nBM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells t...