May 18, 2020 -- NantKwest announced that it received investigational new drug (IND) authorization from the U.S. Food and Drug Administration (FDA) 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.
The firm entered into an agreement with the National Marrow Donor Program to develop an automated method to expand and generate multiple dose forms using a modular, closed system from affiliate ImmunityBio. The "GMP-in-a-box" system expands the scalable manufacture and distribution of cryopreserved stem cell products.
The product is powered by MSC, multipotent progenitor cells that have been shown to restore immune function and contribute to viral clearance. Prior research in ARDS patients has shown that MSC treatment is safe and may reduce key markers of inflammatory processes.
The firm plans to initiate a phase Ib, randomized, double-blind, placebo-controlled study in the second quarter in 2020.