On May 18, 2020, NantKwest, now part of ImmunityBio, announced it had 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 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, to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

BM-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 that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.