Scaling-up the production of BM.allo-MSC with NANT 001 System to treat

Recently, our partner NantKwest, Inc. has announced the FDA authorization of an IND Application for a Mesenchymal Stem Cell Product aimed at the treatment of COVID-19 patients that require ventilation.

In this ongoing Phase 1b, randomized, double-blind, placebo-controlled study (NCT04397796), patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 are currently being treated with BM-Allo.MSC, an allogeneic Mesenchymal Stem Cell (MSC) product derived from human Bone Marrow that is produced with the NANT 001 System, a technology that is truly enabling a scalable manufacture of this therapy for its broadly distribution.

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.

The therapeutic will be administered to a total of 45 patients 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.