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Kidney Week

Abstract: PO0871

Clinical Relevance of AKI Trial Data for Severe COVID-19 Patients

Session Information

Category: Coronavirus (COVID-19)

  • 000 Coronavirus (COVID-19)

Authors

  • Barcia, Rita N., Sentien Biotechnologies, Lexington, Massachusetts, United States
  • O'Rourke, Brian, Sentien Biotechnologies, Lexington, Massachusetts, United States
  • Nguyen, Sunny Huynh, Sentien Biotechnologies, Lexington, Massachusetts, United States
  • Tilles, Arno William, Sentien Biotechnologies, Lexington, Massachusetts, United States
  • Garg, Payal, Sentien Biotechnologies, Lexington, Massachusetts, United States
  • Gemmiti, Christopher V., Sentien Biotechnologies, Lexington, Massachusetts, United States
  • Miller, Brian, Sentien Biotechnologies, Lexington, Massachusetts, United States

Group or Team Name

  • Sentien Biotechnologies
Background

Coronavirus disease 19 (COVID-19), caused by SARS-CoV-2 was declared a pandemic in March 2020 and remains without any approved treatments. After entering the cells, the virus begins to replicate and viral antigen is presented to antigen presenting cells (APCs), the cells that stimulate the body’s normal anti-viral immune response. In severe cases however, this immune reaction becomes dysregulated as evidence by high levels of certain cytokines and chemokines in the blood, a reaction known as cytokine storm. This results in a systemic uncontrolled inflammatory state that triggers a violent attack by the immune system to the body, causes acute respiratory distress syndrome (ARDS) and multiple organ failure, leading to death.

Methods

Mesenchymal stromal cells (MSCs) are a unique source of secreted factors that modulate an inflammatory response and enhance the repair of injured tissue. MSCs have been extensively studied in ARDS and other acute organ injuries. Sentien has created a novel delivery approach to enable sustained exposure to MSCs and their secreted factors, overcoming limits of cell transplantation/infusion while preserving their broad acting and dynamically responsive properties. Our lead product, SBI-101, contains allogeneic human MSCs inoculated into a hollow-fiber hemofilter, which enables communication with patient blood via the semi-permeable membrane, while maintaining MSC viability. Through this interplay, SBI-101 aims to restore balance to the immune system by reprogramming the molecular and cellular components of blood in patients with severe inflammation and organ injury.

Results

Sentien’s Phase I/II clinical study of SBI-101 in critically ill patients with Dialysis-Requiring Acute Kidney Injury (AKI-D) has produced data to support the therapeutic hypothesis of SBI-101. Consistent with MSC biology, inflammatory markers, such TNFa and IFNg, were shown to be modulated, suggestive of a shift from a pro- to an anti- inflammatory state in treated patients.

Conclusion

Data obtained in our AKI-D trial showed modulation of many biological molecules and immune populations that may be correlated with severe COVID-19 immunopathology. Here we make the case, using our existing AKI-D trial data, that SBI-101 may be of therapeutic benefit to severe cases of COVID-19.