BARDA is collaborating with Sentien Biotechnologies to evaluate the company’s cell-based therapeutic platform in people with sepsis, initially focusing on those with acute kidney injuries associated with sepsis (sepsis-AKI), including from COVID-19.
The partnership will further Sentien’s prior research and clinical studies in patients with systemic inflammatory disease, a condition associated with sepsis. This study will evaluate the ability of Sentien’s lead therapeutic product, SBI-101, to mitigate the severe symptoms of hospitalized sepsis-AKI patients. The goal is to support regulatory path activities to advance an effective and durable therapeutic approach to restore patient health (also known as host homeostasis) and improve clinical outcomes.
Sepsis occurs when an infection or other insult to the body produces a dysregulated host response in a patient, which can cause serious tissue damage, organ failure, and even death. Patients presenting with sepsis have limited therapeutic options, and approaches that target pathogens may not be sufficient once a dysregulated response to an infection has started. Sentien offers a novel cell therapy platform that has the potential to broadly treat acute inflammatory disorders, like sepsis, which can arise from almost any infection.
Sentien has developed a combination product consisting of an ex vivo (outside of the body) hollow fiber blood-filtration device that contains immobilized mesenchymal stem cells (MSCs), which are found in adult bone marrow. This product allows for interaction between the MSCs in the device and the patient’s cells that flow through the device, enabling controlled and sustained delivery of MSC-secreted factors to the patient’s blood. The technology has the potential to restore immune balance and improve clinical outcomes in patients exhibiting systemic inflammation as a response to an injury or infection.
There are currently no host-targeted sepsis therapeutic products that are U.S. Food and Drug Administration (FDA)-approved and available. If successful, SBI-101 would address the clinical need to restore immune balance in this patient population. Rather than upregulating or downregulating specific aspects of the immune system, this innovative blood conditioning approach is designed to re-program and modulate the patient’s immune response. Further development of this technology may enable new treatment options for hospitalized patients, reduce length of stay for hospitalized patients, and improve clinical outcomes.
The BARDA-Sentien collaboration will support regulatory path activities to position this technology for the treatment of sepsis and other acute inflammatory indications.
About Sentien Biotechnologies, Inc.:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
Sentien Biotechnologies, Inc. is a privately held, clinical-stage company developing novel ex- vivo cell therapy applications to treat conditions caused by systemic, immune-mediated inflammation. Sentien’s lead product, SBI-101, integrates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, hollow-fiber device. By immobilizing MSCs within a blood-contacting device, SBI-101 enables controlled, dynamic, and sustained delivery of MSC- secreted factors to the patient’s blood, without the need for direct injection of the MSCs themselves.