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Sentien Biotechnologies Completes Enrollment of First Cohort in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19

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Sentien Biotechnologies Completes Enrollment of First Cohort in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced it has completed enrollment of the first cohort in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19.  SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT).

In addition, the independent Data Safety Monitoring Board has reviewed the safety data from the first cohort and supports continuation of the study and dose escalation.

“We are pleased to have reached this milestone in our evaluation of SBI-101 for the treatment of severe COVID-19,” said Sentien CEO, Brian Miller.  “We are grateful to the patients and clinical site investigators and staff for their participation in the study and we look forward to continued collaboration as we commence enrollment of the second cohort.”

“There is increasing evidence that the serious clinical consequences of COVID-19 infection on the lungs and the kidneys is mediated by a dysregulated immune response” said Sentien Chief Medical Officer, Dr. Allen Nissenson.  “We are encouraged by what we’ve observed in the first cohort and are eager to continue pursuing the therapeutic hypothesis that treatment with SBI-101 will restore a favorable immune response and result in improved clinical outcomes.”

SBI-101 is a combination product that integrates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, blood-contacting device.  MSCs are a unique source of therapeutic secreted factors that modulate the immune-mediated inflammatory response to acute organ injury.  By keeping the MSCs confined 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.  SBI-101 integrates into a standard blood circuit such as used with renal replacement therapy, thereby providing patients with both standard-of-care and MSC-mediated blood conditioning in a single session.

The multi-center trial is a randomized, controlled, ascending dose Phase 1/2 study in patients with COVID-19 requiring RRT.  The primary objective of the trial is to evaluate the safety and tolerability of SBI-101; endpoints for efficacy and pharmacodynamic responses to SBI-101 therapy will also be evaluated.

Please visit https://clinicaltrials.gov/ct2/show/NCT04445220 for more information about the study.

About Sentien Biotechnologies

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.

SBI-101 has been evaluated in a Phase 1b/2a study in subjects with dialysis-requiring acute kidney injury (AKI-D).  An initial readout from the study provides preliminary evidence of anti-inflammatory and wound healing effects consistent with the SBI-101 therapeutic hypothesis.  Building on this data, SBI-101 is being evaluated in COVID-19 patients suffering from severe systemic inflammation.

Sentien’s technology can be applied to additional systemic inflammatory indications in both acute and chronic diseases, focusing on complex conditions where single-factor agents have not been effective.

For more information, please visit www.sentienbiotech.com.

Media Contact

Brian Miller, CEO
Sentien Biotechnologies, Inc.
(781) 361-9031
info@sentienbiotech.com

Sentien Announces First Subject Dosed in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19

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Sentien Biotechnologies Announces First Subject Dosed in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced that the first subject has been enrolled in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19 at the University of New Mexico (UNM) Hospital.  SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT).

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Sentien-Led Team Awarded $2.4M Contract from the U.S. DoD and MTEC

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Sentien Biotechnologies-Led Team Awarded $2.4M Contract from the U.S. Department of Defense and the Medical Technology Enterprise Consortium

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, has been awarded a $2.4 million contract from the Medical Technology Enterprise Consortium (MTEC).  The funds will be used to support the development of a potency assay for mesenchymal stromal cells (MSCs) in regenerative medicine products. Read More >

Sentien Biotechnologies Announces Open IND in Phase 1/2 Trial of SBI-101 for Patients with COVID-19

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Sentien Biotechnologies Announces Open IND in Phase 1/2 Trial of SBI-101 for Patients with COVID-19

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the evaluation of Sentien’s lead asset, SBI-101, for the treatment of severe COVID-19.  Approval of this IND allows Sentien to initiate a Phase 1/2 study with a focus on COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT). Read More >

Sentien Biotechnologies Names Dr. Allen R. Nissenson as Chief Medical Officer

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Sentien Biotechnologies Names Dr. Allen Nissenson as Chief Medical Officer

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced the hiring of Allen R. Nissenson, M.D., F.A.C.P., as its Chief Medical Officer.  Dr. Nissenson will join Sentien’s executive team and oversee the clinical development of Sentien’s lead product, SBI-101.  Dr. Nissenson serves as an Emeritus Professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles, Emeritus Chief Medical Officer of DaVita Kidney Care, and a member of the Board of Directors of Angion Biomedica Corp and Rockwell Medical, Inc. Read More >

Sentien Biotechnologies Names Richard Ganz as Executive Chairman

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Sentien Biotechnologies Names Richard Ganz as Executive Chairman

LEXINGTON, MA – Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced the appointment of Richard Ganz as Executive Chairman.  Mr. Ganz will continue to lead Sentien’s Board of Directors, a role he has filled for the past nine years, as well as work closely with CEO Brian Miller and Sentien’s management team. Read More >

Sentien Biotechnologies, Inc. Announces Open Enrollment in Phase 1/2 Trial of SBI-101 for Patients with Acute Kidney Injury

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Sentien Biotechnologies, Inc. Announces Open Enrollment in Phase 1/2 Trial of SBI-101 for Patients with Acute Kidney Injury

Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, announced that it has opened enrollment in its Phase 1/2 trial of SBI-101 for adult patients with acute kidney injury (AKI).  This trial is Sentien’s first clinical program.
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Sentien Biotechnologies, Inc. Announces $12 Million Series A Financing

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Sentien Biotechnologies, Inc. Announces $12 Million Series A Financing

Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, announced today that it has closed a $12 million Series A investment round. The financing was co-led by Boehringer Ingelheim Venture Fund USA, Inc. (BIVF USA) and BioInnovation Capital, and joined by Chiesi Ventures, MBL Venture Capital Co., Ltd, and Mass Medical Angels. The Series A round will be used to fund initial clinical development of Sentien’s SBI- 101 for the treatment of acute kidney injury (AKI).
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