Oqory (samtonadstrocel) / Personalized Stem Cells, Sorrento - LARVOL DELTA

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | Phase classification: P2a ➔ P2 | N=60 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • HGF

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2 | N=43 | Terminated | Sponsor: Sorrento Therapeutics, Inc. | N=100 ➔ 43 | Trial completion date: Mar 2023 ➔ Nov 2022 | Recruiting ➔ Terminated; Due to considerably slow enrollment, unable to reach enrollment targets

Enrollment change • Trial completion date • Trial termination • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

CoronaStem1: Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Sorrento Therapeutics, Inc. | Recruiting ➔ Completed | N=20 ➔ 10 | Trial completion date: Jan 2022 ➔ Aug 2021 | Trial primary completion date: Jan 2022 ➔ Jun 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Feb 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

BR: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Jun 2022 ➔ Sep 2023 | Initiation date: Oct 2021 ➔ Jul 2022 | Trial primary completion date: Apr 2022 ➔ Jul 2023

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • HGF

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2021 ➔ Nov 2021

Enrollment open • Trial initiation date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=100 ➔ 0; Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • PCR

Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=100 ➔ 0; Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2a; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=30 ➔ 0; Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • HGF • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; N=100 ➔ 60

Enrollment change • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

BR: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

New P2a trial • Infectious Disease • Novel Coronavirus Disease • HGF • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Acute Respiratory Distress Syndrome • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • PCR

Study of Intravenous COVI-MSC for Treatment of COVI-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (clinicaltrials.gov) - P2a; N=30; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

New P2a trial • Infectious Disease • Novel Coronavirus Disease • HGF • PCR

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • PCR

Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Pivotal Clinical Trial of COVI-MSC in Hospitalized COVID-19 Patients With Acute Respiratory Distress Syndrome (GlobeNewswire) - "Given the emergency status in Brazil, Sorrento has worked with ANVISA to obtain fast turn-around for the Phase 2 Pivotal clinical trial submission following positive Phase 1b results in the U.S; Maintaining an extreme sense of urgency, Sorrento anticipates commencing enrollment of patients in the study in June 2021. Sorrento Therapeutics, Inc....announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 Pivotal clinical trial of COVI-MSC™...The Brazil study is a Phase 2 Pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of three infusions of COVI-MSC™, administered every other day..."

New P2 trial • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces Positive Results of Phase 1b Study of COVI-MSC Treatment of ICU Covid-19 Patients, Achieving 100% (10 out 10) Discharge Rate (GlobeNewswire) - P1b, N=10; "Sorrento Therapeutics, Inc....announced today the completion of enrollment in its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) infusions...The 10th patient had been under treatment for nearly 2 weeks without improvement and was discharged after the 2nd COVI-MSC infusion with oxygen saturations in the high 90s on room air....The study met its primary objective: to demonstrate the safety of intravenous infusion of allogeneic adipose MSC cells...Sorrento will be working with the FDA in the near future once the full dataset is available to plan a placebo-controlled pivotal study to support an emergency use authorization (EUA) submission. The study is expected to be conducted across multiple sites in the United States and Brazil."

P1 data • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces Positive Preliminary Results of Phase 1b Study of COVI-MSC for Treatment of ICU COVID-19 Patients (GlobeNewswire) - P1b, N=20; CoronaStem1 (NCT04486001); Sponsor: Sorrento Therapeutics, Inc.; "Sorrento Therapeutics, Inc....announced today positive preliminary results from its Phase 1b study...The first three patients enrolled tolerated treatment well and improved rapidly. Each of the three patients was discharged from the hospital within a week of starting the patient’s COVI-MSC infusions and two patients were discharged on the day of their last infusion....Each of the infusions were well-tolerated and no patient reported any infusion-related adverse events....Additional enrollment continues....'I am looking forward to working with Sorrento in continuing to offer COVI-MSC treatments to patients in this study and in the proposed controlled phase 2 study'."

P1 data • Infectious Disease • Novel Coronavirus Disease

Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

New P2 trial • Infectious Disease • Novel Coronavirus Disease

CoronaStem1: Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2021 ➔ Jan 2022; Trial primary completion date: Jan 2021 ➔ Jan 2022

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

CoronaStem1: Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; Initiation date: Aug 2020 ➔ Dec 2020

Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Sorrento Adds Mesenchymal Stem Cell Program (MSC) That Has Been Cleared for a Phase 1 Trial by the FDA to the Pipeline of COVID-19 Focused Rescue Therapies (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19....Sorrento will be assuming responsibility for executing the Phase 1 trial....Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities."

Licensing / partnership • New P1 trial • Infectious Disease • Novel Coronavirus Disease