Sorrento Therapeutics Inc (NASDAQ:SRNE) reported positive results from its phase 1b clinical trial of COVI-MSC (human allogeneic adipose-derived mesenchymal stem cells) to treat patients who are suffering from coronavirus induced ARD.
MSC-COV-101 is a non-randomized, single-arm phase 1b clinical trial evaluating the efficacy and safety of COVI-MSC administered every alternate day.
The main objective of this clinical trial is to assess the safety of intravenous administration of adipose MSC cells in people suffering from coronavirus-induced acute respiratory distress syndrome or acute respiratory distress.
Enrolls ICU patients with respiratory failure
Sorrento enrolled ICU patients suffering from coronavirus-induced respiratory failure, poor oxygenation, and diffuse pulmonary infiltrates for the phase 1b clinical trial. In the clinical trial, all 9 patients have responded positively and eliminated the need for oxygen concentration. As a result, they are shifted out of the ICU and discharged in 7 days from the hospital after administering 3rd COVI-MSC. It has not observed any safety issues related to the infusion in the trial.
Associate professor (sleep medicine, Critical, Pulmonary Care, and medicine) at UCSF Fresno, Eyad Almasri, is the leading investigator for this ongoing clinical study.
In discussion with FDA for Phase 2 clinical trials
Sorrento is in discussions with the US FDA to commence a phase 2 clinical study at various Mexico, Brazil, and the US sites. It will identify the sample size and gather necessary data to request EUA (Emergency Use Authorization) for COVI-MSC.
CEO of Sorrento Therapeutics, Henry Ji, said the company is excited that its treatments save the lives of several people. The company is working to advance this product into a phase 2 clinical trial.
Receives clearance to begin the clinical study of Anti-CD47
Sorrento received the clearance of the US FDA in March 2021 to commence the clinical study of Anti-CD47 antibody for curing Multiple Malignancies.
Following the FDA nod, the company will begin the basket trial of STI-6643 at Tampa, Florida-based Moffitt Cancer Center. The clinical trial will be lead by David A. Sallman.
The company identified STI-6643 from its G-MAB library. Sorrento gave the title of Phase 1B clinical trial for the open-label basket trial. STI-6643 demonstrated red blood cell binding in the pre-clinical trials.