Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in COVID-19 Positive Patients

• Phase 1 clinical trial for STI-1499 (COVI-GUARD) in hospitalized COVID-19 patients has received FDA notice that it may proceed with patient enrollment.
• The initial trial is expected to enroll rapidly and is expected to be followed by large trials targeting a potential Emergency Use Authorization (EUA) submission as early as before the end of this year.
• Sorrento has initiated cGMP manufacturing to produce 50,000 doses in anticipation of a potential EUA.

SAN DIEGO, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients.

As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.

STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.

Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient.

The highest proposed dose (200 mg per patient) in the phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies. The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations.

The STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the US program.

More information about the phase 1 clinical trial can be found on www.clinicaltrials.gov (NCT# 04454398).

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir”, “Seprehvec”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD and T-VIVA-19; and diagnostic test solutions, including COVI-TRACK and COVI-TRACE.