Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 (COVI-GUARD) | SRNE Message Board Posts

Sorrento Therapeutics, Inc.

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Msg  551 of 574  at  9/17/2020 2:35:27 AM  by

grepgrep


 In response to msg 549 by  grepgrep
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Re: Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in COVID-19 Positive Patients

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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.

 Full press release can be found here:  https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-receives-us-fda-clearance-proceed-phase-1-clinical


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