eClinical Technology and Industy News

Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2

Excerpt from the Press Release:

SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today.

Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes it has addressed all questions and followed the recommendations from the agency for all sections of the IND.

As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% neutralizing effect (in vitro) of the antibody and that a low dose prevented SARS-CoV-2 from infecting healthy cells in such preclinical in vitro studies.

Animal data generated by Dr. Paessler’s laboratory at the University of Texas Medical Branch at Galveston (UTMB) in Syrian Golden Hamsters infected with SARS-CoV-2, justify the IND filing and continued clinical development. This established model, while limited, is the most predictive animal model currently available for this disease. The data were presented to federal agencies and will be published as soon as possible in a scientific journal.

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