eClinical Technology and Industy News

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

Excerpt from the Press Release:

SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it is filing an investigational new drug application (IND) for intravenous (IV) COVI-AMG (STI-2020) to treat COVID-19 patients with mild symptoms and to evaluate safety and pharmacokinetics in healthy volunteers.

Sorrento has previously submitted an IND for COVI-GUARD™ (STI-1499), the parent antibody for COVI-AMG. That submission was cleared by the FDA in September. Sorrento has built on the knowledge from the prior IND requirements to file this new IND, including information and data about Sorrento’s affinity maturation process that further enhanced the potency of this antibody.

As Sorrento previously announced, in preclinical studies, STI-2020 demonstrated a 100% neutralizing effect (both in vitro and in vivo) and at a very low dose prevented SARS-CoV-2 from infecting healthy cells and causing COVID-19-like disease in golden Syrian hamsters.

Click the button below to continue reading the Press Release:

Continue Reading The Article

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?