Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2
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.
The high potency of the antibody may potentially translate to more doses per bioreactor manufacturing run, lower cost per dose, and allow for rapid deployment and availability to patients. Sorrento has initiated cGMP manufacturing to produce 100,000 doses, expected to be available early next year, in anticipation of a potential EUA.
In order to speed up development toward EUA submission, Sorrento is also planning on initiating dosing in a healthy population in order to rapidly generate safety and pharmacokinetic results.
The STI-2020 antibody has been evaluated in preclinical studies against multiple strains of SARS-CoV-2, including the highly contagious D614G variant, the current dominant strain globally.
The STI-2020 antibody has been engineered and demonstrated in preclinical studies to avoid ADE (antibody-dependent enhancement) which may be associated with the serious side effects of some oher neutralizing antibodies and vaccines.
More information about the phase 1 clinical trial can be found on www.clinicaltrials.gov (NCT# NCT04584697).
About Sorrento Therapeutics, Inc.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
Autonomation and Predictability in IIoT
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