Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2
- Category: Antibodies
- Published on Monday, 09 November 2020 17:57
- Hits: 887
- IND filing today for STI-2020 (COVI-AMG™) for the treatment of COVID-19 in patients with mild symptoms and a separate safety and pharmacokinetic study in healthy volunteers.
- These initial trials are expected to be followed by pivotal trials with a goal of potentially receiving an EUA (Emergency Use Authorization).
- Animal model data (golden Syrian hamsters infected with SARS-CoV-2) demonstrated a highly effective neutralizing profile.
- This antibody has been engineered for ultra-high potency, with an expected effective dose in humans to be much lower than current known antibodies being assessed by others in active trials, which would allow for a simple IV-push administration that is suitable in the outpatient setting.
- This antibody has been engineered and validated in preclinical studies to avoid antibody-dependent enhancement (ADE) to potentially increase the safety profile.
- Additional in vitro experiments demonstrated the complete virus neutralizing property of STI-2020 against the highly contagious D614G SARS-CoV-2 variant.
- Sorrento has initiated cGMP manufacturing to produce 100,000 doses, expected to be available early next year, in anticipation of a potential EUA.
SAN DIEGO, CA, USA I November 09, 2020 I 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 other 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 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®"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™ and COVI-DROPS™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
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
SOURCE: Sorrento Therapeutics