Sorrento Therapeutics Inc (SRNE)

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News: Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trials for STI-2020 (COVI-AMG) in Healthy Volunteers and in Newly Diagnosed COVID-19 Patients
2020-12-09 09:00:04 AM ET (GlobeNewswire)
   
   
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG). The trials will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms.

Sorrento previously announced that STI-2020 demonstrated a complete neutralizing effect at a very low dose in preclinical studies and high potency that may potentially enable rapid deployment and availability to patients. Sorrento has initiated cGMP manufacturing to produce up to 100,000 doses in anticipation of a potential EUA.

The FDA has been requesting that IND sponsors evaluate SARS-CoV-2 neutralizing antibodies in development for activity against antibody drug-resistant SARS-CoV-2 variants, including the E484K, F490S, Q493R and S494P mutations. Sorrento has evaluated the binding activity of STI-2020 against all of these variants in preclinical studies and the binding affinity of STI-2020 against each of the variants is similar to or better than that observed for wild-type SARS-CoV-2. In addition, STI-2020 demonstrated similarly strong binding affinities to the currently dominant D614G variant and the mink-associated N439K variant as compared to that for wild-type SARS-CoV-2.

To expedite development toward a potential EUA submission, Sorrento is planning on initiating dosing in a healthy population. "Since COVI-AMG comes in a small volume IV-push formulation, made possible by the high potency of this unique antibody, we expect trials to enroll very quickly. This combination potentially makes STI-2020 an ideal candidate for the early treatment of SARS-CoV-2 infection in an outpatient setting," stated Mike Royal, MD, Chief Medical Officer of Sorrento.

More information about the Phase 1 clinical trials can be found at 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(TM) library"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T(TM)"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir(R)"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD(TM), COVI-AMG(TM), COVI-SHIELD(TM), Gene-MAb(TM), COVI-MSC(TM) and COVI-DROPS(TM); and diagnostic test solutions, including COVI-TRACK(TM), COVI-STIX(TM) and COVI-TRACE(TM).

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(TM)), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido(R) (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(R) was approved by the FDA on February 28, 2018.