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     207  0 Kommentare Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2 - Seite 2

    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.

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

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