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Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients

  • FDA granted IND clearance today for the commencement of a Phase 1 safety and pharmacokinetic study for STI-2099 (COVIDROPS™) in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of STI-2020 (COVI-AMG™).
  • Initial trials are expected to be followed by a Phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration.
  • This is the first FDA clearance of a clinical trial of intranasal administration of a neutralizing antibody against the SARS-CoV-2 virus.

/EIN News/ -- SAN DIEGO, March 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it has received clearance from the FDA for its Investigational New Drug application (IND) for its Phase 1 study of the safety and pharmacokinetics of intranasal (IN) STI-2099 (COVIDROPS) in both healthy volunteers and patients with mild COVID-19.

As previously announced, Sorrento is currently evaluating an intravenous formulation of this potent antibody, STI-2020 (IV), in a Phase 1 study in healthy volunteers and COVID-19 patients with mild symptoms. This small volume IV-push formulation is being tested against the dominant strain of the SARS-CoV-2 virus in the U.S. as well as the emerging UK variant. Sorrento expects to evaluate STI-2099 (IN) alone or in combination with STI-2020 (IV) to treat newly diagnosed patients.

Treatment with STI-2099 has the potential to halt the COVID-19 infection at the earliest stage in the nasal passages before it has a chance to spread to the lungs, and, if the infection has already hit the lungs, prevent the development of severe infections. If found to be safe and effective following clinical trials, STI-2099 i has the potential to prevent hospitalization or discharge hospitalized COVID-19 patients faster. “We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies,” said Dr. Henry Ji, Chairman and CEO of Sorrento.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. 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 COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

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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Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the therapeutic potential of STI-2099 and STI-2020 and their respective impacts on the SARS-CoV-2 virus; the preclinical and clinical testing of STI-2099 and STI-2020; the potential safety and effectiveness of STI-2099 and STI-2020; the expectation of conducting clinical trials to evaluate STI-2099 alone or in combination with STI-2020; the expected impact STI-2099 and STI-2020 will have against current and future variants of SARS-CoV-2 virus; the potential for STI-2099 to halt infection of the lungs or prevent severe infection; the potential for STI-2099 to prevent hospitalization or accelerate the discharge rate for hospitalized COVID-19 patients; the expected development of additional intranasal antibody formulations that have activity against SARS-CoV-2 virus variants that evade inhibition; and Sorrento’s potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting pre-clinical and clinical studies and seeking regulatory approval for STI-2099, including the timing for receipt of any such approval; conducting and receiving results of clinical trials; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 therapeutic product candidates strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2020, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Alexis Nahama, DVM (SVP Corporate Development)

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

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