Sorrento Announces IND Filing for COVI-DROPS, an Intranasal Formulation of a High Potency Neutralizing Antibody Against SARS-CoV-2

  • IND filing today for STI-2099 (COVI-DROPS™) for a phase 1 safety and pharmacokinetic study in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of COVI-AMG™.
  • Initial trial is 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.

SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it is filing an investigational new drug application (IND) for intranasal (IN) COVI-DROPS (STI-2099) to study the safety and pharmacokinetics in both healthy volunteers and patients with mild COVID-19.

As Sorrento previously announced, in preclinical studies, high potency STI-2099 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 Syrian golden hamsters.

A single intra-nasal administration of STI-2099 12 hours after infection prevented disease-associated weight loss in treated hamsters. The impact of the treatment was observed within 24 hours of STI-2099 treatment, demonstrating unique disease treatment properties as compared to intravenously administered antibodies.

“We believe STI-2099 has the potential to be broadly deployable for early treatment in an outpatient setting. The intranasal route is expected to be enabled by the high potency of the antibody and is quite promising against this highly contagious respiratory pathogen,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “In addition, it is now understood that COVID-19 is a local and systemic disease; therefore, we believe the best course of action would be to attack this highly contagious pathogenic virus both locally and systemically.”

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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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 potency and potential neutralizing profile of STI-2099 and the impact on SARS-CoV-2; the preclinical testing of STI-2099; the safety, pharmacokinetics and efficacy of STI-2099; the expectation of the commencement of any phase 2 trial for STI-2099; the predictive value of the animal model used in preclinical studies; the potential potency of STI-2099; the expected effective dose in humans; the expected administration method of STI-2099; the potential for STI-2099 to be administered as a combination nasal and intravenous injection; the potential deployability of STI-2099; the best course of action against COVID-19; 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 studies and seeking IND regulatory approval for STI-2099; conducting and receiving results of clinical trials for STI-2099; the clinical and commercial success of STI-2099 against preventing and treating SARS-CoV-2 virus infections; the viability and success of STI-2099 in anti-viral therapeutic areas, including coronaviruses; 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 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, 2019, 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.

ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
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