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Sorrento Announces COVISHIELD (STI-9199) Antibody Nasal Drops Prevent Productive SARS-CoV-2 Infections When Given 24 Hours Prior to Virus Exposure

Last Updated on March 2, 2022 by GlobeNewsWire

STI-9199 neutralizing antibody (nAb) nasal drops prevent productive infections when given to animals 24 hours before they are exposed to COVID.
This intranasal STI-9199 may potentially give the option to take a dose of STI-9199 to prevent spread of infection within a home and to allow travel or attendance at a social event with added protection from infection.

SAN DIEGO, March 02, 2022 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that new preclinical results demonstrate that pretreating an animal with intranasal neutralizing antibody (STI-9199) twenty-four (24) hours prior to being exposed to SARS-CoV-2 virus prevents productive infection in the treated animals. These data suggest that an individual who is at high risk of exposure to the SARS-CoV-2 virus could potentially be protected by taking STI-9199 nasal neutralizing antibody. For example, if a member of a household becomes infected, the others in the house could be treated with intranasal STI-9199 to potentially prevent them from being infected. This prevention could work in vaccinated and unvaccinated individuals but needs to be confirmed in clinical studies. Other potential use cases for this intranasal STI-9199 include pretreatment of front-line healthcare workers, individuals in long-term care facilities or students in schools, where treatment could potentially provide blanket coverage. In addition, travelers on a plane could be pre-treated, which would potentially allow for air and ocean cruise travel with added protection when mask-wearing is not required.

These options will be fully evaluated in clinical studies starting with household prevention and healthcare workers, and the results from these studies will be informative for other blanket protection opportunities.

Sorrento previously announced that this antibody (STI-9167) has a broad neutralizing activity against the SARS-CoV-2 virus and all of its major variants of concern, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.

The IND for the intranasal STI-9199 (COVISHIELD) product was cleared by the FDA today to proceed.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease 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(TM) library”), immuno-cellular therapies (“DAR-T(TM)”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec(TM)”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG(TM), COVISHIELD(TM), COVI-MSC(TM) and COVIDROPS(TM); and diagnostic test solutions, including COVITRACK(TM) and COVIMARK(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 (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. SEMDEXA announced highly statistically significant positive top-line results from its Phase III Pivotal Trial C.L.E.A.R Program for its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica). ZTlido(R) was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com

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 STI-9199 (COVISHIELD); the potential neutralizing potency of STI-9199 against SARS-CoV-2 and its variants of concern (VOCs), including the Omicron BA.1, Omicron BA.1+R346K, and Omicron BA.2. VOCs; the potential safety and efficacy of STI-9199; the preclinical and clinical testing of STI-9199; the potential for STI-9199 to be administered as a prophylactic pretreatment to prevent productive SARS-CoV-2 infection, including being administered 24 hours prior to exposure; the potential for STI-9199 to be an effective prophylactic pretreatment against SARS-CoV-2 infection in various high risk settings, including household, healthcare, long-term care, school, air and travel, and social settings; the potential for STI-9199 to be an effective prophylactic in vaccinated and unvaccinated individuals; the potential for STI-9199 to offer blanket protection from SARS-CoV-2 infection; the potential clinical trial design for STI-9199; the potential for preclinical results to be replicated in clinical studies; 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 technologies and prospects, including, but not limited to risks related to seeking regulatory approval for STI-9199; 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 Sorrento in the execution of its 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.

Media and Investor Relations

Sorrento(R) and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB(TM), DAR-T(TM), Seprehvec(TM), SOFUSA(TM), COVI-AMG(TM), COVISHIELD(TM), COVIDROPS(TM), COVI-MSC(TM), COVITRACK(TM) and COVIMARK(TM) are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA(TM) is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido(R) is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

(C)2022 Sorrento Therapeutics, Inc. All Rights Reserved.




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