Sorrento Announces COVISHIELD (STI-9167) Antibody Strongly Neutralizes BA.2 Omicron Sublineage Virus as Well as BA.1 and BA.1+R346k Omicron Viruses

• STI-9167 neutralizing antibody (nAb) maintains high neutralization potency against the recently emerging Omicron sublineage BA.2 as was previously demonstrated for the Omicron sublineage BA.1 viruses, including Omicron BA.1 (+R346K mutation).
• An IND application for COVISHIELD™ IN, formulated for intranasal (IN) administration for clinical use in the context of early symptomatic and asymptomatic infections, was submitted to the FDA on February 1, 2022.

SAN DIEGO, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that additional preclinical results demonstrate broad spectrum COVISHIELD (STI-9167) neutralizing activity against Omicron BA.1, Omicron BA.1+R346K, and the increasingly prevalent sublineage, Omicron BA.2. The Omicron BA.2 encodes the core spike mutations that serve to generally define the Omicron lineage, however, it carries additional spike mutations that were not identified within the BA.1 Omicron sublineage. The BA.2 Omicron virus is reported to have 50% more enhanced transmissibility as compared to the BA.1 Omicron viruses and may cause potentially similar disease severity as the Delta virus. Using VSV pseudotyped viruses, STI-9167 neutralization potency was benchmarked against antibody reagents based on EUA-approved SARS-CoV-2 nAbs. STI-9167 neutralization activity was the topmost performing nAb among the comparative nAb treatments, similar to the recently EUA-approved LY-1404 nAb but superior to all other EUA-approved nAbs in neutralizing Omicron BA.1, BA.1+R346K and BA.2 viruses.

About COVISHIELD and COVISHIELD IN

Initially isolated as a SARS-CoV-2 (WA-1 strain) neutralizing antibody candidate following vaccination of transgenic mice, the STI-9167 antibody was optimized to maximize protein stability and minimize interactions with host Fc gamma receptors. COVISHIELD (STI-9167) is an intravenous (IV) formulation and COVISHIELD IN (STI-9199) is a proprietary IN formulation of COVISHIELD. Using established master cell banks, GMP drug products for COVISHIELD and COVISHIELD IN have been generated at Sorrento in preparation for anticipated Phase 1 through pivotal Phase 2/3 human clinical trials. Technology transfer of methods and GMP processes in support of commercial-scale GMP manufacturing is currently underway.

About Clinical Development Plans for COVISHIELD (STI-9167) and COVISHIELD IN (STI-9199)

Sorrento has demonstrated the protective effects of SARS-CoV-2 nAbs administered by either IV or IN routes in preclinical COVID-19 animal models and the safety of other SARS-CoV-2 nAbs administered by IV and IN routes to human subjects (e.g., COVI-AMG™ and COVIDROPS™). Development of COVISHIELD and COVISHIELD IN formulations will proceed along independent paths. Current clinical study plans for COVISHIELD IN, outlined in an IND application received for review on February 1, 2022 and pending feedback from regulatory agencies, call for evaluation of safety following antibody administration at single doses in healthy normal adults or asymptomatic Omicron infected patients, followed by large Phase 2/3 clinical trials globally for newly infected COVID-19 patients. The IND application in support of similar Phase 1 trials of COVISHIELD is scheduled for submission in the first half of March 2022.

About Sorrento Intranasal nAbs for the Treatment of COVID-19

In Phase 1 and Phase 2 clinical studies of COVIDROPS (STI-2099), the IN formulation of COVI-AMG (STI-2020), a SARS CoV-2 nAb with demonstrated activity in vitro and in vivo against multiple VOCs including Alpha, Delta, Lambda, and Mu, IN dose levels up to 60 mg have been well tolerated. COVID-19 patients with newly diagnosed SARS-CoV-2 infections were treated with STI-2099 in randomized, double-blind, placebo-controlled Phase 2 trials in the US and UK. The primary efficacy endpoint in Phase 2 studies is viral load reduction in nasopharyngeal (NP) swab material by qRT-PCR.

In the US Phase 2 study, outpatient adults received a single instillation of 10 mg or 20 mg or 40 mg COVIDROPS or placebo with a randomization of 1:1:1:1. The US Phase 2 study recently concluded (n=96 individuals treated) and data is pending. In the UK Phase 2 study, outpatient adults received a single instillation of 10 mg or 20 mg COVIDROPS or placebo in their homes with a randomization of 2:2:1. The study recently reached the 50% enrollment threshold (n=179 individuals treated) and the interim analysis data (including VOC sequencing) is pending.

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™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.

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 (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^® 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-9167 and STI-9199; the potential neutralizing potency of STI-9167 and 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-9167 and STI-9199; the preclinical and clinical testing of STI-9167 and STI-9199; the potential for STI-9167 and STI-9199 to exhibit superior or similar neutralization against SARS-CoV-2 and all of its VOCs as compared to other EUA-approved nAbs; the expected impact STI-9167 and STI-9199 will have against current and future VOCs of SARS-CoV-2; the expected dosing and/or routes of administration for STI-9167 and STI-9199; Sorrento's internal drug product manufacturing capabilities in support of clinical development, including the GMP production of STI-9167 and STI-9199 to support Phase 1 through pivotal Phase 2/3 human clinical trials; the expectations and timing for submitting an Investigational New Drug (IND) application for STI-1967; the potential clinical trial design for STI-9167 and STI-9199 through Phase 2/3 global clinical trials; the potential for preclinical results to be replicated in clinical studies; the potential safety and efficacy of STI-2020 and STI-2099; 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 approvals for STI-9167, STI-9199, STI-2020 and STI-2099; 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

Contact: Dorman Followwill
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Sorrento^® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ 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.

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