Sorrento Announces FDA Authorization to Proceed With Phase 1 Study Of Intranasal STI-9199 (COVISHIELD), a Potent Neutralization Antibody Against Covid-19 Viruses

Rhea-AI Summary

FDA has granted IND clearance for STI-9199 (COVISHIELD) to Sorrento Therapeutics (SRNE) for a Phase 1 study focusing on safety and pharmacokinetics in healthy volunteers. This will be followed by Phase 2/3 trials in the USA, UK, and Mexico targeting mild to moderate COVID-19 patients. STI-9199 shows efficacy against key SARS-CoV-2 variants, including Omicron strains. Sorrento plans to consult with the FDA on endpoints for a pivotal study, which could lead to Emergency Use Authorization pending successful trial results.

Positive

• FDA clearance for STI-9199 (COVISHIELD) for a Phase 1 trial.
• Potential for a multinational Phase 2/3 trial targeting COVID-19.
• Demonstrated activity against multiple SARS-CoV-2 variants, including Omicron.

Negative

• Regulatory risks associated with seeking approvals for STI-9199.
• Clinical development risks, including potential delays or failures in clinical trials.

• FDA granted IND clearance today for STI-9199 (COVISHIELD^™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers.
  
• Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients.
• STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.
  

SAN DIEGO, March 02, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intranasal (IN) STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.

The Phase 1 study will be at a single clinical site in San Diego and will be followed by multinational (USA, UK and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.

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 COVIMARK^™.

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-9199 (COVISHIELD); the therapeutic and clinical potential of STI-9199; the potential safety and efficacy of STI-9199; the preclinical and clinical testing of STI-9199; the expectation of conducting a Phase 1 clinical trial, followed by Phase 2/3 trial(s), to evaluate STI-9199; Sorrento’s plans to discuss with FDA the endpoint criteria for a pivotal study that could result in an Emergency Use Authorization for STI-9199; and Sorrento’s 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

Contact: Dorman Followwill
Email: mediarelations@sorrentotherapeutics.com

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 COVIMARK^™ 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.

©2022 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What is the purpose of the Phase 1 study for STI-9199 (COVISHIELD)?

The Phase 1 study aims to evaluate the safety and pharmacokinetics of STI-9199 in healthy volunteers.

What are the next steps after the Phase 1 trial for STI-9199?

Following the Phase 1 study, Sorrento plans to conduct multinational Phase 2/3 trials in COVID-19 patients.

What does the FDA clearance for STI-9199 mean for Sorrento Therapeutics?

The FDA clearance allows Sorrento to begin clinical trials, which is a critical step toward potential Emergency Use Authorization.

What variants of SARS-CoV-2 has STI-9199 shown efficacy against?

STI-9199 has demonstrated activity against all tested variants, including Omicron BA.1, BA.1+R346K, and BA.2.

When was the IND clearance for STI-9199 announced?

The IND clearance for STI-9199 was announced on March 2, 2022.