Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Pivotal Clinical Trial of COVI-MSC™ in Hospitalized COVID-19 Patients With Acute Respiratory Distress Syndrome

Rhea-AI Summary

Sorrento Therapeutics (SRNE) announced clearance from Brazil's ANVISA to proceed with a Phase 2 Pivotal clinical trial for COVI-MSC, targeting hospitalized COVID-19 patients with ARDS. This multi-center, randomized study will enroll 100 patients, comparing COVI-MSC to placebo and standard care. The trial aims to confirm positive Phase 1b results, with patient enrollment expected to begin in June 2021. Sorrento is leveraging local partnerships and existing relationships with healthcare facilities to expedite the trial process amidst the ongoing COVID-19 crisis in Brazil.

Positive

• Clearance received from ANVISA for Phase 2 trial of COVI-MSC.
• Study aims to evaluate safety and efficacy in 100 COVID-19 patients.
• Expected rapid patient enrollment due to high COVID-19 burden in Brazil.
• Partnership with Synova Health for enhanced trial execution.

Negative

• None.

• Brazil Phase 2 Pivotal clinical trial of COVI-MSC is now authorized to proceed.
  
• The study will compare therapy using mesenchymal stem cells to placebo (and standard of care) in 100 COVID-19 patients hospitalized due to acute respiratory distress syndrome (ARDS).
• Given the emergency status in Brazil, Sorrento has worked with ANVISA to obtain fast turn-around for the Phase 2 Pivotal clinical trial submission following positive Phase 1b results in the U.S.
• Maintaining an extreme sense of urgency, Sorrento anticipates commencing enrollment of patients in the study in June 2021.

SAN DIEGO, May 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 Pivotal clinical trial of COVI-MSC™, an injectable infusion of mesenchymal stem cells, for the treatment of hospitalized COVID-19 patients suffering from ARDS.

The Brazil study is a Phase 2 Pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of three infusions of COVI-MSC™, administered every other day, to hospitalized patients experiencing moderate or severe COVID-19 with ARDS. The study is expected to enroll 100 patients (33 placebo and 67 treated patients) in three months from the date of first enrollment. Sorrento expects this projected pace of enrollment due to the extensive COVID-19 disease burden in Brazil, Sorrento’s partnership with a leading local clinical research organization (Synova Health), and existing relationships with high quality medical centers throughout the country. The current partnership with Synova Health leverages high quality clinical trial sites in addition to a dozen centers already enrolling COVID-19 patients for another Sorrento Phase 2 clinical trial (Abivertinib). Additional studies are also being discussed for early clearance in parallel or immediately following this study. Priority access to multiple trials is being given to Brazilian patients following the rapid and openly collaborative interactions Sorrento has been able to establish with ANVISA regulators.

“We are very satisfied with the progress made in Brazil so far, and we have developed strong local relationships in support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “By focusing on the geographies most impacted by COVID-19, we are able to implement synergistic programs to answer safety and efficacy questions related to our product candidates while helping patients where the disease has been spreading the most. We expect this next Phase 2 Pivotal study to confirm the clinical benefits initially observed in our recently completed open label Phase 1b study. If confirmed, we are ready to establish a plan for development and manufacturing commitments that are required by ANVISA to take the product candidate from clinical trials to emergency use authorization (EUA) approval, including generating the data needed to support making the drug accessible prior to any full registration.”

The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.986743/2021-44, COMUNICADO ESPECIAL (CE) Nº 0004/21 – GSTCO/DIRE1/Anvisa.

Details of the Brazilian Clinical Study can be found at:
Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress - Full Text View - ClinicalTrials.gov

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^®", “Seprehvec™”). 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 1B 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.

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 the initiation of a Phase 2 study for COVI-MSC; the expected number of patients to be enrolled in the Phase 2 study; the expected timing for commencing and completing enrollment of the Phase 2 study; Sorrento’s expectation to utilize its partnership with Synova Health and other existing relationships with medical centers throughout Brazil to facilitate enrollment of the Phase 2 study; Sorrento’s ability to use centers enrolling COVID-19 patients for Sorrento’s Phase 2 clinical trial of Abivertinib for enrollment of patients in the Phase 2 clinical trial for COVI-MSC; the potential for the Phase 2 study to be considered for expansion as a global trial; the potential for Sorrento to recruit patients for the Phase 2 study in the U.S. and Brazil; the potential for additional studies to receive clearance in parallel or immediately following the Phase 2 study; Sorrento’s ability to implement synergistic programs that answer safety and efficacy questions related to product candidates; Sorrento’s expectation that the Phase 2 study will confirm clinical benefits initially observed in Sorrento’s open label Phase 1b study of COVI-MSC; the potential therapeutic benefits of COVI-MSC; Sorrento’s ability to establish a plan for development and manufacturing commitments needed for emergency use approval if clinical benefits of COVI-MSC are confirmed; the potential for pre-clinical and clinical data and results to be replicated in future clinical trials; regulatory approvals of COVI-MSC; and the completion of clinical trials of COVI-MSC. 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 seeking regulatory approval for COVI-MSC; 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 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.

Contact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD^TM, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVI-TRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

© 2021 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What is the purpose of Sorrento's Phase 2 trial for COVI-MSC?

The trial aims to evaluate the safety and efficacy of COVI-MSC in treating hospitalized COVID-19 patients suffering from ARDS.

When is patient enrollment expected to begin for the COVI-MSC trial?

Patient enrollment for the trial is anticipated to commence in June 2021.

How many patients will be enrolled in the COVI-MSC study?

The study plans to enroll 100 patients, with 67 receiving treatment and 33 receiving a placebo.

What are the expected outcomes of the COVI-MSC trial?

The trial aims to confirm clinical benefits observed in the earlier Phase 1b study.

What regulatory approval has Sorrento received for the COVI-MSC trial?

Sorrento has received clearance from Brazil's regulatory agency ANVISA to conduct the Phase 2 Pivotal clinical trial.