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STI 4398

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Drug Profile

STI 4398

Alternative Names: COVIDTRAP™ protein; STI-4398

Latest Information Update: 10 Jun 2020

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At a glance

  • Originator Sorrento Therapeutics
  • Developer Sorrento Therapeutics; University of Texas Medical Branch
  • Class Antivirals; Enzymes; Immunoglobulin Fc fragments; Recombinant fusion proteins
  • Mechanism of Action ACE modulators; Virus replication inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 05 Jun 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (unspecified route) before June 2020 (Sorrento Therapeutics pipeline, June 2020)
  • 05 Jun 2020 Preclinical trials in COVID-2019 infections in USA (unspecified route) (Sorrento Therapeutics pipeline, June 2020)
  • 05 Jun 2020 Sorrento Therapeutics plans a clinical trial for COVID-2019 infections (Prevention) in USA

Development Overview

Introduction

STI 4398, a proprietary ACE2 (angiotensin-converting enzyme 2)-Fc fusion protein is being developed by Sorrento Therapeutics for the prevention and treatment of COVID-2019 infections. The ACE2-Fc protein binds to the S1 domain of spike protein of the SARS-CoV-2 virus thereby blocking its binding to the ACE2 receptors present on the target respiratory epithelial cells and inhibiting viral replication. STI-4398 preserves the ACE2 enzyme activity by converting angiotensin II to angiotensin 1-7, resulting in reduced vasoconstriction and increased blood flow to the infected lung tissue. The drug potentially also confers organ protection and reduces severe acute respiratory distress syndrome in COVID-19 patients. This indicates therapeutic potential for late-stage COVID-19. The recombinant fusion protein is expected to demonstrate better efficacy and longer half-life which may allow it to be used prophylactically to confer short-term and durable passive immunity (with repeated doses) to those that are regularly exposed to the virus (healthcare workers) or are at particular risk following an exposure event (elderly, patients with hypertension or immune-compromised patients). Preclinical development is underway in the US.

Company Agreements

In March 2020, Sorrento Therapeutics entered into a research testing agreement with the University of Texas Medical Branch at Galveston for the preclinical testing of Sorrento’s COVID-19 therapeutic product candidates. The testing will be performed at the University of Texas Medical Branch where most recently a COVID-19 viral isolate was obtained and the infection cell model for the SARS-CoV-2 virus was established. University of Texas Medical Branch will be advancing Sorrento’s proprietary COVID-19 product candidates. [1]

Key Development Milestones

In June 2020, Sorrento Therapeutics received guidance from the US FDA evaluate STI 4398, in a clinical trial to for both prevention and treatment of COVID-2019 infections [2] .

In in vitro studies, STI 4398 at low concentration, neutralised and inhibited SARS-CoV-2 virus and prevented infection in African green monkey kidney epithelial cells (VERO/E6 cells) [2] .

Early research is underway in the US. Sorrento plans to commence preclinical studies for STI 4398 in the first half of 2020, to test its neutralization and blocking activity in preventing SARS-CoV-2 virus from infecting ACE2-expressing cells [3] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class Antivirals, Enzymes, Immunoglobulin Fc fragments, Recombinant fusion proteins
  • Target ACE; Coronavirus spike glycoprotein; Virus replication
  • Mechanism of Action ACE modulators; Virus replication inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Trial Landscape

Indication Phase 0 Phase I Phase II Phase III Phase IV
COVID 2019 infections - 1 - - -

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical USA unspecified / unspecified Sorrento Therapeutics, University of Texas Medical Branch 05 Jun 2020
COVID 2019 infections - - Preclinical USA unspecified / unspecified Sorrento Therapeutics 05 Jun 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Sorrento Therapeutics Originator USA
Sorrento Therapeutics Owner USA
University of Texas Medical Branch Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Regulatory Status Sorrento Therapeutics plans to file an IND application for COVID-19 infections after completion of IND enabling studies in 2020 (9288125) [3] 27 Mar 2020
30 Jun 2020 Trial Update Sorrento Therapeutics plans to conduct preclinical studies for COVID-2019 infections (SARS-CoV-2 coronavirus infections) in the first half of 2020 (9288125) [3] 30 Mar 2020

Development History

Event Date Update Type Comment
05 Jun 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (unspecified route) before June 2020 [2] (Sorrento Therapeutics pipeline, June 2020) Updated 10 Jun 2020
05 Jun 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (unspecified route) [2] (Sorrento Therapeutics pipeline, June 2020) Updated 10 Jun 2020
05 Jun 2020 Trial Update Sorrento Therapeutics plans a clinical trial for COVID-2019 infections (Prevention) in USA [2] Updated 10 Jun 2020
05 Jun 2020 Trial Update Sorrento Therapeutics plans a clinical trial for COVID-2019 infections in USA [2] Updated 10 Jun 2020
31 Mar 2020 Licensing Status Sorrento Therapeutics enters into a research agreement with University of Texas Medical Branch for preclinical testing for COVID-2019 therapeutics [1] Updated 07 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (unspecified route) [3] Updated 01 Apr 2020
20 Mar 2020 Regulatory Status Sorrento Therapeutics plans to file an IND application for COVID-19 infections after completion of IND enabling studies in 2020 [3] [3] Updated 01 Apr 2020
20 Mar 2020 Trial Update Sorrento Therapeutics plans to conduct preclinical studies for COVID-2019 infections (SARS-CoV-2 coronavirus infections) in the first half of 2020 [3] [3] Updated 01 Apr 2020

References

  1. SORRENTO AND THE UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON ENTER INTO PRECLINICAL TESTING AGREEMENT FOR COVID-19 THERAPEUTIC CANDIDATES.

    Media Release

  2. Sorrento COVIDTRAP(TM)(STI-4398) Demonstrates in Preclinical Studies its Ability to Completely Inhibit SARS-CoV-2 Viral Infection In Vitro.

    Media Release

  3. SORRENTO DEVELOPS STI-4398 (COVIDTRAP(Tm) PROTEIN) FOR POTENTIAL PREVENTION AND TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19).

    Media Release
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