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STI 4398

Drug Profile

STI 4398

Alternative Names: COVIDTRAP™ protein; STI-4398

Latest Information Update: 07 Apr 2020

At a glance

  • Originator Sorrento Therapeutics
  • 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

  • Research COVID 2019 infections

Most Recent Events

  • 31 Mar 2020 Sorrento Therapeutics enters into a research agreement with University of Texas Medical Branch for preclinical testing for COVID-2019 therapeutics
  • 23 Mar 2020 Early research in COVID-2019 infections in USA (unspecified route)
  • 20 Mar 2020 Sorrento Therapeutics plans to file an IND application for COVID-19 infections after completion of IND enabling studies in 2020

Development Overview

Introduction

STI 4398, a proprietary ACE2 (angiotensin-converting enzyme 2)-Fc fusion protein is being developed by Sorrento Therapeutics for the 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). Early research 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. [1]

Key Development Milestones

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 [2] .

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)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA unspecified / unspecified Sorrento Therapeutics 23 Mar 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) [2] 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) [2] 30 Mar 2020

Development History

Event Date Update Type Comment
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) [2] 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 [2] [2] 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 [2] [2] 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 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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