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STI 6991

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Drug Profile

STI 6991

Alternative Names: I-Cell™ COVID-19 cellular vaccine - Sorrento Therapeutics; STI-6991

Latest Information Update: 07 Apr 2020

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At a glance

  • Originator Sorrento Therapeutics
  • Class COVID-19 vaccines; Synthetic vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical 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
  • 25 Mar 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (IM)
  • 25 Mar 2020 Sorrento Therapeutics announces intention to submit IND to US FDA for COVID-2019 infections (Prevention)

Development Overview

Introduction

STI 6991 is a cellular decoy vaccine comprised of non-replicating human erythroleukemia K562 cells that are engineered to express membrane-bound S1 protein of the SARS-CoV-2 virus, being developed by Sorrento Therapeutics for the prevention of COVID-2019 infection. The vaccine candidate was developed by leveraging the I-Cell™ platform technology of Sorrento Therapeutics. The K562 cells are irradiated to prevent their replication and are designed to be administered by intramuscular injection as a vaccine. The K562 cell line are HLA negative and are as a result considered safe. The cells then express the S1 protein of the virus on a decoy cell surface and elicit both T cell and B cell immune response. This response will be triggered again upon exposure to SARS-CoV-2 coronavirus which will prevent attachment of the S1 spike protein with the ACE2 (angiotensin converting enzyme 2) on the normal human cell surface, thereby potentially preventing infection. Preclinical development is ongoing 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

Sorrento Therapeutics, as of March 2020, are in discussion with the Center for Biologics Evaluation and Research of the US FDA for required IND-enabling studies. The company intends to initiate phase I trial by mid year of 2020 [2] .

In March 2020, Sorrento Therapeutics announced that they are investigating the ability of STI 6991 to elicit T cell an B cell response in animal models [2]

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class COVID-19 vaccines, Synthetic vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

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 IM / Injection Sorrento Therapeutics 25 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
30 Jun 2020 Trial Update Sorrento Therapeutics plans a phase I trial for COVID-2019 infection (Prevention) in USA in mid-2020 (IM) [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
25 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (IM) Updated 03 Apr 2020
25 Mar 2020 Regulatory Status Sorrento Therapeutics announces intention to submit IND to US FDA for COVID-2019 infections (Prevention) [2] Updated 03 Apr 2020
25 Mar 2020 Trial Update Sorrento Therapeutics plans a phase I trial for COVID-2019 infection (Prevention) in USA in mid-2020 (IM) [2] Updated 03 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 Launches Novel I-Cell(TM) COVID-19 Cellular Vaccine Program.

    Media Release
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