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Research programme: peptide vaccines - Generex Biotechnology

Drug Profile

Research programme: peptide vaccines - Generex Biotechnology

Alternative Names: Ii-Key-SARS-2 vaccine - EpiVax/Generex Biotechnology; 2019-nCoV vaccine - EpiVax/Generex Biotechnology; SARS-CoV-2 Vaccine - EpiVax/Generex Biotechnology

Latest Information Update: 29 May 2020

At a glance

  • Originator Generex Biotechnology Corporation
  • Developer EpiVax; Generex Biotechnology Corporation
  • Class Peptide 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

  • Research COVID 2019 infections

Most Recent Events

  • 22 May 2020 Generex Biotechnology has patents pending for Ii-Key-SARS-2 peptides
  • 19 Mar 2020 Early research in COVID-2019 infections in China (unspecified route)
  • 04 Mar 2020 Generex Biotechnology and EpiVax agree to co-develop peptide vaccines for COVID-19 infections

Development Overview

Introduction

Generex Biotechnology are jointly developing peptide vaccines against the novel coronavirus SARS-CoV-2 (COV-2019) using the patented NuGenerex (subsidiary of Generex Biotechnology) Immuno-Oncology (NGIO - Formerly Antigen Express) Ii-Key technology. Early research is underway in China.

Generex Biotechnology will utilise li-Key peptide vaccine platform of NuGenerex Immune-Oncology. Major histocompatibility complex (MHC) class II associated invariant chain (Ii) derived Ii-Key peptide is involved in the regulation of the formation, trafficking, and antigen-presenting functions of MHC class II complexes, essential for the activation of T cells in the immune response. When the peptide is linked to an antigenic epitope, it displaces the resident antigens from the antigen binding grove on MHC Class II molecules. This renders the MHC molecules to present the Ii-Key epitope to selectively activate T-helper type 1 cells responses. These events increase the duration and intensity of the immune responses. The interaction reduces the binding affinity of the antigenic binding groove on the MHC class II molecule and any previously resident epitope is discharged.

Company Agreements

In March 2020, Generex Biotechnology signed a contract with EpiVax to generate peptide vaccines against the nCOV-2019 corona virus using the patented NuGenerex Immuno-Oncology (NGIO - Formerly Antigen Express) Ii-Key technology. The companies will use EpiVax's computational tools to predict epitopes that can be used for the development of these vaccines. Using the epitopes predicted by EpiVax, Generex will manufacture a series of synthetic amino acid peptides that mimic the epitopes of the virus and will send them to China for testing. In collaboration with a team in China, Generex will test the reactivity of these peptides in blood samples that have been collected from patients who have recovered from COVID-19 infections. [1]

Key Development Milestones

In May 2020, Generex Biotechnology initiated ex vivo human immune system studies with convalescent blood samples that will provide the data to select the Ii-Key-SARS-CoV-2 peptides for a "complete vaccine" that promotes B cell production of neutralizing antibodies and activates CD4+ T-Cell responses (TH1) that promote immune memory and potential long-term protection from coronavirus infection [2] .

Patent Information

In May 2020, Generex Biotechnology announced that provisional patent applications have been filed for the Ii-Key-SARS-2 peptides, protecting intellectual property rights for the company and COVID-19 vaccine products based on the viral sequences with Ii-Key [2] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class Peptide vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research China unspecified / unspecified EpiVax, Generex Biotechnology Corporation 19 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Generex Biotechnology Corporation Originator Canada
Generex Biotechnology Corporation Owner Canada
EpiVax Technology Provider USA

Development History

Event Date Update Type Comment
22 May 2020 Patent Information Generex Biotechnology has patents pending for Ii-Key-SARS-2 peptides [2] Updated 29 May 2020
19 Mar 2020 Phase Change Early research in COVID-2019 infections in China (unspecified route) Updated 26 Mar 2020
04 Mar 2020 Licensing Status Generex Biotechnology and EpiVax agree to co-develop peptide vaccines for COVID-19 infections [1] Updated 17 Mar 2020

References

  1. Generex Signs Contract with EpiVax to Develop Ii-Key Peptide Vaccines to Address the Coronavirus Pandemic.

    Media Release
  2. Generex Subsidiary NGIO Advances COVID-19 Vaccine Program with the Manufacturing of Patent-Pending Ii-Key-SARS-CoV-2 Peptides.

    Media Release
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