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Research programme: DNA vaccines - Greffex

Drug Profile

Research programme: DNA vaccines - Greffex

Alternative Names: Avian influenza vaccine - Greffex; Aznthrax vaccine - Greffex; Dengue vaccine - Greffex; Ebola virus vaccine - Greffex; GREANX; GREDEN/V1-4; GREFLU/CAL; GREFLU/VIE; GreVac™ vaccines; GREVAX; H1N1 vaccine - Greffex; H7N9 vaccine - Greffex; HIV vaccine - Greffex; MERS-CoV vaccine - Greffex; Middle east respiratory syndrom coronavirus vaccine - Greffex; Plague vaccine - Greffex; Tuberculosis vaccine - Greffex; Universal influenza vaccine - Greffex

Latest Information Update: 13 Aug 2019

At a glance

  • Originator Greffex Inc
  • Class Anthrax vaccines; Bacterial vaccines; Dengue vaccines; DNA vaccines; Influenza A virus H1N1 vaccines; Influenza A virus H5N1 vaccines; Influenza virus vaccines; Plague vaccines; Tuberculosis 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 Anthrax; Coronavirus infections; Dengue; Influenza A virus H1N1 subtype; Influenza A virus H5N1 subtype; Influenza A virus H7N9 subtype; Influenza virus infections
  • Research Ebola virus infections; HIV infections; Plague; Tuberculosis

Most Recent Events

  • 13 Aug 2019 Early research is still ongoing for Ebola virus infections, HIV infections, Plague and Tuberculosis in USA (Parenteral) (Greffex pipeline, August 2019)
  • 13 Aug 2019 Preclinical development is ongoing for Anthrax, Coronavirus infections, Dengue, Influenza A virus H1N1 subtype, Influenza A virus H5N1 subtype, Influenza A virus H7N9 subtype in USA (Parenteral) (Greffex pipeline, August 2019)
  • 13 Aug 2019 Greffex plans clinical trials for avian influenza vaccine for Influenza virus infections (Greffex pipeline, August 2019)

Development Overview

Introduction

Greffex is developing DNA vaccine therapeutics for a variety of indications. The vaccines which are based on the company's GREVAX™ Universal Platform and GreVac™ Plug-And-Play technology are designed as small synthetic nanoparticles of genes packaged in adenoviral shells that can be modified to deliver genetic payloads wherever most beneficial. The vaccines target cells that kick start the immune system and do not need chemical adjuvants. Preclinical development of candidates for anthrax, coronavirus infections, dengue, influenza A virus H1N1 subtype, influenza A virus H5N1 subtype, influenza A virus H7N9 subtype is ongoing in USA. Early research of candidates for Ebola virus infections, HIV infections, Plague and Tuberculosis is underway in USA.

Company Agreements

In May 2017, Greffex and Texas A& M University System entered into a Master Research Agreement for research and development of Greffex vaccines. Financial terms of the agreement were not disclosed [1]

Key Development Milestones

In May 2013, Greffex announced that it had constructed the first comprehensive vaccine for H7N9 avian influenza, using its GREVAX™ technology [2] .

Greffex is carrying out preclinical development of vaccines for anthrax (GREANX™, in collaboration with the US Army Medical Research Institute for Infectious Diseases), dengue (GREDEN/V1-4™, in collaboration with the National Institute of Allergy and Infectious Diseases), influenza A H5N1 (GREFLU/VIE™) and influenza A H1N1 (GREFLU/CAL™). The company is also developing a universal influenza vaccine.

Greffex is also applying its GREVAX™ technology to develop vaccines for ebola virus infections, HIV infections, plague and tuberculosis. Early research in these indications is underway.

Financing information

In September 2019, Greffex got a contract of up to $US18.9 million with the National Institute of Health’s National Institute for Allergy and Infectious Diseases, to develop and exploit its GreVacTM Plug-And-Play technology for the production of vaccine candidates for biodefense and infectious diseases [3] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Anthrax vaccines, Bacterial vaccines, Dengue vaccines, DNA vaccines, Influenza A virus H1N1 vaccines, Influenza A virus H5N1 vaccines, Influenza virus vaccines, Plague vaccines, Tuberculosis vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07A-C (Anthrax vaccines)

    J07A-K (Plague vaccines)

    J07A-N (Tuberculosis vaccines)

    J07B-B (Influenza vaccines)

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

    J7E1 (Influenza vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Anthrax - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Coronavirus infections - - Preclinical USA Parenteral / unspecified Greffex Inc 13 Aug 2019
Dengue - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Ebola virus infections - - Research USA Parenteral / unspecified Greffex Inc 01 May 2013
HIV infections - - Research USA Parenteral / unspecified Greffex Inc 01 May 2013
Influenza A virus H1N1 subtype - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Influenza A virus H5N1 subtype - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Influenza A virus H7N9 subtype - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Influenza virus infections - - Preclinical USA Parenteral / unspecified Greffex Inc 01 May 2013
Plague - - Research USA Parenteral / unspecified Greffex Inc 01 May 2013
Tuberculosis - - Research USA Parenteral / unspecified Greffex Inc 01 May 2013

Commercial Information

Involved Organisations

Organisation Involvement Countries
Greffex Inc Originator USA
Greffex Inc Owner USA
National Institute of Allergy and Infectious Diseases Collaborator USA
Texas A&M University Collaborator USA

Brand Names

Brand Name Organisations Indications Countries
GREANX Greffex Inc Anthrax USA
GREDEN/V1-4 Greffex Inc Dengue USA
GREFLU/CAL Greffex Inc Influenza A virus H1N1 subtype USA
GREFLU/VIE Greffex Inc Influenza A virus H5N1 subtype USA
GREVAX Greffex Inc Influenza virus infections USA

Development History

Event Date Update Type Comment
13 Aug 2019 Active Status Review Early research is still ongoing for Ebola virus infections, HIV infections, Plague and Tuberculosis in USA (Parenteral) (Greffex pipeline, August 2019) Updated 13 Aug 2019
13 Aug 2019 Active Status Review Preclinical development is ongoing for Anthrax, Coronavirus infections, Dengue, Influenza A virus H1N1 subtype, Influenza A virus H5N1 subtype, Influenza A virus H7N9 subtype in USA (Parenteral) (Greffex pipeline, August 2019) Updated 13 Aug 2019
13 Aug 2019 Phase Change - Preclinical Preclinical trials in Coronavirus infections in USA (Parenteral) before August 2019 (Greffex pipeline, August 2019) Updated 13 Aug 2019
13 Aug 2019 Trial Update Greffex plans clinical trials for avian influenza vaccine for Influenza virus infections (Greffex pipeline, August 2019) Updated 13 Aug 2019
15 May 2017 Licensing Status Greffex and Texas A& M University collaborate to develop DNA vaccines [1] Updated 13 Aug 2019
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Anthrax in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Dengue in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-A virus H7N9 subtype in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-A-virus-H1N1-subtype in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-A-virus-H5N1-subtype in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-virus-infections in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for research development in Ebola-virus-infections in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for research development in HIV-infections in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for research development in Plague in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for research development in Tuberculosis in USA (Parenteral) Updated 16 Jul 2016
07 May 2013 Licensing Status Research programme: vaccines - Greffex is available for licensing as of 07 May 2013. http://www.greffex.com Updated 08 May 2013
01 May 2013 Phase Change Early research in Ebola virus infections in USA (Parenteral) Updated 08 May 2013
01 May 2013 Phase Change Early research in HIV infections in USA (Parenteral) Updated 08 May 2013
01 May 2013 Phase Change Early research in Plague in USA (Parenteral) Updated 08 May 2013
01 May 2013 Phase Change Early research in Tuberculosis in USA (Parenteral) Updated 08 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Influenza virus infections in USA (Parenteral) Updated 08 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Anthrax in USA (Parenteral) Updated 07 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Dengue in USA (Parenteral) Updated 07 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Influenza-A virus H1N1 subtype in USA (Parenteral) Updated 07 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Influenza-A virus H5N1 subtype in USA (Parenteral) Updated 07 May 2013
01 May 2013 Phase Change - Preclinical Preclinical trials in Influenza-A virus H7N9 subtype in USA (Parenteral) Updated 07 May 2013

References

  1. Texas A&M University System (TAMUS) and Greffex, Inc. sign agreement to collaborate on advanced process and manufacturing development.

    Media Release
  2. H7N9: Greffex Beats the Clock to Build the First Comprehensive H7N9 Vaccine.

    Media Release
  3. Greffex, Inc. Awarded NIH Contract for up to $18.9 Million to Develop a Plug-And-Play Technology Platform to Expedite the Production of Vaccine Candidates for Biodefense and Emerging Infectious Diseases.

    Media Release
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