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Research programme: therapeutics - Dyadic International/EnGen Bio

Drug Profile

Research programme: therapeutics - Dyadic International/EnGen Bio

Latest Information Update: 28 Feb 2020

At a glance

  • Originator Dyadic International; EnGen Bio
  • Developer Dyadic International; EnGen Bio; Israel Institute for Biological Research
  • Class Anti-infectives; Monoclonal antibodies; 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; Unspecified

Most Recent Events

  • 25 Feb 2020 Dyadic International expands the collaboration with the Israel Institute for Biological Research to develop a rVaccine candidate and monoclonal antibodies against COVID-2019-infections
  • 25 Feb 2020 Early research in COVID-2019-infections in Israel (Parenteral)
  • 27 Feb 2018 Dyadic International enters into a collaboration with Mitsubishi Tanabe Pharma Corporation to produce two target protein in C1 technology

Development Overview

Introduction

Dyadic International, using its C1 gene expression platform, is developing recombinant vaccines and neutralizing agents comprising targeted antigens, monoclonal antibodies, biosimilars/biobetters, and therapeutic proteins. The programme is at early research phase of development in Israel.

Dyadic International in collaboration with the Israel Institute for Biological Research are developing an rVaccine candidate and monoclonal antibodies (mAbs) against COVID-2019 infections, using the proven C1 gene expression platform.

Earlier, Dyadic Nederland B.V (a subsidiary of Dyadic International), and EnGen Bio were collaborating on a research programme to develop significant protein production based on Thermothelomyces heterothallica (formerly Myceliophthora thermophila), using Dyadic's proprietary and patented C1 platform technology, for undisclosed indications. Upon successful completion of proof of concept studies Sanofi had option rights to the C1 technology for its vaccine application. Early research was underway in the Netherlands. However, in August 2016, Sanofi terminated its agreement with Dyadic and development was discontinued.

Company Agreements

In February 2020, Dyadic International expanded the collaboration with the Israel Institute for Biological Research, against COVID-2019 infections. IIBR will explore the potential of Dyadic's industrially proven C1 gene expression platform to express gene sequences and targets developed by IIBR into both an rVaccine candidate and monoclonal antibodies (mAbs) that may help combat the outbreak of the COVID-19 virus (Coronavirus). Earlier, in January 2018, Dyadic International had entered into a research and development collaboration with the Israel Institute for Biological Research (IIBR), wherein the former will progress its C1 expression platform for the development and manufacture of recombinant vaccines and neutralizing agents comprising targeted antigens and monoclonal antibodies, to combat emerging diseases and threats. The work will be performed at IIBR’s laboratories. [1] [2]

In February 2018, Dyadic International entered into a funded proof of concept research collaboration to explore the potential of its C1 technology to produce two vital therapeutic proteins for human health indications with Mitsubishi Tanabe Pharma Corporation. [3]

In July 2017, Dyadic International entered into a research and development agreement with VLP The Vaccines Company, so as to leverage the BDI team’s know-how in the development of next generation vaccines and drugs. Additionally, Dyadic will utilize BDI’s previous C1 industrial fermentation scale-up and commercialization experience with yeast and filamentous fungi processes to further advance Dyadic’s proprietary C1 technology for biopharmaceutical product development and production. Dyadic engaged BDI to provide research and development services for an aggregate of approximately US$2.1 million over two years, including €1 million through a Research Services Agreement to develop designated C1 based product candidates and another US$1 million through a Service Framework Agreement for certain research projects specified by Dyadic. All of the data and any products developed from the funded research projects will be owned by Dyadic. As part of these research agreements, Dyadic received a 16.1% equity interest in BDI Holdings and a 3.3% equity interest in VLPbio. [4]

In August 2016, Dyadic received 60-day notice from Sanofi for the termination of Proof-of-concept, exclusive option and technology transfer agreement. In October 2016, the effective termination date of the agreement, Sanofi’s prior option rights to the C1 technology previously covered by the agreement will be reverted back to Dyadic. Upon such reversion, Dyadic expects to leverage the knowledge gained, and the progress made from the meaningful improvements to the C1 expression system across all biologic vaccine and drug indications [5] . Dyadic and Sanofi Pasteur entered into a research collaboration to develop vaccine in May 2011. Under the agreement, Sanofi is funding the research, which will be conducted under the guidance of Dyadic, coordinated by EnGen Bio. Dyadic's C1 technology uses patented strains of the fungus Myceliopthora thermophila (formerly known as Chrysosporium lucknowense) (C1) to discover and express both eukaryotic and prokaryotic genes. EnGen Bio uses a novel manufacturing system to generate biologics and vaccines [6] .

Key Development Milestones

As of February 2020, Dyadic International in collaboration with the Israel Institute for Biological Research are developing an rVaccine candidate and monoclonal antibodies (mAbs) against COVID-2019 infections [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Anti-infectives, Monoclonal antibodies, Vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

    J07 (Vaccines)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

    J7 (Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research Israel Parenteral / unspecified Dyadic International, Israel Institute for Biological Research 25 Feb 2020
Unspecified - - Research Israel Parenteral / unspecified Dyadic International, Israel Institute for Biological Research 16 Jan 2018
Unspecified - - Discontinued (Research) Netherlands Parenteral / unspecified Dyadic International, EnGen Bio 08 Aug 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
Dyadic International Originator USA
EnGen Bio Originator USA
EnGen Bio Owner USA
Dyadic International Owner USA
BDI Pharma Collaborator USA
Israel Institute for Biological Research Collaborator Israel
VLPbio Collaborator Spain
Mitsubishi Tanabe Pharma Corporation Collaborator Japan

Development History

Event Date Update Type Comment
25 Feb 2020 Licensing Status Dyadic International expands the collaboration with the Israel Institute for Biological Research to develop a rVaccine candidate and monoclonal antibodies against COVID-2019-infections [2] Updated 28 Feb 2020
25 Feb 2020 Phase Change Early research in COVID-2019-infections in Israel (Parenteral) [2] Updated 28 Feb 2020
27 Feb 2018 Licensing Status Dyadic International enters into a collaboration with Mitsubishi Tanabe Pharma Corporation to produce two target protein in C1 technology [3] Updated 17 Aug 2018
16 Jan 2018 Licensing Status Dyadic International enters into a collaboration with Israel Institute for Biological Research for development of recombinant vaccines and neutralising agents [1] Updated 18 Jan 2018
16 Jan 2018 Phase Change Early research in Undefined indication in Israel (Parenteral) Updated 18 Jan 2018
10 Jul 2017 Licensing Status Dyadic International enters into a collaboration with VLP The Vaccines Company and BDI Pharma for development of recombinant vaccines [4] Updated 17 Aug 2018
21 Sep 2016 Licensing Status Sanofi terminates its agreement with Dyadic International [5] Updated 21 Sep 2016
08 Aug 2016 Phase Change - Discontinued Discontinued for Undefined indication in Netherlands (Parenteral) [5] Updated 21 Sep 2016
12 May 2016 Active Status Review Development is ongoing in Netherlands Updated 17 May 2016
02 May 2011 Licensing Status Dyadic International enters into a research agreement with Sanofi Pasteur Updated 17 May 2016
02 May 2011 Phase Change Early research in Undefined indication in Netherlands (Parenteral) Updated 03 May 2011

References

  1. Dyadic International, Inc. Announces Research and DevelopmentCollaboration with the Israel Institute for Biological Research (IIBR)to Combat Emerging Diseases & Threats.

    Media Release
  2. Dyadic and The Israel Institute for Biological Research (IIBR) Expand Collaboration to Combat Emerging Diseases.

    Media Release
  3. Dyadic International, Inc. Announces Research and Development Collaboration with Mitsubishi Tanabe Pharma Corporation To Produce Two Target Proteins in C1.

    Media Release
  4. Dyadic Announces an Important Multi-Year Research and Development Arrangement to Further Advance Its Proprietary C1 Technology.

    Media Release
  5. Dyadic International Reports the Termination of Agreement With Sanofi Pasteur.

    Media Release
  6. Dyadic Netherlands Enters Into R&D Collaboration With Sanofi Pasteur and EnGen Bio.

    Media Release
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