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Research programme: synthetic biology therapeutics - Ginkgo/Synlogic

Drug Profile

Research programme: synthetic biology therapeutics - Ginkgo/Synlogic

Alternative Names: Synthetic Biotic™ - Synlogic/Ginkgo

Latest Information Update: 28 Feb 2024

At a glance

  • Originator Ginkgo Bioworks; Synlogic
  • Class Hepatoprotectants; Neuroprotectants; Probiotics
  • Mechanism of Action Bacteria replacements; Gastrointestinal microbiome modulators
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • No development reported Hyperoxaluria; Liver disorders; Neurological disorders

Most Recent Events

  • 28 Feb 2024 No recent reports of development identified for preclinical development in Hyperoxaluria in USA (PO)
  • 28 Jan 2022 No recent reports of development identified for research development in Liver-disorders in USA (PO)
  • 28 Jan 2022 No recent reports of development identified for research development in Neurological-disorders in USA (PO)

Development Overview

Introduction

Synlogic, in collaboration with Ginkgo Bioworks, is developing a discovery engine of living drugs for the treatment of liver, neurological disorders and secondary hyperoxaluria. The companies intend to combine Ginkgo’s automated foundry and expertise in high-throughput organism screening and design, with Synlogic’s insights and expertise in discovery, translational and clinical development of Synthetic Biotic medicines. Synlogic’s synthetic biology and microbiome technology re-engineers naturally occurring micro-organisms with genetic circuits, that transform these micro-organisms into programmable symbiotic living therapeutics, that exhibit exquisite genetic control in response to pathophysiological signals. Early research for liver disorder and neurological disorder is underway in the US. Preclinical development is underway for the treatment of secondary hyperoxaluria in the US.

Synlogic and Ginkgo will jointly seek strategic partners for portfolio expansion, clinical development, and commercialisation in neurological and liver diseases.

As at January 2022, no recent reports of development had been identified for research development in Liver-disorders in USA (PO), research development in Neurological-disorders in USA (PO).

As at February 2024, no recent reports of development had been identified for preclinical development in Hyperoxaluria in USA (PO).

Company Agreements

In August 2022, Synlogic announced clinical development of SYNB 2081 for the treatment of gout developed in partnership with Ginkgo Bioworks. SYNB 2081 is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo. In June 2019, Synlogic and Ginkgo Bioworks announced a platform collaboration to accelerate expansion and development of Synlogic’s pipeline of Synthetic Bioticmedicines using Ginkgo’s cell programming platform. The agreement provides an $US80.0 million equity investment at a premium in Synlogic by Ginkgo and entry into a long-term strategic platform collaboration. Synlogic also paid $US30.0 million to Ginkgo for synthetic biology services to be provided over an initial period of five years which can be extended. In December 2017, Synlogic and Ginkgo had entered into a collaboration to discover new living medicines to treat neurological and liver disorders. The agreement will combine Synlogic’s insights and expertise in discovery, translational and clinical development of Synthetic Biotic medicines, with Ginkgo’s automated foundry and expertise in high-throughput organism screening and design. [1] [2]

Key Development Milestones

In January 2020, Synlogic reported that optimised oxalate-consuming strains has been transferred from Ginkgo Bioworks for the development in secondary hyperoxaluria, resulting due to excessive ingestion or absorption of oxalate from gastrointestinal tract. In preclinical studies, prototype strains has demonstrates oxalate lowering effect [3] [4] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation unspecified
  • Class Hepatoprotectants, Neuroprotectants, Probiotics
  • Target Bacteria; Gastrointestinal microbiome
  • Mechanism of Action Bacteria replacements; Gastrointestinal microbiome modulators
  • WHO ATC code

    A05B-A (Liver therapy)

    A16A (Other Alimentary Tract and Metabolism Products)

    N07 (Other Nervous System Drugs)

  • EPhMRA code

    A16A (Other Alimentary Tract and Metabolism Products)

    A5B (Hepatic Protectors, Lipotropics)

    N1 (Anaesthetics)

    N7 (Other CNS Drugs)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Hyperoxaluria - - No development reported (Preclinical) USA PO / unspecified Ginkgo Bioworks, Synlogic 28 Feb 2024
Liver disorders - - No development reported (Research) USA PO / unspecified Ginkgo Bioworks, Synlogic 28 Jan 2022
Neurological disorders - - No development reported (Research) USA PO / unspecified Ginkgo Bioworks, Synlogic 28 Jan 2022

Commercial Information

Involved Organisations

Organisation Involvement Countries
Ginkgo Bioworks Originator USA
Synlogic Originator USA
Ginkgo Bioworks Owner USA
Synlogic Owner USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Synlogic - Clinical Phase Unknown - 08 Dec 2017

Development History

Event Date Update Type Comment
28 Feb 2024 Phase Change - No development reported No recent reports of development identified for preclinical development in Hyperoxaluria in USA (PO) Updated 28 Feb 2024
28 Jan 2022 Phase Change - No development reported No recent reports of development identified for research development in Liver-disorders in USA (PO) Updated 28 Jan 2022
28 Jan 2022 Phase Change - No development reported No recent reports of development identified for research development in Neurological-disorders in USA (PO) Updated 28 Jan 2022
09 Jan 2020 Phase Change - Preclinical Preclinical trials in Hyperoxaluria in USA (PO) before January 2020 [3] Updated 16 Jan 2020
11 Dec 2017 Licensing Status Synlogic and Ginkgo Bioworks agree to develop synthetic biology therapeutics for Neurological and Liver disorders in USA [1] Updated 14 Dec 2017
11 Dec 2017 Phase Change Early research in Liver disorders in USA (PO) [1] Updated 14 Dec 2017
11 Dec 2017 Phase Change Early research in Neurological disorders in USA (PO) [1] Updated 14 Dec 2017
08 Dec 2017 Licensing Status Research programme: synthetic biology therapeutics - Ginkgo/Synlogic is available for licensing as of 08 Dec 2017. https://www.synlogictx.com/ Updated 04 Jan 2018

References

  1. Synlogic and Ginkgo Bioworks Announce Collaboration as First Step Toward Building an Unprecedented Discovery Engine for Novel Living Medicines in Neurological and Liver Disorders.

    Media Release
  2. Synlogic and Ginkgo Bioworks Establish Transformational Platform Collaboration for the Accelerated Development of Novel Synthetic Biotic(Tm) Medicines.

    Media Release
  3. Synlogic Outlines Upcoming Milestones for Clinical Programs and Unveils New Preclinical Pipeline Programs.

    Media Release
  4. Synlogic corpoprate presentation - January 2020. Internet-Doc 2020;.

    Available from: URL: https://investor.synlogictx.com/static-files/756afa06-34b6-4e40-b051-8c665a1cc711
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