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Research programme: inflammatory bowel disease therapeutics - AbbVie/Synlogic

Drug Profile

Research programme: inflammatory bowel disease therapeutics - AbbVie/Synlogic

Alternative Names: Synthetic Biotic™ - Synlogic

Latest Information Update: 28 Apr 2023

At a glance

  • Originator Synlogic
  • Class Anti-inflammatories; Probiotics
  • Mechanism of Action Bacteria replacements; Immunomodulators; 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 Inflammatory bowel diseases

Most Recent Events

  • 28 Apr 2023 No recent reports of development identified for preclinical development in Inflammatory-bowel-diseases in USA (PO)
  • 21 May 2020 Research programme: inflammatory bowel disease therapeutics - AbbVie/Synlogic is available for licensing as of 21 May 2020. https://www.synlogictx.com/
  • 21 May 2020 Synlogic terminates its collaboration with AbbVie for the development of synthetic biotic medicines for inflammatory bowel disease

Development Overview

Introduction

Orally administered synthetic biotics to correct disease-causing metabolic dysregulation within the gut microbiome are being developed by Synlogic, in collaboration with Abbvie, for the treatment of inflammatory bowel diseases including Crohn's disease and ulcerative colitis. Synlogic's synthetic biology and microbiome technology re-engineers naturally occurring micro-organisms with genetic circuits, which transform these micro-organisms into programmable symbiotic living therapeutics, that exhibit exquisite genetic control in response to pathophysiological signals. Preclinical development is underway in the US.

As at April 2023, no recent reports of development had been identified for preclinical development in Inflammatory-bowel-diseases in USA (PO).

Company Agreements

In May 2020, Synlogic terminated its collaboration with AbbVie for the development of synthetic biotic medicines for the treatment of inflammatory bowel disease. Upon termination, Synlogic regains all rights to develop these and new IBD synthetic biotic medicines for all effectors targeting IBD. Synlogic further also regains the rights to partner its IBD programs. The original agreement was first announced in September 2015, without disclosing the partnered company. Later, In February 2016, the two companies entered into a multi-year research and development agreement for developing therapeutics for treatment of certain forms of inflammatory bowel disease, such as Crohn's disease and ulcerative colitis. Under the terms of the original agreement, Synlogic was to discover and optimise synthetic biotic-based drug candidates, and Abbvie was responsible for the clinical development, regulatory filings and worldwide marketing of the resulting therapeutics. Synlogic also provided AbbVie with an exclusive option to acquire a Synlogic subsidiary ('IBDCo'), which would then have an exclusive worldwide license to develop and commercialize synthetic biotic medicines for the treatment of IBD. AbbVie agreed to pay Synlogic an upfront payment of $US 2.0 million and up to $US 16.5 million upon the achievement of certain research milestones. [1] [2] [3] [4] [5]

In November 2015, Synlogic in-licensed synthetic biology circuitry technology from Massachusetts Institute of Technology [6] .

Key Development Milestones

In June 2017, Synlogic reported the identification of synthetic biotic leads for the treatment of inflammatory bowel disease, under the first discovery phase of the collaboration with AbbVie. The milestone triggered a payment of $US2.0 million to Synlogic received in December 2015, and supported advancement into the next phase of the collaboration. Later, in March 2019, advancement of the collaboration into the lead optimisation phase triggered another undisclosed milestone payment to Synlogic, from AbbVie [5] [4] .

Financing Information

Synlogic closed a a Series B financing round with $US40 million in additional financing, bringing the total investment in its combined Series A and B financing to $US70 million. The company intends to use the financing to accelerate development of their synthetic biologic therapeutics [7] .

In January 2015, Synlogic raised $US5 million in a series A financing from the Bill & Melinda Gates Foundation, and plans to use the funding to develop its first-in-class proprietary microbial engineering platform, for the development of therapeutic microbes and advance its preclinical pipeline across several clinical applications [8] .

In July 2014, Synlogic raised $US29.4 million in a series A financing, and plans to use the funding to develop its first-in-class proprietary microbial engineering platform, for the development of therapeutic microbes and advance its preclinical pipeline across several clinical applications [9] .

Patent Information

Synlogic owns intellectual property for synthetic biology therapeutics, being developed in collaboration with AbbVie, for inflammatory bowel disease (IBD) [6] .

Synlogic holds one US patent application and five international applications relating to synthetic biology circuitry technology which is jointly owned by the company and Massachusetts Institute of Technology (MIT), which expires in December 2035, excluding any patent term adjustments or extensions. These provide coverage for engineered bacteria having genetic circuitry designed to specifically address inflammatory bowel disease [6] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation unspecified
  • Class Anti-inflammatories, Probiotics
  • Target Bacteria; Microbiome
  • Mechanism of Action Bacteria replacements; Immunomodulators; Microbiome modulators
  • WHO ATC code

    A07E (Intestinal Antiinflammatory Agents)

  • EPhMRA code

    A7E (Intestinal Anti-Inflammatory Agents)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Inflammatory bowel diseases - - No development reported (Preclinical) USA PO / unspecified Synlogic 28 Apr 2023

Commercial Information

Involved Organisations

Organisation Involvement Countries
Synlogic Originator USA
Synlogic Owner USA
Massachusetts Institute of Technology Technology Provider USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Synlogic - Unspecified - 21 May 2020

Development History

Event Date Update Type Comment
28 Apr 2023 Phase Change - No development reported No recent reports of development identified for preclinical development in Inflammatory-bowel-diseases in USA (PO) Updated 28 Apr 2023
21 May 2020 Licensing Status Research programme: inflammatory bowel disease therapeutics - AbbVie/Synlogic is available for licensing as of 21 May 2020. https://www.synlogictx.com/ Updated 29 May 2020
21 May 2020 Licensing Status Synlogic terminates its collaboration with AbbVie for the development of synthetic biotic medicines for inflammatory bowel disease Updated 29 May 2020
12 Mar 2019 Regulatory Status Synlogic and AbbVie intend to file an IND for planned clinical development in Inflammatory bowel disease [5] Updated 14 Mar 2019
12 Mar 2019 Trial Update Synlogic and AbbVie plan clinical development in Inflammatory bowel disease [5] Updated 14 Mar 2019
11 Mar 2019 Phase Change - Preclinical Preclinical trials in Inflammatory bowel diseases in USA (PO) Updated 11 Mar 2019
20 Mar 2018 Patent Information Synlogic has patent protection for synthetic biology therapeutics and related technology for the treatment of inflammatory bowel disease in USA and countries worldwide [6] Updated 23 Apr 2018
01 Nov 2015 Licensing Status Synlogic in-licenses synthetic biology circuitry technology from Massachusetts Institute of Technology [6] Updated 23 Apr 2018
17 Sep 2015 Phase Change Early research in Inflammatory bowel disease in USA (PO) Updated 18 Feb 2016
17 Sep 2015 Licensing Status Synlogic and Abbvie company agree to co-develop synthetic biology therapeutics in USA for inflammatory bowel disease (9184525; 9191143) Updated 04 Jan 2016

References

  1. Synlogic Accelerates Business Growth with Appointment of President, Expansion of Financing, and an Industry Collaboration.

    Media Release
  2. Synlogic Announces First Industry Collaboration to Develop a New Class of Medicines Designed to Power the Microbiome.

    Media Release
  3. Synlogic Progresses Clinical and Preclinical Pipeline and Outlines 2018 Catalysts.

    Media Release
  4. Synlogic Meets First Discovery Milestone in Partnership with AbbVie.

    Media Release
  5. Synlogic Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update.

    Media Release
  6. Synlogic Form 10-K, March 2018. Internet-Doc 2018;.

    Available from: URL:
  7. Synlogic Secures $40 Million in Series B Financing.

    Media Release
  8. Synlogic Secures $5 Million Investment in Series A Funding Round.

    Media Release
  9. Synlogic Secures $29.4 Million Series A Financing Led by Atlas Venture and New Enterprise Associates.

    Media Release
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