Synlogic & Ginkgo Bioworks Announce Investigational Synthetic Biotic Medicine for the Treatment of Homocystinuria

Synlogic, Inc. and Ginkgo Bioworks recently announced the nomination of SYNB1353, an investigational Synthetic Biotic medicine for the treatment of homocystinuria (HCU). SYNB1353 is the first product developed through a research collaboration between Synlogic and Ginkgo and the first investigational medicine developed on Ginkgo’s platform to enter IND-enabling studies. Synlogic expects to file an investigational new drug (IND) application with the US FDA for SYNB1353 and begin clinical development in 2022.

“SYNB1353 is an exciting addition to the Synlogic pipeline aimed at helping patients living with diseases of methionine metabolism. Starting with HCU, we see these diseases as the natural next step in our metabolic portfolio after the successful proof of concept of synthetic biotics in phenylketonuria announced earlier this year. This program builds on what we have learned from our metabolic program work to date, with the potential to provide a new therapeutic option to reduce the devastating consequences of these diseases,” said Dr. David Hava, Chief Scientific Officer at Synlogic. “The advancement of SYNB1353 illustrates both the potential of our Synthetic Biotic platform to generate new therapeutic candidates and the value of our collaboration with Ginkgo.

“We’re so honored to be able to support Synlogic in building their incredible platform to provide potential new treatment options for people living with difficult to treat diseases,” added Patrick Boyle, Head of Codebase at Ginkgo. “This is just the beginning for a new generation of medicines unlocked by the power of synthetic biology, and we’re excited to be working with Synlogic on multiple additional preclinical programs in their portfolio.”

HCU is an inherited disorder caused by the loss of function of cystathionine beta-synthase, which results in excessive accumulation of homocysteine and its metabolites in the blood and urine. Patients develop multisystem clinical manifestations, including ectopia lentis, bone defects, intellectual disability, and life-threatening thromboembolisms. Many patients are required to comply with a rigid methionine-restricted diet and have few treatment options available.

SYNB1353 is an engineered strain of the probiotic bacteria E. coli Nissle (EcN) which consumes methionine within the gastrointestinal tract, preventing methionine absorption and conversion to homocysteine in plasma. During the collaboration, SYNB1353 was designed using Ginkgo’s proprietary codebase. The high-throughput testing of codebase libraries by Ginkgo enabled SYNB1353 to advance from preclinical proof-of-concept to candidate strain in the space of a year.

Researchers from Synlogic and Ginkgo will present preclinical data supporting advancement of SYNB1353 into IND-enabling studies at the International Congress of Inborn Errors of Metabolism 2021. The poster, Development of an Investigational Methionine-consuming Synthetic Biotic Medicine (SYNB1353) for the Treatment of Homocystinuria, will be available at the International Congress of Inborn Errors of Metabolism 2021 on November 21-23, 2021 in Sydney, Australia. Following the event, the poster will also be available to view on www.synlogictx.com.

SYNB1353 is a novel medicine in development for the treatment of diseases of methionine metabolism including homocystinuria (HCU). SYNB1353 is designed to lower plasma homocysteine levels by metabolizing methionine, a precursor to homocysteine, in the gastrointestinal (GI) tract. SYNB1353 was developed using Synlogic’s Synthetic Biotic platform incorporating components of Ginkgo Bioworks’ codebase. Synlogic holds worldwide development and commercialization rights to SYNB1353.

Synlogic is bringing the transformative potential of synthetic biology to medicine. With a premier synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic’s proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including phenylketonuria (PKU) and enteric hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology. For more information, visit  https://www.synlogictx.com/.

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company’s platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com.

Formed in 2019, the Synlogic – Ginkgo collaboration is a 5-year, $30-million strategic platform collaboration which accelerates expansion and development of Synlogic’s pipeline of Synthetic Biotic medicines using Ginkgo’s cell programming platform, including Ginkgo’s foundry and codebase. Synlogic has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to certain intellectual property covering such products.