Developing Synthetic Biotics for Gout with Synlogic

Ginkgo and Synlogic announce the second drug candidate—a treatment for gout—in their partnership to develop synthetic biotics

Last November, we announced that SYNB1353, an engineered strain of the probiotic bacteria E. coli Nissle (EcN) designed and developed through a collaboration between Ginkgo and Synlogic, was to be nominated for investigational new drug (IND) status with the U.S. Food and Drug Administration (FDA). This would mark the first medicine developed on Ginkgo’s platform to enter IND-enabling studies but just the beginning of our work with Synlogic to create living medicines.

Today, we’re pleased to share Synlogic’s announcement of SYNB2081, a new drug candidate developed in partnership between our two companies for the treatment of gout.

Addressing unmet needs for patient care

Gout is a complex form of inflammatory arthritis that occurs when excess uric acid in the body forms crystals in the joints. Patients experience a range of symptoms, including intense joint pain, inflammation and redness, and limited range of motion in the affected joints. Unfortunately, current treatment options present limitations in both safety and efficacy, highlighting a need for new approaches.Gout is also a recognized risk factor in chronic kidney disease (CKD).

SYNB2081 is a synthetic biotic designed to lower uric acid for the treatment of gout. We’re honored to work with the Synlogic team in this pioneering next step to potentially help patients living with gout. As we’ve seen the Synlogic pipeline develop the past year, we’re eager to continue supporting Synlogic in generating additional therapeutic candidates.

SYNB2081 is named after one of the largest and best-preserved Tyrannosaurus rex specimens in the world. Nicknamed “Sue,” the specimen is housed at the Field Museum in Chicago and is officially named FMNH PR 2081. Data from “Sue” suggests that dinosaurs like the Tyrannosaurus rex suffered from gout much in the same way as other reptiles and birds do.

What if we could program microbes to act as medicine?

“With our second drug candidate into clinical development, this not only demonstrates the value of combining Ginkgo’s Codebase with our Synthetic Biotic platform, but also highlights the potential to develop Synthetic Biotics across a range of diseases, giving us the potential to provide meaningful new treatment options to patients in need,” said Dr. David Hava, Chief Scientific Officer, Synlogic.

The advancement of SYNB2081 and SYNB1353 are clear indicators of the transformative platform Synlogic has created to power new medicines through synthetic biology.

Find the full press release here along with all of the latest news from the Ginkgo team.

What will you grow with Ginkgo?

Optimizing the Brightness of Glowing Plants with Light Bio

Leveraging Ginkgo’s engineering capabilities to optimize performance of Light Bio’s light-emitting plants

We’re excited to announce a new collaboration with Light Bio – a company creating bioluminescent plants for home and garden. The agreement will leverage Ginkgo’s plant cell assays for bioluminescence engineering. The aim: to improve the luminescent output and efficiency of the enzymes within Light Bio’s glowing ornamental plants.

Nothing captures the wonder of biology quite like seeing glowing plants in person. Our platform enables developers to imagine with biology and to design all types of cells, from bacteria and yeast to mammalian and plant cells. We’re so excited to bring this unique application onto our platform and to help Light Bio bring the magic of glowing plants to people.

Light Bio has discovered a new type of bioluminescence mechanism and uses synthetic biology to engineer plants to efficiently emit light. The original light emission pathway Light Bio uses in its glowing plants comes from bioluminescent mushrooms. The company is now focused on expanding its engineering capabilities to support the creation of glowing plants.

“We are excited to collaborate with Ginkgo toward additional multifold output and efficiency improvements powered by Ginkgo’s plant cell engineering capabilities across both individual enzyme and metabolic pathway improvements,” said Keith Wood, CEO, Light Bio.

What will you grow with Ginkgo?

Developing Water Quality Biosensors with FREDSense

Ginkgo’s strain development capabilities to help develop advanced biosensors

Today, we’re excited to announce our partnership with FREDsense Technologies Corp, a next generation water quality platform company leveraging synthetic biology to build field kits for faster, cheaper, and more efficient analysis. Through this partnership, we seek to build four distinct microbial strain biosensors, compatible with FREDsense’s field-ready hardware for remote water quality monitoring applications.

Demand for scalable monitoring and testing systems has increased, as water quality becomes an ever-growing environmental and public health concern. Conventional water quality test results are often delayed, since samples must be transported to labs for chemical analysis. FREDsense builds portable solutions to efficiently assess the chemicals in the water at the source. This allows for rapid modification of water treatment processes in real-time without the need for external lab equipment.

Supporting real-time field detection of harmful molecules and toxins in any water source

The biosensors in development by Ginkgo aim to support real-time field detection of harmful molecules, and may be used to generate solutions for groundwater and industrial water management systems.

Partnering with FREDsense is an exciting opportunity to apply our strain development capabilities to powerful biosensor technology for an important application. Protecting our water sources is a mission critical initiative: life on this planet as we know it depends on it. We’re eager to work toward enhancing the capabilities of FREDsense’s platform to monitor for harmful contaminants in water.

“Water is our most critical resource, and we now have the technology to detect in real-time many of the threats or contaminants that can impact the water that our environments and communities depend on,” says David Lloyd, CEO of FREDsense. “Through this partnership with Ginkgo, we aim to introduce rapid, simple and accurate testing to deliver water quality monitoring systems to those that most need it. We believe that synthetic biology is the key to solving some of the biggest challenges facing the water industry globally and are very excited to partner with Ginkgo on this vision.”

Find the full press release here along with all of the latest news from the Ginkgo team.

What will you grow with Ginkgo?

New Platform Venture: Launching BiomEdit

BiomEdit intends to leverage Ginkgo’s platform to discover and develop microbiome-based animal health products to improve animal health, animal protein production, and livestock disease monitoring.

We’re excited to announce the launch of BiomEdit, a microbiome innovation company that is expected to discover, develop, and introduce novel probiotics, bioactive molecules, engineered microbial medicines and microbial monitoring services for animal health.

Microbiome science is a rapidly growing field creating breakthroughs in animal health based on the microbial communities that live in animals and their surrounding environment. BiomEdit intends to discover, develop and introduce differentiated products that address some of the greatest needs for innovation in animal health, including medicated feed ingredients, nutritional health and therapeutics for livestock and pet species, as well as biosecurity technology for animal disease monitoring.

BiomEdit is Ginkgo’s latest platform venture, created in partnership with Elanco Animal Health — a leading global animal health company.

In October 2021, Elanco announced its intention to carve out its microbiome platform and pipeline under the leadership of Aaron Schacht, BiomEdit CEO and former Elanco executive vice president of Innovation, Regulatory and Business Development, to concentrate and focus more resources on its high value late-stage Pet Health pipeline. BiomEdit is the result of this separation, and was developed with Ferment Co., the company creation studio that helps ideate and launch new companies across a variety of end-markets that use cell programming to support human and environmental health and well-being.

Elanco will contribute intellectual property and a pipeline of ongoing programs to BiomEdit, which will be staffed with members of the former Elanco microbiome R&D team. The team brings the expertise and experience needed to build on the foundation of microbiome work started at Elanco. By leveraging foundational programs from Elanco, intellectual property from both Elanco and Ginkgo, and an experienced team, BiomEdit should be well positioned as a stand-alone company to develop and launch innovative products to address unmet needs in animal health.

“Livestock producers and veterinarians are calling for new products that address antibiotic resistance and improve livestock sustainability,” said Mr. Schacht. “Coupling the platform, pipeline and deep expertise of the former Elanco microbiome team with Ginkgo’s unique screening and strain engineering capabilities will accelerate and amplify our ability to advance novel animal microbiome inspired products for animal health.”

“Elanco is excited to continue its participation in the microbiome by partnering with Ginkgo, Viking Global Investors and Anterra Capital to create the next-generation animal health innovation player,” said Jeff Simmons, president and CEO of Elanco Animal Health. “We wish Aaron and his team the best as they build out this novel innovation platform to address unmet needs in animal health, such as alternatives to antibiotics.”

Ginkgo has significant expertise in the discovery, design and monitoring of microbes at scale for a wide array of functions.

BiomEdit plans to leverage Ginkgo’s state-of-the-art cell programming platform to improve the design and development of probiotics, bioactives, engineered microbial medicines, and microbial monitoring services. BiomEdit joins other Ginkgo platform ventures such as Joyn Bio, Motif FoodWorks, Allonnia, Arcaea, Verb Biotics and Ayana Bio.

We are always on the lookout for opportunities to accelerate our partners’ abilities to address massive challenges, such as antibiotic resistance in livestock. Together, we see Ginkgo and BiomEdit addressing significant opportunities in the animal health industry with new breakthroughs based on microbiome science. We deeply depend on the health of animals in our ecosystem and supply chains; the potential applications for our cell programming platform in this area are far reaching.

In addition to the assets and intellectual property contributed by Elanco and Ginkgo, BiomEdit is launching with a targeted Series A funding raise of $40 million, with participation by Viking Global Investors and Anterra Capital. In exchange for their respective asset and intellectual property contributions, Elanco and Ginkgo are expected to retain approximately 40% combined proportional ownership of BiomEdit, on a fully-diluted basis, upon the completion of the Series A financing. Elanco’s ownership will be in non-voting shares.

J.P. Morgan Securities LLC acted on behalf of Elanco as sole placement agent on the financing.

Find the full press release here along with all of the latest news from the Ginkgo team.

Discovering Novel Live Biotherapeutics with Microba

What if you could use bacteria as therapeutics?

Microba Life Sciences, a precision microbiome science company, and Ginkgo announced a partnership to identify single-strain, live bacteria product (LBP) candidates against autoimmune diseases. The collaboration aims to build on Microba’s precision approach to LBP development with an in-depth evaluation of the company’s strains using Ginkgo’s high throughput, automated screening capabilities.

Microba will leverage Ginkgo’s high throughput screening capabilities to identify potential therapeutic candidates for autoimmune diseases.

The human gut microbiome is composed of trillions of bacteria that have an outsized influence on human health and disease. In recent years, scientists have developed a deeper understanding of the relationship between specific bacteria residing in the gut and various health outcomes, leading to a growing interest in using bacteria for therapeutic applications. Clinical trials using live biotherapeutics – biological products that contain live microorganisms applicable to the prevention, treatment, or cure of a disease – have delivered promising results.

There is growing consensus that live biotherapeutics may represent a major class of therapeutics in the coming years.

“We believe the human microbiome currently represents a missing piece in the treatment of major chronic diseases, and as a result a number of microbiome-based therapeutics are progressing through clinical development globally” said Luke Reid, CEO at Microba. “Ginkgo’s high throughput screening automation combined with our novel data-driven approach to therapeutic discovery from the microbiome can potentially accelerate development of breakthrough new drugs for autoimmune diseases.”

Leveraging Ginkgo’s platform to discover, develop, and optimize live biotherapeutics

Through this partnership, Ginkgo will provide high-throughput screening for Microba’s proprietary library of human microbiome-isolated strains, with the goal of improving treatment for autoimmune diseases such as lupus, psoriatic arthritis, and certain autoimmune liver diseases. Microba plans to leverage Ginkgo’s high-throughput anaerobic culturing, multi-omics data collection and analysis, functional bioassay screening, and media and fermentation optimization capabilities to generate data sets that may help characterize potential therapeutic and non-therapeutic uses of the strains. The initial partnership combining Microba’s biobank and Ginkgo’s anaerobic development capabilities is expected to run approximately two years.

Microba is doing truly innovative work during an exciting time for the field of microbiome science. We’re happy to welcome new partners like Microba as we apply our platform to more applications in the living therapeutics and microbiome space.

Microba plans to launch its initial Public Offering (IPO) on the Australian Securities Exchange on April 5. In connection with the partnership, Ginkgo is investing $3.5 million USD in Microba. The IPO was fully underwritten by Canaccord Genuity and Bell Potter.

Find the full press release here along with all of the latest news from the Ginkgo team.

Investigational Synthetic Biotic Medicine for Homocystinuria with Synlogic

Homocystinuria (HCU) is an inherited disorder that affects tens of thousands of people every day. HCU occurs when a person is unable to metabolize the amino acid methionine, a precursor to homocysteine; the result is an excessive accumulation of homocysteine and its metabolites in a person’s blood and urine. Patients develop multiple symptoms, including bone defects, intellectual disabilities, and life-threatening blood vessel obstructions. Many patients are required to comply with rigid, restrictive diets and have few treatment options available.

What if we could tell bacteria inside these patients to metabolize methionine, lowering homocysteine levels and reducing the effects of diseases like HCU?

SYNB1353, an engineered strain of the probiotic bacteria E. coli Nissle (EcN), was designed and is being developed through a collaboration between Synlogic and Ginkgo to do exactly that. This novel strain has the ability to consume methionine in the human gut, helping to avoid excessive accumulation and conversion to homocysteine in plasma. 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.

“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.”

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 U.S. Food and Drug Administration (FDA) for SYNB1353 and begin clinical development in 2022. 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.

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. 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.

Read the full press release here.

Advancing Treatments for Orphan and Rare Diseases with Selecta Biosciences

Rare and orphan diseases affect hundreds of thousands of Americans, and many treatments cause unwanted immune responses.

What if you could mitigate unwanted immune responses and amplify the efficacy of therapies?

This is exactly what Selecta Biosciences aims to do in collaboration with Ginkgo. Together, we plan to design novel and improved enzymes with transformative and therapeutic potential to advance treatments for select orphan and rare diseases. This partnership leverages the unique platforms of both companies: Selecta’s clinically-validated ImmTOR™ platform, which is developing tolerogenic therapies, and Ginkgo’s horizontal platform for cell programming.

Under the terms of the collaboration, Ginkgo is eligible to earn upfront research and development fees and milestones, including certain milestone payments in the form of Selecta common stock, clinical and commercial milestone payments of up to $85M in cash, as well as further downstream value in the form of royalties on sales.

“We are excited to partner with Ginkgo and expect that our ImmTOR technology, in combination with Ginkgo’s high throughput enzyme discovery, design, and screening capabilities will bring us one step closer to improving the sustained efficacy of novel biologic therapeutics,” said Carsten Brunn, PhD, CEO at Selecta Biosciences. “Further, this collaboration builds on extensive preclinical as well as strong clinical data from Selecta’s Phase 2 COMPARE trial for the treatment of chronic refractory gout that further supports ImmTOR’s potential for sustained therapeutic benefit when combined with immunogenic enzymatic therapies. We look forward to expanding our pipeline and ultimately delivering on our shared mission to improve the lives of patients in need.”

Ginkgo works with a growing list of industry leaders that are addressing outstanding medical challenges with diverse therapeutic modalities, and we are thrilled to partner with Selecta in an effort to discover, engineer, and develop next generation therapeutic enzymes. We’re excited to support Selecta in its mission to improve the quality of life for patients with unmet medical needs by expediting and maximizing Selecta’s capabilities.

Read the full press release here.

Developing High-Efficacy Adjuvants for Vaccines with SaponiQx

Adjuvants—substances known to enhance our immune response—are a key component of many existing vaccines. And while vaccines are one of the most powerful tools we have to fight pandemics, ensuring widespread access to efficacious vaccines continues to be a major challenge around the world.

SaponiQx, a new subsidiary announced today by Agenus, plans to use Ginkgo’s platform to drive innovation in novel adjuvant discovery and vaccine design.

Their efforts will focus on building an innovative adjuvant platform to deliver both sustainable manufacturing approaches and a secure supply of known adjuvants, as well as discover novel adjuvants and develop new, more effective vaccines utilizing optimized antigen-adjuvant pairings.

Ginkgo’s experience in metabolic engineering, enzymatic diversification, and process optimization can be applied to discover novel adjuvants and improve current manufacturing processes that can then be applied toward developing better-integrated vaccines. We’re proud that our platform is being used by companies across the vaccine supply chain to develop and manufacture the materials necessary for life-saving vaccines.

Garo Armen, CEO and Chairman of Agenus and Executive Chairman of SaponiQx, had this to say: “Agenus is pleased for SaponiQx to collaborate with Ginkgo Bioworks to develop its novel saponin products from sustainably sourced raw materials, with a goal to meet the current demands placed on the vaccine industry for pandemic vaccines. The QS21 Stimulon™ adjuvant has shown long term efficacy and long-term protection in both commercially launched and experimental vaccines.”

New Platform Ventures: Launching Verb Biotics, Ayana Bio

Today we’re announcing the launch of two new companies via the Ferment Consortium: Verb Biotics and Ayana Bio.

Verb—a probiotics innovation company—will focus on identifying and designing new strains of probiotic bacteria with advanced properties for human nutrition, health, and wellness. Ayana plans to support human health and wellness by harnessing bioactive compounds for use as complementary medicine.

Verb Biotics
The probiotics category is a $50B global industry that’s growing rapidly. As awareness and understanding of the human microbiome—the trillions of bacteria that live in and on your body—has grown over the past decade, there’s been tremendous interest in probiotic-enhanced foods, beverages, and supplements. Many existing probiotic products use strains of bacteria common to yogurt and other fermented products, but these strains have a number of challenges including limited shelf life, poor stability, and restrictive metabolic profiles.

Since Ginkgo has significant expertise in the discovery and design of microbes with a wide array of functions, Verb plans to leverage our high-throughput platform to perform sequencing, proteomics and metabolomics analysis, pathway design, cell culturing, and fermentation work in order to improve the design and development of probiotics.

Verb is launching with $30 million in Series A funding provided by Viking Global Investors and Cascade Investment.

Ayana Bio
To address issues ranging from supporting a healthy immune system, to aiding metabolism, to promoting healthy aging, consumers are looking for health products that are complementary to conventional medicine. Two categories of products that offer complementary health products—nutraceuticals and traditional medicines—represent over $400 billion.

The bioactive ingredients that go into products in these categories come from a range of natural sources such as medicinal plants and fungi. However, unsustainable harvesting, variability in the source organisms, and the methods of preparation all contribute to uncertainty around these important molecules and limit the potential for widespread use.

Ayana plans to collaborate with global industry leaders in consumer packaged goods, supplements, specialized nutrition, over-the-counter medicines, and traditional medicines to bring to market standardized bioactives that provide consumers with confidence in quality and reliability. Our cell programming platform will support Ayana’s mission to bring to market high purity, clean and reliable medicinal bioactives in convenient forms.

Ayana is launching with $30 million in Series A funding provided by Viking Global Investors and Cascade Investment.

Ferment Consortium
The Ferment Consortium is a company creation studio that works with Viking Global Investors and Cascade Investment to help incubate, fund, and launch new companies that use cell programming to support human and environmental health and wellbeing. (Psst! If you have a great idea of how to grow the future, Ferment Co would love to hear from you.)

Verb and Ayana join our other Platform Ventures: Joyn Bio, Allonnia, and Motif FoodWorks, which recently raised a $226 million Series B round led by Ontario Teachers Pension Plan and BlackRock.

Accelerating Production of Essential Medicines with Antheia

Partnership enables Antheia to broaden its pipeline of critical active pharmaceutical ingredients and key starting materials

Nearly half of all medicines today are sourced from nature, and many of the most widely used essential medicines are sourced directly from medicinal plants. The World Health Organization classifies “essential medicines” as medicines “that satisfy the priority healthcare needs of the population.”

But the supply chains for some of our most critical plant-based medicines are quite fragile. The specialty plants that are currently used to produce these medicines can require years to grow and harvest, and uncontrollable factors — such as weather — affect availability and reliability of supply. Transporting and processing adds more cost, complexity, and risk. In short, our reliance on specialty plants comes with many supply chain risks. When there’s extreme demand or a constrained supply, many plant-based medicines, including widely used analgesics and sedatives, can quickly become in short supply. We recently saw this occur during the COVID-19 pandemic. Furthermore, extracting medicines from specialty plants can be very expensive; the high cost of production means many developing countries cannot afford some of these essential medicines.

Synthetic biology platforms, such as those created by Antheia and Ginkgo, make it possible for critical medicines to be produced on-demand in a much more efficient and environmentally friendly process. Additionally, when it comes to plant-based pharmaceuticals, biomanufacturing has significant advantages in supply chain resiliency and agility, cost, quality control, sustainability, and efficiency compared to conventional crop farming and processing. Synthetic biology gives us an additional way to grow these essential medicines.

Antheia, who is enabling next-generation plant-inspired medicines, and Ginkgo, with our leading horizontal platform for cell programming, are announcing today a new cell programming partnership to accelerate the development and production of essential medicines using synthetic biology. Antheia plans to leverage our industry-agnostic platform — specifically, our high-throughput enzyme design and high-throughput screening capabilities — to broaden their pipeline of critical active pharmaceutical ingredients (APIs) and key starting materials (KSMs).

Antheia will leverage Ginkgo’s industry-agnostic platform — specifically, our high-throughput enzyme design and high-throughput screening capabilities.

Kristy Hawkins, CSO and co-founder at Antheia had this to share about the news: “We’re committed to using synthetic biology to enable more equitable access to essential medicines. By partnering with Ginkgo, a global leader in organism engineering, we are greatly increasing our ability to develop essential medicines at the speed and scale necessary to drive change in global pharma supply chains.”

Antheia’s focus is on plant-inspired pharmaceuticals that are too complex to be produced through scaled synthetic chemistry processes. They’ve managed to efficiently produce highly-complex pharmaceuticals by pioneering whole-cell engineering, a technique that reconstructs multiple steps of a biosynthetic pathway of unprecedented complexity in yeast cells. This partnership with Ginkgo enables Antheia to tap into a set of complementary capabilities and resources at Ginkgo to create synergies that allows Antheia to achieve more with its own technology platform. Through our partnership, Antheia plans to leverage Ginkgo’s extensive and rapid cell programming platform and biological codebase to greatly expand and accelerate its strain and enzyme engineering work.

Both organizations are committed to using biology to build a better future, and we look forward to a long lasting partnership and positive impact in the world. We believe Antheia is at the cutting edge of using synthetic biology to produce entire classes of medicines that were previously inaccessible; we’re thrilled that Ginkgo’s platform can support innovators like Antheia and create next generation manufacturing technologies for essential medicines.