Category: Therapeutics & Vaccines

Discovering Novel Live Biotherapeutics with Microba

Posted on by Jennifer Wipf

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.

Developing Next-Generation Gene Therapy Capsids with Selecta Biosciences

Posted on by Ankit Saxena

Selecta Biosciences intends to use Ginkgo’s cell programming platform to develop next-gen gene therapies using AAV capsids.

Gene therapy is one of the newest wave of treatments for many rare or orphaned diseases. However, current methods often result in unwanted immune responses.

What if you could grow the newest generation of therapies for human disease?

Together with Selecta Biosciences, Ginkgo is launching a collaboration to develop safer and more effective next-generation gene therapy adeno-associated viral capsids. Adeno-associated viruses (AAVs) are a type of gene delivery vector system. But several obstacles, including how these viruses interact with the immune system (immunogenicity), how well they can get into the cells (tropism), and how well they get DNA into the cells’ genomes (transduction efficiency), must still be overcome before fully realizing the AAV vector systems for many patient treatments. There are many types of AAVs, and they each work differently in different tissues, partially because of variations in the capsid–the protein coat of the virus.

The partnership with Selecta leverages the unique platforms of both companies as we seek to develop next-generation viral capsids with improved transduction, enhanced tissue tropism, and reduced immunogenicity. Ginkgo plans to design and engineer the capsids, and Selecta will conduct all pre-clinical and clinical studies thereafter.

“We are excited to continue our partnership with Ginkgo in a second collaboration that leverages Ginkgo’s leading cell engineering platform to design viral vector capsids with the goal of improved transduction, enhanced tissue tropism and reduced immunogenicity” said Carsten Brunn, CEO of Selecta Biosciences. “By combining ImmTOR with next-generation, fit-for-purpose AAV vectors, we hope to further improve the safety and efficacy of AAV-mediated gene therapies.”

Under the terms of the collaboration, Ginkgo is eligible to earn upfront research and development fees and milestone payments, including certain milestone payments in the form of Selecta common stock. In addition, Ginkgo is eligible to earn clinical, regulatory and commercial milestone payments of up to $200 million in cash for each of a specified number of products, which have the potential to total, in the aggregate, up to $1.1 billion. Ginkgo is also entitled to potential further downstream value in the form of royalties on sales.

Jason Kelly, CEO of Ginkgo, added, “Gene therapies utilize naturally occurring viral capsids that elicit immune responses and often exhibit safety and toxicity issues. We believe our collaboration with Selecta has the potential to confront major challenges within the gene therapy space and represents an important application of our cell programming platform. We look forward to executing on our shared vision and offering a potential solution for challenges in gene therapies that prevent treatment for millions of patients.”

Read the full press release here.

Improving the Manufacture of Biosynthetic Heparin with Optimvia

Posted on by James Waters

Optimvia will leverage Ginkgo’s cell and enzyme engineering platform as well as its fermentation process development expertise to improve the manufacture of biosynthetic heparin.

Heparin is a life-saving drug that prevents blood clots and is classified as an essential medicine by the World Health Organization. In addition to acting as an anticoagulant, it is important in treating a great number of medical issues, including adult respiratory distress syndrome, allergic rhinitis, asthma, and inflammatory bowel disease. Currently, however, it is isolated from animal sources, mostly pig or cattle, which are limited by livestock availability.

What if you could grow life-saving medicines on demand?

Optimvia is a biotechnology company specializing in engineering enzymes and their cofactors to synthesize complex therapeutic molecules. Ginkgo’s platform serves customers across industries seeking to develop new and better products using biotechnology, including partnerships to improve manufacturing processes and strengthen supply chains of key medicines. Producing non-animal derived heparin on Ginkgo’s platform is intended to be the proof of principle for Optimvia’s technology for the synthesis of sulfated glycans.

Enabling enzymatic manufacturing could create supply chain diversity and reduce or eliminate the need for high volume extraction of heparin from porcine intestines.

“The goal of producing biosynthetic heparin is similar to Genentech’s famous breakthrough of creating insulin through recombinant cell-based methods as opposed to relying on extraction from pig pancreas,” said Keith Kleeman, CEO, Optimvia. “We believe that combining Optimvia’s novel technology and Ginkgo’s capabilities will enable commercially viable, cost effective and safe biosynthetic heparin that could eliminate the world’s dependence on livestock sourced heparin entirely.”

Under this partnership, Optimvia seeks to leverage Ginkgo’s cell and enzyme engineering platform, as well as its fermentation process development expertise, to rapidly improve the performance of Optimvia’s biosynthetic heparin manufacturing technology.

“Ginkgo’s platform helps emerging startups develop and optimize their products and reach commercial scale,” said Ginkgo CEO Jason Kelly. “We’re pleased to welcome Optimvia as the newest member in our ecosystem. We believe scalable synthetic heparin could introduce much needed resiliency to the drug supply chain, improve access to this essential medicine, and reduce our dependence on industrial animal agriculture.”

Read the full press release here.

Investigational Synthetic Biotic Medicine for Homocystinuria with Synlogic

Posted on by Patrick Boyle

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

Posted on by Ankit Saxena

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

Posted on by Jennifer Wipf

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

Posted on by Jason Kakoyiannis

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.

Engineering Living Biotherapeutics for Gastrointestinal Health with Tantu

Posted on by Cecylia Ferrandon

Digestive disorders affect tens of millions of people in the U.S. each year, and current treatments don’t sufficiently promote gastrointestinal healing, resulting in many patients undergoing invasive surgeries to improve their quality of life.

But what if you could specifically design a living medicine—a microbe—that aids intestinal healing, transforming the way these patients are cared for?

That’s exactly what Tantu Therapeutics is trying to do. They’re working to create an orally administered, living biotherapeutic that will produce and apply anti-inflammatory therapeutic proteins directly into diseased sites in the gut. The living medicine aims to improve gut barrier function and faster mucosal healing in patients where systemic anti-inflammatory therapies are not enough.

And they’ve come to Ginkgo to help accelerate the research and development of this new therapeutic. We plan to apply our automated foundry to speed up the traditionally slow process of candidate strain construction and genomic integration and validation. Our goal is to accelerate Tantu’s first program and potentially help them reach clinical proof of concept in patients faster.

Tantu’s lead therapeutic candidate is an engineered microbe that produces anti-inflammatory and healing agents from inside the gut lumen—something that no clinically approved therapeutic currently does. Tantu’s local delivery strategy is designed to improve patient outcomes by reducing reliance solely on systemic anti-inflammatory drugs, which can suppress a patient’s immune system. Their living biotherapeutic products are being designed to complement proven approaches to further improve patients’ health and quality of life.

Through our platform, we’re able to support startups in the biotech industry as they bring new innovations to the field and society.

We’re excited to partner with a pre-seed company like Tantu; our goal is to reduce their time-to-market. Our program with Tantu gives us the opportunity to leverage our expertise in pharmaceuticals and support the development of a potentially transformative therapeutic for the millions struggling with digestive disorders.

Companies across numerous industries use Ginkgo’s cell programming platform to find more effective, environmentally friendly ways to create products including food ingredients, fragrances, cosmetics, medicines, and more. By enabling the design of organisms that can produce valuable biological products, we’re helping accelerate the development of innovative, bio-based solutions to the world’s most pressing challenges.

Accelerating Production of Essential Medicines with Antheia

Posted on by Ena Cratsenburg

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.

Manufacturing Breakthrough for mRNA Raw Materials with Aldevron

Posted on by Patrick Boyle

The global biotech community has come together during the pandemic to develop and deliver multiple effective and safe vaccines for COVID-19. However, more than two thirds of the global population has yet to be vaccinated – one way to reach the rest of the world is through enabling more scalable production of the raw materials needed to make vaccines. Today, I’m excited to announce our collaboration with Aldevron, a world leader in manufacturing mRNA vaccines and raw materials. We’ve been working with them since earlier this year to optimize the production of an important component often required to manufacture mRNA vaccines and therapies: the vaccinia capping enzyme (VCE).

Through our collaboration, Aldevron is now able to produce over 10 times more VCE per batch than the previous process, a significant manufacturing breakthrough for this critical component.

Aldevron, who has a successful history manufacturing high-quality components for genetic medicines, has the exclusive rights to the protocol conditions for this newly developed manufacturing process.

When placed in our bodies, mRNA vaccines use ribosomes—the cellular machinery that reads and translates mRNA into useful proteins—to produce a viral antigen. Human mRNA is “capped,” meaning the beginning of the mRNA sequence is modified with a 7-methylguanylate molecule. This specific cap structure needs to be added to mRNA vaccines and therapeutics to ensure the mRNA is recognized by our ribosomes and prevent premature degradation of the mRNA. VCE is a common tool for adding this specific cap structure to mRNA in vaccine manufacturing. However, it’s typically expensive and difficult to produce in mass quantities. In partnership with Ginkgo, Aldevron is working to ensure that there are sufficient quantities of VCE to meet rising vaccine demands.

This manufacturing improvement is an exciting milestone for Ginkgo as we continue to expand the capabilities of our cell programming platform to enable customers in the pharmaceutical ecosystem to improve their products and manufacturing processes. Aldevron has been a great partner with us on improving VCE, which we believe is a key ingredient to scaling mRNA production globally. This breakthrough represents a momentous growth opportunity for them as they continue to bolster their expansive portfolio of products.

Tom Foti, President of Aldevron’s Protein Business Unit, shared his excitement: “I’m very excited about combining the additive strengths of Ginkgo Bioworks’ development expertise and Aldevron’s manufacturing horsepower to yield an optimized manufacturing method for vaccinia capping enzyme. Historically, this enzyme has been difficult to produce, and we believe this yield breakthrough will accelerate mRNA therapeutic and vaccine development for manufacturing teams around the world.”