Category: Therapeutics & Vaccines

 

We’re thrilled to have been awarded a 5-year contract alongside SaponiQx, Inc., totaling up to $31 million including program options, to discover and develop next-generation vaccine adjuvants.

This award comes to us from the Defense Threat Reduction Agency’s (DTRA) Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense (CBD) Program, through the Medical CBRN [Chemical, Biological, Radiological, and Nuclear] Defense Consortium (MCDC) requirement 22-05, “Adjuvant Activity to Vaccines Prototype.”

We’ve been partners with SaponiQx in adjuvant discovery and development since 2021, and we’re honored to work with them on this project. Together, we will use a combination of high-throughput empirical and artificial intelligence/machine learning approaches, including Generative Molecular Design (GMD), to develop superior novel saponin-based adjuvants.

Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination. Currently, only a handful of adjuvants are available for human use in licensed vaccines. SaponiQx’s STIMULON™ QS-21 is a key adjuvant component in market-leading vaccines for shingles, malaria, and respiratory syncytial virus. Novel adjuvants with enhanced properties, including tailored humoral and cellular immune responses, could pave the way for a new wave of innovative vaccines against existing and emerging pathogens.

The COVID-19 pandemic revealed the critical need for safe, effective, and accessible vaccines against emerging biothreat agents.

Imagine a future where vaccines are not only more affordable but also provide consistent protection in fewer doses, without causing discomfort or requiring refrigeration. We’re very excited by this opportunity to strengthen and expand the SaponiQx–Ginkgo partnership and to work with DTRA to make that future a reality.

Building on our achievements with STIMULON QS-21, SaponiQx is excited to realize our company’s founding vision of harnessing the potential of Generative Molecular Design to dramatically increase access to lifesaving vaccines around the world.

Rebecca Kurnat, Head of Operations at SaponiQx

We aim to demonstrate in the laboratory and in animal studies the ability of these novel adjuvants to protect against challenges from biothreat agents, such as the plague, and to provide lower cost, sustainable and scalable manufacturing processes by leveraging Ginkgo’s leading platform for cell programming. Together, we intend to design candidate adjuvants using SaponiQx’s leading platform for adjuvant generation, and to identify additional candidates by screening natural extracts for previously uncharacterized saponins and creating non-natural saponins with enzyme-based techniques. Harnessing a first-of-its-kind “data lake” for adjuvants, we plan to use iterative GMD to propose and optimize adjuvant structures against eight functional parameters. Adjuvant candidates will be put through in-depth testing, first in the laboratory for immune and toxicity responses, and then in studies of their effectiveness in protecting vaccinated animals from pathogens; QS-21 and the related QS-7 will serve as benchmarks.

By leveraging our leading platform for cell programming, we also intend to develop more affordable, sustainable, and scalable adjuvant manufacturing processes.

Ginkgo will develop a first-generation Adjuvant Development Candidate (ADC) production method, using a heterologous production strain such as brewers’ yeast, Saccharomyces cerevisiae. Our platform powers iterative Design–Build–Test–Learn-driven cell engineering to enable the rapid prototyping, optimization, and development of proteins, enzymes, metabolic pathways, and whole organisms under commercial-scale manufacturing conditions. Development of a first-generation ADC production method could facilitate further development of a sustainable mass-production manufacturing process for these complex adjuvants.

Today we’re thrilled to provide updates on our business at the J.P. Morgan Healthcare Conference in San Francisco, live and on webcast at 9:45am PT/12:45pm ET.

In short, we:

• Expect to meet our 2023 new program and revenue guidance ranges
• Ended 2023 with nearly $950 million in cash and cash equivalents, a strong balance sheet providing multi-year runway as we see operational efficiencies in our business
• See strong growth among blue chip pharma and biotech (“biopharma”) customers including Pfizer, Novo Nordisk, Merck and Boehringer Ingelheim
• Will highlight more updates today at the 42nd Annual J.P. Morgan Healthcare Conference at 9:45 a.m. PT (12:45 p.m. ET) here.

I’m very pleased with the robust revenue and program growth we have seen in 2023, particularly in the biopharma sector – growing the portion of our cell engineering revenue that is attributable to biopharma customers by more than 50% over the past year.

Our strong balance sheet, with nearly $950 million of cash and cash equivalents, positions us well to take advantage of strategic opportunities while the market faces continued pressure. This, combined with the meaningful improvements we have seen in operational efficiency, gives us a long runway as we plan to increase new programs while reducing operating expenses. I’m proud of our team’s accomplishments in 2023 and am excited to drive continued strong growth in our biopharma vertical in 2024.

Preliminary 2023 Key Performance Highlights

• Ginkgo continues to expect Total revenue of $250 – $260 million in 2023
  • Preliminary unaudited Cell Engineering revenue is expected to be within the previously disclosed guidance range of $145 – $150 million in 2023
  • Preliminary unaudited Biosecurity revenue is expected to be in line with the previously disclosed guidance of up to $110 million in 2023
• New Cell Programs are expected to be within the previously disclosed guidance range of 80-85 new Cell Programs added to the platform in 2023
• Ginkgo signed or advanced several major new biopharma programs in 2023, including with Pfizer, Merck, Novo Nordisk, and Boehringer Ingelheim in which Ginkgo is eligible to receive, in aggregate, over $1.2 billion in upfront research payments, research fees and development and commercial milestones. Ginkgo also successfully completed the pilot phase of a program with Novo Nordisk, as well as completed a gene therapy collaboration with Biogen.
• In connection with its strategic partnership with Google Cloud, Ginkgo is training a series of foundation and application-specific models incorporating Ginkgo’s proprietary metagenomics and assay-labeled training data as well as data from public repositories. Ginkgo’s ability to bring together automated data generation at scale with AI models targeted towards customer program areas is expected to be the foundation for additional pharmaceutical partnerships in 2024.
• Ginkgo ended 2023 with nearly $950 million of cash and cash equivalents, putting Ginkgo in a strong financial position to pursue its strategic objectives while driving towards profitability

We plan to report fourth quarter and full year 2023 financial results in February 2024, at which time we intend to provide our outlook for full year 2024.

To learn more about Ginkgo’s biopharmaceutical services offerings, visit https://www.ginkgobioworks.com/offerings/biopharmaceutical/.

What will you grow with Ginkgo?

Today we’re thrilled to announce the formation of our new Biopharma Advisory Board!

This council of experts from across the biopharmaceutical industry will provide critical insight into the development of Ginkgo’s core platform service offerings across target discovery, drug discovery, optimization, and manufacturing. The group, which will conduct regular meetings at Ginkgo and with its partners, includes (in alphabetical order) —

• Norbert Bischofberger, PhD, is the President and Chief Executive Officer of Kronos Bio, a clinical-stage biopharmaceutical company developing medicines that target the deregulated transcription that is the hallmark of cancer and other serious diseases. Prior to Kronos, Dr. Bischofberger spent 28 years at Gilead, where he presided over the development and approval of more than 25 medicines for a range of serious conditions, including the transformation in the treatment of diseases such as HIV and viral hepatitis. Notably, he is one of the inventors of Tamiflu, an oral medication on the market for both the prevention and treatment of influenza A and B. Norbert was part of the core management team that grew Gilead from less than 50 employees with no revenues to 10,000 employees with $25B in revenue.
• Jeff Legos, PhD, MBA, is currently an Executive Vice President and Global Head of Oncology and Hematology at Novartis, where he leads development, registration, approval, and life cycle management for a clinical pipeline of 35+ assets across a broad range of cancers and blood disorders. Dr. Legos has a proven track record of successfully leading large multinational teams across all functions and stages of R&D in both his current and previous role as Vice President and Global Medicine Development Leader at GlaxoSmithKline, which has resulted in more than 30 global regulatory drug and companion diagnostic approvals.
• John Maraganore, PhD, served as the founding Chief Executive Officer and a Director of Alnylam from 2002 to 2021. Under his leadership, Alnylam helped lead the interventional RNA revolution by launching the first RNAi therapeutic medicine, ONPATTRO®, in 2018, followed by four more RNAi therapeutics through mid-2022. Dr. Maraganore was the chair of the Biotechnology Innovation Organization (BIO) from 2017 to 2019 and is an active mentor to leaders across the biotechnology industry. John is the principal of JMM Innovation, and also serves as a Venture Partner for Arch Ventures and Atlas Ventures, an executive partner for RTW Investments, a senior advisor for Blackstone Life Sciences, and as an advisor for M28.
• Paolo Martini, PhD, is the Chief Scientific Officer of International Therapeutic Research Centers and the Founder of Rare Diseases at Moderna, where he previously worked on messenger RNA therapy for rare and orphan diseases. He has more than 20 years of experience in drug discovery working on molecular mechanisms underlying monogenic and multigenic metabolic and fibrotic disorders as well as hematologic malignancies.
• Mark McCamish, MD, PhD, is the President & Chief Executive Officer of IconOVir Bio, a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus therapy to improve the treatment of patients with cancer. He was previously the President & Chief Executive Officer of Forty Seven, which he led from a valuation of $169M to an acquisition by Gilead for $4.9B. Previously he has had extensive experience at multiple companies including Abbott, Amgen, and Novartis/Sandoz and is a renowned expert in biologic and biosimilars development and manufacturing.
• Christi Shaw is an Independent Director on the Boards of Beam Therapeutics, ReAlta Life Sciences, and Avantor. She previously served as Chief Executive Officer of Kite Pharma and as Senior Vice President at Eli Lilly & Company, where she was President of Lilly Bio-Medicines. Ms. Shaw has also held prominent leadership roles at Johnson & Johnson and Novartis where she served as US Country Head and President. Christi co-founded the More Moments More Memories Foundation which provides financial assistance to help cancer patients access potentially life saving clinical trials.

Together, this council represents a wide breadth of technical experience and deep business expertise that will contribute to the development of Ginkgo’s service offerings in Gene Therapy, Cell Therapy, RNA, Biologics, Process R&D and more.

Over the past year, we announced new R&D services collaborations with Boehringer Ingelheim, DARPA, Esperovax, Merck, Pfizer, Prokarium, Sensible, Synplogen, WARF, as well as advancements in its work with Novo Nordisk, Persephone Biosciences, and Synlogic. Ginkgo acquires and integrates new technologies to expand its horizontal platform, with past acquisitions serving to develop our capabilities in AAV and circular RNA.

The discovery and development of new medicines is critically important and incredibly challenging. Advanced technologies in high throughput automation, synthetic biology, and more recently AI, have opened up possibilities for the development of novel modalities and exploration of more design space for the discovery and optimization of new targets and candidate therapies.

It’s an incredibly exciting time for the industry as these technologies come together at scale, and we’re thrilled to have this group of luminaries as part of our inaugural cohort of advisors.

“I’m excited to welcome this incredible deep bench of wisdom and creativity to the Ginkgo family,” said Jennifer Wipf, SVP & Head of Commercial at Ginkgo Bioworks. “These leaders have shaped the modern vaccines and therapeutics landscapes by spearheading the discovery, testing, manufacturing, and deployment of entirely new modalities, and reinventing how researchers and drugmakers work with more familiar areas of medicine. I can’t wait to see how their mentorship, insights, and provocations help our growing team reach new heights.”

“We live in a global, interconnected society, and therefore, we are all susceptible to the spread of novel infectious diseases. Now more than ever, the speed of drug discovery and development is important,” said Norbert Bischofberger, Ginkgo Biopharma Advisory Board member. “Ginkgo’s experience in accelerating biological R&D across modalities and their extensive work in biosecurity and epidemiology positions the company to make a meaningful impact. I look forward to supporting the growth of their team and offerings.”

“Ginkgo represents a huge opportunity for businesses who want to take new pharmaceuticals to market. By outsourcing risky R&D to a partner with unprecedented scale, companies can optimize their approach to new modalities and targets wherever they are in the pipeline,” said John Maraganore, Ginkgo Biopharma Advisory Board member. “Our industry is at a pivotal moment. More and more of biopharma can leverage scale and AI to turn scientific uncertainty into predictable engineering, so I’m thrilled to be able to contribute to the energy and movement I saw firsthand when I spoke onstage with Jen at Ferment.”

To learn more about Ginkgo’s biopharmaceutical services offerings, visit https://www.ginkgobioworks.com/offerings/biopharmaceutical/.

What will you grow with Ginkgo?

Today we’re thrilled to announce the successful completion of our gene therapy collaboration previously announced with Biogen in May 2021!

Together, we aimed to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors. The collaboration achieved our goals of enhancing the AAV production titers of Biogen’s gene therapy manufacturing processes.

We’re proud to work with industry-defining partners like Biogen to help global leaders in the biopharmaceutical industry redefine what’s possible in therapeutics discovery and manufacturing.

Significant improvements like these are the result of a platform-based approach to biological R&D. They are possible because our program leads work closely with our collaboration partners to take full advantage of the broad scale and deep sophistication of our highly-automated foundry and growing codebase.

Learn more about Ginkgo’s Gene Therapy Services here.

What will you grow with Ginkgo?

We’re thrilled to receive a grant from the Bill & Melinda Gates Foundation!

Under this grant, we will work to develop a live cell therapeutic that can produce antibodies to fight human immunodeficiency virus (HIV) and/or malaria directly in the body.

Protein therapeutics have transformed the standard of care for many diseases — the best known example being insulin for diabetes — and have helped to extend lives across the world, thanks to revolutionizing treatments of diseases such as anemia, cancers, and certain genetic disorders. Yet access to these therapeutics remains a challenge, especially in low- and middle-income countries (LMICs), because of complex manufacturing processes and degradation during storage and delivery of such therapeutics. Developing a new therapeutic delivery modality for patients could increase accessibility and lower cost of treatment.

We will focus on creating a prototype engineered cell line that can express antibodies for the treatment of HIV and/or malaria via an implantable device.

Globally, approximately 39 million people live with HIV, which attacks the body’s immune system and weakens its ability to fight infection. The World Health Organization (WHO) reports that nearly half the world’s population is at risk of malaria transmission, with 96% of malaria-caused deaths in 2020 taking place in the WHO Africa Region. The engineered cell line would be designed to act as a “cell factory” capable of delivering protein therapeutics to the patient for up to a year, or longer. This prototype cell line could potentially lead to protein therapeutic delivery systems that function as long-term and cost-effective treatments for these diseases.

Ginkgo, with support from the foundation, plans to use its expertise in mammalian cell engineering to engineer highly synthetic cell lines that have both high productivity and extended longevity.

We will use our expertise in genomics and systems biology to predict the genomic components underlying these complex cellular phenotypes. We will then utilize our expertise in genome engineering, including a fully automated clonal cell line generation workflow, to combine these features in a mammalian chassis. This engineered cell line will be combined with an implant device for continuous delivery of the therapeutic antibodies. If successful, the eventual product could create a novel delivery platform for antibody-based therapies in communities where access to such drugs is challenging.

Protein-based drugs were some of the earliest applications of cell programming for medicine half a century ago. We’re honored to be receiving support from the Gates Foundation to reimagine how these medicines are made and delivered so that we can open up access to these critical therapies. We look forward to leveraging our learnings from this project to ensure the success of future programs with our partners.

Learn more about Ginkgo’s biopharmaceutical services at https://www.ginkgobioworks.com/offerings/biopharmaceutical/.

What will you grow with Ginkgo?

Today we are pleased to announce the completion of our first collaboration together with Persephone Biosciences — a Bacteroides engineering toolkit!

Under the collaboration, both Persephone and Ginkgo have access to this reusable toolkit. Persephone will utilize the technology to develop a pipeline of microbiome therapeutics, and Ginkgo can use the technology as part of our broader platform offering for future customers.

The technology comprises a set of generalizable genetic tools which can facilitate rapid Bacteroides engineering, including in the high-throughput anaerobic engineering context. Over the course of this collaboration, Ginkgo incorporated our flagship hardware and software workflows under an anaerobic blanket, meaningfully extending its cell engineering platform capabilities to perform productively in an anaerobic environment.

Ginkgo and Persephone announced in April 2022 that we would collaborate to develop novel microbiome products based on the bacterial genus Bacteroides, a promising vehicle for stable and long-term delivery of microbial products. Through this collaboration, a high-throughput anaerobic cell engineering platform has been developed. With it, Ginkgo designed and screened hundreds of promoters, shuttle vectors, ribosome binding sites, and terminators to characterize their efficiency and expression levels and selected parts across the expression range for the final toolkit.

While Persephone plans to utilize the Bacteroides technology for the rapid generation of therapeutics from its planned and ongoing oncology biomarker studies, Ginkgo may leverage the toolkit to address a wide range of customer needs and applications, including for customers developing microbiome based therapeutics.

At Ginkgo, we are growing our network of partners and striving to provide a platform to all the innovators that have a vision of using biology to solve the world’s most pressing problems.

Continuous improvement to our platform is key, and together with Persephone’s expertise in the microbiome and with bacterial strains, we’ve improved yet another valuable offering in a therapeutic area of interest to many of our partners.

“We’re delighted with the results of our collaboration with Ginkgo Bioworks. The resulting technology offers us previously unimaginable inhouse scale, that promises to save us valuable time as we seek to rapidly generate therapeutics from our oncology biomarker studies, including our ongoing ARGONAUT trial. This in turn could enable us to bring much-needed better health outcomes – across a range of cancer types – much sooner than would otherwise be possible.”

Stephanie Culler, co-founder and CEO of Persephone Biosciences

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

What will you grow with Ginkgo?