Ginkgo Bioworks and SaponiQx Awarded MCDC Contract to Discover and Manufacture Next-Generation Vaccine Adjuvants Using Generative Molecular Design

Rhea-AI Summary

Ginkgo Bioworks and SaponiQx, Inc. have been awarded a 5-year, $31 million contract by DTRA's JSTO for the CBD Program to develop next-generation vaccine adjuvants. The partnership aims to discover novel saponin-based adjuvants using high-throughput empirical and AI/machine learning approaches, potentially leading to innovative vaccines against biothreat agents.

Insights

Biotechnology Analyst

The recent contract awarded to Ginkgo Bioworks and SaponiQx by the DTRA signifies a strategic investment in the field of immunology and vaccine development. The focus on discovering and developing novel saponin-based adjuvants is particularly noteworthy, as adjuvants are crucial for enhancing the efficacy of vaccines by stimulating a stronger immune response. This development could have a significant impact on the biotech industry, potentially leading to the creation of more effective vaccines against a range of pathogens.

From a biotechnological perspective, the use of high-throughput empirical methods alongside artificial intelligence and machine learning, including Generative Molecular Design (GMD), represents an innovative approach to adjuvant development. This technology-driven methodology could accelerate the discovery process and lead to more targeted adjuvant profiles, tailored to specific immune responses. The success of this partnership could set a precedent for future collaborations in the sector, potentially leading to a surge in demand for similar technological platforms.

Healthcare Economist

The contract's potential to drive down vaccine costs while enhancing their efficacy and storage requirements addresses key economic challenges in global healthcare. Affordable vaccines that are effective in fewer doses and without the need for refrigeration could revolutionize vaccine distribution, particularly in low-income regions where such logistical hurdles are significant barriers to immunization programs. This could lead to broader immunization coverage and a reduction in the economic burden of infectious diseases.

Moreover, the development of scalable manufacturing processes for these adjuvants, as mentioned by Ginkgo Bioworks, could lead to a more efficient vaccine production ecosystem. The use of brewers' yeast, Saccharomyces cerevisiae, for heterologous production of the Adjuvant Development Candidate (ADC) is a cost-effective strategy that could have far-reaching economic implications, potentially disrupting the current vaccine production paradigm.

Pharmaceutical Manufacturing Expert

The announcement highlights a shift towards sustainable manufacturing processes within the pharmaceutical industry. Ginkgo's cell programming platform's emphasis on a Design–Build–Test–Learn approach is indicative of the industry's move towards more agile and adaptable production methods. The heterologous production strain method using brewers' yeast could be a game-changer for adjuvant mass-production, offering a sustainable and scalable alternative to traditional manufacturing processes. This could lead to a significant reduction in production costs and environmental impact, aligning with the broader industry trend towards green manufacturing practices.

The iterative GMD process for optimizing adjuvant structures against functional parameters is an advanced technique that could lead to breakthroughs in the production of complex biological molecules. If successful, this approach could be adopted by other pharmaceutical companies, potentially leading to a more diverse and robust market for vaccine adjuvants and other biological compounds.

BOSTON and LEXINGTON, Mass., Feb. 15, 2024 /PRNewswire/ -- The Defense Threat Reduction Agency's (DTRA) Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense (CBD) Program has awarded, through the Medical CBRN [Chemical, Biological, Radiological, and Nuclear] Defense Consortium (MCDC) requirement 22-05, "Adjuvant Activity to Vaccines Prototype," a 5-year contract totaling up to $31 million including program options to the team of Ginkgo Bioworks, Inc. (NYSE: DNA) and SaponiQx, Inc. (a subsidiary of Agenus Inc., NASDAQ:AGEN) to discover and develop next-generation vaccine adjuvants. Partners in adjuvant discovery and development since 2021, Ginkgo, which is building the leading platform for cell programming and biosecurity, and SaponiQx, developing a visionary adjuvant development platform, 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," said Jennifer Wipf, SVP, Head of Commercial Cell Engineering at Ginkgo Bioworks. "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," said Rebecca Kurnat, Head of Operations at SaponiQx.

The partners 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. The partners 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, they 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 Ginkgo's leading platform for cell programming, the partners 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. Ginkgo's 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.

About Ginkgo Bioworks

Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and concentricbyginkgo.com, read our blog, or follow us on social media channels such as X (formerly known as Twitter) (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks and @ConcentricByGinkgo), Threads (@GinkgoBioworks) or LinkedIn.

About SaponiQx

Founded in 2021, SaponiQx, a subsidiary of Agenus Inc., stands at the forefront of saponin-based adjuvant discovery and manufacturing. Its mission is to provide scalable and affordable vaccine adjuvants to enhance global health. Its proprietary adjuvant, STIMULON QS-21, forms an integral part of the AS01 adjuvant used in several leading vaccines. STIMULON is a trademark of Agenus Inc., the parent company of SaponiQx Inc.

Forward-Looking Statements of Ginkgo Bioworks

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the uncertainty regarding the demand for passive monitoring programs and biosecurity services, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) our ability to realize the expected benefits of merger and acquisition transactions, (vii) the outcome of any legal proceedings against Ginkgo, including as a result of recent acquisitions, (viii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (ix) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (x) the product development or commercialization success of our customers. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on November 8, 2023 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

GINKGO BIOWORKS INVESTOR CONTACT:

investors@ginkgobioworks.com 

GINKGO BIOWORKS MEDIA CONTACT:

press@ginkgobioworks.com 

Forward-Looking Statements of SaponiQx

This press release includes forward-looking statements, subject to risks and uncertainties, concerning the development of vaccines and adjuvants. Refer to the Risk Factors in Agenus' latest Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the SEC for a detailed discussion of these risks.

SAPONIQX MEDIA CONTACT:

communications@saponiqx.com

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SOURCE Ginkgo Bioworks

FAQ

What is the contract awarded to Ginkgo Bioworks and SaponiQx by DTRA's JSTO for the CBD Program?

The contract is for the development of next-generation vaccine adjuvants and totals up to $31 million over 5 years.

What are adjuvants in vaccines?

Adjuvants are components in vaccines that help enhance the immune response to vaccination by increasing its magnitude, breadth, and duration.

What is the key adjuvant component developed by SaponiQx?

SaponiQx's STIMULON™ QS-21 is a key adjuvant component in market-leading vaccines for shingles, malaria, and respiratory syncytial virus.

How do Ginkgo Bioworks and SaponiQx plan to develop novel adjuvants?

The partners plan to use a combination of high-throughput empirical and AI/machine learning approaches, including Generative Molecular Design (GMD), to develop superior novel saponin-based adjuvants.

What is the goal of developing novel adjuvants against biothreat agents?

The goal is to protect against challenges from biothreat agents like the plague and to provide lower cost, sustainable, and scalable manufacturing processes for vaccines.