• Ginkgo, under a grant from the Bill & Melinda Gates Foundation, 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
• Ginkgo will apply its cell engineering expertise towards creating a fundamentally new cell-based therapeutic delivery modality which could change the future of biologics delivery in medicine

BOSTON, Dec. 13, 2023 /PRNewswire/ -- – Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, has received a grant from the Bill & Melinda Gates Foundation to develop a novel cell-based technology for improving protein therapeutics delivery for patients in low- and middle-income countries (LMICs).

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 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.

Ginkgo 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. Ginkgo will use its expertise in genomics and systems biology to predict the genomic components underlying these complex cellular phenotypes. Ginkgo will then utilize its 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," said Jennifer Wipf, Ginkgo's Head of Commercial, Cell Engineering. "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/.

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.

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 the partnership and 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.

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