Ginkgo Bioworks Strengthens End-to-End R&D Capabilities in Gene Therapy through Acquisition of StrideBio's AAV Capsid Discovery and Engineering Platform Assets

Platform includes large library of existing capsids, which have been optimized for performance and targeting across a range of application areas through validation in large animal models

The addition of StrideBio's structure-guided AAV engineering capabilities combined with Ginkgo's already extensive assets make Ginkgo a unique one-stop shop capable of providing R&D services for gene therapy manufacturing across capsid, payload, and cell line optimization

As part of the transaction, Ginkgo also receives IP and data for StrideBio's lead preclinical asset for Arrhythmogenic Right Ventricular Cardiomyopathy, a rare genetic heart disease, which Ginkgo plans to sell or outlicense to a commercial partner

BOSTON, April 5, 2023 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced the acquisition of StrideBio's adeno-associated virus (AAV) capsid discovery and engineering platform assets with a secondary close scheduled upon the transfer of certain additional in-license agreements to Ginkgo. Ginkgo will incorporate these capabilities and IP into its end-to-end AAV gene therapy development platform, allowing Ginkgo's customers to leverage new tools to effectively target many different tissue types, and potentially to improve the safety profile of their future gene therapies. Ginkgo is also receiving StrideBio's existing library of capsids, which includes advanced candidates extensively tested in large animal models, and which are now available for licensing and broader partnership. Additionally, Ginkgo receives the IP and data for StrideBio's lead preclinical asset for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), a rare genetic heart disease, which Ginkgo plans to sell or outlicense to a commercial partner.  The acquisition is focused on the enabling platform IP of StrideBio and does not include any real estate.  One employee of StrideBio will transfer to Ginkgo as part of the transaction, joining Ginkgo's mammalian engineering team.

AAV remains the preferred viral vector for gene therapy, used in hundreds of active clinical trials. However, pharmaceutical developers focusing on AAV still face challenges pertaining to limitations in targeted biodistribution, pre-existing immunogenicity and manufacturability. StrideBio's STRIVE platform –which uses a structural-engineering approach for generating novel AAV capsids to address these limitations – has produced a library of candidates that includes mature assets with strong evidence demonstrated for both performance and targeting across multiple animal models.

StrideBio's platform generates capsids that are designed to overcome current limitations of first-generation gene therapies, including reduced seroprevalence, improved tropism for cell types beyond the liver such as those in the central nervous system and muscle tissue, and increased gene transfer efficiency, with the potential for improved safety and reduced doses in the clinic.

"The StrideBio team has built a deep pipeline of AAV capsids and libraries to address critical challenges facing clinical gene therapy with a focus on reducing vector dose and improving safety by limiting off-target biodistribution," said Aravind Asokan, Ph.D, who co-founded StrideBio with Pat Ritschel and the late Mavis Agbandje-McKenna. "With Ginkgo's expertise and scale, we hope to amplify this effort and deploy this platform to the gene therapy industry and ultimately, patients."

"Combining Ginkgo's engineering and discovery capabilities in enzymes, regulatory elements, and capsids enables a holistic approach to designing an AAV gene therapy, so that we can support our partners across the entire process of designing the viral vector," said Narendra Maheshri, Head of Mammalian Engineering at Ginkgo. "We are thrilled to integrate the STRIVE platform and know-how into our foundry to augment our capabilities in capsid engineering, and we look forward to continuing to expand our existing end-to-end capabilities in AAV discovery and manufacturing."

Ginkgo has significantly expanded its work and capabilities in gene therapy in recent years by acquiring Circularis' proprietary circular RNA and promoter screening platform, partnering with Biogen to improve AAV manufacturing, and partnering with Selecta Biosciences to develop AAV capsids with altered tropism and immunogenicity. Ginkgo has developed several capabilities which enhance its ability to leverage assets like those in this acquisition, including its ability to efficiently and quickly generate a massive set of candidates for testing, its scaled approach to protein engineering, and its ability to apply sequencing and computational pipelines to accelerate the analysis of capsid effectiveness in tissues of interest. To discuss how you can benefit from Ginkgo's biopharma and life science R&D capabilities, sign up for Ginkgo Office Hours to speak with our team today.

Foley Hoag LLP is providing legal counsel to Ginkgo, while Ropes & Gray LLP is serving as legal advisor to StrideBio.

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 Twitter (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks and @ConcentricByGinkgo), 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 acquisition 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 unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (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 annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (the "SEC") on March 13, 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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SOURCE Ginkgo Bioworks