• Collaboration with University of Wisconsin Professors Krishanu Saha (PI) and Christian Captini (co-PI) to discover novel and improved GD2 CAR designs to treat solid tumors and validate them in vivo

MADISON, Wis. and BOSTON, April 13, 2023 /PRNewswire/ -- The Wisconsin Alumni Research Foundation (WARF), which has a mission of supporting research at the University of Wisconsin-Madison, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced a partnership to leverage Ginkgo's proprietary high-throughput combinatorial CAR discovery and screening platform with the aim of discovering next generation GD2 CAR T-cell therapies with improved persistence, proliferation, fitness, and other functional properties to improve efficacy for the treatment of solid tumors.

Through this partnership, Ginkgo will collaborate with the University of Wisconsin-Madison researchers Professor Krishanu Saha, Ph.D., as principal investigator (PI) and Dr. Christian Capitini, M.D. as co-PI. Professor Saha's lab focuses on developing the next-generation cell engineering techniques to advance human therapeutics, and Dr. Capitini is a pediatric oncologist who has extensive clinical experience with CAR T-cell therapies, including serving as a site PI for the clinical trial that led to the first FDA approval of a CAR T-cell therapy. The two have collaborated on the development of a GD2 CAR T-cell therapeutic candidate for the treatment of neuroblastoma, a type of cancer generally affecting young children, using a non-viral, site-specific integration method developed by Professor Saha and published in the Journal for the Immunotherapy of Cancer:Production and characterization of virus-free, CRISPR-CAR T cells capable of inducing solid tumor regression.

Under this collaboration, Ginkgo will use its pooled CAR screening platform to design and characterize novel intracellular signaling domains that prevent the exhaustion of T-cells in the GD2 solid tumor context. Any novel designs will be validated in high throughput in vitro screens and in in vivo murine models. In addition, Ginkgo and WARF plan to collaborate on the development of a pooled in vivo screening platform to advance novel CAR discovery further.

"Ginkgo's high throughput screening method has proven successful inenabling massively parallel testing of CAR designs, and has already led to the discovery of new intracellular domains (ICD) combinations," said Krishanu Saha, a professor at the University of Wisconsin-Madison. "By partnering with Ginkgo, we aim to unlock the potential to transform patient outcomes and reimagine the future of solid tumor cancer treatment."

CAR T-cell therapies show tremendous promise for the treatment of cancer. However, their use has thus far largely been limited to targeting blood cancers because they have failed to show consistent efficacy in treating solid tumors, which represent approximately 90% of adult human cancers. Part of the challenge when applying CAR T-cell therapies to solid tumors is T-cell exhaustion, a state of dysfunction arising from excessive antigen stimulation in the immunosuppressive environment of a solid tumor.

WARF and Ginkgo hope to work towards solving this challenge by utilizing Ginkgo's high-throughput combinatorial CAR discovery platform. As a platform technology company, Ginkgo can leverage its full stack of mammalian cell engineering expertise and capabilities to enable the high throughput screening of CAR T-cells to help discover and optimize future next-generation therapeutic candidates for its partners.

"WARF is delighted to see this important collaboration," says Erik Iverson, WARF CEO. "We know these alliances between our university researchers and leading biotech industry partners have the potential to result in benefits that positively impact human health."

"This collaboration represents a fantastic opportunity to demonstrate the potential value of pooled CAR screening approaches directly in the context of devastating diseases like early childhood cancers," said Narendra Maheshri, Head of Mammalian Engineering at Ginkgo. "It's especially exciting to work with pioneers like Professors Saha and Capitini, who have pushed R&D boundaries in the laboratory and whose approach is thoroughly grounded in the translation of their findings for clinical impact."

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.

About WARF

The Wisconsin Alumni Research Foundation (WARF) helps steward the cycle of research, discovery, commercialization and investment for the University of Wisconsin-Madison and provides annual support to the university to advance research and innovation. Founded in 1925 as an independent, nonprofit foundation, WARF manages more than 2,000 patents and an investment portfolio as it funds university research, obtains patents for campus discoveries and licenses inventions to industry. For more information, visit warf.org and view WARF's Cycle of Innovation.

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 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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