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Ginkgo Bioworks in Partnership with STRM.BIO and University of British Columbia in Project to Develop In Vivo CAR Therapies Under ARPA-H's EMBODY Program

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Ginkgo Bioworks (NYSE: DNA) announced a collaboration with STRM.BIO and the University of British Columbia under ARPA-H's EMBODY program to develop in vivo CAR therapies for autoimmune diseases on Oct 23, 2025.

The project, INVITE-ME, will combine STRM.BIO's megakaryocyte-derived extracellular vesicle delivery platform with Ginkgo's RNA construct design, nucleic acid AI, and immune cell engineering to pursue long-lived, tissue-specific CAR expression that could selectively eliminate autoreactive B and T cells without ex vivo manipulation.

Ginkgo Bioworks (NYSE: DNA) ha annunciato una collaborazione con STRM.BIO e con l'Università della Colabria Britannica nell'ambito del programma EMBODY di ARPA-H per sviluppare terapie CAR in vivo per malattie autoimmuni il 23 ottobre 2025.

Il progetto, INVITE-ME, combinerà la piattaforma di consegna basata su vescicole extracellulari derivate da megacariociti di STRM.BIO con la progettazione di costrutti RNA di Ginkgo, l'IA degli acidi nucleici e l'ingegneria delle cellule immunitarie per perseguire un'espressione CAR a lunga durata e tessuto-specifica che potrebbe eliminare selettivamente le cellule B e T autoreattive senza manipolazione ex vivo.

Ginkgo Bioworks (NYSE: DNA) anunció una colaboración con STRM.BIO y la Universidad de Columbia Británica bajo el programa EMBODY de ARPA-H para desarrollar terapias CAR in vivo para enfermedades autoinmunes el 23 de octubre de 2025.

El proyecto, INVITE-ME, combinará la plataforma de entrega de vesículas extracelulares derivadas de megacariocitos de STRM.BIO con el diseño de constructos de ARN de Ginkgo, la IA de ácidos nucleicos y la ingeniería de células inmunitarias para perseguir una expresión CAR de larga duración y específica de tejido que podría eliminar selectivamente a las células B y T autoreactivas sin manipulación ex vivo.

Ginkgo Bioworks (NYSE: DNA)STRM.BIO브리티시 컬럼비아 대학교와 ARPA-H의 EMBODY 프로그램 아래 자가면역 질환을 위한 in vivo CAR 치료를 개발하기 위한 협력을 2025년 10월 23일 발표했습니다.

프로젝트 INVITE-ME은 STRM.BIO의 거대핵구세포유래 외세포 소포 전달 플랫폼과 Ginkgo의 RNA 구성 설계, 핵산 AI, 면역세포 공학을 결합하여 조직 특이적이고 장기 지속되는 CAR 발현을 추구하고, ex vivo 조작 없이 자가반응성 B 및 T 세포를 선택적으로 제거할 수 있을지 모색합니다.

Ginkgo Bioworks (NYSE: DNA) a annoncé une collaboration avec STRM.BIO et l'Université de la Colombie-Britannique dans le cadre du programme EMBODY d'ARPA-H pour développer des thérapies CAR in vivo pour les maladies auto-immunes le 23 octobre 2025.

Le projet INVITE-ME combinera la plateforme de délivrance de vésicules extracellulaires dérivées des mégacaryocytes de STRM.BIO avec la conception de constructs d'ARN de Ginkgo, l'IA des acides nucléiques et l'ingénierie des cellules immunitaires afin de poursuivre une expression CAR à longue durée et spécifique au tissu qui pourrait éliminer sélectivement les cellules B et T autoreactives sans manipulation ex vivo.

Ginkgo Bioworks (NYSE: DNA) kündigte am 23. Oktober 2025 eine Zusammenarbeit mit STRM.BIO und der University of British Columbia im Rahmen des EMBODY-Programms von ARPA-H an, um in vivo CAR-Therapien gegen Autoimmunerkrankungen zu entwickeln.

Das Projekt INVITE-ME wird STRM.BIOs Plattform zur Lieferung von extrazellulären Vesikeln, die aus Megakaryozyten stammen, mit dem RNA-Konstrukt-Design von Ginkgo, der Nukleinsäure-KI und der Immunzell-Engineering kombinieren, um eine langwirksame, gewebespezifische CAR-Expression zu verfolgen, die autoreaktive B- und T-Zellen selektiv ohne ex vivo Manipulation eliminieren könnte.

Ginkgo Bioworks (NYSE: DNA) أعلنت عن تعاون مع STRM.BIO و جامعة كولومبيا البريطانية ضمن برنامج EMBODY من ARPA-H لتطوير علاجات CAR في الجسم للأمراض المناعية الذاتية في 23 أكتوبر 2025.

المشروع INVITE-ME سيجمع منصة توصيل حويصلات خارج الخلية مشتقة من الخلايا الماجوكارية المكوّنة للصفائح الدموية مع تصميم بنى RNA، والذكاء الاصطناعي للأحماض النووية، وهندسة الخلايا المناعية لاستهداف تعبير CAR طويل الأمد ومحدد بنسيج معين قد يزيل الخلايا B و T ذات الاستجابة الذاتية بشكل انتقائي دون معالجة خارج الجسم.

Ginkgo Bioworks (NYSE: DNA)宣布与 STRM.BIO 以及 不列颠哥伦比亚大学 在 ARPA-H 的 EMBODY 计划下合作,开发用于自身免疫病的体内CAR治疗,时间为 2025 年 10 月 23 日。

该项目 INVITE-ME 将把 STRM.BIO 的巨核细胞来源的细胞外囊泡递送平台与 Ginkgo 的 RNA 构建设计、核酸 AI 以及免疫细胞工程相结合,追求长期存在且组织特异的 CAR 表达,从而有望在不进行体外操作的情况下选择性清除自身反应性 B 细胞和 T 细胞。

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Ginkgo joins ARPA-H-backed partnership to develop in vivo CAR therapies using STRM.BIO's MV delivery and RNA design.

Combining Ginkgo Bioworks RNA construct design with STRM.BIO megakaryocyte-derived extracellular vesicles and University of British Columbia self-amplifying RNA expertise creates a clear technical pathway to attempt in situ CAR engineering of bone marrow-resident cells. The program, funded under ARPA-H's EMBODY initiative and announced on Oct. 23, 2025, targets autoimmune indications such as SLE and MG and explicitly aims to avoid ex vivo cell manufacturing and genome editing.

Key dependencies and risks include demonstrated delivery efficiency of the MV platform to relevant T/B progenitors in humans, the durability and tissue-specificity of the self-amplifying RNA constructs, and safety around selective depletion of autoreactive lymphocytes without broad immunosuppression. The announcement contains no clinical or preclinical outcome data, so technical and regulatory execution remain open questions.

Watch for concrete milestones such as preclinical proof-of-concept, reported delivery biodistribution, safety readouts, and any ARPA-H milestone dates or funding notices over the next 12–36 months. Near-term indicators will be published data on MV-mediated cargo delivery and construct expression lifetime; those will materially affect program de‑risking.

Ginkgo Bioworks to apply its RNA construct design expertise to develop long-lived, tissue-
specific, and highly potent
in vivo CAR therapies for autoimmune diseases

BOSTON, Oct. 23, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced a collaboration with STRM.BIO and the University of British Columbia (UBC) as part of the Advanced Research Projects Agency for Health's (ARPA-H) Engineering of Immune Cell Inside the Body (EMBODY) program. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D. The partnership aims to develop in vivo chimeric antigen receptor (CAR) therapies for autoimmune diseases, leveraging Ginkgo's expertise in RNA construct design and immune cell engineering.

Autoimmune diseases, such as systemic lupus erythematosus (SLE) and myasthenia gravis (MG), affect millions of people worldwide and pose significant public health challenges. These conditions are characterized by the immune system mistakenly attacking the body's own cells, leading to chronic inflammation and tissue damage. Current treatments often involve systemic immunosuppression, which can result in increased risks of infection and other side effects due to broad immune suppression.

The project, titled "IN VIvo T-cell Engineering with Megakaryocyte EVs" (INVITE-ME), focuses on developing in vivo CAR-T therapies for autoimmune diseases by combining STRM.BIO's proprietary megakaryocyte-derived extracellular vesicle (MV) delivery system with Ginkgo's RNA construct design expertise. The MV platform delivers complex genetic cargo directly to bone marrow-resident cells, enabling in situ engineering of T cells without the need for costly and lengthy ex vivo manipulation. This approach aims to create transformative therapies that could eliminate autoreactive immune cells, potentially offering durable treatments for diseases like SLE and MG.

"This is an exciting opportunity to partner with ARPA-H, STRM.BIO, and UBC on an important effort in a unique public-private partnership structure," said Jesse Dill, Government BD Lead at Ginkgo Bioworks. "Our team is thrilled to extend and apply Ginkgo's RNA design capabilities to support the development of this exciting new modality for in vivo CAR-T therapeutics."

"Our advanced capabilities in RNA construct design and screening make us a strong partner for teams aiming to push the boundaries for this new therapeutic modality," added Dr. Taeyoon Kyung, Senior Engineer at Ginkgo Bioworks. "We look forward to contributing to this significant project and using our platform to advance novel optimized RNA-based therapeutics to the clinic."

"We are delighted to have Ginkgo Bioworks and UBC partner with us on this groundbreaking initiative," said Dr. David Raiser, COO of STRM.BIO. "By combining STRM.BIO's MV delivery platform with Ginkgo's expertise in RNA construct design, we aim to create transformative therapies that could redefine the management of autoimmune diseases. This collaboration brings together leading-edge technologies and expertise to address a significant unmet medical need."

The partnership will leverage Ginkgo's nucleic acid AI and machine learning capabilities, along with its immune cell engineering expertise, to identify and optimize constructs for long-lived, tissue-specific, and highly potent expression of CAR genes. UBC will provide further expertise in the design of self-amplifying RNA motifs, further extending the potency and lifetime of these constructs. The goal is to develop in vivo CAR therapies that can selectively eliminate autoreactive B and T cells without the need for ex vivo cell manipulation or genome editing.

This initiative underscores Ginkgo's commitment to advancing RNA engineering and establishing itself as a credible partner in RNA cargo design for therapeutics companies. By participating in this groundbreaking program, Ginkgo plans to further develop and demonstrate its capabilities in RNA engineering and in vivo therapeutic delivery, contributing to the advancement of novel treatments for complex autoimmune diseases.

To learn more about how you can bring innovative biological solutions to life, please visit our page for Ginkgo Genetic Medicines.

About Ginkgo Bioworks
Ginkgo Bioworks builds the tools that make biology easier to engineer for everyone. Ginkgo R&D Solutions delivers customizable R&D packages—such as protein engineering, nucleic acid design, and cell-free systems—giving partners a comprehensive way to accelerate innovation across therapeutics, diagnostics, & manufacturing. Ginkgo Automation sells modular, integrated laboratory automation so scientists can spend their days planning and analyzing experiments rather than pipetting in the lab. Ginkgo Datapoints uses Ginkgo's in-house automation to generate the large lab data sets to power your AI models. Ginkgo Biosecurity is building and deploying the next-generation infrastructure and technologies that global leaders need to predict, detect, and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and ginkgobiosecurity.com, read our blog, or follow us on social media channels such as X (@Ginkgo and @Ginkgo_Biosec), Instagram (@GinkgoBioworks), 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) our ability to realize near-term and long-term cost savings associated with our site consolidation plans, including the ability to terminate leases or find sub-lease tenants for unused facilities, (ii) 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, (iii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, including with respect to our solutions and tools offerings, (iv) the risk of downturns in demand for products using synthetic biology, (v) the uncertainty regarding the demand for passive monitoring programs and biosecurity services, (vi) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vii) the outcome of any pending or potential legal proceedings against Ginkgo, (viii) our ability to realize the expected benefits from and the success of our Foundry platform programs and Codebase assets, (ix) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, (x) the product development, production or manufacturing success of our customers, (xi) our exposure to the volatility and liquidity risks inherent in holding equity interests in other operating companies and other non-cash consideration we may receive for our services, (xii) the potential negative impact on our business of our restructuring or the failure to realize the anticipated savings associated therewith and (xiii) the uncertainty regarding government budgetary priorities and funding allocated to government agencies. 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 February 25, 2025 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

About STRM.BIO
Based in Cambridge, MA, STRM.BIO is a pre-clinical, venture-backed biotechnology company leveraging extracellular vesicles as a platform to develop and deliver targeted genetic medicines in vivo that are safe for repeat dosing. Our vision is to open the door to the future of medicine for patients living with rare diseases worldwide and bring gene therapy to life. Please visit www.strm.bio to meet our growing team of partners and collaborators and stay up to date on our progress.

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SOURCE Ginkgo Bioworks

FAQ

What did Ginkgo Bioworks (DNA) announce on Oct 23, 2025 about in vivo CAR therapies?

Ginkgo announced a collaboration with STRM.BIO and UBC under ARPA-H's EMBODY program to develop in vivo CAR therapies using STRM.BIO's MV delivery and Ginkgo's RNA construct design.

What is the INVITE-ME project and how does it aim to treat autoimmune diseases?

INVITE-ME combines megakaryocyte-derived extracellular vesicle delivery with optimized RNA constructs to engineer T cells in situ and target autoreactive B and T cells without ex vivo processing.

Which autoimmune diseases are cited as targets for Ginkgo's in vivo CAR program (DNA)?

The announcement cites systemic lupus erythematosus (SLE) and myasthenia gravis (MG) as example autoimmune targets.

What technologies will Ginkgo (DNA) contribute to the EMBODY partnership?

Ginkgo will contribute RNA construct design, nucleic acid AI and machine learning, and immune cell engineering expertise to optimize long-lived, tissue-specific CAR expression.

Will the INVITE-ME approach require ex vivo cell manipulation or genome editing?

The program aims to avoid ex vivo cell manipulation and genome editing by delivering RNA cargo in vivo to bone marrow-resident cells via STRM.BIO's MV platform.

Who are the partners and program leadership involved in the ARPA-H EMBODY project announced Oct 23, 2025?

Partners are Ginkgo Bioworks, STRM.BIO, and the University of British Columbia; EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D.
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