Applied DNA Announces Joint Development Agreement to Integrate Linea(TM) IVT Platform Into CDMO Kudo Biotechnology's MRNA Manufacturing Workflow
Applied DNA Announces Joint Development Agreement to Integrate Linea(TM) IVT Platform Into CDMO Kudo Biotechnology's MRNA Manufacturing Workflow
- Agreement Seeks to Leverage Linea IVT Platform to Enable Kudo Bio to Offer a Differentiated mRNA Manufacturing Capability with Mitigated dsRNA and Reduced Turnaround Times -
-協議旨在利用Linea IVT平台使Kudo Bio能夠提供差異化的mRNA製造能力,同時降低dsRNA並縮短週轉時間-
STONY BROOK, NY and NEEDHAM, MA / ACCESSWIRE / December 14, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, and Kudo Biotechnology (Kudo Bio), a leading global mRNA CDMO offering end-to-end cGMP mRNA manufacturing solutions, today announced their entry into a joint development agreement (the "JDA") to integrate Applied DNA's Linea IVT platform (the "Platform") into Kudo Bio's commercial mRNA manufacturing workflows.
紐約州石溪和馬薩諸塞州尼德姆/ACCESSWIRE/2023年12月14日/基於聚合酶鏈反應的DNA技術的領導者應用DNA Sciences, Inc.(納斯達克股票代碼:APDN)(應用DNA)和提供端到端 cGMP mRNA 製造解決方案的全球領先的 mRNA CDMO 工藤生物技術(Kudo Bio)今天宣佈簽訂聯合開發協議(“JDA”),以整合應用的DNA Lind 將 IVT 平台(“平台”)融入工藤生物的商用 mRNA 製造工作流程。
Under the terms of the JDA, the Companies will seek to optimize mRNA quality, yields, and mitigation of contamination by double-stranded RNA ("dsRNA") in an integrated workflow at manufacturing scale and establish a global co-marketing relationship. Upon successful completion of the JDA, the Companies plan to negotiate agreements to enable the commercial launch of the joint workflow in the second half of calendar 2024.
根據JDA的條款,兩家公司將尋求在製造規模的綜合工作流程中優化mRNA質量、產量並減少雙鏈RNA(“dsRNA”)的污染,並建立全球聯合營銷關係。JDA成功完成後,兩家公司計劃就協議進行談判,以使聯合工作流程能夠在2024年的下半年商業上線。
The Linea IVT Platform combines Applied DNA's enzymatically produced Linea DNA IVT templates and its proprietary Linea RNA polymerase ("RNAP"), obtained through the recent acquisition of Spindle Biotech, to provide what Applied DNA believes to be numerous advantages over conventional mRNA manufacturing methods, including the prevention or reduction of dsRNA contamination and reduced mRNA manufacturing turn-around-times.
Linea IVT平台結合了應用DNA的酶促產生的Linea DNA IVT模板及其通過最近收購Spindle Biotech獲得的專有Linea RNA聚合酶(“RNAP”),提供了應用DNA認爲與傳統mRNA製造方法相比具有的衆多優勢,包括預防或減少dsRNA污染以及縮短mRNA製造週轉時間。
Dr. James A. Hayward, president and CEO of Applied DNA, stated, "The JDA is an important first step in the enablement of the commercial availability of a differentiated mRNA workflow empowered by our powerful platform. We believe that upon completion of the work under the JDA, Kudo Bio will possess critical advantages in turnaround time, scalability, and dsRNA reductions as compared to other mRNA CDMOs."
Applied DNA總裁兼首席執行官詹姆斯·海沃德博士表示:“JDA是實現由我們強大平台支持的差異化mRNA工作流程商業化的重要第一步。我們相信,與其他mRNA cdMO相比,JDA下的工作完成後,Kudo Bio將在週轉時間、可擴展性和減少dsRNA方面擁有關鍵優勢。”
Added Molly S. McGlaughlin, CEO of Kudo Bio, "We are excited to work with Applied DNA, a clear technology leader, to access cutting-edge technologies to significantly improve our customers' cost of goods, speed to clinic, and overall safety to their patients!"
Kudo Bio首席執行官Molly S. McGlaughlin補充說:“我們很高興能與無疑的技術領導者Applied DNA合作,獲得尖端技術,從而顯著提高客戶的商品成本、進入診所的速度和患者的整體安全!”
About the Linea DNA and Linea IVT Platforms
關於 Linea DNA 和 Linea IVT 平台
The Linea DNA platform is a completely cell-free DNA production platform founded on Applied DNA's long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.
Linea DNA平台是一個完全無細胞的DNA生產平台,其基礎是應用DNA在大規模酶促生產DNA方面的長期專業知識。Linea DNA平台能夠生成從毫克到克不等的DNA,可以生成大小從100bp到20kb不等的高保真DNA結構。通過Linea DNA平台產生的DNA不含其他DNA來源中的不確定DNA序列,可快速擴展,並且可以對DNA結構進行簡單的化學修飾。
The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and saRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of dsRNA contamination; and 3) simplified mRNA production workflows.
Linea IVT平台將通過Linea DNA平台製造的DNA IVT模板與專有的Linea RNAP相結合,使mRNA和sarNA製造商能夠更快地生產應用DNA認爲更好的mRNA,與傳統的 mRNA 生產相比,具有以下優勢:1) 消除質粒 DNA 作爲起始材料;2) 預防或減少 dsRNA 污染;3) 簡化 mRNA 生產工作流程。
About Kudo Biotechnology
關於工藤生物科技
Kudo Biotechnology is a leading global mRNA CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has a state-of-the-art clinical GMP manufacturing facility and MSAT laboratories in Shanghai, a Process Science Center of Excellence in Needham, MA, and with additional presence in Singapore. Offering a complete suite of services in pDNA, mRNA, LNP and Fill-Finish, our GMP manufacturing facility spans over 57,000 sqf and is designed in accordance with cGMP and global regulatory guidelines. Kudo's facility features two plasmid lines, three mRNA lines, two LNP bulk lines, and one drug product fill & finish line. It can cater to manufacturing needs for preclinical through Phase 2 clinical trials, with capacity to manufacture up to 40 million vials/year for Phase 3 and commercial manufacturing. Our cutting-edge equipment is customized for mRNA and LNP drug development, and we offer a range of additional services, including Process and Analytical Development, Technology Transfer, Testing & Release, and Supply Chain Management. Kudo provides comprehensive solutions for our clients' drug development needs, and has a robust quality management system to ensure the highest quality and to comply with global regulations. For more information, please visit , or follow us on LinkedIn @KudoBio
Kudo Biotechnology是全球領先的mRNA CDMO,提供世界一流的端到端 mRNA 製造解決方案,全部集中在一個屋檐下。Kudo在上海擁有最先進的臨床GMP製造設施和MSAT實驗室,在馬薩諸塞州尼德姆擁有卓越的過程科學中心,並在新加坡設有分支機構。我們的 GMP 製造工廠提供 pDNA、mRNA、LNP 和 Fill-Finish 等全套服務,佔地面積超過 57,000 平方英尺,設計符合 cGMP 和全球監管準則。工藤的設施包括兩條質粒生產線、三條 mRNA 生產線、兩條 LNP 散裝生產線和一條藥品灌裝和終點線。它可以通過2期臨床試驗滿足臨床前生產需求,能夠每年生產高達4000萬瓶,用於3期和商業化生產。我們的尖端設備專爲 mRNA 和 LNP 藥物研發量身定製,並提供一系列附加服務,包括工藝和分析開發、技術轉讓、測試和發佈以及供應鏈管理。Kudo爲客戶的藥物研發需求提供全面的解決方案,並擁有強大的質量管理體系,以確保最高質量並符合全球法規。欲了解更多信息,請訪問或在 LinkedIn 上關注我們 @KudoBio
About Applied DNA Sciences
關於應用 DNA 科學
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, we operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. ("Spindle"), the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
應用DNA Sciences是一家生物技術公司,開發生產和檢測脫氧核糖核酸(“DNA”)的技術。使用聚合酶鏈反應(“PCR”)來實現DNA的生產和檢測,我們在三個主要業務市場開展業務:(i)酶促製造用於生產基於核酸的療法的合成DNA,以及通過我們最近收購Spindle Biotech, Inc.(“Spindle”),開發和銷售用於生產mRNA的專有RNA聚合酶(“RNAP”)(ii) 在分子診斷和基因檢測服務中檢測 DNA 和 RNA;以及 (iii) 製造和檢測工業供應鏈安全服務的 DNA。
Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.
請訪問 adnas.com 了解更多信息。在推特和領英上關注我們。加入我們的郵件列表。
Forward-Looking Statements
前瞻性陳述
The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, unknown future demand for its biotherapeutics or diagnostic products and services, the inherent risk and unknown outcome of research and development projects, the unknown amount of revenues and profits that will result from the Linea DNA and/or Linea IVT platforms, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT or Linea DNA platforms approved for human therapeutic use, our need to raise substantial additional funds, and various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 7, 2023, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
根據1933年《證券法》第27A條、1934年《證券交易法》第21E條和1995年《私人證券訴訟改革法》的含義,Applied DNA在本新聞稿中發表的聲明可能具有 “前瞻性” 性質。前瞻性陳述描述了Applied DNA的未來計劃、預測、戰略和預期,這些陳述基於假設,涉及許多風險和不確定性,其中許多風險和不確定性超出了Applied DNA的控制範圍。由於其淨虧損歷史、財務資源有限、未來對其生物療法或診斷產品和服務的需求未知、研發項目的固有風險和未知結果、Linea DNA和/或Linea IVT平台將產生的收入和利潤金額未知、從未有過使用PCR生產的DNA技術和/或Linea IVT或Linea IVT的商業藥品這一事實,實際結果可能與預期的結果存在重大差異 ea DNA 平台獲准用於人類治療,我們需要籌集大量額外資金,Applied DNA在美國證券交易委員會的報告和文件中不時詳述的各種其他因素,包括其於2023年12月7日提交的10-K表年度報告,以及其向美國證券交易委員會提交的其他報告,這些報告可在www.sec.gov上查閱。除非法律另有要求,否則Applied DNA沒有義務公開更新任何前瞻性陳述以反映本文發佈之日後的新信息、事件或情況,也沒有義務反映意外事件的發生。
Contacts:
聯繫人:
Applied DNA Sciences
應用 DNA 科學
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
投資者關係聯繫人:Sanjay M. Hurry,917-733-5573,sanjay.hurry@adnas.com
Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
項目聯繫人:Brian Viscount,631-240-8877,brian.viscount@adnas.com
Web:
網頁:
Twitter: @APDN
推特:@APDN
Kudo Biotechnology
Kelvin Chan, PhD
Director, Business Development
kelvin@kudobio.com
Web:
工藤生物科技
陳凱文,博士
業務發展董事
kelvin@kudobio.com
網頁:
###
###
SOURCE: Applied DNA Sciences, Inc.
來源:應用DNA科學公司
譯文內容由第三人軟體翻譯。