Applied DNA宣布达成联合开发协议，将Linea™ IVT平台整合到Kudo Biotechnology的mRNA生产工作流程中-动脉网

Applied DNA Announces Joint Development Agreement to Integrate Linea(TM) IVT Platform into CDMO Kudo Biotechnology’s mRNA Manufacturing Workflow

BioSpace 等信源发布 2023-12-14 21:31

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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

该协议旨在利用Linea IVT平台，使Kudo Bio能够提供差异化的mRNA制造能力，减少dsRNA并缩短周转时间

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..

纽约州石溪市和马萨诸塞州李约瑟市/ACCESSWIRE/2023年12月14日/应用DNA科学公司（纳斯达克：APDN）（应用DNA），基于PCR的DNA技术的领导者，以及全球领先的mRNA CDMO提供端到端cGMP mRNA制造解决方案的工藤生物技术（工藤生物），今天宣布签署联合开发协议（“JDA”），以整合应用DNA的Linea™IVT平台（“平台”）进入工藤生物的商业mRNA制造工作流程。。

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..

根据JDA的条款，这些公司将寻求在制造规模的综合工作流程中优化mRNA质量，产量和减轻双链RNA（“dsRNA”）的污染，并建立全球共同营销关系。成功完成JDA后，两家公司计划谈判协议，以便在2024年下半年商业启动联合工作流程。。

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平台结合了应用DNA酶促产生的Linea™DNA IVT模板及其专有线性™RNA聚合酶（“RNAP”）是通过最近收购Spundle Biotech获得的，它提供了Applied DNA认为比传统mRNA制造方法具有许多优势，包括预防或减少dsRNA污染以及减少mRNA制造周转时间。。

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.'.

应用DNA总裁兼首席执行官詹姆斯·海沃德（JamesA.Hayward）博士表示，“JDA是实现由我们强大的平台授权的差异化mRNA工作流程商业可用性的重要第一步。我们相信，在完成JDA下的工作后，与其他mRNA cDMO相比，Kudo Bio将在周转时间，可扩展性和dsRNA减少方面具有关键优势。”。

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首席执行官莫莉·麦克劳克林（Molly S.McGraughlin）补充道，“我们很高兴能与技术领先者Applied DNA合作，获得尖端技术，以显着提高客户的商品成本，诊所速度以及患者的整体安全！”

About the Linea™ DNA and Linea™ IVT Platforms

关于线路™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.

Linea DNA平台是一个完全无细胞的DNA生产平台，基于Applied DNA在大规模酶促DNA生产方面的长期专业知识。Linea DNA平台能够产生从毫克到克的DNA，可以产生大小从100bp到20kb的高保真DNA构建体。

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..

通过Linea DNA平台产生的DNA不含其他DNA来源中发现的不定DNA序列，具有快速扩展性，并可对DNA构建体进行简单的化学修饰。。

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平台将通过Linea DNA平台制造的DNA IVT模板与专有的Linea结合起来™RNAP使mRNA和saRNA制造商能够更快地生产Applied DNA认为更好的mRNA，优于传统的mRNA生产，包括：1）消除质粒DNA作为起始材料；2）预防或减少dsRNA污染；3）简化mRNA生产工作流程。。

About Kudo Biotechnology

关于工藤生物技术

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.

工藤生物技术是全球领先的mRNA CDMO，提供世界一流的端到端mRNA制造解决方案，所有这些都在一个屋檐下。工藤在上海拥有最先进的临床GMP生产设施和MSAT实验室，在马萨诸塞州李约瑟市拥有卓越的过程科学中心，并在新加坡设有分支机构。

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.

我们的GMP生产设施占地57000平方英尺，提供pDNA、mRNA、LNP和填充表面的全套服务，并根据cGMP和全球监管指南进行设计。工藤的工厂拥有两条质粒线，三条mRNA线，两条LNP批量线和一条药品填充和终点线。

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.

它可以满足临床前到第二阶段临床试验的制造需求，能够为第三阶段和商业制造每年制造多达4000万瓶。我们的尖端设备是为mRNA和LNP药物开发定制的，我们还提供一系列附加服务，包括过程和分析开发、技术转让、测试和发布以及供应链管理。

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 www.kudobio.com, or follow us on LinkedIn @KudoBio.

工藤为客户的药物开发需求提供全面的解决方案，并拥有强大的质量管理体系，以确保最高的质量并符合全球法规。有关更多信息，请访问www.kudobio.com，或通过LinkedIn@kudobio关注我们。

About Applied DNA Sciences

关于应用DNA科学

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.

Applied DNA Sciences是一家开发生产和检测脱氧核糖核酸（“DNA”）技术的生物技术公司。使用聚合酶链反应（“PCR”）来实现DNA的生产和检测，我们在三个主要业务市场运营：（i）酶促生产合成DNA，用于生产基于核酸的治疗剂，并通过我们最近收购Spundle 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..

（“纺锤体”），开发和销售专有的RNA聚合酶（“RNAP”），用于生产mRNA治疗剂；（ii）在分子诊断和基因检测服务中检测DNA和RNA；（iii）为工业供应链安全服务制造和检测DNA。。

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

有关更多信息，请访问adnas.com。在Twitter和LinkedIn上关注我们。加入我们的邮件列表。

Forward-Looking Statements

前瞻性声明

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.

根据《1933年证券法》第27A节、《1934年证券交易法》第21E节和《1995年私人证券诉讼改革法》，Applied DNA在本新闻稿中的声明可能具有“前瞻性”。前瞻性陈述描述了Applied DNA的未来计划、预测、战略和期望，并基于假设，涉及许多风险和不确定性，其中许多风险和不确定性超出了Applied DNA的控制范围。

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.

由于其净亏损历史、有限的财务资源、对其生物治疗或诊断产品和服务的未来需求未知、研发项目的固有风险和未知结果、Linea DNA产生的收入和利润数额未知，实际结果可能与预测结果大不相同™和/或直线™IVT平台，从未有使用PCR产生的DNA技术和/或Linea IVT或Linea DNA平台批准用于人类治疗的商业药品，我们需要筹集大量额外资金，以及Applied DNA的SEC报告和文件中不时详细介绍的各种其他因素，包括12月7日提交的10-K表格年度报告，2023年，以及它向SEC提交的其他报告，可在www.SEC.gov上查阅。

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..

除非法律另有要求，否则Applied DNA没有义务公开更新任何前瞻性声明，以反映本协议日期后的新信息、事件或情况，或反映意外事件的发生。。

Contacts:

联系人：

Applied DNA Sciences

应用DNA科学

Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

投资者关系联系人：Sanjay M.Harry，917-733-5573，sanjay.hurry@adnas.com

Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

项目联系人：Brian Viscount，631-240-8877，brian.viscount@adnas.com

Web: www.adnas.com

网址：www.adnas.com

Twitter: @APDN