SEATTLE--(BUSINESS WIRE)--Curi Bio, the industry leader in developing human stem cell-based platforms for drug discovery, today announced the signing of a Memorandum of Understanding (MOU) for scientific and strategic collaboration with Genetox and DreamCIS. Genetox, an emerging biopharmaceutical company specializing in the sale and manufacture of botulinum toxin (BoT) for cosmetic and therapeutic purposes, and DreamCIS, a leading provider of CRO services supporting clinical development and regulatory affairs, will collaborate with Curi Bio to use the company’s cutting-edge neuromuscular junction (NMJ) model as a non-animal potency assay for advancing Genetox’s BOTAONE (botulinum toxin) through US FDA approval..

西雅图--（商业新闻短讯）--Curi Bio是开发基于人类干细胞的药物发现平台的行业领导者，今天宣布与Genetox和DreamCIS签署科学和战略合作谅解备忘录（MOU）。Genetox是一家新兴的生物制药公司，专门销售和制造用于美容和治疗目的的肉毒杆菌毒素（BoT），DreamCIS是支持临床开发和监管事务的CRO服务的领先供应商，将与Curi Bio合作使用该公司的尖端神经肌肉接头（NMJ）该模型是通过美国FDA批准推进Genetox的BOTAONE（肉毒杆菌毒素）的非动物效力测定。。

BoT is renowned for its therapeutic applications, including the treatment of chronic pain, autonomic disorders, congenital neuromuscular conditions, and cosmetic enhancements. Accurate potency assessment of manufactured lots is essential for safe and effective dosing of the potent neurotoxin. Current standards utilize the mouse lethality bioassay, which is slow, costly, and controversial.

BoT以其治疗应用而闻名，包括治疗慢性疼痛，自主神经疾病，先天性神经肌肉疾病和美容美甲。制造批次的准确效力评估对于安全有效地服用强效神经毒素至关重要。目前的标准利用小鼠致死率生物测定，这是缓慢的，昂贵的和有争议的。

US lawmakers recently passed the FDA Modernization Act 2.0 which removed the animal testing regulatory mandate for new investigational drug applications. As an industry leader in delivering human functional data using its advanced platforms for global pharmaceutical and biotechnology companies, Curi Bio has already completed multiple projects that have displaced the use of many animal studies for the discovery of next-generation medicines..

美国立法者最近通过了FDA现代化法案2.0，该法案取消了新研究药物应用的动物测试监管规定。作为使用其先进平台为全球制药和生物技术公司提供人体功能数据的行业领导者，库里生物已经完成了多个项目，这些项目取代了许多动物研究用于发现下一代药物。。

Shortly after the bill’s passage, Curi Bio was awarded a Small Business Innovation Research grant to develop a novel human stem-cell based neuromuscular junction. The project has supported Curi Bio’s development of a next-generation 3D human neuromuscular junction model used for disease modeling, for pharmaceutical and cosmetics potency assays, and for testing broad pathogenicity.

法案通过后不久，库里生物获得了一笔小企业创新研究资助，用于开发一种新型的基于人类干细胞的神经肌肉接头。该项目支持Curi Bio开发下一代3D人类神经肌肉接头模型，用于疾病建模，药物和化妆品效力测定以及测试广泛的致病性。

The project is currently underway in collaboration with Dr. Alec Smith and Dr. David Mack at the University of Washington and has the goal of delivering human data for animal-free functional potency assays. The project will deliver a functional potency assay for botox research and manufacture in a turnkey, scalable format.

该项目目前正在与华盛顿大学的Alec Smith博士和David Mack博士合作，目标是为无动物功能效力测定提供人类数据。该项目将以交钥匙、可扩展的格式为肉毒杆菌毒素的研究和生产提供功能效力测定。

Once developed, the assay could be further extended towards a variety of devastating human neuromuscular diseases such as amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth disease (CMT). The project was awarded to Curi Bio by the National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS) in conjunction with the Food and Drug Administration (FDA)..

一旦开发出来，该测定法可以进一步扩展到各种破坏性的人类神经肌肉疾病，例如肌萎缩侧索硬化症（ALS）和Charcot-Marie-Tooth病（CMT）。该项目由美国国立卫生研究院（NIH）和国家转化科学促进中心（NCATS）与美国食品和药物管理局（FDA）共同授予Curi Bio。。

With this MOU, Genetox shows its commitment to making Curi Bio’s NMJ-based potency assay a key part of BOTAONE’s manufacturing, quality control, and product release processes. Genetox will seek approval for its BOTAONE product from regulatory authorities, including the Korean FDA and United States FDA.

通过这份谅解备忘录，Genetox展示了其致力于使Curi Bio基于NMJ的效价测定成为BOTAONE制造，质量控制和产品发布过程的关键部分。Genetox将寻求监管机构（包括韩国FDA和美国FDA）对其BOTAONE产品的批准。

This MOU represents an innovative advancement in the field of botox production and regulatory acceptance and marks the first steps of a paradigm shift where in vitro human functional data are used for regulatory approval. As the biopharmaceutical industry shifts towards non-animal testing methodologies, this joint effort underscores the commitment of the three companies to innovation and to ethical research practices..

该谅解备忘录代表了肉毒杆菌生产和监管接受领域的创新进步，标志着将体外人体功能数据用于监管批准的范式转变的第一步。随着生物制药行业转向非动物测试方法，这项共同努力突显了这三家公司对创新和伦理研究实践的承诺。。

“This collaboration represents a significant step forward in our mission to revolutionize drug discovery and development,” said Dr. Nicholas A. Geisse, CEO of Curi Bio. “As we continually refine our 3D neuromuscular junction model to develop a clinically-relevant potency assay utilizing human data, we are excited to collaborate with industry leaders and forward thinkers like Genetox and DreamCIS to accelerate the approval process for BOTAONE in the US.

Nicholas a.Geisse博士说：“这种合作代表着我们彻底改变药物发现和开发使命的重要一步，库里生物首席执行官：“随着我们不断完善我们的3D神经肌肉接头模型，以利用人类数据开发临床相关的效力测定，我们很高兴与业界领袖和前瞻性思想家（如Genetox和DreamCIS）合作，以加快BOTAONE在美国的审批流程。

This endeavor paves the way for more ethical and efficient drug testing methodologies in the future.”.

这一努力为未来更具道德和效率的药物检测方法铺平了道路。”。

“We at Genetox are thrilled to embark on this strategic partnership with Curi Bio and DreamCIS,” said Dr. Jong Deok Ahn, CEO of Genetox. “We are confident that this innovative technology will not only facilitate the FDA approval process for BOTAONE, but also set a new standard for the development of botulinum toxin-based therapeutics across the industry.”.

Genetox首席执行官Jong Deok Ahn博士表示：“我们Genetox很高兴与Curi Bio和DreamCIS建立战略合作关系。”。“我们相信，这项创新技术不仅将促进FDA对肉毒杆菌酮的批准程序，而且还将为整个行业开发基于肉毒杆菌毒素的疗法制定新标准。”。

“This initiative not only aligns with our dedication to employing cutting-edge science, but also to our responsibility towards more humane and sustainable research practices,” said Dr. Jeounghee Yoo, CEO of DreamCIS. “We look forward to achieving remarkable milestones together and contributing to a healthier future for patients worldwide.”.

DreamCIS首席执行官Jeounghee Yoo博士表示：“这一举措不仅符合我们致力于采用尖端科学的决心，也符合我们对更人道和可持续研究实践的责任。”。“我们期待着共同实现非凡的里程碑，为全世界患者创造更健康的未来。”。

About Curi Bio

关于Curi Bio

Curi Bio unlocks novel workflows and delivers functional human data to inform biopharmaceutical R&D decision-making. Through an integrated platform featuring advanced 3D tissue models of disease, biosystems enabling clinically relevant functional analyses and AI/ML-enabled insights, Curi Bio melds functional and analytical assessments for drug safety, efficacy, and potency.

库里生物解锁新的工作流程，并提供功能性人类数据，为生物制药研发决策提供信息。通过一个以先进的疾病3D组织模型为特征的集成平台，biosystems实现了临床相关的功能分析和AI/ML支持的见解，Curi Bio-melds对药物安全性，功效和效力进行了功能和分析评估。

By offering leading global pharmaceutical end users an integrated preclinical platform along with highly predictive human stem cell tissue models to generate clinically-relevant data, Curi Bio is bridging the gap between preclinical R&D and clinical outcomes, accelerating the discovery and development of safer, more effective medicines..

通过为全球领先的制药最终用户提供一个集成的临床前平台以及高度预测性的人类干细胞组织模型来生成临床相关数据，Curi Bio正在弥合临床前研发与临床结果之间的差距，加速发现和开发更安全，更有效的药物。。

For more information, please visit www.curibio.com.

欲了解更多信息，请访问www.curibio.com。

About Genetox

Genetox

Genetox is a biopharmaceutical company specializing in botulinum toxin, fillers, medicines, and cosmetic solutions. The company leverages cutting-edge research and development to create innovative and effective products that meet the highest quality standards. Genetox is committed to providing patients with safe and reliable solutions to improve their health and well-being..

Genetox是一家生物制药公司，专门从事肉毒杆菌毒素，填充剂，药物和化妆品解决方案。该公司利用尖端的研究和开发，创造出符合最高质量标准的创新高效产品。Genetox致力于为患者提供安全可靠的解决方案，以改善他们的健康和福祉。。

For more information, please visit http://genetox.co.kr/.

欲了解更多信息，请访问http://genetox.co.kr/.

About DreamCIS

关于DreamCIS

Established in April 2000, DreamCIS is a Korean Contract Research Organization (CRO) providing comprehensive R&D services to biopharmaceutical companies, including clinical trial operations, post-marketing surveillance, and data management. Since listing on the KOSDAQ in 2020, DreamCIS has expanded its business through strategic acquisitions, including MediTip, a leading Korean regulatory affairs consulting company, and LCS, a preclinical consulting company.

DreamCIS成立于2000年4月，是一家韩国合同研究组织（CRO），为生物制药公司提供全面的研发服务，包括临床试验操作，上市后监测和数据管理。自2020年在KOSDAQ上市以来，DreamCIS通过战略性收购扩大了业务，包括韩国领先的监管事务咨询公司MediTip和临床前咨询公司LCS。

In collaboration with its parent company Tigermed, DreamCIS offers a one-stop, full-scope suite of clinical trial services spanning the entire duration of new drug development..

DreamCIS与其母公司Tigermed合作，在新药开发的整个过程中提供一站式全方位的临床试验服务。。

For more information, please visit https://www.dreamcis.com/home/.

有关更多信息，请访问https://www.dreamcis.com/home/.