▎药明康德

 

美国费城/圣路易斯/圣地亚哥，2022年6月16日——专注于细胞和基因疗法的CTDMO药明生基今日宣布与美国生物技术公司Wugen就新型免疫细胞疗法WU-NK-101达成生产合作，该疗法能够利用免疫记忆的自然杀伤（NK）细胞来治疗肿瘤。药明生基将为WU-NK-101提供生产和检测服务，赋能Wugen公司早日将这一创新细胞疗法产品带给肿瘤患者。

 

Wugen是一家临床阶段的生物技术公司，位于美国圣路易斯和圣地亚哥，致力于开发“现货型”细胞疗法产品线，以治疗各种血液和实体恶性肿瘤。WU-NK-101是Wugen 公司专有Moneta™平台上开发的第一个项目。该项目旨在利用免疫记忆NK细胞的超能、长效抗肿瘤能力，商业化大规模生产新一代、“现货型”肿瘤免疫治疗性细胞。WU-NK-101目前处于临床前开发阶段，计划在不久的将来展开临床试验，用于治疗严重急性髓细胞白血病（AML）和其他实体肿瘤。

药明生基的一体化CTDMO平台将为WU-NK-101的开发提供细胞疗法所需的GMP生产和检测服务，助力监管申报和临床试验，赋能客户加速研发进程。

“我们很高兴与药明生基开展合作。”Wugen总裁兼首席执行官Dan Kemp博士表示：“药明生基在细胞治疗领域的专业生产经验、一体化的GMP生产和检测能力，将帮助我们持续推进异体WU-NK-101项目快速进入临床试验阶段，早日为患者带来更便捷、有效的治疗方法。”

“异体NK细胞疗法的开发是加速创新癌症疗法进入临床管线的重要一步。”药明生基首席执行官张幼翔博士表示：“我们很高兴能与Wugen达成合作，助力解决癌症疗法开发中面临的挑战，提高创新疗法的可及性，造福全球患者。”

关于Wugen

Wugen是一家临床阶段的生物技术公司，致力于开发下一代用于治疗癌症的“现货型”免疫记忆自然杀伤（NK）细胞疗法和CAR-T细胞疗法。Wugen正在利用其专有的 Moneta™平台和深厚的基因组工程专业技能来开创一种新型的免疫记忆NK细胞疗法，以治疗血液和实体恶性肿瘤。更多信息，请访问www.wugen.com。

关于药明生基

药明生基是药明康德旗下专注于细胞和基因疗法的CTDMO，致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。更多信息，请访问www.wuxiatu.com。

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WuXi ATU andWugen Announce Manufacturing Partnership to Expedite the Delivery of Novel CellCancer Immunotherapies

June 15, 2022 (PHILADELPHIA, PA; ST. LOUIS, MO and SAN DIEGO, CA) – WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Develo pment and Manufacturing Organization (CTDMO), and Wugen Inc., a clinical-stage biotechnology company based in St. Louis and San Diego, today announced a partnership to produce Wugen’s WU-NK-101, a novel immunotherapy that harnesses the power of memory natural killer (NK) cells to treat cancers. WuXi ATU will provide manufacturing and testing services for WU-NK-101 to enable the delivery of this innovative cell therapy product to cancer patients.

Wugen aims to develop a pipeline of off-the-shelf cell therapy products to treat a broad range of hematological and solid tumor malignancies. As Wugen’s first program from the company’s proprietary Moneta™ platform, WU-NK-101 leverages the hyper-functional, long-lasting anti-tumor functionality of memory NK cells to manufacture next-generation, off-the-shelf cancer cell therapies at commercial scale. WU-NK-101 is currently in development to treat acute myelogenous leukemia (AML) and solid tumors.

WuXi ATU’s integrated CTDMO platform enables the development of WU-NK-101 by leveraging the company’s Good Manufacturing Process (GMP) cell therapy manufacturing and testing capabilities to support regulatory filings and clinical trials. 

 

“We are delighted to partner with WuXi ATU,” said Dr. Dan Kemp, President and Chief Executive Officer of Wugen. “With WuXi ATU’s cell therapy manufacturing expertise, integrated GMP manufacturing and testing capabilities, we can keep advancing our allogeneic WU-NK-101 program into clinical trials and accelerate the timeline for delivering convenient, effective therapeutics to patients.”

“The development of allogeneic NK cell therapies is a significant step towards accelerating the progress of these innovative cancer therapeutics into the clinical pipeline,” said Dr. David Chang, Chief Executive Officer of WuXi ATU. “We’re delighted to partner with Wugen to help make these life-saving cancer treatments less challenging to produce and more accessible to patients in need.”

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary Moneta™ platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

About Wugen

Wugen, Inc., is a clinical-stage biotechnology company developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer. Wugen is leveraging its proprietary Moneta™ platform and deep genomic engineering expertise to pioneer a new class of memory NK cell therapies with a cytokine-induced memory-like (CIML) phenotype, uniquely designed to treat hematological and solid tumor malignancies. For more information, please visit www.wugen.com.

About WuXi Advanced Therapies (WuXi ATU)

As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information, please visit www.advancedtherapies.com.

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