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ESCO ASTER AND WUHAN BIO-RAID BIOTECHNOLOGY ESTABLISH MEMORANDUM OF UNDERSTANDING FOR LENTIVIRAL VECTOR PLATFORM TO SUPPORT CAR-T PIPELINE IN CHINA

 

Jul 19, 2018

 

SINGAPORE AND CHINA, July 19, 2018 – Esco Aster, a contract development and manufacturing organization (CDMO) of Esco Group, today announced the launch of lentiviral vector platform and bioproduction technologies to support the Chimeric Antigen Receptor Therapy (CAR-T) pipeline in China.

Through an international collaboration, Esco Aster has launched the lentivirus platform and bioproduction technologies in Wuhan Bio-Raid Biotechnology’s large state-of-art manufacturing cGMP facility, and the MoU signing was witnessed by Mr. Sam Tan, Singapore Minister of State for Foreign Affairs & Ministry of Social and Family Development, during his courtesy call on the Wuhan municipal leaders (see Annex).

“We are very pleased and excited to enter into this strategic partnership with Wuhan Bio-raid Biotechnology, one of the prominent players in CAR-T therapies in China. This partnership,results from the purchase of Esco’s Biological Safety Cabinet,is a strong motivation for entering a win-win collaboration with this highly dynamic company, ” said Mr. Xiangliang Lin, Esco Aster, Chief Executive Officer.

To meet Chinese market’s demand for lentiviral vector (LVV) needed for CAR-T clinical trials, Esco Aster aims to support CAR-T pipelines from discovery to delivery through cGMP production. Their expansion to the emerging CAR-T field is built upon a history of success in the commercialisation of Tide Motion bioreactors.

Esco Aster has successfully applied a process-intensive novel seed-train cell culture strategy using adherent HEK 293T cells. Vials from a high-density cell bank are used for direct seeding into a single-use CelCradle™ bioreactor to generate adequate cell numbers needed for LVV production in TideCell®. This process-intensive seed train strategy as opposed to conventional seed trains, provides a smaller working footprint, time-, cost- and manpower-effectiveness. Such an implementation and improvement can vastly increase the productivity of current LVV cell culture manufacturing facilities.

“Traditionally viral vectors are generated using cumbersome multi-stacked 2D vessels. Comparing them with our patented bioreactors, we have successfully shown the manufacturability of viral vectors towards a commercial scalable process adding overall advantages in terms of simple protocols, ease and relatively low cost to generate Lentiviral vectors,” said Dr. Calista Ng, Esco Aster, Bioprocessing Scientist.

“Given that Wuhan Bio-Raid is one of the leading CAR-T companies across China, we are excited to further our viral vectors development capability in cGMP manufacturing suites executed with the expansive scientific resources and expertise to rapidly establish a reliable commercial supply for the most difficult to manufacture CAR-T therapies,” said Mr. Zhang Tong Chun, Wuhan Bio-Raid Technology, Chief Executive Officer.

Above is reproduced at BioSpectrum.

 

Esco Aster Pte. Ltd.

21 Changi South Street 1
Singapore 486777
T: +65 6251 9361
E: mail@escoaster.com

Wuhan Bio-Raid Co. Ltd.

Bio-Lake B4-2-019, High-Tech Road No. 666
East-Lake New and High-Tech District
Wuhan Hubei, China 430075
T: +86 2787570668
E: cart@bio-raid.com

 

About Esco Group

Esco Group’s vision is to invent, discover, and commercialise enabling technologies to make human lives healthier and safer. Esco Group is a Singapore-based life sciences ecosystem builder comprising over 30 companies, 1000 employees, with proprietary products and services sold in 100 countries. Esco Group’s operating businesses are in life sciences equipment, medical devices, bioprocess tools and services. As of July 2018, Esco Group has invested RMB100 Million into a new 20,000m2 manufacturing and innovation centre based in Jiangsu, China.

Esco Ventures is the corporate venture investment arm of Esco Group and invests in life sciences start-ups globally. Esco Ventures X, the incubation arm of Esco Ventures, builds biotech start-ups based on in-house inventions and academic technologies.

Esco Aster is a contract development and manufacturing organisation (CDMO) focusing on offering vaccine-, cell- and gene-therapy development and biomanufacturing services using its proprietary Tide Motion technology, bioprocessing and bioengineering equipment. For more information, visit www.escoaster.com

About Wuhan Bio-Raid

Founded in September 2014, Wuhan Bio-Raid is led by Professor Zhang Tong Cun, Dean of Biomedical Research Institute of Wuhan University of Science and Technology and a clinical immunology expert and clinical researcher of Duke University, Stanford University, University of North Carolina, Wuhan University of Science and Technology. The company is committed to the clinical research and industrialization of chimeric antigen receptor T cell (CAR-T) technology.

The company has CD19, CD20, CD22, CD30, CD33, BCMA and other self-developed CAR-T immune cell therapy technologies and cooperated with Tongji Hospital affiliated to Huazhong University of Science and Technology. Through various collaborations with universities and clinical institutions, the company has established a complete CAR-T technology translation medicine research and development platform, and actively carries out research and development of the next generation of CAR-T technology, including CAR-T of new specific targets (such as CD123, BCMA, TIM3, immune-enhanced CAR-T and regulatable CAR-T). For more information, visit www.bio-raid.com

About CAR-T Therapy and Timelines

Cell therapy and regenerative advanced medicine products have gained significant importance, particularly in the field of Chimeric antigen receptor T (CAR-T) therapy.

August 2017: Novartis’ CTL019 Kymriah, licensed from University of Pennsylvania, gaining FDA approval for patients with acute lymphoblastic leukemia (ALL) for pediatric and young adults.

December 2017: After Gilead’s acquisition of Kite Pharma (US$12 Billion in cash) in 2017, Kite Pharma’s Yescarta was approved for adult patients with relapsed/ refractory large B cell lymphoma.

January 2018: Celgene bought Juno Therapeutics for US$ 9 Billion to expand into CAR T therapy.

March 2018: Temasek and Sequoia China has recently announced the lead round of Series A financing of US $90 Million in JW Therapeutics China, alongside with WuXi AppTec Group, that focus on JWCAR029, a CAR-T therapy for treatment of B-cell malignancies, to develop a therapeutic pipeline and build a new commercial manufacturing facility.

March 2018: Chinese FDA approved the clinical trial application of LCAR-B38M CAR-T cell reinfusion preparation from Nanjing Legend Biotech.

May 2018: Novartis announced the FDA has approved Kymriah for its second indication to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma.

 

Annex – MoU Signing Ceremony

附录 – 谅解备忘录签约仪式


Mr. Lin Xiangliang, CEO of Esco Aster (left) and Mr. Zhang Tong Chun (right), CEO of Wuhan Bio-Raid after signing the Memorandum of Understanding for lentiviral vector platform

 

 

艺思高艾斯特与武汉波睿生物达携手合作
建立慢病毒载体平台以支持中国CAR-T细胞制备工艺

新加坡与中国,2018年7月19日 – 艺思高艾斯特,作为新加坡艺思高集团 (Esco Group) 旗下专门为生物研究开发生产的外包服务公司 (Contract Development Manufacturing Organisation),今天宣布将使用其慢病毒载体技术平台来支持中国迅速发展的CAR-T(Chimeric Antigen Receptor Therapy)免疫细胞治疗法。

此次跨国合作为业内首例,艺思高艾斯特与武汉波睿达生物将共同推动,并实现慢病毒载体平台的建立和cGMP级慢病毒大规模的制备工艺的实现。此谅解备忘录 (MoU)签约仪式是在新加坡外交部兼社会及家庭发展部政务部长,陈振泉 (先生)与武汉市高层领导的正式会晤并见证下进行的(如附录)。

“我们非常高兴这次可以与武汉波睿达生物成为战略合作伙伴;武汉波睿达是中国CAR-T免疫细胞治疗研究第一梯队中的一员。这一伙伴关系的建立起源起于武汉波睿达生物采购了多台艺思高的生物安全柜。我们十分期待这一合作关系可以为我们带来双赢的结果,” 林向亮(先生)表示,艺思高艾斯特,首席执行官。

为了满足中国CAR-T免疫细胞治疗临床试验对慢病毒载体的需求,艺思高艾斯特旨在通过cGMP级慢病毒载体大规模生产来支持中国的CAR-T细胞免疫治疗产业化。艺思高艾斯特扩展到新兴的CAR-T细胞免疫领域是建立在艺思高艾斯特潮汐式生物反应器成功商业化的历史基础上的。

艺思高艾斯特已成功地应用HEK 293T贴壁细胞进行高密度的细胞培养。使用TideCell® 在一个单一的CelCradle™ 生物反应器进行HEK 293T细胞的扩增级cGMP级慢病毒载体的生产。这种大规模的293T细胞扩增不同于传统的293T细胞扩增,它仅需要在一个较小的体系里,较短的时间里,较低的经济、人力成本的条件下即可完成。这样的实施和改进可以极大地提高当前慢病毒载体贴壁细胞培养生产设施的生产效率。

“传统上,病毒载体是使用繁琐的多层叠的2D容器生产的。将这种容器与我们的潮汐式生物反应器相比,我们成功地展示了病毒载体的商业化可扩展性,在简单的协议、易用性和相对低的成本下产生了慢病毒载体的整体优势,” 黄娇玲 (博士)解释,艺思高艾斯特,生物加工工艺科学家。

“武汉波睿达生物科技有限公司是中国领先的CAR-T细胞免疫治疗公司中的一员,我们很高兴与艺思高艾斯特开展战略合作来提高我们cGMP级慢病毒载体的生产能力,进而加速我们在CAR-T免疫细胞治疗药品的申报进程,” 张同存 (先生)表示,武汉波睿达生物,首席执行官。

 

关于艺思高集团

艺思高集团 (Esco Group) 的愿景是发明及发现创新技术并将其商业化,从而使人类生活更健康、更安全。艺思高集团是一家总部位于新加坡致力于生命科学与医疗健康领域的研创型国际化企业,拥有30多家分公司,员工超过1000人,其自营产品与服务覆盖全球100多个国家。艺思高集团的经营范围涵盖生命科学设备、医疗设备、生物工艺处理工具及相关服务。日前,艺思高集团投资1亿元人民币在江苏省苏州市太仓兴建了江苏创新中心,新工厂占地面积2万平方米,计划于2019年底前完工。

艺思高风险投资公司 (Esco Ventures),在全球范围内投资生命科学初创企业。艺思高风险投资平台系统X (Esco Ventures X) 是创新发明和科学研究孵化转化成为生命健康初创公司。

艺思高艾斯特(Esco Aster) 是旗下专门为生物研究开发生产的外包服务公司 (CDMO), 为医药企业提供上游和下游生物处理创新药研发及大型制造(cGMP)合成方案。2018年7月,为加快推进CAR-T制备病毒工艺技术平台的合作,新加坡艺思高艾斯特有限公司将与武汉波睿达生物科技有限公司签署战略合作框架协议,将在病毒载体开发、制备和过程分析等领域合作,加快在中国推进研发CAR-T免疫细胞疗法技术。

更多关于艺思高集团详细介绍,请查看中文官网址www.escolifesciences.cn

关于武汉波睿达生物

武汉波睿达生物科技有限公司成立于2014年9月,位于光谷生物城生物创新园,是一家专注于CAR-T免疫细胞治疗技术的生物科技型创新企业,与华中科技大学附属同济医院、武汉科技大学生物医学研究院等建立了密切的合作关系,依托湖北省血液免疫细胞治疗临床医学研究中心,建立了完整的CAR-T技术转化医学研发平台,已自主研发CD19、CD20、CD22、CD30、CD33、BCMA等多项CAR-T免疫细胞治疗技术,同时还积极进行下一代CAR-T技术研发,包括新特异靶点的CAR-T(如CD38、CD123等),免疫增强型CAR-T,可调控型CAR-T等。

更多关于武汉波睿达生物详细介绍,请查看www.bio-raid.com

关于CAR-T免疫治疗法

细胞治疗和再生的先进药物产品已经显示其显著的重要性,尤其是在嵌合抗原受体T(CAR-T)治疗领域。

2017年8月:诺华公司的CTL019 KMYRAH,宾夕法尼亚大学授权,获得FDA批准用于治疗急性淋巴细胞白血病(ALL)儿童和年轻患者。

2017年12月:2017年Gilead收购KITA制药公司(120亿美元现金)之后,Kite制药公司的YESARTA被批准用于复发/难治性大B细胞淋巴瘤的成人患者。

2018年1月:Celgene以90亿美元的价格收购朱诺来进入CAR-T免疫细胞治疗领域。

2018年3月:淡马锡和红杉中国最近宣布在JW生物科技(上海)有限公司领投9000万美元A轮融资,与药明康德集团合作,专注于JWCAR029,一种治疗B细胞恶性肿瘤的CAR-T疗法,以形成一种治疗模式和一个新的商业化治疗方案。

2018年3月:中国食品药品监督管理局批准了南京传奇生物技术公司LCAR-B38 M CAR-T免疫细胞治疗开展临床试验。

2018年5月:诺华宣布FDA批准Kymriah的第二个适应症:治疗复发/难治性大B细胞淋巴瘤。