药明生基与茂行生物就通用型CAR-T产品达成战略合作 | Bilingual News

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关键词：战略合作合作

资讯来源：药明康德

发布时间： 2023-06-09

▎药明康德内容团队编辑

日前，药明生基与茂行生物美国公司T-MAXIMUM Pharmaceutical（简称：T-MAXIMUM）共同宣布达成战略合作协议。药明生基将为茂行生物的MT-027通用型CAR-T细胞产品在美国提供一体化测试、工艺开发、申报批生产及IND申报等全流程服务。

MT-027产品是茂行生物自主研发的一款靶向B7-H3的同种异体通用型CAR-T细胞治疗产品，适应症为复发性高级别脑胶质瘤，此前已获美国FDA授予的孤儿药资格。

关于此次合作，茂行生物CEO尚小云博士表示：“我们非常高兴能与药明生基成为战略合作伙伴，茂行生物致力于通用型CAR-T产品的开发。我们希望充分利用药明生基CTDMO服务平台，快速推进MT-027产品的测试、工艺开发、申报批生产和IND申报。未来也期待双方在更多产品管线上的深度合作。”

茂行生物联合创始人、董事王小平先生，首席技术官兼全球注册事务高级副总裁范勇博士出席了签约仪式，并一同参观了药明生基费城生产基地。

药明生基董事长兼首席执行官胡正国先生表示：“非常感谢茂行生物对药明生基的认可。我们非常高兴能为茂行生物提供一体化CTDMO服务。通用型CAR-T作为细胞疗法未来的发展方向，有望为患者带来更即时可用的‘现货型’疗法。药明生基将赋能茂行生物加速MT-027产品的开发，造福更多病患。”

▲茂行生物和药明生基签约仪式现场（左二为药明生基董事长兼首席执行官胡正国先生，左三为药明生基首席商务官陈琪博士，左一为药明生基首席技术官张幼翔博士；右三为茂行生物CEO尚小云博士，右一为茂行生物联合创始人、董事王小平先生，右二为茂行生物首席技术官兼全球注册事务高级副总裁范勇博士）

关于MT027

MT027是用健康供者T细胞制备的靶向B7-H3的同种异体嵌合抗原受体T细胞（UCAR-T）注射液，是新一代的现货型嵌合抗原受体T细胞（CAR-T）产品，与目前主流的自体CAR-T细胞产品相比，可即时、及时用于患者，以解决因制备周期过长、制备产能不足、患者T细胞不符合制备条件等常见原因而导致的大量患者无法接受CAR-T治疗的医疗需求未能满足的问题。此外，同种异体CAR-T细胞的预期医疗费用大幅降低，可极大减轻患者经济负担。

MT027通过基因修饰技术将靶向B7-H3的嵌合抗原受体（CAR）表达于基因编辑T细胞表面制备而成。茂行生物针对B7-H3靶点的MT027产品避免了因外源性T细胞与患者免疫系统之间相互作用而可能出现的移植物抗宿主病（GvHD）和宿主抗移植物反应（HvGR），在复发高级别胶质瘤中初步展示了良好的安全性和有效性。

药明生基

药明生基致力于加速和变革细胞治疗、基因治疗及其他高端治疗的开发、测试、生产和商业化，以独特的商业模式将强大的测试能力与工艺开发及生产平台能力紧密结合，为合作伙伴的CGT疗法提供从发现到上市申请准备阶段（DNA到BLA）的服务。截至2023年第一季度，药明生基为68个项目提供了开发与生产服务，其中包括52个临床前和临床I期项目，8个临床II期项目，8个临床III期项目（其中2个项目处在上市申请审核阶段，2个项目处于上市申请准备阶段）。目前，我们已助力一家美国客户完成一个将成为世界首个创新肿瘤淋巴细胞疗法（TIL）项目的上市许可申请（BLA）；以及助力一家中国客户完成CAR-T细胞治疗的慢病毒载体（LVV）项目的BLA，并顺利通过国家药品监督管理局食品药品审核查验中心（CFDI）药品注册核查的现场延伸检查，成为中国首家通过CFDI LVV注册现场核查的CGT CDMO。

WuXi ATU and T-MAXIMUM Announce Strategic Partnership of Cooperation for MT-027 UCAR-T

WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO), and T-MAXIMUM signed a strategic collaboration agreement. WuXi ATU will provide integrated testing, development and manufacturing and IND filing services for T-MAXIMUM's UCAR-T product MT-027.

MT-027 is a universal allogeneic CAR-T cell therapy product targeting B7-H3 for the treatment of recurrent high-grade glioma. It has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).

"We are delighted to be a strategic partner with WuXi ATU,"said Dr. Xiaoyun Shang, CEO of T-MAXIMUM. "T-MAXIMUM's mission is to develop UCAR-T product for patients in need, and we are glad to take the full advantage of WuXi ATU's CTDMO platform to accelerate MT-027 testing, process development, manufacturing and IND filing. In the future, we also desire to deepen our collaboration on more pipeline products."

Xiaoping Wang, Co-founder and Director of T-MAXIMUM, and Dr. Yong Fan, Chief Technology Officer and Senior Vice President of Global Regulatory Affairs, attended the signing ceremony and visited the WuXi ATU's Philadelphia site.

"We are grateful for T-MAXIMUM's trust in WuXi ATU to provide integrated CTDMO services for T-MAXIMUM's UCAR-T product MT-027. UCAR-T, as an important modality of cell therapy products, has great potential to offer patients more readily available 'off-the-shelf' cell therapy treatment." Edward Hu, Chairman and CEO of WuXi ATU said, "WuXi ATU will work together with T-MAXIMUM to accelerate MT-027's development to bring this life saving treatment to patients in need efficiently."

▲T-MAXIMUM & WuXi Advanced Therapies Contract Signing Ceremony. The second on the left is Edward Hu, Chairman and CEO of WuXi ATU, the third on the left is Dr. Angela Chen, Chief Business Officer of WuXi ATU , the first on the left is Dr. David Chang, Chief Technology Officer of WuXi ATU, and the third on the right is Dr. Xiaoyun Shang, CEO of T-MAXIMUM, the first on the right is Xiaoping Wang, Co-founder and Director of T-MAXIMUM, the second on the right is Dr. Yong Fan, Chief Technology Officer and Senior Vice President of Global Regulatory Affairs of T-MAXIMUM.

About MT027

MT027, an allogeneic chimeric antigen receptor T-cell (UCAR-T) therapy targeting B7-H3, is prepared using T cells from healthy donors. As a next-generation off-the-shelf CAR-T product, MT027 can be immediately and readily available for patients, addressing the common challenges of autologous cell therapies such as lengthy preparation cycles, insufficient capacity, and patients' T cells not meeting the manufacturing criteria, which often result in many patients unable to receive CAR-T therapy timely. Additionally, the expected medical costs are significantly reduced, relieving patients' financial burden.

MT027 is developed through genetic modification techniques, where CAR targeting B7-H3 is expressed on the surface of gene-edited T cells, which avoids the GvHD and HvGR that may arise from interactions between exogenous T cells and the patient’s own immune system with promising safety and efficacy in the treatment of recurrent high-grade gliomas.

T-MAXIMUM Biotech

T-MAXIMUM Biotech is dedicated to the development of universal cellular drugs, exploring the treatment of "incurable" diseases with cellular drugs as the ultimate form of medication. The team is composed of renowned experts in the field of immunotherapy and gene editing and senior industry professionals in the field of biopharmaceuticals. The company's core technology platform, gene-edited allogeneic immunotherapy, adopts the 3.0 version of its completely independent intellectual property rights to achieve allogeneic universal CAR-T cell therapy, addressing the risk of graft-versus-host disease and rejection of allogeneic immune cells, and the obtained allogeneic CAR-T cells persist well in patients. The company is currently focusing on advanced malignant tumors, and its first product pipeline for recurrent gliomas has achieved validation of efficacy and safety in preliminary clinical studies. The company plans to promote the launch of at least one product to the market and multiple products into clinical phase II in the next five years.

T-MAXIMUM Biotech always adheres to the corporate philosophy of "integrity innovation, quiet water flowing deep, and collaborative integration", overcoming the difficulties to solve the clinical problem of no cure, to be the real original innovation, and to be a globally leading innovative company in cell therapy, to provide the means for "incurable" diseases.

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 genetherapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information, please visit https://www.advancedtherapies.com