ATU Archives - WuXi Advanced Therapies

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

Posted on June 6, 2023June 4, 2024 by Amy Lamperti

June 6, 2023 – Boston, Massachusetts. WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO), and T-MAXIMUM today 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, former 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 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

Clinical Phase I/II IND Approval! The first cell therapy project in Korea supported by WuXi Advanced Therapies receives MFDS approval

Posted on March 16, 2023June 4, 2024 by Amy Lamperti

Wednesday March 8, 2023 – TICAROS, a Korean CAR-T developing biotech in partnership with WuXi Advanced Therapies (WuXi ATU) received IND approval from the Korean Ministry of Food and Drug Safety (MFDS).

WuXi Advanced Therapies is a global Contract Testing, Development and Manufacturing Organization (CTDMO). WuXi ATU has delivered solutions through the OXGENE plasmid optimization, GMP lentivirus manufacturing and IND application filling, for TICAROS’ new CAR-T cell therapy product in Korea. In this collaboration, WuXi ATU supported customer not only for the process development and manufacturing of LVV for the CAR-T product, but also prepared the IND filing documentations with high quality and speed to obtain MFDA approval for phase I and phase II clinical trials in one application. This greatly accelerates the TICAROS’s efforts to develop new cell therapy product to patients in need.

Mr. Jae Won Lee, CEO of TICAROS, said: “I am very grateful to WuXi ATU for its excellent work in the development of our next-generation CAR-T cell therapy. The cooperation with WuXi ATU in the Oxford UK, China sites has greatly improved the speed of our drug development.”

“Congratulations to TICAROS for the approval of CAR-T IND in Korea, and appreciate TICAROS’ recognition of WuXi ATU CTDMO services.” Edward Hu, Chairman and CEO of WuXi ATU said, “This is the first IND approval supported by WuXi ATU in Korea. WuXi ATU’s one-stop CTDMO service platform will continue to empower cell and gene therapy innovation companies, support global customers to accelerate the development, testing and manufacturing of innovative cell and gene therapies for patients in needs.”

TICAROS’ New CAR-T Cell Therapies

TICAROS’ next generation immunotherapies is being developed for intractable haematologic malignancies and advanced solid tumors. TICAROS’ cutting-edge platform technologies include CLIP CAR (Clamping-based Immunological Synapse Potentiating CAR) Technology, a strategy to stabilize immune synapse between CAR-T cells and target tumor cells by modifying CAR structure, which results in maximized efficacy of CAR-T cells and CONVERTER CAR Technology, which enables selective inhibition of CTLA4 only in tumor-specific CAR-T cells without affecting other T cells in patients’ blood. Thus, the selective inhibition of CTLA-4 only in CAR-T cells potentiates CAR-T activity without causing serious autoimmunity.

About TICAROS Co., Ltd (TICAROS)

TICAROS Co.Ltd is a biotech which develops next generation immunotherapies for both hematological and solid cancers. Recently, alongside with antibody techniques, immuno-oncology therapies are evolving into novel cellular therapeutics which harbor immune cell therapies and gene therapies together. Especially, the outstanding clinical efficacy of CAR-T cell therapies and the potential for successful TCR-T therapies are leading a new era of cancer therapeutics. TICAROS develops matchless CAR-T and cell therapeutics for cancer treatment, by leveraging accumulated experiences and technologies of immunologists at Seoul National University, College of Medicine. We hope that these efforts will lead to a novel breakthrough in treatment of not only intractable hematologic malignancies, but also of advanced solid tumors.

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 https://advancedtherapies.com/

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,800 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.” Please visit: http://www.wuxiapptec.com.

WuXi Advanced Therapies Announces Licensing Agreement with Janssen

Posted on August 12, 2022June 4, 2024 by Amy Lamperti

August 11, 2022 – PHILADELPHIA, PA. WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced a licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral (AAV) vectors than traditional AAV manufacturing systems. Janssen will also have access to work on WuXi ATU’s proprietary clonal suspension HEK293 cell line. This agreement was facilitated by Johnson & Johnson Innovation.

AAV vectors are commonly used for the delivery of gene therapies to patients due to their ability to transduce numerous cell and tissue types. WuXi ATU’s TESSA™ technology responds to industry demand for large scale AAV manufacturing by producing higher quality AAV particles more efficiently. WuXi ATU has also successfully scaled up the TESSA™ technology to 200L; this achieved a 10-fold higher yield and a significantly higher percentage of full AAV capsids, greatly reducing overall AAV production costs compared to traditional plasmid-based AAV production systems.

“We are honored that Janssen selected WuXi ATU’s TESSA™ technology.” said David Chang, CEO of WuXi Advanced Therapies. “We remain committed to improving the TESSA™ platform to produce faster and more cost effective AAV products for patients.”

As a Contract Testing, Development and Manufacturing Organization (CTDMO) with global operations, WuXi ATU will continue to enhance its capability and capacity to help customers develop and deliver life-changing cell and gene therapies faster for patients in need.

About WuXi Advanced Therapies (WuXi ATU)

About WuXi AppTec

Media Contact:
Davy Wu | mediainquiries@wuxiapptec.com

WuXi Advanced Therapies Testing Facility To Receive EMA GMP Certificate for New Philadelphia Facility

Posted on January 7, 2022June 4, 2024 by Amy Lamperti

January 07, 2022 – Philadelphia. WuXi Advanced Therapies (WuXi ATU) announced it has successfully completed a remote European Medicines Agency (EMA) inspection for its advanced therapies testing facility at 400 Rouse Boulevard in its Philadelphia Navy Yard Campus, and received confirmation that the issuance of GMP certificate is in progress. This certification will not only mark an important milestone for WuXi ATU, the advanced therapies business unit of WuXi AppTec, on its global quality system, but it will underscore its commitment to providing cell and gene therapy Contract Testing Development and Manufacturing Organization (CTDMO) services with the highest standards for customers.

The issuance of GMP certificate followed a remote inspection conducted by Ireland’s Health Products Regulatory Authority (HPRA) in December 2021. The comprehensive inspection covered Virology and Mycoplasma Quality Control testing and the facility’s entire quality system. The positive inspection outcome will support ongoing submissions to the EMA for new biologics and cell and gene therapy products from our global commercial partners.

The new state-of-the-art testing facility, which officially opened two months ago, has tripled WuXi ATU’s capacity for testing to meet the growing demand among the cell and gene therapy industry. The Biosafety Testing team has significant expertise in assay development, biologics safety testing, viral clearance and commercial lot release assays and will benefit from increased capacity with this new testing facility expansion in Philadelphia.

“At WuXi ATU, delivering the highest quality standards for our customers and meeting global regulatory standards are among our top priorities.” said Dr. David Chang, Chief Executive Officer of WuXi ATU. “The EMA certificate for biosafety testing at our new Philadelphia facility is a testimony to our commitment to being a trusted partner to our customers. As demand for cell and gene therapies grow, we will further enhance our CDMTO platform to better enable customers in Philadelphia and beyond to bring ground-breaking therapeutics to patients as quickly, reliably and consistently as possible.”

As a CTDMO with global operations, WuXi ATU’s unique business model integrates powerful testing capabilities with its advanced therapies process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing. This allows all assay development, biosafety, viral clearance, and product release testing to be completed in-house, shortening customers’ timelines for the approval of advanced therapies. WuXi ATU has supported more than 1,700 customer submissions for biosafety testing through industry-leading testing and analytical assay development, enabling the delivery of more effective and accessible advanced therapies to patients.

About WuXi Advanced Therapies (ATU)

WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organization (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies for customers worldwide. Our technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance. Ultimately, our complete end-to-end solutions support pioneering companies to deliver breakthrough cell and gene therapies to the patients who need them. For more information, please visit www.advancedtherapies.com.