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://www.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