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SHANGHAI, Aug. 24, 2022 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, has announced the 2022 Interim Results.
Business Highlights
- CT053: completed enrollment for pivotal Phase II trial in Chinawith plan to submit the NDA to the NMPA in the third quarter of 2022
- CT041: initiated a confirmatory Phase II clinical trial in China
- CT041: was granted RMAT by the FDA
- CT041: data from a China Investigator-Initiated Trial was published in Nature Medicine
- Continuous development of innovative CAR T technologies to empower the next generation pipeline products
- US CGMP manufacturing facility began operations, with plan to support clinical trials in North America from second half 2022
- Appointed CARsgen CMO and CARsgen US President
Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said that “In the first half of 2022, CARsgen has made significant progresses in advancing our technology innovations, product pipeline, and business operations in the US and Chinadespite the impact of the COVID-19 pandemic. CT041 has become the world’s first and the only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial. For CT053, we plan to submit the NDA to the NMPA in the third quarter of 2022. Our US CGMP manufacturing facility has also started operations. We continue to dedicate ourselves to advancing innovative CAR T technologies to address the major challenges of the industry. We have also established in-house, vertically integrated manufacturing capabilities . Driven by the vision of Making Cancer Curablewe expect to bring innovative and differentiated cell therapy to cancer patients around the world as soon as possible, creating value for investors and the public.”
1. Steady development of product pipeline with leadership position in CAR T cell against solid tumors
CT053
CT053 is an upgraded fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. It incorporates a CAR construct with a fully human BCMA-specific single-chain variable fragment (scFv) with lower immunogenicity and increased stability , which overcomes the challenge of T-cell exhaustion by reducing the self-activation of CAR T cells in the absence of tumor-associated targets.
CT053 received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for the treatment of R/R MM from the US FDA in 2019, PRIority Medicines (PRIME) eligibility in 2019 and Orphan Medicinal Product designation in 2020 for the treatment of R/R MM from the European Medicines Agency (EMA), and Breakthrough Therapy designation for the treatment of R/R MM from the NMPA in 2020.
CARsgen has completed the patient enrollment of the pivotal Phase II trial patients in China (LUMMICAR STUDY 1) and plans to submit the NDA to the NMPA in the third quarter of 2022. CARsgen is conducting the pivotal Phase 2 trial in North America (LUMMICAR STUDY 2), and the Company plans to submit the BLA to the US FDA in the end of 2023. The Company also plans to conduct additional clinical trials to develop CT053 as an earlier line of treatment for multiple myeloma.
An update from the China investigator-initiated trials (IITs) was published in …
Full story available on Benzinga.com
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