Source: Pharmaceutical Technology
The CAR-T cell therapy involves modifying patients’ T-cells to express a CAR that targets BCMA, a protein found on multiple myeloma cell surface. Credit: Nemes Laszlo / Shutterstock.com. Source: Pharmaceutical Technology
The B cell maturation antigen (BCMA)-targeted autologous chimeric antigen receptor (CAR)-T product candidate is indicated to treat adults with relapsed or refractory multiple myeloma who have not responded to three lines of previous therapies. The therapy involves modifying patients’ T-cells to express a CAR that targets BCMA, a protein commonly found on the surface of multiple myeloma cells. The cells are then infused back into the patient to attack and kill the cancer cells. The approval is based on results from the LUMMICAR STUDY 1, a Phase II clinical trial conducted in China.
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Source: Pharmaceutical Technology
Nanobiotix files patent for porous, high-z, carbon-free particles for oncology therapy Source: Pharmaceutical Technology
The multicentre open-label, single-arm trial demonstrated that zevorcabtagene autoleucel has “encouraging” efficacy and a favourable safety profile. CARsgen is also conducting a separate Phase Ib/II LUMMICAR STUDY 2 in North America. This trial aims to assess the efficacy and safety of CAR-T therapy in the same patient population. In 2019, the therapy received multiple designations from international regulatory agencies, including regenerative medicine advanced therapy and orphan drug designations from the US Food and Drug Administration. The European Medicines Agency granted priority medicines and orphan medicinal product designations in 2019 and 2020 respectively. The NMPA awarded zevorcabtagene autoleucel breakthrough therapy designation in 2020. Huadong Medicine gained sole rights to commercialise the CAR-T therapy within the territory. “Guided by the vision of making cancer curable, we remain committed to exploring new technologies, expanding our product pipeline with global rights to address the major challenges of CAR T-cell therapies, and bringing innovative and differentiated cell therapies to cancer patients worldwide.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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Free WhitepaperCell and gene therapies: Pipe dream to pipeline
The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Source: Pharmaceutical Technology
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