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Stapuldencel (also known as stapuldencel-T or DCVAC/PCa) is an autologous dendritic cell-based active cellular immunotherapy developed by Sotio Biotech. The therapy is produced by collecting a patient's own dendritic cells and pulsing them ex vivo with a prostate tumor cell lysate that contains a broad spectrum of tumor-associated antigens (TAAs). This process is designed to activate the dendritic cells, which, upon re-administration to the patient, stimulate a T-cell mediated immune response against prostate cancer cells. Stapuldencel has been evaluated in several clinical settings, most notably in the Phase III VIABLE trial for metastatic castration-resistant prostate cancer (mCRPC), as well as in Phase II trials for localized and metastatic prostate cancer.
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