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APC8015F
- Development stage
- Unknown
- Lead developer
- Dendreon
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Dendritic Cell Vaccines → Immune Effector Cells → Other Cell Types → Cell Therapies
- Administration
- Intravenous
01
Overview
APC8015F is an autologous active cellular immunotherapy developed by Dendreon for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is a specific formulation of sipuleucel-T (Provenge) manufactured from cryopreserved peripheral blood mononuclear cells (PBMCs) rather than fresh cells. The manufacturing process involves activating a patient's own antigen-presenting cells (APCs) in vitro with PA2024, a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). Once infused, these activated cells are intended to stimulate a T-cell mediated immune response against prostate cancer cells expressing the PAP antigen. APC8015F was primarily utilized in crossover protocols, such as the Phase 2 trial for patients who experienced disease progression while on the placebo arm of the pivotal Phase 3 IMPACT trial.
- Other names
- frozen sipuleucel-Tcryopreserved sipuleucel-T
02
Targets
PAP (Prostatic acid phosphatase)CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)
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