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This is a **combination immunotherapy regimen** used in early-phase clinical investigation, especially in newly diagnosed glioblastoma. It consists of: - **APVAC vaccine**: a personalized, multi-peptide cancer vaccine, designed for each patient to target tumor-associated and patient-specific mutated antigens, aiming to elicit multi-specific CD4+ and CD8+ T cell responses that kill tumor cells. - **Poly-ICLC (Hiltonol)**: a synthetic double-stranded RNA adjuvant that mimics viral infection, activating the innate immune response by stimulating Toll-like receptor 3 (TLR3) and MDA5, inducing type I interferon (IFN-I) and IL-15, and enhancing T-cell expansion and response. - **Sargramostim (Leukine, GM-CSF)**: a recombinant human granulocyte-macrophage colony-stimulating factor, which promotes the production, maturation, and function of dendritic cells, neutrophils, and macrophages, assisting in antigen presentation and adaptive immunity. The combination is designed to maximize tumor antigen presentation (via sargramostim), stimulate innate and adaptive immune activation (via poly-ICLC), and provide highly personalized tumor targeting (APVAC vaccine). The regimen is used in combination with first-line temozolomide maintenance therapy for glioblastoma, administered primarily as intradermal (vaccine and GM-CSF) and subcutaneous (poly-ICLC) injections. Development and trials are led by Immatics and BioNTech.
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