Spring Intro 2023

22/03/2023

Gene Therapy Landscape 2023

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Product Labels from FDA Approved Products

2. (CAR)T Gene Therapy: B-Cell lymphoma (Yescarta) Pharmacology Studies ….. 4 studies, 1 in mice Anti-Murine CD19 CAR T-Cell Activity in a Syngeneic Mouse LymphomaModel8 No biodistribution, safety pharmacology or toxicology studies with KTE-C19 were conducted. . Toxicology studies , as described in the International Conference on Harmonization (ICH) Safety (‘S’) guidelines, consisting of pharmacokinetics, acute toxicology, chronic toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, safety pharmacology, and immunotoxicity were not conducted 1. Cell Therapy: Prostate Cancer (Provenge) Autologous peripheral blood mononuclear cells: activated with recombinant human protein, PAP-GM-CSF: prostatic acid phosphatase (PAP) linked to granulocyte macrophage colony-stimulating factor (GM-CSF )

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