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Adenovirus-p16 is a recombinant adenoviral vector engineered to deliver and express the full-length human *p16INK4a* (CDKN2A) tumor suppressor gene in target cells. The drug utilizes adenovirus-mediated gene transfer to induce *p16* expression, leading to G1 cell cycle arrest and suppression of tumor cell proliferation. *p16* acts by inhibiting cyclin-dependent kinase 4 (CDK4), blocking phosphorylation of retinoblastoma protein (pRb), and thereby preventing cell cycle progression at the G1/S checkpoint. This gene therapy approach aims to compensate for frequent *p16* gene deletions in tumors, restoring cell cycle regulation and reducing tumor invasiveness. The main applications investigated have included glioma[1], pancreatic cancer[3], and laryngeal carcinoma[7]. In preclinical models, adenovirus-p16 induced cell cycle arrest, inhibited proliferation, and suppressed tumor growth, particularly as supplementary therapy to surgery or chemotherapy.
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