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FRAME-001 is a personalized therapeutic cancer vaccine designed for the treatment of advanced (stage III-IV) non-small cell lung cancer (NSCLC). It is based on the identification and selection of tumor-specific neoantigen peptides, particularly those arising from frameshift mutations unique to each patient's tumor (the "Framome"). These neoantigens are synthesized as peptides and formulated into a vaccine, which is then administered in combination with the immune checkpoint inhibitor pembrolizumab. The goal is to stimulate a robust anti-tumor immune response by activating CD4+ and CD8+ T cells against these patient-specific targets. The formulation includes up to 24 selected neoantigen peptides mixed with the adjuvant Montanide ISA 51 VG. Developed under GMP conditions, FRAME-001 represents an individualized immunotherapy approach aiming to enhance clinical outcomes in NSCLC patients who have stable disease after initial standard-of-care therapy[1][2][3][4][5][6][7].
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