cretostimogene grenadenorepvec

Cretostimogene grenadenorepvec is an investigational, conditionally replicating oncolytic immunotherapy based on a serotype 5 adenovirus. It is engineered to selectively replicate in tumor cells with defects in the retinoblastoma (Rb) pathway, which are common in urothelial carcinomas such as non-muscle invasive bladder cancer (NMIBC). The virus contains two key modifications for tumor selectivity and potency: insertion of an E2F1 promoter to restrict replication to Rb-defective cells, and insertion of the gene encoding granulocyte-macrophage colony stimulating factor (GM-CSF), a cytokine that stimulates anti-tumor immune responses. Upon intravesical administration, cretostimogene infects tumor cells via Coxsackievirus and Adenovirus Receptors (CAR), replicates within them causing cell lysis, and releases both viral/tumor antigens and GM-CSF. This dual mechanism results in direct tumor cell killing as well as stimulation of systemic anti-tumor immunity. Cretostimogene grenadenorepvec is being developed primarily for BCG-unresponsive NMIBC by CG Oncology and has received FDA Fast Track and Breakthrough Therapy Designations[1][3][4][5][6][7][8].

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cretostimogene grenadenorepvec