CG Oncology (CGON.US) announced that it has obtained positive results in a phase 3 clinical trial of developing oncolytic virus therapy cretostimogene in the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients who do not respond to BCG (BCG).
Zhitong Finance App learned that CG Oncology (CGON.US) announced that it is developing oncolytic virus therapy cretostimogene and has obtained positive results in a phase 3 clinical trial to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients who do not respond to BCG (BCG). 75.2% (79/105) of patients achieved complete remission. Furthermore, 29 patients maintained complete remission for more than 12 months. This treatment has been granted breakthrough therapy certification and fast track status by the US FDA.
According to reports, Cretostimogene is an oncolytic virus immunotherapy administered by injection into the bladder. The administration method is similar to BCG treatment. It is based on a modified adenovirus type 5 (Ad5) skeleton, contains a tumor-specific promoter, and carries a transgene that expresses granulocyte-macrophage colony stimulating factor (GM-CSF). This design allows cretostimogene to be selectively expressed in tumor cells, and after cell lysis, GM-CSF is released along with tumor-specific antigens and other risk signals. GM-CSF can activate dendritic cells (DCs), which recognize tumor antigens and present them to cytotoxic and helper T cells, thereby promoting their maturation. These T cells are then able to circulate throughout the body to identify and attack remaining tumor cells.
CG Oncology is the first biotech company to complete an IPO in 2024, raising US$380 million through the IPO in January of this year. The company's oncolytic viral therapy, cretostimogene, is currently being tested in 3 clinical trials.