CG Oncology, Inc. today announced a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO^® (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study.

CG0070, CG Oncology's lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

“We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with OPDIVO in metastatic urothelial cancer,” said Arthur Kuan, CEO of CG Oncology. “The clinical results to date for CG0070 make it a potential promising agent in bladder cancer and other tumor types, as monotherapy or in combination with immune checkpoint inhibitors.”

CG Oncology will sponsor the study and Bristol Myers Squibb will provide nivolumab. Additional details of the collaboration were not disclosed.

OPDIVO^® is a trademark of Bristol-Myers Squibb Company.

About CG Oncology

CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer. Our lead candidate, CG0070, is a selective oncolytic immunotherapy in a Phase 3 trial with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a combination Phase 2 study of CG0070 with KEYTRUDA^® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO^® (nivolumab), and additional indications in other solid tumors are being pursued with CG0070 in combination with other immune checkpoint inhibitors. At CG Oncology, we aim to take the next evolutionary step in delivering innovative cancer care to millions of patients in need worldwide. Learn more at www.cgoncology.com.

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