CG Oncology Announces First Patient Dosed in Phase 1b Study of Oncolytic Immunotherapy CG0070 in Combination with OPDIVO® (nivolumab) in Muscle-Invasive Bladder Cancer

CG Oncology Announces First Patient Dosed in Phase 1b Study of Oncolytic Immunotherapy CG0070 in Combination with OPDIVO® (nivolumab) in Muscle-Invasive Bladder Cancer

- Investigator-Initiated Study Will Be Conducted at Moffitt Cancer Center and Enroll Up to 30 Patients with Muscle-Invasive Bladder Cancer -

November 12, 2020 08:00 AM Eastern Standard Time

IRVINE, Calif. & TAMPA, Fla.--(BUSINESS WIRE)--CG Oncology, Inc. announced today that the first patient has been treated in an investigator-initiated Phase 1b study evaluating the safety and efficacy of CG0070 in combination with OPDIVO® (nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. CG0070, the company’s lead product candidate, is a selective oncolytic immunotherapy.

The multi-center trial is being led by Roger Li, M.D. of Moffitt Cancer Center in Tampa, Florida. “We are excited to offer this novel combination to patients without any alternatives for systemic treatment prior to radical cystectomy,” said Li. “Additionally, this study will also enable us to investigate whether CG0070 can be used as the match to ignite the anti-bladder cancer immune response and to further our understanding of the mechanisms underpinning successful immunotherapy.”

“CG0070 dosing of the first patient in our Phase 1b combination study with anti-PD1 antibody OPDIVO represents a key milestone for our oncolytic immunotherapy clinical program,” said Arthur Kuan, Chief Executive Officer at CG Oncology. “The combination regimen of CG0070 and OPDIVO may provide improved outcomes for patients, based on extensive preclinical and clinical research of both these candidates to date. We are excited to advance our investigational oncolytic immunotherapy CG0070 to improve the lives of patients with MIBC.”

The Phase 1b study will evaluate CG0070 combined with nivolumab in cisplatin-ineligible patients with MIBC. The single-arm, multi-center trial will enroll up to 30 patients with or without pelvic lymphadenopathy and who show no evidence of distant metastases prior to radical cystectomy. Primary endpoints of the trial will be safety and pathological complete response rate. For additional information about the clinical trial, visit www.clinicaltrials.gov (NCT04610671).

About CG0070

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in Non-Muscle-Invasive Bladder Cancer (NMIBC) following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

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 which has completed a Phase 2 trial for the treatment of high-grade NMIBC after BCG failure. Additional indications in MIBC and other solid tumors are being pursued with CG0070 in combination with immune checkpoint modulators. 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.