CG Oncology Announces First Patient Dosed in Phase 2 Clinical Trial of CG0070, an Oncolytic Immunotherapy, in Combination with KEYTRUDA® (pembrolizumab) for Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin

IRVINE, Calif.–(BUSINESS WIRE)–CG Oncology, Inc., a clinical-stage immuno-oncology company, today announced the first patient has been dosed in CORE1, a Phase 2 clinical trial of CG0070 in combination with KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

“We are motivated to advance this crucially important program, despite the challenges presented under the current global pandemic,” said Arthur Kuan, CEO of CG Oncology. “CG0070, an oncolytic immunotherapy which has been administered to over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with KEYTRUDA, which earlier this year was the first therapy in approximately 20 years approved for this indication.”

Under a previously announced clinical collaboration with Merck relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information can be found at www.clinicaltrials.gov, identifier: NCT04387461

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About CG0070

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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 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 Muscle-Invasive Bladder Cancer (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.

Contacts

Bing Kung

Vice President, Business Development

CG Oncology

(949) 354-4246

[email protected]
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Media

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KKH Advisors

(917) 291-5744

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