On December 9, 2020 CG Oncology, Inc., a clinical-stage immuno-oncology company, reported 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) (Press release, CG Oncology, DEC 9, 2020, View Source [SID1234572531]).
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"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
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.