SANTA ANA, Calif.--(BUSINESS WIRE)--Cold Genesys, Inc. today announced that it has entered into a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of Cold Genesys' lead oncolytic immunotherapy candidate CG0070 with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in a Phase 2 clinical study.
The trial is planned to evaluate the preliminary safety and efficacy of CG0070 plus KEYTRUDA in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), an unmet medical need, as no treatment for this indication has been approved by the FDA in approximately 20 years.
CG0070, an investigational 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, which is present in many cancers. Several CG0070 clinical studies including a completed Phase 2 study (BOND2) have demonstrated a favorable safety profile and encouraging efficacy in patients with NMIBC following BCG failure.
"We are delighted to be collaborating with Merck on this innovative combination approach," said Arthur Kuan, CEO of Cold Genesys. "CG0070, which has demonstrated clinical safety and efficacy in over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with KEYTRUDA, which also has demonstrated single agent activity in the indication."
Cold Genesys will sponsor the study. Additional details of the collaboration were not disclosed.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
CG0070, a selectively replicative 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 Rb pathway. CG0070 was designed to work in two complementary ways. First, it replicates inside the tumor’s cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, which can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells. In advanced clinical studies, CG0070 has been shown to be a safe and efficacious agent in NMIBC following BCG failure. The scientific rationale and clinical results to date of CG0070 make it a promising agent to be developed for a variety of solid tumor types to be used alone or in combination with immune checkpoint modulators.
About Cold Genesys
Cold Genesys is a clinical-stage immuno-oncology company focused on the development of oncolytic immunotherapies to combat cancer. The company's lead candidate CG0070 has completed an investigation in a Phase 2, single-arm, open-label, multicenter study (BOND2) for patients with NMIBC who failed BCG therapy and refused cystectomy. In addition, Cold Genesys is exploring the use of CG0070 in combination with immune checkpoint modulators in different solid tumors.