IRVINE, Calif.–(BUSINESS WIRE)–CG Oncology, Inc. has announced today an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co., Ltd. (“Kissei”) for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China. CG Oncology has completed an investigational Phase 2 study of CG0070 in the United States in patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC). In addition, CG Oncology is studying the use of CG0070 in combination with immune checkpoint inhibitors in bladder cancer and other solid tumors.

“We are very excited to partner with Kissei, an R&D-oriented Japanese pharmaceutical company that shares our interests in developing innovative medicines for patients with debilitating urological and oncology conditions,” said Arthur Kuan, CEO of CG Oncology. “Kissei possesses a track record of commercial success with both in-licensed and proprietary therapies in Asian markets, and their dedication to develop CG0070 in these territories makes Kissei an ideal partner. We sincerely look forward to collaborating with them to accelerate the development of CG0070 and to globalize patient access to a potentially important new therapeutic.”

Under the terms of this agreement, CG Oncology receives a licensing fee of $10 million in cash, with the potential for an additional $100 million in development and commercial milestone payments, and will receive certain royalties on sales of CG0070 in the territories licensed by Kissei. CG Oncology also receives a $30 million equity investment from Kissei. Further financial details of the agreement were not disclosed.

“Through our extensive experience with in-licensed and proprietary therapies, we have strong expertise to successfully develop and commercialize CG0070 in Japan, and other countries,” said Mutsuo Kanzawa, Chairman and CEO of Kissei. “We look forward to collaborating closely with CG Oncology to address the significant unmet medical needs of patients with this innovative medication.”

About CG0070

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 retinoblastoma (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 inhibitors.

About CG Oncology

CG Oncology, previously known as 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, CG Oncology is exploring the use of CG0070 in combination with immune checkpoint inhibitors in different solid tumors. Learn more at www.cgoncology.com.

About Kissei Pharmaceutical Co., Ltd.

Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide. Kissei is engaged in bringing new drugs into the world through drug discovery and licensing activities in the field of urology, nephrology/dialysis, and rare/intractable diseases, which are its focus fields.