• 2024
  • 2023
  • 2022
  • 2021
  • 2020

back

March 27, 2020

Licensing Agreement for CG0070, a Drug for Bladder Cancer

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa) announced that it has entered into a licensing agreement with CG Oncology, Inc. (Head Office: California, the US; CEO: Arthur Kuan; "CG") for its oncolytic viral therapy drug CG0070, which is under development for the treatment of bladder cancer for twenty Asian countries such as Japan, South Korea, Taiwan with the exception of China.

Under the terms of this agreement, we will make a $30 million equity investment in CG and pay a $10 million licensing fee after initiation of Phase III clinical trials in the United States. In addition, we will pay CG up to $100 million in development and commercial milestone payments, as well as certain royalties on sales in our territory.

Kissei Pharmaceutical has been working to expand the product portfolio in the fields of urology, kidney and dialysis and high unmet medical needs. Through this agreement, we will further strengthen our commitment to treating urological diseases and aim at providing CG0070 to patients suffering from bladder cancer soon.

This agreement has negligible effects on Kissei's consolidated business forecasts for the fiscal year ending in March 2020.




《Reference》

About Bladder Cancer
Bladder cancer is a malignant tumor that begins in the lining of the urothelium (transitional cell) of the bladder. The estimated number of patients with bladder cancer in Japan exceeds 20,000 a year, and approximately 75% are men. Both men and women have a high percentage of bladder cancer from the 60-year-old age group. Bladder cancer is largely divided into two groups, non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). For NMIBC, especially for carcinoma in situ of the bladder, standard-of-care treatment is Bacillus Calmette-Guerin (BCG) therapy first. Currently, in most patients with NMIBC who failed BCG therapy or are recurrent, radical cystectomy is indicated. Preservation of the bladder is also desired to maintain the patient's quality of life, and viral therapy is being researched and developed as new pharmacotherapies.

About Oncolytic Viral Therapy
Viral therapy is a new treatment for tumor cells that infects cancer cells with viruses that have been modified to specifically multiply in cancer cells without harming healthy cells, and then destroy and amplify the cancer cells. These viruses are called oncolytic viruses. Some oncolytic viruses are expected to be effective not only in the direct destruction of cancer cells, but also in activating an immunological response in human body.

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 II 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. For more details on CG Oncology, please visit www.cgoncology.com.