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March 24, 2021

Participation in global Phase III clinical trial for CG0070, a drug for bladder cancer

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa, "Kissei") announced that it has initiated a clinical study in Japan by participating in a global Phase III trial (BOND3), which is conducted by CG Oncology, Inc. (Head Office: California, the US; CEO: Arthur Kuan; "CG"), in 4 countries with the focus on the US for the oncolytic viral therapy drug, CG0070. Kissei acquired the exclusive development and marketing right of the agent for twenty Asian countries such as Japan, South Korea, Taiwan with the exception of China in March 2020.

BOND3 is an open-label phase-III trial with non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) following Bacillus Calmette-Guerin (BCG) failure with the primary endpoint being complete response rate.

Following in-licensing the drug, Kissei has been preparing for the start of the Japan part of BOND3 study, including obtaining approval in December 2020 for the first-class use of the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartahena Act).

Kissei has been working to expand the product portfolio in the fields of urology, kidney and dialysis and high unmet medical needs. Kissei will soon proceed with this trial appropriately to aim at providing CG0070 to patients suffering from bladder cancer.

The milestone payment is triggered by this event, but expenses will be recorded in the fiscal year ending March 2022. We will disclose the projected financial results for the fiscal year ended March 22 at the time of the announcement of the financial results for the fiscal year ended in March 2021, scheduled on May 2021.




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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.

About Bacillus Calmette-Guerin (BCG) and carcinoma in situ of the bladder (CIS):
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 in the first-line setting. 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 oncolytic 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 while sparing healthy cells, and then destroying 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 oncolytic immunotherapy in which adenovirus is genetically modified to enhance bladder tumor cells selectivity and anticancer activity, and is injected into the bladder using a urinary tract catheter.
It does not replicate in normal cells, but it replicates inside the tumor cells selectively, causing tumor cell lysis and immunogenic cell death. In addition, the immune system (T cells) activated by the antigen released from the destroyed tumor cells further attacks the cancer cells, showing anticancer activity by a two-step mechanism. CG0070 contains a GM-CSF transgene, which promotes the activation of the immune system.
In clinical studies conducted so far, CG0070 has been shown to be a safe and efficacious agent in NMIBC following BCG failure. It is expetected to be 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, Inc.:
CG Oncology is a clinical-stage immuno-oncology company focused on the development of oncolytic immunotherapies to combat cancer. The company's CG0070 has completed an investigation in a Phase II for patients with NMIBC who failed BCG therapy. 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 https://www.cgoncology.com/