CG Oncology, Inc., announced today completion of patient enrollment for BOND-003, a single arm, Phase 3, monotherapy study evaluating cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

In the BOND-003 study there are 110 patients enrolled with BCG-Unresponsive High-Risk NMIBC across North America and the Asia-Pacific regions. The primary endpoint of the study is complete response (CR) at any time. Secondary endpoints include CR at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety. For more information about BOND-003, visit www.clinicaltrials.gov (NCT04452591).

“As a patient advocacy organization, it is exciting to see new treatments get closer to being available to bladder cancer patients with BCG-unresponsive disease, who have so few options available. Many will only have the option of bladder removal, which is not always available due to other health concerns,” said Andrea-Maddox Smith, Chief Executive Officer, Bladder Cancer Advocacy Network (BCAN). “We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials.”

“We would like to thank all those who partnered with us to complete this study especially patients, care givers, physicians and health care teams in the United States and globally who helped us reach this important milestone,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “We are intensely focused on developing bladder-sparing therapeutics and are actively engaged in making cretostimogene available to patients as soon as possible.”

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA^® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO^® (nivolumab).

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer this year. NMIBC is the most common form of bladder cancer, representing approximately 75% of cases. Four times more men are diagnosed with bladder cancer than women and is the fourth most common type of cancer in men in the United States.

About CG Oncology

CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, please visit: www.cgoncology.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230724507618/en/