CG Oncology to Present New Phase 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin at SITC 2022 Annual Meeting

IRVINE, Calif., October 24, 2022 – CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, announced acceptance of an oral presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually and in person in Boston, MA from November 8-12, 2022.

CG Oncology will present safety and efficacy data from CORE1, an ongoing Phase 2 clinical trial of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which is fully enrolled with 35 patients treated with therapy, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Details of the oral presentation are as follows:

Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 666
Presenter: Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center
Session Date & Time: Thursday, November 10, 2022, 11:55am-12:55pm Eastern Standard Time
Location: Boston Convention & Exhibition Center, Room 258ABC, or online at https://www.sitcancer.org/2022/home

About CG0070

Our lead candidate, CG0070, is an intravesically delivered selective oncolytic immunotherapy agent that is currently in a Phase 3 trial for the treatment of BCG-unresponsive NMIBC. It is also in Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO® (nivolumab).

About CG Oncology

CG Oncology is a privately-held oncolytic immunotherapy company that is intensely focused on developing bladder saving therapeutics for all people with bladder cancer. At CG Oncology we see a world where urologic cancer patients can benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, go to www.CGOncology.com

Contacts

Bing Kung
Vice President, Business Development
CG Oncology
bd@cgoncology.com

Media
Kimberly Ha
KKH Advisors
(917) 291-5744
kimberly.ha@kkhadvisors.com