- Durability Results from BOND-003 data will be presented as a late breaker as part of AUA’s Practice-changing, Paradigm-shifting Clinical Trials in Urology -
- Additional updates from across CG Oncology’s clinical trial program, including translational data, planned -
IRVINE, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced BOND-003 study of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer has been selected as a late breaker as part of American Urological Association (AUA)’s Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2s). Designed to showcase the exceptional, groundbreaking studies that are expected to change the day-to-day practice of urology, P2s are reserved for the most impactful studies and will be presented on the Plenary stage. Additionally, CG Oncology will present updates to ongoing clinical trials evaluating cretostimogene across the non-muscle invasive bladder cancer (NMIBC) treatment landscape which are expected to influence urology practice, as well as one interactive poster on translational data. The AUA Annual Meeting, scheduled from April 26-29, 2025, in Las Vegas, Nevada, is the largest gathering of urologists in the world, where leaders in the field share groundbreaking research, new guidelines and the latest advances in urologic medicine.
CG Oncology will have a series of key presentations and updates on cretostimogene grenadenorepvec including:
P2s: Paradigm-shifting, Practice-changing Clinical Trials in Urology: BOND-003 Cohort C- Phase 3, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma In Situ
Session: Saturday Morning Plenary Session
Presenter: Mark D. Tyson, MD, MPH; Urologic Oncologist in the Department of Urology at Mayo Clinic in Phoenix, Arizona
Presentation Date & Time: Saturday, April 26, 2025, 10:40 AM to 10:50 AM PT
Location: Venetian Ballroom, The Venetian Convention & Expo Center
IP02-28: Translational Correlates using Urinary Genomic Disease Burden to Assess Cretostimogene Grenadenorepvec: Updated Analysis from the BOND-003 and CORE-001 Trials
Session: IP02- Bladder Cancer- Non-Invasive I
Presenter: Colin P. N. Dinney, MD; Professor and Chairman of the Department of Urology at The University of Texas M D Anderson Cancer Center
Presentation Date & Time: Saturday, April 26, 2025, 7:00 AM to 9:00 AM PT
Location: Marco Polo 701, The Venetian Convention & Expo Center
Updates to the CORE-008 Trial Protocol: A Phase 2 Multi-Arm, Multi-Cohort Study to Evaluate Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk Non-Muscle Invasive Bladder Cancer
Session: Clinical Trials in Progress- Bladder Cancer
Presenter: Trinity J. Bivalacqua, MD, PhD Professor of Urology and Oncology at the University of Pennsylvania
Presentation Date & Time: Monday, April 28, 2025, 9:56 AM to 10:04 AM PT
Location: Learning Lab, The Venetian Convention & Expo Center
Trial in Progress: BOND-003 Cohort P- A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Session: Clinical Trials in Progress- Bladder Cancer
Presenter: Mark D. Tyson, MD, MPH; Urologic Oncologist in the Department of Urology at Mayo Clinic in Phoenix, Arizona
Presentation Date & Time: Monday, April 28, 2025, 9:40 AM to 9:48 AM PT
Location: Learning Lab, The Venetian Convention & Expo Center
Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec Versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Session: Clinical Trials in Progress- Bladder Cancer
Presenter: Max Kates, MD, Associate Professor of Urology and Oncology and Director of the Bladder Cancer Program in the Brady Urological Institute at Johns Hopkins
Presentation Date & Time: Monday, April 28, 2025, 10:28 AM to 10:36 AM PT
Location: Learning Lab, The Venetian Convention & Expo Center
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in patients with intermediate-risk NMIBC. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
(508) 654-2277
sarah.connors@cgoncology.com
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
chau.cheng@cgoncology.com
