Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — AUA Annual Meeting 2024
16 slides from Cg Oncology's conference presentation, May 5, 2024
Slide 1: BOND-003 Cohort P: Single-arm Study of Intravesical Cretostimogene in BCG-Unresponsive NMIBC
BOND-003 Cohort P: A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary-Only, BCG-Unresponsive NMIBC https://cgoncology.com/wp- content/uploads/2024/05/AUA 2024 Tyson_ BOND-003 Cohort P_ Learning Lab_TIP_Presentation Final.pdf Fo
Slide 2: Disclosures
Disclosures • CG Oncology- No Conflicts of Interest ©2022 Mayo Foundation for Medical Education and Research | slide-2
Slide 3: What is Cretostimogene Grenadenorepvec?
What is Cretostimogene Grenadenorepvec? • Conditionally replicating adenovirus • Highly immunogenic • Oncolytic immunotherapy • Encodes GM-CSF • Insertion of human E2F-1 promoter • Binds to Coxsackie Adenovirus Receptor (CAR) • Robust expression in all stages of bladder cancer • Viral replication re
Slide 4: Oncolytic Immunotherapy: Selective Oncolysis and Potent Anti-Tumor Immune Response
Oncolytic Immunotherapy: Spreads to additional tumor cells Selective Oncolysis and Potent inducing a chain reaction of Anti-Tumor Immune Response cancer cell death Targets and Destroys 1 Cancer Cells Enters target cell Replicates and kills the cell Stimulation of Anti-tumor Virus stimulates cytokine
Slide 5: BCG-UR NMIBC Study Design Considerations
BCG-UR NMIBC STUDY DESIGN CONSIDERATIONS Recommendations from 2018 FDA Guidance • Single-arm trials appropriate for BCG-UR NMIBC studies • Primary efficacy endpoints: • CR in patients with CIS • Time-to-event endpoint for patients with completely resected Ta/T1 disease CIS +/- Ta/T1- Carcinoma in si
Slide 6: Cretostimogene Monotherapy Results: 75.2% CR at Any Time
Cretostimogene Monotherapy Results: 75.2% CR at Any Time Overall Complete Response 100 75.2% (95% CI, 65% - 83%) Overall CR Rate (%) 75 50 25 0 (n=105) Efficacy data cutoff as of 01APR2024 Efficacy analysis centrally confirmed. All pts have active disease at baseline prior to enrollment. Received ad
Slide 7: Cretostimogene Shows Durable Responses Over Time
Cretostimogene Shows Durable Responses Over Time • 53.8% of repeat induction patients converted to CR • 52 patients have DOR ≥ 6 months (all ongoing; 8 pending) • 29 patients have DOR ≥ 12 months (all ongoing; 22 pending) • 14 patients have DOR ≥ 21 months (all ongoing; 36 pending) • 92.4% CFS; none
Slide 8: Cretostimogene Has Been Generally Well-Tolerated
Cretostimogene Has Been Generally Well-Tolerated Cretostimogene (n=112) Preferred Term (MedDRA v.26.1) • Most AEs were Grade 1-2 Any Grade (%) Grade ≥ 3 Patients reporting ≥ 1 0 (0) • No grade ≥ 3 treatment-related AEs or 70 (62.5%) TRAE deaths reported Treatment-Related AE reported in >10% patients
Slide 9: Fast Track & Breakthrough Therapy Designations Granted
Fast Track & Breakthrough Therapy Designations Granted for Cretostimogene Monotherapy in BCG-UR CIS +/- Papillary Disease! ©2022 Mayo Foundation for Medical Education and Research | slide-9
Slide 10: Significant Unmet Need for BCG-UR Papillary NMIBC
Significant Unmet Need for BCG-UR Papillary NMIBC • Current FDA approved agents for patients with BCG-UR HR NMIBC with CIS +/- Ta/T11 • There is a growing incidence of patients with papillary (Ta/T1) NMIBC2-3 • Unmet need for highly effective, well- tolerated, readily available, and durable treatmen
Slide 11: BOND-003 Cohort P: BCG-UR, Papillary-Only NMIBC
BOND-003 Cohort P: BCG-UR, Papillary-Only NMIBC Study Design BOND-003 : BCG-UR, High-Risk NMIBC Cohort C Cohort P CIS +/- Ta/T1 Ta/T1 only (n=112) Induction + Maintenance with (N~75) Cretostimogene Primary Primary Endpoint: Endpoint: CR HG-EFS CIS +/- Ta/T1- Carcinoma in situ, with or without Ta/T1;
Slide 12: BOND-003 Cohort P- Papillary Only, BCG-UR, HR-NMIBC
BOND-003 Cohort P- Papillary Only, BCG-UR, HR-NMIBC Cohort C (N=112): Primary Endpoint: Cohort P (N~75): Primary Endpoint: • Age ≥ 18 yo • CR at any time • Age ≥ 18 yo • HG-EFS • ECOG PS 0-2 • Pathologically confirmed • Pathologically confirmed Secondary BCG-UR HR-NMIBC papillary (Without CIS) Secon
Slide 13: Experience with Cretostimogene
Experience with Cretostimogene • Familiar and convenient instillation process/schedule for practices oThaw time up to 10 minutes • Administered by allied healthcare professionals (MAs, RNs) • Generally well-tolerated regimen • 100% of patients with successful instillation on BOND-003 • Streamlined i
Slide 14: BOND-003 Cohort P: Trial in Progress
BOND-003 COHORT P: TRIAL IN PROGRESS • First sites opened and patients enrolled March 2024 • Contact Information: • First patients dosed Mark Tyson, MD, MPH, • Anticipated recruitment timeline BOND-003 Global PI, 12 months Tyson.Mark@mayo.edu • 35+ sites selected across North America and Japan • Fur
Slide 15: Acknowledgements
Acknowledgements All Bladder Cancer Patients and Their Families The Study Coordinators and Nurses Key Collaborators CG Oncology Woodson W. Smelser, Washington University, MO Andy Darilek Rian J. Dickstein, Chesapeake Urology, MD Rebecca Tregunna Daniel E. Zainfeld, Urology San Antonio, TX Nataliya H
Slide 16: Thank You & Questions
THANK YOU https://cgoncology.com/wp- content/uploads/2024/05/AUA 2024 & QUESTIONS Tyson_ BOND-003 Cohort P_ Learning Lab_TIP_Presentation Final.pdf For individual reference only. The information accessed through this QR code is intended solely for individual reference and should not be altered, modi