Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — AUA Annual Meeting 2024
17 slides from Cg Oncology's conference presentation, May 3, 2024
Slide 1: Pivotal Results from BOND-003: Phase-3 Study of Intravesical Cretostimogene Grenadenorepvec
Pivotal Results from BOND-003: A Phase-3, Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of BCG- Unresponsive, High-Risk, NMIBC with CIS https://cgoncology.com/wp- content/uploads/2024/05/AUA 2024 P2 Plenary: Practice-changing, Paradigm-shifting Clinical Trial in Urology Tyso
Slide 2: Disclosures
Disclosures • CG Oncology- No Conflicts of Interest ©2024 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 further 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
Slide 5: BOND-003: Phase-3 Single Arm, BCG-UR NMIBC with CIS
BOND-003: Phase-3 Single Arm, BCG-UR NMIBC with CIS Cohort C Population (N=112): Primary Endpoint: • Age ≥ 18 yo • CR at any time • ECOG PS 0-2 • Pathologically confirmed Secondary Endpoints: BCG-UR HR NMIBC with CIS • Duration of Response +/- papillary disease • CFS, PFS, RFS Response Assessments:
Slide 6: BOND-003: Patient Demographics (Cohort C)
BOND-003: Patient Demographics (Cohort C) Subjects in Efficacy Dataset N=112 % Gender Male 83 74.1 Female 29 25.9 • Majority of patients are: Age (Years) • Male (74%) Mean (SD) 72.9 (9.19) • White (61%) Median (Range) 74.0 (43-90) • > 65 years (83%) Age (Categories) < 65 19 17.0 • Highly pre-treated
Slide 7: 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 8: Cretostimogene Has Shown Durable Responses Over Time
Cretostimogene Has Shown 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;
Slide 9: Cretostimogene Has Been Generally Well-Tolerated
Cretostimogene Has Been Generally Well-Tolerated Cretostimogene (n=112) Preferred Term • Most AEs were Grade 1-2 (MedDRA v.26.1) Any Grade (%) Grade ≥ 3 • No grade ≥ 3 treatment-related AEs or Patients with ≥ 1 TRAE 70 (62.5%) 0 (0) deaths reported Treatment-Related AE reported in > 10% patients • 2
Slide 10: Experience with Cretostimogene
Experience with Cretostimogene • Familiar and convenient instillation process/schedule for practices • Thaw 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
Slide 11: Cretostimogene Has Potential to Become Backbone Therapy in NMIBC Treatment Landscape
Cretostimogene Has Potential to Become Backbone Therapy in NMIBC Treatment Landscape1 Trial BOND-003 CORE-0012 QUILT 3.032 NCT02773849 KEYNOTE-057 Cretostimogene + Intervention Cretostimogene N-803 + BCG Nadofaragene Pembrolizumab Pembrolizumab Oncolytic Oncolytic IL-15 Superagonist Gene Therapy Mec
Slide 12: Fast Track & Breakthrough Therapy Designations Granted
Fast Track & Breakthrough Therapy Designations Granted for Cretostimogene Monotherapy in BCG-UR CIS +/- Papillary Disease! ©2024 Mayo Foundation for Medical Education and Research | slide-12
Slide 13: Next Phase of BOND-003 Trial (Cohort P)
Next Phase of BOND-003 Trial (Cohort P) Trial Extension & Addition of BCG-UR Papillary Only Cohort Treatment Extension Addition of Papillary Cohort (n~75) Maintenance Extension: Dosing Schedule: Complete Responders eligible for Standard Cretostimogene induction maintenance through Year 3 and mainten
Slide 14: Cretostimogene Expanded Access Program (EAP)
Cretostimogene Expanded Access Program (EAP) Program Objectives Dosing Regimen Data Collection • Available for a broader range Induction Course: of patients with CIS-containing • Safety Weekly x 6 BCG-UR NMIBC • Efficacy • Prioritize geographically and Second Induction: • PROs ethnically diverse pop
Slide 15: Further Steps: SUO-CTC Supported Clinical Trials
Further Steps: SUO-CTC Supported Clinical Trials PIVOT-006: Phase-3 Adjuvant CORE-008: Phase-2 Multi-arm, Cretostimogene Versus Multi-cohort Cretostimogene Surveillance in IR-NMIBC in HR-NMIBC • >90 sites participating • Cohort A: BCG-Naïve • Patients dosed! • Cohort B: BCG-Exposed • Dr. Robert Svat
Slide 16: Acknowledgements
Acknowledgements All Bladder Cancer Patients and Their Families The Study Coordinators and Nurses Key Collaborators CG Oncology Edward Uchio, UC Irvine, CA Andy Darilek Jong-kil Nam, Pusan University, South Korea Nataliya Hnat Don Lamm, BCG Oncology, AZ James Burke Trinity Bivalacqua, UPenn, PA Calv
Slide 17: Thank You!
THANK YOU! https://cgoncology.com/wp- content/uploads/2024/05/AUA 2024 Tyson_BOND-003_Plenary 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, modified, or reproduced in any way.