Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — AUA 2023 Annual Meeting
12 slides from Cg Oncology's conference presentation, 2023
Slide 1: CORE-001: Phase 2 Study of Cretostimogene Combined with Pembrolizumab in NMIBC
CORE-001: Phase 2, Single Arm Study of Cretostimogene Grenadenorepvec (CG0070) Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Roger Li1, Gary D. Steinberg 2 , D. Lamm3, E. Uchio4, Paras Shah5, Ashish Kamat6, Trin
Slide 2: Cretostimogene Grenadenorepvec (CG0070)
Cretostimogene Grenadenorepvec (CG0070) Cancer-selective Oncolytic Adenovirus Engineered to Preferentially Replicate in Tumor Cells E2F Promoter along with GM-CSF transgene inserted into wild-type adenovirus backbone GENE / PROTEIN FUNCTION E2F Leads to selective viral replication in tumor cells, bu
Slide 3: Cretostimogene Mechanism of Action
Cretostimogene Mechanism of Action
Slide 4: Phase 1 Cretostimogene Monotherapy for High-Risk, BCG-Failure NMIBC
Phase 1 Cretostimogene Monotherapy for High-Risk, BCG-Failure NMIBC, CIS-Containing or Papillary (NCT00109655) N = 35 NMIBC CIS-containing or Ta/T1 Design: Dose-escalation, intravesical (IVe) administration Trial Type: Open label Regimen: Multi-Dose = Multi-Schedule = Endpoints: Safety, Dose and Mul
Slide 5: Phase 2 Cretostimogene Monotherapy for High-Risk, BCG-Failure NMIBC
Phase 2 Cretostimogene Monotherapy for High-Risk, BCG- Failure NMIBC, CIS-Containing (NCT02365818) Cretostimogene (CG0070) Primary Endpoint 46 Patients Single-Arm, Open-Label CR Rate Positive CR Rate & Duration of Response CR at Any Time CR at 6 Mo CR at 12 Mo 65% 44% 28% 30/46 20/46 13/46 Favorable
Slide 6: Phase 3 BOND-003 Cretostimogene Monotherapy for BCG-Unresponsive NMIBC
BOND-003 Phase 3 Cretostimogene Monotherapy for High-Risk, BCG- Unresponsive NMIBC, CIS-Containing (NCT04452591) N = 110 NMIBC CIS-containing Design: Single-arm, intravesical (IVe) administration Trial Type: Open label Regimen: Endpoints: Complete Response (CR) Second induction course1 = Maintenance
Slide 7: Phase 2 Cretostimogene + KEYTRUDA for BCG-Unresponsive NMIBC
Phase 2 Cretostimogene + KEYTRUDA® for High-Risk, BCG-Unresponsive NMIBC, CIS-containing (NCT04387461) N = 35 NMIBC CIS-containing Design: Single-arm, intravesical (IVe) CG0070 + intravenous (IV) pembrolizumab Trial Type: Open label Regimen: Endpoints: Second induction course1 = Maintenance courses2
Slide 8: CORE-001 Demographics and Baseline Characteristics
CORE-001 Demographics and Baseline Characteristics N % Subjects in dataset 35 Gender Male 33 94.3 Female 2 5.7 Age (Years) <65 8 22.9 >65 27 77.1 ECOG 0 27 77.1 1 7 20 2 1 2.9 BCG History: Number of prior instillations Median (range) 12 (9 - 30) Baseline High-risk NMIBC Disease status: Persistent hi
Slide 9: CORE-001: Cretostimogene + KEYTRUDA Combo for BCG-Unresponsive NMIBC
CORE-001: Cretostimogene + KEYTRUDA® Combo for BCG-Unresponsive NMIBC
Slide 10: CORE-001 Treatment Related Adverse Events
CORE-001 Treatment Related Adverse Events Preferred Term Grade 1 (N%) Grade 2 (N%) Grades 1 and 2 (N%) Bladder spasm 11 (31.4%) 4 (11.4%) 15 (42.9%) ▪ Predominantly transient, grade 1-2 local genito-urinary AE Fatigue 11 (31.4%) 2 (5.7%) 13 (37.1%) Pollakiuria 9 (25.7%) 1 (2.9%) 10 (28.6%) ▪ Grade 3
Slide 11: Conclusions
Conclusions ▪ Monotherapy activity of Cretostimogene grenadenorepvec in NMIBC after BCG failure has been established in two past studies of Cretostimogene Grenadenorepvec, V0046 and BOND-002 ▪ The combination of Cretostimogene grenadenorepvec and pembrolizumab appears to be highly active in BCG-unre
Slide 12: Acknowledgements
Acknowledgements ▪ CG Oncology ▪ Key Collaborators ▪ James Burke ▪ Gary Steinberg, NYU, New York ▪ Edward Uchio, University of California Irvine, Irvine, CA ▪ Paola Grandi ▪ Don Lamm, BCG Oncology, Phoenix, AZ ▪ Nataliya Hnat ▪ Paras Shah, Mayo Clinic, Minnesota ▪ Andy Darilek ▪ Ashish M. Kamat, MDA