CG Oncology(US:CGON)2024-05-03 21:30Summary of CG Oncology Conference Call - May 03, 2024 Company Overview - Company: CG Oncology - Product: Credo Simogene (an investigational oncolytic immunotherapy) - Indication: Treatment of high-risk BCG unresponsive non-muscle invasive bladder cancer (NMIBC) Key Points and Arguments Clinical Trial Results - BOND-three Trial: Phase III registrational study evaluating Credo Simogene - Complete Response (CR) Rate: - 75.2% CR at any time for 105 evaluable patients, maintaining from 75.7% in December 2023 [6][23] - 79 complete responders reported, the highest number in this indication [23] - Durability of Response: - 83% of patients maintained CR for over 12 months [24] - 54% of initial non-responders converted to CR after a second induction [13][43] - Safety Profile: - No Grade 3 or higher adverse events reported [14][25] - 94.5% of patients completed all protocol-mandated treatments [25] Mechanism of Action - Dual Mechanism: Designed to replicate in and kill cancer cells while inducing antitumor immunity [8] - Oncolytic Immunotherapy: Mechanism supports the observed efficacy and safety [26] Comparisons with Other Therapies - Efficacy Comparison: - Credo Simogene's 75.2% CR rate compares favorably to: - 62% for combination therapy with MEO3 and BCG - 51% for Nadopiragine - 41% for Pembrolizumab [16] - Safety Comparison: - No Grade 3 or higher treatment-related adverse events, positioning Credo Simogene as a potentially safer option [14][16] Regulatory Designations - FDA Designations: Fast Track and Breakthrough Therapy designations granted for Credo Simogene [18] Trial Amendments and Future Studies - New Cohorts: Introduction of a treatment extension phase for complete responders and a new high-grade papillary cohort (Cohort P) [19] - Expanded Access Program: Designed to enhance geographic and ethnic diversity in patient data collection [20] Market Insights - Target Patient Population: - The prevalence of high-risk patients is estimated to be at least twice the incidence population [77] - Therapeutic Landscape: - Patients typically receive 2 to 4 lines of therapy after BCG treatment [79] Manufacturing and Logistics - Manufacturing Process: No changes to the robust process used in the Phase III trial, ensuring a lower risk profile for commercial launch [51] - Cold Storage and Shipping: Credo Simogene will be shipped in a just-in-time manner at -50 degrees Celsius, with a preparation time of 10 minutes [53][54] Additional Important Points - Patient Demographics: Most patients were white, male, and of Medicare age, with a median age of 73 [12] - Physician Feedback: High enthusiasm from urologists regarding the results, particularly appreciating the simplified installation process [29][32] - Reinduction Acceptance: Reinduction is a common practice in BCG therapy, and the results from Credo Simogene support this approach [42][45] This summary encapsulates the critical insights and data presented during the CG Oncology conference call, highlighting the efficacy, safety, and future potential of Credo Simogene in treating high-risk NMIBC.