CG Oncology, Inc. (CGON)
CG Oncology, Inc., a late-stage clinical biopharmaceutical company, develops and commercializes cretostimogene grenadenorepvec for patients with bladder cancer in the United States. The company’s product candidate is cretostimogene, an investigational oncolytic immunotherapy, which is in phase 2 clinical trials of cretostimogene in patients with high-risk NMIBC after BCG failure; a phase 3 clinical trials to evaluate the safety and efficacy of cretostimogene as monotherapy in the treatment of patients who have received adequate BCG therapy with high-risk BCG-unresponsive, CIS-containing NMIBC and BCG-unresponsive Ta, or T1 papillary tumors; phase 3 BOND-003 Cohort C trials as a single agent; phase 3 BOND-003 Cohort P as a single agent in patients with BCG-UR papillary-only NMIBC. It also develops cretostimogene monotherapy for intermediate-risk NMIBC following TURBT, which is in phase 3 PIVOT-006 clinical trials to assess the safety and efficacy of adjuvant cretostimogene; and cretostimogene monotherapy for high-risk NMIBC in phase 2 CORE-008 clinical trials to assess the safety and clinical outcomes of cretostimogene in treating patients with high-risk NMIBC, including BCG-exposed and BCG-naïve NMIBC. The company was formerly known as Cold Genesys, Inc. and changed its name to CG Oncology, Inc. in June 2020. CG Oncology, Inc. was founded in 2010 and is headquartered in Irvine, California.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
CG Oncology Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Active, not recruiting
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Cretostimogene Grenadenorepvec
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
NCT04452591Enrollment190StartOct 2020Primary CompletionJun 2030est.CompletionDec 2031est. - Phase 3Active, not recruiting
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Cretostimogene Grenadenorepvec
Non Muscle Invasive Bladder Cancer, Urologic Cancer +2
NCT06111235Enrollment367StartDec 2023Primary CompletionNov 2026est.CompletionFeb 2029est. - Phase 2/3Terminated
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
CG0070 Adenovirus Vector
Transitional Cell Carcinoma, Bladder Cancer +2
NCT01438112Enrollment22StartMar 2014Primary CompletionJun 2016CompletionJun 2016 - Phase 2Withdrawn
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
oncolytic adenovirus expressing GMCSF
Bladder Cancer, High Grade +1
NCT02143804Enrollment0StartMar 2014Primary CompletionMar 2015CompletionMar 2015 - Phase 2Completed
Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure
CG0070
Bladder Cancer
NCT02365818Enrollment66StartJun 2015Primary CompletionAug 2018CompletionFeb 2019 - Phase 2Completed
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
CG0070, Pembrolizumab Injection
Non Muscle Invasive Bladder Cancer
NCT04387461Enrollment35StartDec 2020Primary CompletionMar 2023CompletionMay 2024 - Phase 2Recruiting
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Cretostimogene Grenadenorepvec
High-Risk Non-Muscle-Invasive Bladder Cancer
NCT06567743Enrollment325StartSep 2024Primary CompletionMar 2027est.CompletionDec 2027est. - Expanded accessAvailable
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
Cretostimogene Grenadenorepvec
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma +2
NCT06443944Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Active, not recruiting | Cretostimogene Grenadenorepvec | NCT04452591 |
| Phase 3 | Active, not recruiting | Cretostimogene Grenadenorepvec | NCT06111235 |
| Phase 2/3 | Terminated | CG0070 Adenovirus Vector | NCT01438112 |
| Phase 2 | Withdrawn | oncolytic adenovirus expressing GMCSF | NCT02143804 |
| Phase 2 | Completed | CG0070 | NCT02365818 |
| Phase 2 | Completed | CG0070, Pembrolizumab Injection | NCT04387461 |
| Phase 2 | Recruiting | Cretostimogene Grenadenorepvec | NCT06567743 |
| Expanded access | Available | Cretostimogene Grenadenorepvec | NCT06443944 |