CG Oncology, Inc.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2010-01-01
- Employees
- 61
- Market Cap
- $2.4B
- Website
- http://www.cgoncology.com
CG Oncology's Bladder Cancer Drug Shows Promising Durability in Phase 3 Trial
• CG Oncology's cretostimogene grenadenorepvec demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with 34% maintaining complete response at 24 months.
• The FDA has granted Fast Track and Breakthrough Therapy designations to cretostimogene, potentially expediting its regulatory pathway for a disease with limited treatment options.
• The drug's 27.9-month median duration of response may provide a competitive edge over Johnson & Johnson's TAR-200, positioning CG Oncology as a significant player in the bladder cancer treatment landscape.
DelveInsight Report: Over 50 Pipeline Drugs in Development for Urothelial Carcinoma Treatment
• DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space.
• Major pharmaceutical companies including AstraZeneca, Seagen, and Janssen are advancing promising therapies, with notable candidates like disitamab vedotin and cetrelimab in late-stage development.
• Recent clinical trials include Seagen's Phase 2 study of disitamab vedotin with pembrolizumab, and Roche's Phase 1b/II umbrella study investigating multiple combination therapies for advanced urothelial carcinoma.
Clinical Trials Should Be Viewed as Standard Care Option, Not Last Resort, Experts Emphasize
• Leading oncologists at Northwell Health advocate for integrating clinical trials into standard care pathways, emphasizing their role as crucial treatment options rather than last resorts.
• Dr. Richard Carvajal, Deputy Physician-in-Chief at Northwell Health Cancer Institute, stresses that clinical trials access is essential for advancing cancer treatment until cure rates improve significantly.
• Healthcare experts call for enhanced education among medical providers and patients to normalize clinical trials as part of routine treatment discussions and decision-making processes.
FDA Approvals and Clinical Trials: A Look into the Latest Pharmaceutical Developments
The pharmaceutical sector has seen significant advancements with FDA approvals for new treatments and the initiation of clinical trials for innovative therapies. Notably, Eli Lilly's Omvoh has been approved for Crohn's disease, and Johnson & Johnson is advancing its TAR-200 for bladder cancer treatment. These developments underscore the industry's commitment to addressing unmet medical needs through research and innovation.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
FDA Approves ImmunityBio's Bladder Cancer Drug After Second Review
The FDA has approved ImmunityBio's Anktiva, a treatment for non-muscle invasive bladder cancer (NMIBC) that did not respond to BCG vaccine alone, marking the company's first commercial-stage product. This decision comes after initial rejection due to manufacturing quality issues.
Biomarker-Guided Therapy Shows Promise in Bladder Preservation for Muscle-Invasive Bladder Cancer
• A phase II trial of biomarker-driven treatment for muscle-invasive bladder cancer (MIBC) demonstrated a 2-year metastasis-free survival (MFS) rate exceeding 70%.
• Patients with specific genomic mutations achieved complete response after chemotherapy, allowing active surveillance and bladder preservation in a subset.
• The study, although narrowly missing its primary endpoint, suggests a potential strategy to delay or avoid cystectomy in select MIBC patients.
• Ongoing research aims to refine biomarker-guided approaches, potentially incorporating immunotherapy and advanced imaging techniques.
CG Oncology's Cretostimogene Shows Positive Phase 3 Results in Bladder Cancer
• CG Oncology's cretostimogene demonstrated a positive outcome in its Phase 3 BONDER-002 trial for non-muscle invasive bladder cancer (NMIBC).
• The trial results could pave the way for a Biologics License Application (BLA) submission to regulatory authorities for potential approval.
• Cretostimogene is an oncolytic immunotherapy designed to selectively replicate in tumor cells, leading to their destruction and triggering an immune response.
• The BONDER-002 trial evaluated cretostimogene in patients with high-risk NMIBC who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
TARA-002 and Cretostimogene Grenadenorepvec Show Promise in Bladder Cancer
• Protara Therapeutics' TARA-002 demonstrated a 72% complete response rate in non-muscle invasive bladder cancer patients, regardless of prior BCG exposure.
• In BCG-unresponsive patients, TARA-002 achieved a 100% complete response rate at six months, highlighting its potential in a registrational cohort.
• CG Oncology's cretostimogene grenadenorepvec showed a 74.5% complete response rate in BCG-unresponsive patients, with a median duration of response exceeding 27 months.
• Both TARA-002 and cretostimogene grenadenorepvec exhibited favorable tolerability profiles, with minimal treatment-related adverse events.
CG Oncology's Cretostimogene Shows Promise in Phase 3 Bladder Cancer Trial
• CG Oncology will host a conference call on December 5, 2024, to discuss Phase 3 BOND-003 trial results for cretostimogene in high-risk BCG-unresponsive NMIBC.
• The BOND-003 trial evaluates cretostimogene monotherapy as a potential bladder-sparing treatment for non-muscle invasive bladder cancer (NMIBC).
• Dr. Mark Tyson, II from Mayo Clinic, the lead investigator, will present the findings at the Society of Urologic Oncology (SUO) annual meeting.
• Cretostimogene is an investigational oncolytic immunotherapy being studied across multiple clinical trials for NMIBC, including ongoing Phase 3 studies.
Cretostimogene Shows Durable Responses in High-Risk Bladder Cancer
• Cretostimogene monotherapy demonstrated a 74.5% complete response rate at any time in patients with high-risk BCG-unresponsive NMIBC.
• The median duration of response has not been reached but exceeds 27 months, indicating a sustained treatment effect.
• The BOND-003 trial showed a favorable safety profile with no Grade 3 or higher treatment-related adverse events reported.
• 97.3% of patients were free from progression to muscle-invasive bladder cancer at 12 months, highlighting the therapy's potential to prevent disease advancement.
Cretostimogene Shows High Complete Response Rate in BCG-Unresponsive Bladder Cancer
• Cretostimogene monotherapy achieved a 75.2% complete response rate in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
• Durable responses were observed, with 29 patients maintaining complete response for 12 months or longer, suggesting a sustained therapeutic effect.
• The Phase 3 BOND-003 trial reported no Grade 3 or higher treatment-related adverse events, highlighting a favorable safety profile.
• Cretostimogene has received Fast Track and Breakthrough Therapy designations from the FDA, potentially expediting its path to regulatory approval.
Metagenomi Aims for $87M IPO to Advance Novel Gene Editing Platform
• Metagenomi, a preclinical gene editing company, announces plans to raise $87 million through IPO, targeting a $640 million valuation with shares priced between $15-17.
• The company's innovative gene editing platform has secured partnerships with industry leaders Ionis, Moderna, and Affini-T, building on their successful $275 million Series B financing.
• The IPO proceeds will support preclinical development, platform advancement, initial clinical studies, and manufacturing capabilities for therapies targeting hemophilia A, primary hyperoxaluria, and other diseases.
Cretostimogene Shows Promise in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Phase 3 trial of cretostimogene grenadenorepvec shows a 75.7% complete response rate in patients with high-risk BCG-unresponsive NMIBC.
• The 3- and 6-month landmark complete response rates were 68.2% and 63.6%, respectively, indicating sustained efficacy over time.
• The oncolytic immunotherapy was generally well-tolerated, with mostly low-grade genitourinary adverse events and no treatment discontinuations.
• CG Oncology plans to discuss advancing cretostimogene grenadenorepvec with the FDA as a potential new therapy for bladder cancer.
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