CG Oncology is dedicated to developing innovative oncolytic immunotherapies, specifically targeting bladder cancer. Their lead investigational product, cretostimogene grenadenorepvec, is an engineered oncolytic immunotherapy designed to selectively replicate in tumor cells with defective retinoblastoma (Rb) pathways, which are prevalent in urothelial carcinomas. This therapy aims to trigger an anti-tumor immune response by binding to specific receptors on cancer cells, leading to tumor cell lysis and the release of tumor antigens. The addition of granulocyte-macrophage colony-stimulating factor (GM-CSF) to the viral construct is intended to enhance the immune response, potentially improving long-term anti-tumor activity.

Currently, cretostimogene grenadenorepvec is undergoing multiple clinical trials, including Phase 3 studies, to evaluate its efficacy and safety in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Preliminary results from these trials indicate that the therapy has shown clinical benefits and is generally well-tolerated, with a notable percentage of patients achieving complete responses. CG Oncology is also exploring the combination of cretostimogene with other therapies, such as pembrolizumab, to further enhance treatment outcomes for patients with high-risk NMIBC. The company is committed to addressing the unmet needs in bladder cancer treatment, particularly for patients who do not respond to standard therapies.

United States

CG Oncology, Inc. (Nasdaq: CGON), is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. We see a world where urologic cancer patients can benefit from our innovative oncolytic immunotherapies to live with dignity and have an enhanced quality of life.

Our lead candidate, cretostimogene grenadenorepvec, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO® (nivolumab). 

Cancer

Urogenital Diseases

CG Oncology

Non-muscle invasive bladder cancer

Cretostimogene grenadenorepvec (CG0070)

Biologics

Gene Therapy

Cretostimogene

<p class="font_7">Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Cretostimogene is also being evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication and in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.</p>

CG Oncology

Company Details