CG Oncology NASDAQ: CGON is focused on advancing cretostimogene, an oncolytic immunotherapy for non-muscle invasive bladder cancer, Chief Executive Officer Arthur Kuan said during a discussion at the Jefferies Global Healthcare Conference in New York.
Kuan said the company believes the therapy could address a U.S. market of up to 150,000 patients across non-muscle invasive bladder cancer settings. The company’s initial regulatory focus is high-risk BCG-unresponsive disease, a category Kuan described as representing roughly 25,000 patients annually when viewed as a blend of incident and prevalent patients.
Cretostimogene Positioning in BCG-Unresponsive Disease
Kuan said cretostimogene is differentiated from currently approved therapies because it is an oncolytic immunotherapy. He described its mechanism as combining direct tumor oncolysis with activation of an anti-tumor immune response after tumor cell kill.
“It’s sort of this one-two punch that you can deliver in the bladder,” Kuan said.
In the BCG-unresponsive carcinoma in situ cohort, Kuan said cretostimogene has shown a complete response rate at any time of about 76%. He said median duration of response has not been reached but is at least more than 25 months. At landmark time points, he said the 12-month complete response rate was about 46%, while the 24-month complete response rate was 42%.
Kuan said that between 12 and 24 months, 90% of patients who had a complete response at 12 months remained in complete response at 24 months. He added that the study continues to three years and that the company hopes to report data beyond 24 months later this year.
Discussing the competitive landscape, Kuan said currently approved options include Merck’s KEYTRUDA and Johnson & Johnson’s BALVERSA, while J&J’s TAR-200 has reported 12-month landmark data. He said cretostimogene’s tolerability profile is also a key differentiator, stating that the company has reported zero Grade 3 adverse events to date.
BLA Submission Progress and Manufacturing
Kuan said CG Oncology began a rolling biologics license application submission in the fourth quarter of last year and has completed the clinical and non-clinical BLA module submissions. The remaining manufacturing module is expected to be completed by the end of this year, he said.
On manufacturing, Kuan said the company is not changing the GMP process used in its clinical and pivotal trials and that the current process is sufficient for commercial launch. He said the process can yield up to 50,000 vials of cretostimogene annually.
Kuan said the company is focused on inspection readiness, particularly for its fill-and-finish site acquired last July. He said the site previously had been inspected by the FDA’s Center for Devices and Radiological Health with no Form 483 observations, but added that standards for a Center for Biologics Evaluation and Research inspection are different.
“We do have full visibility and line of sight into that, given our investment,” Kuan said.
He said CG Oncology uses a hybrid manufacturing approach, with production outsourced and fill-and-finish capabilities in-house. He also said the company has used former FDA inspectors to help prepare facilities for inspection.
Commercial Preparation and Product Handling
Kuan said CG Oncology has been building relationships with clinical and community urology sites through its BOND-003, CORE-008 and PIVOT-006 studies. He said the company has worked with up to 90 U.S. sites, many of them community practices, and is profiling accounts based on factors such as BCG use, TURBT volume and branded product experience.
The company already has medical science liaisons in the field engaging with customers, Kuan said. For a potential commercial sales force, he said companies in the space tend to land in the range of 50 to 75 field personnel and that CG Oncology likely would be in a similar range.
Kuan said administration is designed to fit into existing urology workflows.
“We typically tell the site that if you can give BCG, you can give cretostimogene,” he said.
He said the product is shipped frozen, can be stored in a refrigerator at 2 to 8 degrees Celsius after arrival, and has previously been described as stable for four to six weeks or potentially longer. Kuan also discussed use of an off-the-shelf closed system transfer device to move the therapy from vial to syringe and saline bag before bladder instillation.
On reimbursement, Kuan said the product category would receive a miscellaneous J-code for the first six months after launch, followed by a permanent J-code. He also noted that NCCN guideline timing will be important for early uptake.
Intermediate-Risk Trial and Future Data
Kuan also discussed PIVOT-006, a 364-patient North American trial in intermediate-risk non-muscle invasive bladder cancer. The trial is randomized one-to-one and evaluates TURBT followed by cretostimogene against TURBT with surveillance. The primary endpoint is recurrence-free survival, measured by hazard ratio.
Kuan said the study includes a broad intermediate-risk population under the AUA/SUO definition and includes a subset of patients with newly diagnosed high-grade Ta disease that is solitary and less than or equal to three centimeters.
He said the company believes, based on discussions with key opinion leaders before starting the trial, that a 30% relative risk reduction would be viewed as meaningful in a setting with no FDA-approved adjuvant therapy.
Kuan said the data could be available “in the coming months,” noting that the trial is event-driven. He said the company expects the intermediate-risk filing would likely be separate and sequential after the BCG-unresponsive application, because the company believes it needs at least 12 months of follow-up in all patients before pursuing that filing.
BCG-Exposed Opportunity
Looking beyond BCG-unresponsive disease, Kuan said he sees BCG-exposed patients as an important future market, estimating at least 50,000 patients fall into that category. He said the company is investing in that area through CORE-008 Cohort CX, which evaluated cretostimogene plus gemcitabine.
In evaluable patients in that study, Kuan said the combination showed a 92% complete response rate. He compared that with the 76% complete response rate at any time observed in BOND-003 with cretostimogene monotherapy.
Kuan said the company expects to provide 12-month data for the combination later this year.
About CG Oncology NASDAQ: CGON
CG Oncology, Inc NASDAQ: CGON is a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibody-based immunotherapies for the treatment of solid tumor cancers. The company leverages a platform-driven approach to identify and optimize antibody candidates that engage key immune checkpoints and co-stimulatory pathways within the tumor microenvironment. Its pipeline encompasses multiple preclinical programs alongside early-phase clinical trials designed to assess safety, dosing and preliminary anti-tumor activity.
Headquartered in South San Francisco, California, CG Oncology conducts clinical research primarily in the United States, collaborating with leading academic medical centers and contract research organizations to advance its lead candidates.
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