CG Raises Standard in Bladder Cancer, Confirms Rare Biotech IPO Success

CG Oncology has announced promising results for its latest bladder cancer treatment, cretostimogene, which has shown a high rate of complete responses in patients. The treatment, based on an oncolytic virus, achieved a 75.2% complete response rate in a late-stage trial that included 105 evaluable patients suffering from non-muscle invasive bladder cancer (NMIBC). These findings were presented at the American Urological Association's annual meeting.

One of the standout aspects of the trial is that none of the patients who reported a complete response had to undergo bladder removal surgery. Additionally, 29 patients maintained a complete response for over a year, with 22 more patients awaiting evaluation. As of April 1, the median duration of response had not been reached, and more data on the durability of the treatment is expected by the end of the year. Importantly, there were no reports of grade 3 or higher adverse events among the patients.

Arthur Kuan, CEO of CG Oncology, expressed great optimism about the results, emphasizing the significance of the 94.5% compliance rate in the study. "Ultimately, for patients, we want to give them something that they can adhere to, and come back for the necessary treatments," Kuan stated ahead of the company's presentation.

CG Oncology is part of a select group of biotech and pharmaceutical companies aiming to advance treatments in the bladder cancer market through various innovative approaches. Cretostimogene stands out as it works independently of Bacillus Calmette-Guerin (BCG), a vaccine commonly used to treat bladder cancer but often plagued by supply issues. The therapy works by infecting cancer cells, which then release cytokines that attract the immune system to fight the tumor.

The therapy’s success has already garnered significant investor confidence, culminating in a $380 million IPO in January 2024, making it the strongest IPO of the year so far. The company plans to submit a new drug application to the FDA around the middle of 2025.

Other treatments in the NMIBC landscape include ImmunityBio’s IL-15 agonist, which received approval in late April after showing a 62% complete response rate among 77 evaluable patients. Johnson & Johnson is also in the mix with its drug-device combo treatment, TAR-200, which reported a 77% complete response rate in a phase 2 trial and is currently in phase 3 studies.

Kuan is confident that CG Oncology’s high response rate positions it strongly against competitors and asserts that the company is well-equipped to compete in the market without needing to partner with larger pharmaceutical companies. “We are going all in,” he said. “We believe this is an area where the bigger players may not have an edge over the ‘smaller players.’”

CG Oncology has cultivated strong relationships with urologists across the country, which Kuan believes will facilitate the drug’s market entry without requiring a massive sales force. Moreover, the treatment’s durability might be further enhanced by combining it with Keytruda, which will be explored at this year’s American Society of Clinical Oncology annual conference. Keytruda was approved to treat NMIBC in 2020 with a 41% complete response rate.

Kuan is hopeful that the combination therapy will yield even better results, citing the prolonged success observed in other indications where immune-oncology combinations are used.

CG Oncology’s commitment to innovation and patient-centric treatments is evident in its aggressive push to bring cretostimogene to market, setting the stage for potentially groundbreaking advancements in bladder cancer care.