A biomedical company, CG Oncology Inc., may be taking on industry giants Merck and Ferring Pharmaceuticals with a new way to treat bladder cancer.
Irvine-based CG announced May 3 a 75% remission rate for high-risk bladder cancer from treatment with its genetically modified viruses, in a Phase 3 BOND-003 clinical trials study. CG made the announcement at the American Urological Association’s Annual Meeting in San Antonio, which took place May 3-6.
CG Oncology’s “data so far … points to a potential new standard of care,” LifeSci Capital analyst Sam Slutsky wrote in a note to investors. “Simply put, our view is that CG’s (drug) appears to be the most/one of the most efficacious options around.”
About 725,000 people in the U.S. have bladder cancer, making it the sixth-most prevalent cancer in the country. The American Cancer Society estimated about 17,000 died last year from the disease and 82,000 people annually are diagnosed with it.
It’s costly to the healthcare system because of the intense follow-up schedule required for patients. Up to half of high-risk patients’ symptoms will recur within one year.
Moreover, a bladder cancer patient has limited options.
The bladder can be removed or repaired, but both procedures have high fatality rates.
Medicines can be administered, but they often have problems because the bladder urinates the anti-cancer drugs out of the body.
In contrast, CG’s “oncolytic immunotherapy” uses genetically modified viruses to target tumors in the bladder.
“We believe there is a huge untapped market opportunity and unmet need,” Slutsky wrote.
In December, the Food and Drug Administration granted both Fast Track Designation and Breakthrough Therapy Designation to CG Oncology. The company plans to seek FDA approval next year and the goal is to begin sales in early 2026.
At the same time, CG’s study sample was of 105 patients, limiting extrapolation. And the measured duration of remission remains short term. So far, 29 patients have maintained remission after one year, said CG Oncology Chief Executive Arthur Kuan, who, nevertheless maintained, that “the therapy is durable.”
Crowded Field
In addition to existing products from Merck and Ferring, CG’s product also has a new competitor in billionaire Patrick Soon-Shiong’s ImmunityBio Inc. (Nasdaq: IBRX), which on April 23 won FDA approval for treating bladder cancer with its Anktiva.
San Diego-based ImmunityBio is valued at around $5.4 billion while CG Oncology has a $1.9 billion market cap. After CG Oncology went public at $19 a share in January, it reached as high as $50 in February; since the May 3 announcement, shares have fallen about 21% to $28.63 at press time.
Slutsky, who placed an $86 target price, estimated that CG Oncology’s medication may generate $1.6 billion annually by 2036.
The Study
Last July, CG Oncology completed enrollment for its BOND-003 study, which is evaluating patients with high-risk non-muscle invasive bladder cancer.
The company said that none of the patients had to undergo a radical cystectomy—removal of the bladder.
“We want to give patients another chance at preserving their bladders,” CG CEO Kuan said.
The company said that none of the patients moved from Grades 1 and 2 into more serious Grades 3 and 4 levels. Grade 5 signals pending death.
Also, all the patients continued the treatment, Kuan said, adding that compliance is often a problem for these treatments.
“We’ve not seen anyone discontinue our drugs because of adverse events. A high dropout rate would tell us something.”
Another point is that CG Oncology’s medication medication alerts the body when a tumor reappears, helping kick off its immune system to fight it, Kuan said.
The IPO
CG Oncology’s successful IPO in January helped it raise $437 million, which Kuan said will be used on clinical developments.
“We see a tremendous opportunity to leverage our research to expand into other bladder indications,” he said.
CG is also testing its medication in a Phase 2 trial, Core-001, that will combine its therapy with Merck’s Keytruda.
“We’re trying to understand if there is a better outcome,” Kuan said. “We’re always thinking of what’s ahead.”
Competitive medications typically have remission rates ranging from 20% to 50% while ImmunityBio’s recently approved Anktiva has a 62% remission rate, Kuan said.
While Merck’s Keytruda and Ferring’s Adstiladrin were approved in recent years, “their efficacy (and safety for Keytruda) leaves more to be desired,” LifeSci Capital analyst Slutsky wrote in his note to investors.
Later this month, CG will be presenting its Phase 2 results at the American Society of Clinical Oncology 2024 Annual Meeting scheduled for Chicago. The results will be presented at a plenary session in front of 10,000 to 15,000 medical professionals, including many urologists who may be using its products going forward, Kuan said.
“A lot is coming to the market right now,” Kuan said. “We’re at the tipping point. We hope to be in that inflection.”
