Can an oncolytic virus therapy challenge the standard of care in bladder cancer? CG Oncology has $120M to find out

15 Nov 2022
endpts.com
Phase 3Executive Change
CG Oncology is cashing in on its interim data update. Tuesday morning, the Irvine, CA-based biotech announced that it raised $120 million — eclipsing the combined $87 million it’s brought in since its inception 12 years ago. The raise comes after CG posted updated data at SITC for its oncolytic virus candidate in combination with Keytruda for non-muscle invasive bladder cancer, or NMIBC, in patients who did not respond to standard Bacillus Calmette-Guérin (BCG) therapy. In the interim update, CG said that 28 of 32 patients had no signs of cancer at the three-months follow-up. Going out to one year, the primary endpoint of the study, 11 of 15 had a complete response to treatment — a 73% response rate thus far. The trial is fully enrolled and the biotech plans to read out the complete data at a cancer conference next year. CG is also testing its oncolytic virus, which works by sneaking into tumor cells and causing them to lyse, as a monotherapy in a Phase III trial, which it plans to have results for in 2024. ORI Capital (which also led the biotech’s Series C), Longitude Capital and Decheng Capital led the way in this round, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Sirona Capital and Ally Bridge Group, an investment firm where CG Oncology CEO Arthur Kuan was one of the first members. And Longitude’s Brian Liu will join CG’s board. “On the medical devices side, we’ve seen very impressive innovation over the last decade in bladder and made several investments in that space. But in contrast, bladder as a whole has been pretty underserved, particularly in bladder cancer: not very much innovation going on, not very much progress. And so when CG came along with data that stood out from the other bladder cancer companies we’d seen, we were very intrigued,” Liu told Endpoints News . With more money comes greater ambitions. With its new funds, the biotech wants to challenge the first-line standard of care of BCG. It is planning a mid-stage trial for intermediate risk NMIBC in patients who haven’t received BCG. The biotech highlighted the BCG shortage — which began in 2019 and led the American Urological Association to make new recommendations on BCG usage in 2020 — as impetus for its new endeavor. Merck is the only producer of BCG in the US and many other countries. The biotech plans to “diversify within bladder cancer,” Kuan said, looking at other potential indications as well for its therapy CG0070. Kuan says he has been hyperfocused on developing cancer therapies since his father passed away in 2013. He said that before his father passed, his father told him that if he could do one thing in life well, then he played his role — cancer therapies have been his one thing for the past eight years. In 2015, he joined CG as its COO, after investing in it as part of Ally Bridge Group. In 2016, he moved up to CEO after founder Alex Yeung retired. There has only been one oncolytic virus cancer therapy that’s made it to market, Amgen’s Imlygic, and it middled. A number of biotechs are working on new oncolytic virus therapies, though not all in bladder cancer. Candel Therapeutics, which went public last year , has a Phase III candidate in prostate cancer. And Replimune recently took out a $200 million loan to bankroll its clinical trials. Big Pharmas are interested in the space too, with J&J, Merck and AstraZeneca all placing their own bets.
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