Cold Genesys has raised $22 million in series C funding to advance its oncolytic immunotherapy for bladder cancer and other solid tumors. The biotech is developing the candidate both as a single agent and in combination therapies and has taken it through phase 2 in non-muscle invasive bladder cancer.
ORI Healthcare Fund led the financing, with Perseverance Capital Management also chipping in. It follows a $13.6 million series A in 2014 and a $10 million series B in 2015, and will “accelerate the growth” of Cold Genesys’ clinical programs.
The company is testing the oncolytic immunotherapy CG0070 in combination with Merck’s Keytruda, in addition to as a monotherapy for non-muscle invasive bladder cancer (NMIBC). It’s also doing preclinical work combining the treatment with an undisclosed immune checkpoint modulator in muscle-invasive bladder cancer and other solid tumors.
Cold Genesys company hopes that CG0070 will become a treatment option for NMIBC patients, for whom BCG immunotherapy—a common treatment for noninvasive bladder cancers—has not worked. Patients who fail BCG typically “have no other choice but to proceed to cystectomy,” the surgical removal of part or all of the bladder, the company says.
"We are a strong believer in using the oncolytic immunotherapy approach in both monotherapy and combo therapy to combat cancer," said Simone Song, a senior partner at ORI Fund, in a statement. "We are very fortunate to have the opportunity to work with an outstanding firm such as Cold Genesys which has completed the Phase 2 study for NMIBC. We have confidence that Cold Genesys will fulfill the unmet medical need for NMIBC, and we also hope that Cold Genesys can become a platform company to benefit patients with various types of solid tumors by applying its oncolytic immunotherapy expertise."
Oncolytic, or tumor-targeting, viruses are an attractive way to rally the immune system against cancer—when they infect a virus, they signal the presence of a tumor to the immune system, tissue that the body would otherwise recognize as “self.” Though oncolytic viruses have shown limited effectiveness in human trials, studies have shown that combining them with immunotherapies, such as checkpoint blockade, could be a promising way forward.
Santa Ana, California-based Cold Genesys isn’t the only player combining its oncolytic virus with Keytruda. Viralytics had been testing its own candidates with Keytruda when Merck inked a $394 million deal in early 2018 to acquire the Australian biotech. Viralytics was investigating its lead candidate, Cavatak, a common cold RNA virus, in three combination trials.
Three months later, Johnson & Johnson ponied up $140 million upfront and promised up to $900 million in milestones for BeneVir Biopharm, another oncolytics specialist. The biotech, based in Rockville, Maryland, grew out of research from New York University professor Ian Mohr, Ph.D.
What sets it apart from other oncolutic viruses is that it’s technology, dubbed T-Stealth, allows its viruses to evade T cells. At the time of the J&J deal, BeneVir hadn’t yet come up with clinical data to validate this hypothesis, but had evidently convinced the Big Pharma with its preclinical work.