Flameouts are the norm for any company that dares to try to stimulate the body’s immune system to fight cancer cells. Cell Genesys, Genitope, Favrille, and Antigenics have been added to the long list of companies that have stumbled in this promising field that hasn’t yet produced a single FDA-approved therapy. One of the sector leaders, Seattle-based Dendreon (NASDAQ: DNDN), is awaiting critical results next month which could validate, or crush, its immune-booster for prostate cancer, Provenge.
Given the hundreds of millions of investor dollars that have been sunk already into these active immunotherapies—sometimes called “cancer vaccines”—why would anybody listen to another startup pitch? Maybe I’m a glutton for punishment, but since Seattle-based CG Therapeutics has recruited two Dendreon veterans to its board, attracted capital from prominent Seattle investor Robert Arnold, and hired a new CEO, I figured it couldn’t hurt to hear the story.
CG Therapeutics’ new CEO is Denise Harrison, who got her biotech experience as chief financial officer of Seattle-based Illumigen Biosciences. That company was sold in December 2007 to Lexington, MA-based Cubist Pharmaceuticals. She’s getting some advice in this first go-round as a CEO from two new board members: Reiner Laus, the CEO of BN Immunotherapeudics and former vice president of R&D at Dendreon, and Julie Eastland, the chief financial officer of Seattle-based VLST and a former vice president of strategic planning at Dendreon.
CG has fixed its sights on a hormone that inspired the company name—hCG. Scientists have known for decades that this hormone plays a key role in early development, when it protects the fetus from being attacked by the immune system (it’s the thing that confirms when a woman is pregnant, turning the test kit blue). Researchers later came to understand this hormone can appear later in life, playing a more nefarious role. It offers that same brand of protection to tumor cells, cloaking them from an immune system that might otherwise kill them like an invading virus.
The company’s scientific team, led by Immunex veteran Tom Hopp, say they have designed a method to lift that protective veil from tumors. Their drug CG-201 aims to do this by taking some synthetic peptides that train the immune system to recognize hallmark signatures of hCG, and fuses them to a diphtheria toxin like the one found in the common DPT childhood immunization. This is supposed to make the hormone look like a foreign invader the immune system should attack.
By knocking out hCG, the company scientists hope they can attack the tumor’s support network on multiple levels. Besides offering protection from the immune system, the hormone is also thought to play a role in cancer by nourishing tumors through helping grow new blood vessels, and by allowing tissues to break down near the tumor that allows it to spread through the body, Hopp says.
An earlier version of CG-201 showed some positive signs, but not enough to move ahead in development, and besides, that intellectual property now belongs to Portland, OR-based AVI Biopharma, Harrison says. So CG’s scientists cooked up a new version on their own, which they say has been shown to be 10 times more potent, and longer-lasting, than the earlier one in rabbit experiments. It’s now ready to go into clinical trials.
Except there’s one big catch. No venture capitalists want to touch another immunotherapy company because of the dismal record. Big Pharma companies will listen, but say they need to see some data in humans before they get on board. So CG needs $3.5 million to run an early-stage clinical trial before it can go ahead.
“Raising money is a bitch,” Hopp says. “VCs are afraid of cancer vaccines.”
The company may not have enough financial backing at the moment, but it has some support from scientists. Vern Stevens, an Ohio State University biologist who invented CG’s predecessor immunotherapy, is a scientific adviser. Karl-Erik and Ingegerd Hellstrom, the pioneering husband-and-wife immunology research duo in Seattle, are working to develop a genetically engineered antibody drug that could be infused alongside CG-201 in the early period while it’s taking time to charge up the immune system, Hopp says.
Eastland told me the team’s tenacity was what encouraged her to join the board. “I am impressed with the passion and energy Denise, Tom and the team bring to ensuring the drug gets back into clinical studies,” Eastland said in an e-mail. “They have put a considerable amount of personal time, energy and funding to keep the program alive.”
CG Therapeutics isn’t the only company aiming at the hCG hormone. Needham, MA-based Celldex Therapeutics (NASDAQ: CLDX) is developing an immune-boosting treatment against colorectal, pancreatic, bladder, ovarian, and breast tumors. Researchers in China are also taking a keen interest in this target, although Hopp says he’s not aware of a version moving ahead in commercially-sponsored trials.
The initial clinical trial is designed to enroll 18 to 24 patients, and ought to yield data on whether CG-201 is safe and promising within 12 months, Hopp says. The initial uses will be for ovarian and bladder cancers, which express high amounts of the hormone of interest. If CG can get that far, in a grim financing environment, then it’s confident that doors will start opening from VCs and pharmaceutical partners who want to bet on the next big thing.
For a guy who still hasn’t taken the new immunotherapy into the clinic, Hopp didn’t mince words about what kind of potential he sees. “We think this will be the biggest cancer target of all time,” he says. “We think we will have the first successful cancer vaccine. It’s too good to quit on.”
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