The genomics revolution may not have ushered in the age of personalized medicine the way healthcare experts predicted, but innovative diagnostics keep pushing the industry toward the ideal of the "right drug for the right person at the right time."
One company that exemplifies that model is CeMines, a Colorado-based enterprise with an impressive, noninvasive cancer diagnostic in development. The product, which uses molecular fingerprinting to test blood samples, has had a 100 percent accuracy rate for every trial conducted. It not only determines-even in early stages-if a patient has cancer, but provides guidance for which type of treatment will work best.
Another extraordinary thing about the company is that neither Richard Cavalli, CeMines' president, or Bailey Dotson, its CEO, has a pharma background. So how did two real-estate moguls get involved in a business based on transcription factors, molecular fingerprinting, and auto-antibodies?
"So I just put it out to Tom that I was quite impressed with him," Cavalli recalls. "We seemed to have very good chemistry, and we were able to put together a business plan and start CeMines." Named for "cellular mining," CeMines was found-ed in April 2000 in Cavalli's hometown of Evergreen, Colorado. Cavalli's confidence also lead him to invest a half-million dollars from a personal trust into the startup. Soon after, Bailey Dotson, Cavalli's business associate, came on board, and the two men eventually funded the company with another combined half-million dollars from their real-estate development businesses. But CeMines isn't dependent on its founders' faith and generosity. An additional source of funding comes from sales of reagents to more than 150 research institutions worldwide, generating $1.2 million so far. CeMines was developing antibodies for its own research and saw a business opportunity to offer unique reagents to other researchers. The company has also sold $1 million in common stock.
"Our reagents business is increasing in size and number," Cavalli reports. "We have a very good reputation in the research community for providing products that work very well. And we recently created partnerships with the top two industry leaders, Sigma Aldrich and Chemicon International, that have boosted our sales significantly and have opened doors to future increases."
But of course, all that funding is for one greater purpose: to drive the development of the company's star project-blood tumor antibody diagnostics.
Strictly Science Most cancer is currently detected through imaging or biopsies, both of which take place when the tumor is quite large and difficult to treat. A few blood-based diagnostics for hormone-related cancers are on the market, such as the PSA test for prostate cancer and the CA-125 test for ovarian cancer. Neither method is ideal or highly accurate. CeMines' technology combines the best of both worlds. Tumors, which are homogenous in the early stages, develop subpopulations of malignant cells, which trigger the body to produce unique auto-antibodies. The diagnostic tests the patient's blood against dozens of known cancer antigens, looking for a reaction with cancer antibodies. The screening identifies the highly specific molecular subtypes of cancer by analyzing a network of cell regulatory factors. In finding the tumor's cellular fingerprint in the bloodstream, the diagnostic can detect the presence of cancer very early. And by testing it against dozens of antigens, the diagnostic can determine which type of cancer is present. (See "The CeMines Technology.") Neuman, CeMines' chief scientific officer, puts it simply: "There are hundreds of published papers in which people have shown that at the molecular level there are different groups of tumors. Everybody can do it when they have a piece of tumor. What we can do is identify the different molecular groups using noninvasive techniques."
But the technology goes beyond that. "It not only will provide the diagnosis, it will provide a description of the tumor's structure at the molecular level so that targets can be drawn precisely," Cavalli says. "It will offer guided therapeutics, because with a known molecular fingerprint, we can access a database that will show how each specific tumor has reacted historically to specific treatment regimens."
The result is that the company will be able determine which treatment has worked well for that cancer subgroup before. That is good news for patients, who often have to undergo multiple regimens. The diagnostic also allows oncologists to monitor patients whose cancers come back. "What happens is that tumors change," Neuman says. "The patient has one tumor type right now, and in two years, the same patient may have a modified type of the same tumor. So he actually needs a completely different treatment strategy." »
Other good news for the industry is that CeMines' database of molecular cancer fingerprints will eventually allow pharma companies to "design intelligent therapies that target specific signaling pathways," Neuman says. "That is our long-range goal," Dotson adds, "to develop a whole new generation of more intelligently designed drugs that are really a rifle shot to the tumor rather than the shotgun approach that we are forced to use today."
But all that is down the road. Short term, to get FDA approval, the company must conduct large-scale trials with 1,000 people or more. And it may need an additional source of funding to make that happen. "Rather than looking to the market to raise the money," Dotson says, "we are probably looking at partnering. We've had preliminary discussions with two or three major companies."