Allan Maurer
DURHAM, NC & MIAMI, FL—Pique Therapeutics is developing vaccines that may halt aggressive cancers and in early clinical trials doubled the average survival time of patients with late-stage non-small-cell lung cancer (NSCLC) the number one U.S. cancer killer.
About 80 percent of all lung cancers are NSCLC, and they kill more people than colon, breast, and prostate cancer combined. The five-year survival rate for this aggressive killer is less than 5 percent. A million new cases are diagnosed yearly with nearly 200,000 in the United States.
Pique CEO, Chris Meldrum tells TechJournal South that a small Phase I trial of the company’s lead vaccine aimed at NSCLC looked at 19 patients with very late stage disease. Average survival time for these patients is four to six months and even the best drugs currently on the market extend that only by a few months.
“There’s really no hope for these patients,” says Meldrum.
Unprecendented efficacy
Early stage trials primarily test safety, in which the Pique vaccine, which is not a cell-killer (cytotoxic) like most chemotherapy drugs, was well tolerated. But, it also showed strong efficacy, with over a 100 percent improvement in median survival to 11 months. “So far as we know, that kind of improvement has never been seen in clinical trials of drugs for NSCLC,” says Meldrum.
Not only that, says Meldrum, who is also managing director of Golden Pine Ventures, which seed-funded the company, “Six patients in the trial are still alive after four years.”
The company’s therapeutic vaccine, developed by Eckhard R. Podack, M.D., Ph.D, chair of the Department of Immunology and Microbiology at the University of Miami, stimulates patients’ immune systems to attack their cancer.
Stealthy cancers hide from immune system
Cancers have evolved two different methods of avoiding the immune system, Meldrum says. One type, such as melanoma (skin cancer), allows the immune system’s killer cells in, but evades them.
Other cancers, primarily more aggressive types such as NSCL, head and neck, colon, pancreatic and others, create an environment in which no immune response occurs.
Podack theorized that tumors never exposed to immune system killer cells might be the most susceptible to a vaccine that primed the body to assault it with killer T-cells. “We think the more aggressive cancers are more amenable because of this,” says Meldrum.
Seeking $3 million to $5 million
Meldrum explains that the company’s technology uses several unique methods for getting the vaccines to work, such as adding two genes to vaccine cells used to make the cancer open its doors to the immune system.
The company, founded in 2005, is looking for from $3 million to $5 million in a Series A round to do a larger, pivotal Phase II trial. Prior to initiating that trial, the company will discuss an accelerated review (or fast track status) by the U.S. Food and Drug Administration.
Pique has several advantages in moving its drugs to market. Clinical trials are evaluated on how well they meet their predicted end points, such as increased survival time. If the vaccine performs as well in later trials as it did in the earlier ones, it will not have much trouble meeting its goal.
“The nice thing about Pique,” says Meldrum, “is that it’s something investors can get excited about, but it’s also an innovation that could make a real difference in how cancer patients are treated.”
A drug currently on the market (Tarceva)that extends the life of NSCLC patients about two months, had worldwide sales of $650 million last year. So the potential market for the vaccines is huge.
He says the company is raising money now from angel investors in New York City and the East Coast.
On the Web: www.piquetherapeutics.com
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