Antigenics, the developer of a personalized treatment to stimulate the immune system to fight tumors, is asking European regulators for permission to sell its vitespen (Oncophage) treatment for kidney cancer. It’s a big step for the New York-based company—which has 90 of its 98 employees in Lexington, MA—on its quest to be the world’s first to bring such a product to a wide market of patients.
The move comes six months after Antigenics (NASDAQ: AGEN) won clearance to market the immune stimulator in Russia, the first market where the drug is approved for sale. The company is now asking European regulators to do the same, even though its main clinical trial supporting the product failed to reach its primary goal. Antigenics made a case in Russia that although the trial of 604 patients failed to lower the risk of relapse after kidney tumors were surgically removed, it did help 60 percent of people stay in remission longer if they had an intermediate risk of recurrence.
That sort of “subset analysis” of patients is generally considered a “fishing expedition” by the FDA, and isn’t good enough to win approval here in the States. Antigenics hopes to get its treatment cleared in Europe through what’s known as “conditional approval,” a European Union regulatory provision introduced in April 2006 that provides patients access to new drugs when no satisfactory treatment option is readily available, Antigenics says. More than 60,000 people were diagnosed with kidney cancer in EU member countries in 2004 and about half that many died, the company says. Antigenics had three meetings with European regulators to sort through the options before it decided to go ahead and ask for approval, says spokesman Sunny Uberoi.
“This application represents a major achievement in the development of Oncophage, and if approved, will be the first therapeutics cancer vaccine to receive a marketing license from the European agency,” said Garo Armen, Antigenics’ CEO, in a statement.
One of the arguments Antigenics has made is that in patients with intermediate risk of cancer relapse, people on its drug stayed in remission for 4.2 years, compared with 2.5 years for patients who didn’t get it. The immune system wasn’t able to help ward off a relapse in patients with more aggressive forms, researchers have said.
If the company were forced to start over with another trial that prospectively looked only at intermediate-risk patients on Oncophage versus a placebo, it would take six to seven years and wouldn’t be practical, Armen told me earlier this year when I was with Bloomberg News.
Antigenics is one of the few companies still standing in the class of biotech companies aiming to stimulate the immune system against cancer. South San Francisco-based Cell Genesys pulled the plug on its GVAX treatment against prostate cancer recently, and Genitope failed in a large trial of patients with non-Hodgkin’s lymphoma. Seattle-based Dendreon (NASDAQ: DNDN) is still in the running with a trial of 500 men with prostate cancer, to see if its treatment can extend lives with minimal side effects.
The Antigenics treatment is different because it is designed to be personalized, made by slicing out a portion of a patient’s tumor. The tumor tissue is frozen and shipped to the Antigenics plant in Lexington, where it is chopped up, and key proteins filtered out. The treatment is shipped back to the doctor, then injected back into the patient to “teach” the immune system to spot the hallmarks of cancer cells and mount a defense against them. Patients usually get their personalized vaccine four to six weeks after tumors are removed, the company has said.
Antigenics hasn’t been able to start selling its treatment in Russia as quickly as it would like, Uberoi says, because it took longer than expected to get an export license it needed from the FDA. If it can win approval in Europe, it will be interesting to see what Antigenics’ next chess move will be back here in the U.S., the world’s largest healthcare market.