of saying this finding is definitive on whether Oncophage helps patients live longer. The company still needs to track down more patients, and keep following them for at least another nine months for the data to become mature, he says. The absolute numbers are also small—just 18 patients on the Oncophage group of the study had died as of early January (about 10 percent), compared with 32 who died in the control group (18 percent) at the same cut-off date, Antigenics said.
The company is being urged by about two dozen thought leaders to package this data together and send it to the FDA, although Antigenics hasn’t decided whether to do that yet, because it’s possible the FDA may not even consider taking a look at it, Armen says. For now, he’s hopeful this will strengthen Antigenics’ hand with European regulators.
Part of what intrigues researchers so much, and keeps the Antigenics dream alive, is the way the drug is designed to work, by boosting the immune system to fight cancer like a virus. Realization of this immunotherapy concept has eluded science for decades, although Seattle-based Dendreon just reported a significant advance for the field last month when it showed in a clinical trial of 512 men that its immunotherapy helped men on the treatment live longer with minimal side effects.
The Antigenics treatment is different than Dendreon’s—which uses a standard genetically engineered protein on cancer cells to spark the immune system to fight. The Antigenics method doesn’t rely on one biomarker on cancer cells, but rather hopes to spark the immune system to fight multiple biomarkers.
It does this by slicing out a portion of a patient’s tumor, freezing it, and shipping to the Antigenics plant in Lexington. There, 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.
Dendreon’s success created a short-lived burst of enthusiasm for other cancer immunotherapy companies, including Antigenics, but it’s clear the company needs a bigger break than that. Its stock closed Friday at 73 cents, and it had just $14.5 million in cash and investments left in the bank at the end of March. Antigenics is hopeful that the survival benefit is too enticing for regulators to ignore, and that something can be worked out to keep the product alive.
“We can’t accomplish this without regulatory innovation,” Armen says. All the company asks, he says, is that regulators “hear us out on the science, the biology, the facts.”
