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. Last Updated: 07/27/2016

U.S. Firm Seeks Approval for Vaccine

AntigenicsVials of Oncophage pictured in an undated photo. The maker of the vaccine is seeking approval for the drug in Russia.
BOSTON -- Antigenics, one of the few biotechnology companies developing cancer vaccines, said Thursday that it was seeking approval for its experimental vaccine Oncophage in Russia.

The move comes after Oncophage failed to meet the main goal of a late-stage kidney cancer trial, making approval in the United States unlikely in the near term.

Antigenics is betting Russian regulators will be more open than their U.S. counterparts in approving the vaccine based on positive results from a subset of data from the failed trial.

Roughly one-third of the 604 patients enrolled in the trial were tested in Russia, and about 70 percent of those fell into a subgroup of patients whose prognoses following surgery were better than that of the total population.

"Our physicians saw some fantastic results so they are extremely positive, and their opinion is crucial for officials at the [Health and Social Development Ministry]," said Yury Raifeld, chief executive of Raipharm, a Russian consultancy hired by Antigenics to shepherd the vaccine through the regulatory process.

The move to seek Russian approval is unusual for a company as small as Antigenics, which also plans to submit applications for approval elsewhere in the world, including Europe.

But the company's chief executive, Garo Armen, is determined not to give up on the vaccine, which is also being tested -- and has shown promise -- as a treatment for brain cancer.

"The regulatory system in the U.S. is like a garage that hasn't been cleaned in 30 years, containing regulations that are no longer applicable to the changing world of science," said Armen. "The Russian system is a relatively new garage, and much more applicable to today's environment."