Monday, February 13, 2012

OncoPep licenses cancer vaccine, moves to add $500K to Series A

By Lori Valigra

OncoPep Inc., a virtual cancer vaccine developer based in North Andover, said today that it has signed an exclusive, worldwide license agreement with Dana-Farber Cancer Institute for therapeutic, multi-peptide vaccine technology, and that it expects to close an additional $500,000 Series A funding by the end of this quarter.

Company CEO Doris Peterkin told Mass High Tech that the money will boost the $4.5 million in angel funding it received last spring. “We’ve expanded our Series A to $5 million,” she said. Peterkin would not reveal financial details relating to the licensing agreement.

The company will remain virtual for the time being, she added, and will look for partners after a Phase 1/2a clinical trial is completed. Currently, it is handling the clinical trials and supporting its entire program. Pending discussions with the U.S. Food and Drug Administration (FDA), the trial is slated to start later this year, and will last about two years, said Peterkin, who currently is the company’s only employee. About 13-16 patients will be enrolled at four cancer centers across the United States, and the trial will be handled by a contract research organization.

The first vaccine developed from the licensed technology is PVX-410, which is designed to target multiple myeloma cells. The trial will be in patients with smoldering multiple myeloma, an asymptomatic precursor of multiple myeloma that is defined by the extent of multiple myeloma cells present. Peterkin said the company later hopes to expand studies to actual multiple myeloma.

About 1,500 Americans are diagnosed with smoldering multiple myeloma each year. Targeting that small population could qualify the drug from FDA orphan drug status for rare diseases. Peterkin said the company plans to apply for that once the Phase 1/2a trial is started. Incentives for companies to develop orphan drugs include federal tax credits for the research done (up to 50 percent of costs), a guaranteed seven-year monopoly on drug sales for the first company to get FDA marketing approval for a particular drug, and waivers of drug approval application fees and annual FDA product fees.

“We are committed to developing PVX-410, which is a therapeutic cancer vaccine developed to target multiple myeloma cells,” Peterkin said. “This license with Dana-Farber Cancer Institute not only sets the stage for our upcoming clinical trial, but also provides OncoPep with a novel underlying technology that will give the company the opportunity to develop additional therapeutic vaccine candidates in the future.”

 PVX-410 was created in the lab of Dr. Kenneth Anderson at Dana-Farber. It is composed of four proprietary, synthetic peptides to form a therapeutic cancer vaccine that targets specific antigens found on the surface of multiple myeloma cells. PVX-410 has demonstrated the ability to stimulate a strong immune response against multiple myeloma cell lines and patient cells in vitro (in a test tube), the company said. Multiple myeloma is a cancer of the plasma cells for which there is currently no cure.

Peterkin had earlier told Mass High Tech that vaccines are the ideal approach to treating cancer. “They keep patients alive longer,” she said. Cancer vaccine companies have seen a roller coaster ride. For example, the stock of Dendreon Corp., whose Provenge vaccine for metastatic castrate resistant prostate cancer was the first cancer vaccine approved by the FDA, at first boomed, and then fell drastically last fall when sales of the vaccine declined reportedly because of its high price and concerns that it may not extend patients’ lives as long as had been hoped. The stock rose again sharply last week after FDA reviewers questioned the benefit of Amgen Inc.’s competitive vaccine.

“Those of us in the cancer vaccine business expect ups and downs,” Peterkin said. “There’s still a very high level of excitement on immunotherapeutics. I got a call from a patient today who was interested in our vaccine trial.”