Galena’s Drug Culture

By Elizabeth Hayes-Staff reporter- Portland Business Journal

It’s a scary problem for breast cancer survivors: how to keep the cancer in remission following the standard treatment — surgery, chemotherapy, radiation.

“Then they’re sent home to watch and wait and worry about recurrence,” said Mark Ahn, president and CEO of Galena Biopharma.

Galena is working on a solution. The Lake Oswego-based company is in the third phase of a clinical trial for a vaccine called NeuVax that uses the body’s own immune system to activate a specific kind of T-cell to search out and destroy cells that display a specific marker for cancer.

“There’s a lot of excitement about therapeutic cancer vaccines, so this space is one that’s attracting a lot of attention,” said Dennis McNannay, executive director of the Oregon Bioscience Association.

Galena was formed in 2011, when Boston-based RXI merged with Arizona-based Apthera, which had shepherded NeuVax into the second phase of its clinical trials. The combined company changed the name to Galena and moved to Lake Oswego. Galena, which trades on Nasdaq, has raised $66 million to date from its initial and secondary public offerings. Its market value is $150 million, even though it has yet to generate revenue.

Ahn jokes that the company is a “nonprofit not on purpose,” but that’s normal in the biotech industry, where only 10 percent of companies generate revenue and the real value is in the intellectual property and clinical progress.

Galena currently has three cancer-related products either in its pipeline or about to launch, including NeuVax. The others are FBP, another immunotherapy drug that is in early clinical trials, and Abstral, which has been approved to manage cancer pain.

“Our strategy is all oncology all the time,” said Ahn, who has a PhD in economics. “In each program, we’re addressing key unmet needs.”

Ahn sounds particularly excited about NeuVax. When a drug is in a Phase 3 trial that means that it’s being tested for “statistically significant efficacy,” Ahn said. He expects this phase to take about three years; it will encompass 700 patients at 130 hospitals in 16 countries.

About 230,000 women are newly diagnosed with breast cancer each year. Treatment generally entails surgery, followed by chemotherapy and radiation to eliminate any undetected cancer cells. About 55 percent are “lymph node positive,” and of those, one in four will have a recurrence of the disease.

This happens when cells that drive tumor growth break off and migrate into other organs and bone. They can rest there for up to a year before the patient feels any pain. The more cells, the worse are one’s prospects for tumor growth and morbidity.

About 25 percent of all breast cancer patients are eligible for a drug made by Roche and Genentech called Herceptin. NeuVax targets the other 75 percent of cases who achieve remission but have no targeted treatment options to keep them disease free.

“The current drug can’t get to them because of the way it works,” Ahn said. It would simply be far too toxic for most patients.

“The benefit you get for the risk isn’t appropriate, so they only give it to 20 to 30 percent of women,” Ahn said. “Therein lies the problem and the opportunity.”

T-cells help regulate the immune system, but the tumor cells in question evade immune surveillance. There’s a certain peptide (which is derived from an amino acid) that can target a certain protein and activate the immune system to kill these cancer cells.

“It turns out to be very well tolerated, too,” Ahn said.

NeuVax is given once a month for six months and then once every six months as a booster for 36 months altogether. None of the patients on a full dose of NeuVax have had a recurrence, Ahn said.

There are other biotech companies developing a similar therapy, but none is as far along as Galena, he said.

Galena has a second drug in the pipeline called Folate Binding Protein-E39, or FBP. It’s a targeted vaccine aimed at preventing recurrence of ovarian, endometrial and breast cancers. There are 20 patients in a trial currently.

“It’s really exploratory,” Ahn said.

Then there’s Abstral, an analgesic that is administered for pain from all types of cancers. It’s an alternative to amping up a patient’s morphine dosage and can be taken by a tab on the gums. It lasts for about an hour and doesn’t have addictive qualities, though it’s a hundred times more potent than morphine.

Galena announced in March that it was paying $10 million to the Swedish company Orexo AB to buy the rights to Abstral Sublingual Tablets in the U.S. This fall, Galena will begin selling Abstral, which is already available in Europe and Canada.

There’s a $400 million market for such drugs and Ahn said he thinks Galena can achieve 10 to 15 percent market share. Ahn expects to have an Abstral sales force in place by the beginning of October.

“It’s super exciting,” he said. “In the field of molecular biology, we’re only at the beginning of new vistas to treat patients, diagnose and come up with greater insights.”


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