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Dialing down the toxic effects of radiation on cancer patients, Galera gets breakthrough status on Phase IIb data

by brittany meiling | 

A biotechnology company near Philadelphia — armed with data from a Phase IIb trial — just got breakthrough status from the FDA for a drug that might reduce the harmful effects of radiation therapy for cancer patients.

The company, Galera Therapeutics, has an intravenous drug (meant to be taken right before radiation treatment) that might mitigate the toxic effects. Essentially, when patients undergo radiation, their bodies are overwhelmed by a compound called superoxide, which is deployed by the immune system to kill invaders. Normally, the body can break down superoxide, converting it to hydrogen peroxide and molecular oxygen. But when undergoing intense radiation, the body can’t keep up.

“Our drug mimics the effect of that natural enzyme, and does it potently,” Galera’s president and CEO Mel Sorensen tells me.

First, Galera is tackling a severe side effect of radiation that afflicts head and neck cancer patients. These patients often develop a condition called severe oral mucositis, or SOM, which happens when sensitive tissue in the mouth is subjected to excessive superoxide generated during radiation treatment. This breaks down the epithelial cells that line the mouth, causing patients to suffer from severe pain, ulcerations, and bleeding of the mouth. It’s often so bad that the patient can’t eat or drink.

“The problem isn’t just the immediate effect of the pain, soreness, and lack of nutrition, but also the residual effects,” Sorensen said. “It can cause dry mouth for years after treatment.”

In patients with head and neck cancer, radiation is a mainstay, and about 70 percent of patients receiving this treatment develop SOM.

The FDA has granted breakthrough therapy designation for Galera’s drug, coined GC4419, based on the data from a 223-patient, double-blind, randomized, placebo-controlled Phase IIb clinical trial in patients with head and neck cancer. In the trial, GC4419 reduced the duration of SOM from 19 days to 1.5 days (92%), the incidence of SOM by 34%, and the severity of patients’ oral mucositis by 47%.

Although starting with SOM, Sorensen said Galera’s drug might have applications in many different cancers. Hydrogen peroxide, the byproduct Galera’s drug creates when breaking down superoxide, happens to be toxic to tumor tissue, Sorensen said. The company is hopeful that administering the drug in combination with high-dose radiation might protect normal tissue while fighting tumors.

“If we can do both of those, we’ve effectively transformed radiation therapy,” Sorensen said.

The company is now recruiting for a Phase I/II trial testing GC4419 against pancreatic cancer.

Since the company’s founding in 2009, it’s raised $77 million ($20 million Series A, $57 million Series B). Sorensen wouldn’t say how much runway the company has or whether it would need to raise more money before taking GC4419 into Phase III trials. He did note, however, that the company has a strong investor syndicate including Novartis Venture Fund, New Enterprise Associates, Sofinnova, and others.

“We’re looking at all ways to optimize the financial side of this,” Sorensen said. “We’re still thinking about what’s the best way to finance the Phase III, and we’re talking with lots of people.”

Image: Cancer cells. shutterstock