Galera Therapeutics has raised $150 million that will bring a drug designed to ward off inflammatory side effects from radiation therapy into a pivotal phase 3 study. The financing comes one month after the company presented data showing the candidate, dubbed GC4419, appeared to prevent severe oral mucositis (SOM) in patients with head and neck cancers.
The financing, led by Clarus, comprises $70 million in equity and $80 million in royalty financing payable from future sales. A handful of new investors, including Nan Fung Life Sciences and RA Capital joined in, while existing backers New Enterprise Associates, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures also participated. Clarus will receive commercial royalties from the sales of GC4419 and an unnamed related pipeline asset until the total royalty payments reach an undisclosed multiple of $80 million, at which point the royalty will end.
Oral mucositis is a condition in which the epithelial cells lining the gastrointestinal tract break down. This opens the mucus membranes to ulceration and infection, which can make it difficult or impossible for patients to eat. In addition to feeding tubes, patients with SOM may need narcotic analgesics to ease their pain. In some cases, SOM can also be dose-limiting, meaning that subsequent chemotherapy may have to be given in lower doses or delayed altogether.
Radiation is thought to cause oral mucositis by raising superoxide radical levels. In the study, presented at a meeting of the American Chemical Society, the researchers showed that GC4419, an enzyme mimetic, converts superoxide to molecular oxygen and hydrogen peroxide. And, the researchers think the enzyme’s benefits could go beyond the obvious—in addition to getting rid of superoxide, it increases levels of hydrogen peroxide, which kills cancer cells.
"Hydrogen peroxide is very toxic to cancer cells but not to normal cells. Thus, we create two opportunities to improve radiation therapy: reducing toxicity for normal cells while increasing the toxicity to the cancerous ones,” said Dennis Riley, the study leader, at the time.
“The funds provide Galera with ample financial resources to complete the phase 3 clinical trial, begin commercial planning activities and further explore the potential of GC4419 beyond SOM. We look forward to initiating a supportive care trial of GC4419 in radiation-induced esophagitis and a therapeutic trial in a second cancer indication, as well as continuing to evaluate the safety and anti-tumor effect of GC4419 in our ongoing phase 1/2 pancreatic cancer clinical trial,” Galera CEO Mel Sorensen said in a statement.