Blaze Bioscience, a Seattle-based biotech developing “tumor paint” that could help surgeons tell the difference between normal and cancerous tissue, has raised $5 million in new equity funding to help advance its lead product candidate through clinical trials.
Heather Franklin, Blaze’s founder and CEO, says its latest funding round is still open, and could climb to more than $20 million. Blaze has raised a total of $45 million from investors since launching in 2010, she says.
Blaze’s lead candidate, BLZ-100, is a fluorescent imaging agent that can be engineered to target different types of tumors, including ones in the brain. The agent is designed to be injected in patients intravenously before an operation begins, and to be used in tandem with a specific system of cameras and lights that help surgeons visualize BLZ-100.
The 17-employee company is currently enrolling pediatric patients who need brain surgery for central nervous system tumors in a Phase 2/3 study of BLZ-100, Franklin says.
Investigators are seeking to enroll 114 patients in the study, which will take place at Seattle Children’s Hospital and up to 14 other cancer centers across the U.S. If all goes as planned, Blaze would submit a new drug application to the FDA in late 2020, Franklin says.
Blaze’s tool offers the promise of enabling clinicians to better assess what are known as surgical margins, or the edges of tumors that separate them from healthy tissue, Franklin says. With some operations, cancerous tissue is left behind, necessitating additional follow-up surgeries, she says. When operating on a child’s brain, not removing all the tumor cells “can really affect their life, if they have to have higher doses of radiation to their developing brain” during a subsequent procedure, Franklin says.
Another consequence of incorrectly assessing the surgical margins is cutting into healthy tissue, which can lead to side effects for patients, she says. BLZ-100 aims to prevent any of these problems from happening.
BLZ-100 works by entering tumor cells and marking them with a dye. This allows surgeons to highlight the cells using a fluorescent camera and remove them without harming normal tissue.
Today, many doctors use post-operative magnetic resonance imaging scans to verify they’ve removed the entire tumor, Franklin says.
Other companies are also working on technologies that have similarities to BLZ-100. In 2017, the FDA approved Gleolan, an imaging agent for patients with high-grade gliomas developed by Kentucky-based NX Development Corp.
However, Franklin says Gleolan fluoresces in the ultraviolet range of light, whereas BLZ-100 is designed to fluoresce in the near-infrared range. Near-infrared light can be detected underneath tissues more easily than ultraviolet light, she says.
Dallas-based OncoNano is also developing imaging agents to aid surgeons with tumor-removal.
Franklin says she anticipates BLZ-100 will first receive approval to treat brain cancer. After that, Blaze could submit a supplemental new drug application to the FDA to expand the agent’s label to include using it to treat other conditions, such as breast cancer.
“In breast cancer, there’s a quite high rate of re-operation due to close margin,” Franklin says. “We would hope that our product could reduce, if not eliminate, that problem of having to have a repeat surgery or having to have more treatment because the first surgery wasn’t as successful as it might’ve been.”