FDA gives RMAT status to Vigil immunotherapy for ovarian cancer
Maintenance therapy for advanced cancer now in Phase 2b clinical trial
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Gradalis’ experimental immunotherapy platform Vigil (Gemogenovatucel-T) as a potential treatment for advanced ovarian cancer.
RMAT status is given to cellular and engineered therapies showing an early potential in clinical testing to improve care for serious conditions. It aims to help speed the development of important new therapies, and it confers benefits like more frequent feedback from the FDA during the development process.
“The RMAT designation for Vigil highlights the transformative capacity of our unique immunotherapy to benefit women battling advanced ovarian cancer,” David Shanahan, CEO of Gradalis, said in a company press release.
A potential maintenance treatment for stage 3b or 4 ovarian cancer at diagnosis
According to Shanahan, the designation “affirms that Vigil has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions.”
Gradalis is developing Vigil as a maintenance treatment for ovarian cancer that’s stage 3b or 4 — cancer that has started to spread to other parts of the body — in patients whose cancer is homologous recombination proficient and has a high clonal tumor mutation burden. This means that the cancer cells have an intact ability to repair DNA, and they carry a lot of mutations that aren’t normally present in cells. Vigil is designed for use in patients who have undergone surgery and chemotherapy to reduce the size of the tumor.
Vigil aims to treat cancer by prompting the body’s immune system to go after the tumor. The personalized immunotherapy begins with collecting cancer cells that are removed during surgery. These cells are engineered in a laboratory to express lower levels of furin, an enzyme that helps tumor cells avoid the immune system, as well as increased levels of GM-CSF, a signaling protein that activates immune cells to go on the attack. The modified cancer cells are exposed to radiation so they won’t be able to grow, and then returned to the patient to trigger an anti-cancer immune response.
The Phase 2 VITAL trial (NCT02346747) is testing Vigil, administered once monthly four to six times, against a placebo in 92 women with recently diagnosed advanced ovarian cancer, who had a complete response to prior surgery and chemotherapy. It’s main goal is disease-free survival, and the FDA’s decision to grant the therapy RMAT status was based on promising preliminary data, Gradalis reported.
The U.S.-based trial is expected to conclude in December, and patients will be followed for 10 years.
“We continue to advance our Vigil development efforts as we work to bring this investigational therapy to patients as rapidly as possible,” Shanahan said.
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