AIVITA Biomedical is launching a Phase 2 trial to assess the safety and effectiveness of its cell-based immunotherapy for the treatment of an aggressive form of brain cancer, called glioblastoma multiforme.
This follows the approval of an investigational new drug (IND) application by the U.S. Food and Drug Administration for the company’s Root of Cancer technology.
“We are delighted with this opportunity to help glioblastoma multiforme patients, who face the most aggressive form of brain cancer,” Hans Keirstead, PhD, CEO of AIVITA, said in a press release. “This approval reflects the platform nature, the safety, and the manufacturing efficiency of our novel technology.”
The open-label Phase 2 trial (NCT03400917), which is now recruiting, is expected to enroll 55 adult patients with newly diagnosed glioblastoma multiforme who have undergone surgical removal of their tumor.
For a patient to be eligible, the cancer removed during surgery must have been preserved. Patients also must have undergone a successful leukapheresis, a procedure that isolates and collects immune cells from the blood.
University of California, Irvine, will be the study’s first site, and more sites are expected to follow.
AIVITA’s Root of Cancer immunotherapy consists of a cancer vaccine based on a patient’s own cancer cells and dendritic cells, a type of immune cell that presents certain proteins to T-cells, telling them what their targets should be.
Researchers join a patient’s dendritic and tumor cells in the lab, making the dendritic cells present cancer-specific proteins at their surface. When injected back into the patient, these will re-educate T-cells to react against any cancer cells.
Because this broader strategy will also target tumor-initiating cells — key cells in cancer growth and spread — researchers believe it will work better than other dendritic cell therapies presenting only a subset of cancer proteins.
Over the course of the Phase 2 trial, participants will receive multiple dendritic cell injections in addition to standard care, which may include chemotherapy, radiation, or checkpoint inhibitors.
The trial’s main goal is to assess overall survival, but researchers will also evaluate disease progression patterns.
Earlier this month, AIVITA started another Phase 2 trial (NCT02033616) studying Root of Cancer in 99 advanced ovarian cancer patients in the United States. This study is also currently recruiting. For additional information on enrolling, click here.