The Phase 2 clinical trial evaluating AIVITA Biomedical’s cell-based immunotherapy for treating newly-diagnosed advanced ovarian cancer has dosed its first 10 patients.
Women with stage 3 or 4 epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who underwent surgery to remove the larger part of the tumor are eligible. Patients are required to be in good condition.
In the study, patients are randomly assigned to the dendritic cell immunotherapy — called AVOVA-1 — or a monocyte placebo control. Monocytes are a cell type similar to dendritic cells. For every two patients receiving the active treatment, one will get a placebo.
Dendritic cells are cells of the immune system whose job is to present certain proteins to T-cells, which have the capacity to kill tumor cells.
AIVITA’s immunotherapy uses a patient’s own dendritic cells, which are boosted to fight the tumor. This is achieved by putting the dendritic cells together with the tumor cells in the lab, triggering the dendritic cells to present cancer-specific proteins at their surface.
When re-injected into the patient, the dendritic cells will re-educate T-cells to react against the tumor cells. Researchers believe that the immunotherapy can kill the tumor-initiating cells — those responsible for the tumor growth, spreading, and relapse — more effectively than other dendritic cell therapies that present only a subset of tumor proteins.
The study’s main objective is to assess patients’ overall survival in a five-year frame. Additionally, they will also evaluate the time for the cancer to progress or death to occur after the treatment, a parameter called progression-free survival.
Previous data from a Phase 2 trial in patients with advanced melanoma showed that patients treated with the immunotherapy had a significant increase in overall survival, with 54% of patients being alive five years after receiving the treatment, compared to 28% in the control group.
“We’re proud of the manufacturing team here at AIVITA who have made this important moment possible,” Bob Dillman, chief medical officer at AIVITA, said in a press release.
“The team has contributed manufacturing efficiencies which have greatly improved the success rate and speed of creating this treatment, allowing us to treat more patients more reliably. We’ve since randomized several additional patients in this trial and activity is accelerating as we sign on more hospitals and receive additional tumors,” he added.