So far, 11 patients have been included in the study, including one who received the planned eight treatment sessions, under the supervision of Lisa Abaid, MD, principal investigator at Gynecologic Oncology Associates in Newport Beach, California.
Aivita’s immunotherapy uses a patient’s own dendritic cells, which are boosted to fight the tumor. Dendritic cells are a type of immune cell that teaches T cells what is foreign and abnormal and should be targeted for destruction.
Aivita’s researchers develop AVOVA-1 by joining 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 the T cells to react against any cancer cell they encounter.
With this approach, researchers believe they can target tumor-initiating cells — those responsible for cancer growth, spreading, and disease relapse — in a more efficient manner than when dendritic cells carrying only some tumor proteins are used.
The Root Of Cancer trial (NCT02033616) is expected to enroll about 99 patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. To be eligible, patients must have had surgery and have initiated or completed standard post-surgery chemotherapy.
Participants will be randomly assigned AVOVA-1 or a monocyte placebo control. Monocytes are a cell type similar to dendritic cells. They will receive a series of eight injections along with standard care.
The trial’s main goal is to determine whether AVOVA-1 can extend patient survival.
So far, five clinical sites are enrolling participants, but the company expects to open three additional study sites soon. For more information on the trial, click here.
“Interest among oncologists has been extremely high, as our therapy complements standard of care and has such a high efficacy rate,” Robert Dillman, MD, chief medical officer at AIVITA, said in a press release.
“Of the eight subjects currently randomized in our trial, we have been successful in manufacturing treatments for all eight, further evidencing that this technology can be quickly and reliably produced for the treatment of multiple cancer types,” he said.
In addition to ovarian cancer, Aivita is conducting two additional clinical programs to explore this approach in glioblastoma (NCT03400917), an aggressive type of brain cancer, and melanoma (NCT03743298). Both studies are currently recruiting participants in the United States.