AIVITA Biomedical has begun to randomize patients for a Phase 2 clinical trial assessing its cell-based immunotherapy for the treatment of newly-diagnosed advanced ovarian cancer.
Currently recruiting participants at Hoag Memorial Hospital Presbyterian in California, the study is expected to enroll 99 patients who will receive AIVITA’s patient-specific ovarian cancer vaccine or a placebo.
AIVITA’s immunotherapy uses a patient’s own dendritic cells, which are boosted to fight the tumor by exposure to tumor proteins.
Dendritic cells are cells of our immune system that present certain proteins to T-cells, telling them what their targets should be.
Thus, researchers join 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 also will target tumor-initiating cells — key cells in cancer growth and spread ing — researchers believe it will work better than other dendritic cell therapies that present only a subset of cancer proteins.
The Phase 2 trial (NCT02033616) will enroll women with stage 3 or 4 epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received surgery to remove their tumor, and who have started or completed standard chemotherapy regimens.
For a patient to be eligible, the tumor specimen removed during surgery must have been stored. Also, patients must have undergone a successful leukapheresis, a procedure that isolates and collects immune cells from the blood.
Participants will be randomly assigned the immunotherapy — called AVOVA-1 — or a monocyte placebo. Monocytes are a cell type similar to dendritic cells.
The study’s main goal, or primary endpoint, is to assess overall survival, but researchers also will evaluate long-term disease progression patterns.
The study began recruiting participants in January. To date, researchers have received tumor specimens from seven patients, and have successfully generated the vaccine for all of them.
This 100 percent manufacturing success rate provides further evidence about the potential of AIVITA’s Root of Cancer technology platform, supporting the study continuation. Given the success of the trial so far, the company expects to expand the study to other clinical centers.
“I’m very proud that our AIVITA team has so clearly demonstrated feasibility and reproducibility in manufacturing these patient-specific treatments,” Robert Dillman, MD, chief medical officer of AIVITA, said in a press release. “Quick, reliable and cost-effective production is critical for the viability of both patient and company.”
For more information on the study, click here.
Earlier this month, AIVITA also announced the initiation of another Phase 2 trial (NCT03400917) to study the vaccine in 55 adult patients with newly-diagnosed glioblastoma multiforme, an aggressive type of brain cancer.
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