Quashing brain cancer

AIVITA Biomedical, a company founded in 2016 by pioneers in the stem cell industry to create personalized cancer vaccines, has announced updated survival data from a year-end analysis of its ongoing Phase 2 clinical trial in patients with newly diagnosed glioblastoma. AIVITA is a privately held company that develops commercial and clinical-stage programs with curative and regenerative medicines. It uses its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems to support its therapeutic pipeline and commercial line of skin care products.

Patients treated with AIVITA’s AV-GBM-1 had an overall survival rate of 76 percent at both 12 and 15 months, while patients receiving standard-of-care treatment had 12- and 15-month overall survival rates of 61 percent and 48 percent, respectively. The trial, which included 60 patients (42 men and 18 women with an average age of 59), is in its early stages, but according to Dr. Robert O. Dillman, AIVITA’s chief medical officer, “Although treatment and monitoring of patients is ongoing, we are very encouraged by these interim results. We completed accrual to the trial ahead of schedule, thanks to the engagement of our clinical site principal investigators and a truly outstanding manufacturing success rate at AIVITA.”

He added, “No two cancers are alike. The best approach is to use the patient’s own tumor to create unique antigens and make them into vaccines that the body can recognize. They are more specific in terms of purity.”

AIVITA’s cancer immunotherapy offers patients a personalized treatment that targets and eliminates cancer cells wherever they spread by focusing on tumor-initiating cells. The company’s technology can create fully pan-antigen cells from the patient’s own cancer that are capable of seeking out and destroying all cancer cells, potentially even mutated or dormant tumor-initiating cells that drive disease. AV-GBM-1, a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens, is derived from self-renewing tumor-initiating cells. The treatment—which is administered in a series of subcutaneous injections as an adjunctive therapy—is uniquely pan-antigenic, targeting multiple antigens on autologous tumor-initiating cells responsible for the rapid growth of the disease and resistance to standard therapy.

AIVITA is currently conducting three clinical studies in the United States to investigate its platform immunotherapy in patients with glioblastoma, melanoma and ovarian cancer. In a clinical trial in metastatic melanoma, AIVITA’s autologous dendritic cells demonstrated a 72-percent rate of two-year survival and a 54-percent rate of five-year survival in patients. Based on data, AIVITA is currently seeking conditional commercial approval of its melanoma treatment in Japan. The clinical trial in advanced ovarian cancer is a double-blind, randomized Phase 2 study currently enrolling patients at the time of initial diagnosis. Approximately 99 patients will be enrolled and randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

If the data in the glioblastoma trial were final numbers, AIVITA would have exceeded its target goal, according to Dillman. The last patients enrolled will be followed for a total of 15 months. If the results—which are expected by May 2021—are as good as expected, the company will go to a double-blind, randomized trial to seek commercial approval, Dillman said.

“Because the prognosis for glioblastoma is so poor, a study can reach its endpoint in three years,” he added. “The standard treatment for primary glioblastoma has changed very little since 2005. Because every patient with the disease would be eligible to try it, AV-GBM-1 would be deemed to answer a significant unmet need and potentially reach fast-track status.”