AIVITA Biomedical Completes Treatment of Patients in Glioblastoma Immunotherapy Trial

AIVITA Biomedical announced treatment has been completed for all 57 patients in the Phase 2 clinical trial of AV-GBM-1 in patients with glioblastoma. The company was able to manufacture final product at a notable 94% success rate, showing strong commercial and clinical viability.

The eight-site, single-arm study investigates AV-GBM-1, AIVITA's novel immunotherapy for the treatment of glioblastoma that targets the autologous tumor-initiating cells responsible for the rapid growth and proliferation of the disease. AIVITA achieved a 97% success rate in both growing tumor-initiating cells from each patient and in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final treatment given to patients. AV-GBM-1 was well-tolerated, and no patients experienced severe adverse events attributed to the treatment, and no patients discontinued treatment because of side-effects.

"This milestone brings us closer to having a better understanding of the potential for AV-GBM-1 to effectively treat patients with glioblastoma," said Bob Dillman, M.D., chief medical officer of AIVITA. "With such a high manufacturing success rate and no significant side effects, we are hoping this technology will chart a new path forward in immunotherapy."

Out of the 57 patients who participated in the study, the average number of doses injected was 6.9 out of a possible 8. The study's primary endpoint is overall survival (OS) from enrollment date of patients treated with AV-GBM-1, with secondary endpoints including progression free survival from enrollment date and OS and PFS from date of surgical resection.