AIVITA Biomedical announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM).

The analysis focused on 57 patients who were scheduled to receive up to eight doses of AV-GBM-1 over approximately six months. At the time of the analysis, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months. The median length of progression free survival was 10.0 months (95% CI 8.5 to 11.5 months), an improvement of approximately 45% compared to a median of 6.9 months (95% CI 5.8 to 8.2 months) progression free survival in the landmark study that established the standard of care for patients with newly diagnosed GBM. This represented a 38% reduction in risk of progression or death at 6.9 months of treatment. The latest data from the trial was presented at the 35th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC).

"The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers benefit to patients in need," said Robert O. Dillman, M.D., chief medical officer of AIVITA.

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections. The treatment is uniquely pan-antigenic, targeting multiple antigens from autologous tumor-initiating cells that are responsible for the rapid growth of the disease.

"This is a major victory against glioblastoma, a devastating disease that has evaded treatment for far too long," said Hans S. Keirstead, Ph.D., chairman and chief executive officer of AIVITA. "We now have excellent results from Phase 2 clinical studies in both melanoma and glioblastoma, underscoring the tremendous potential of this personalized cancer immunotherapy."

AIVITA is currently conducting three clinical studies in the United States investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan.