Biotech firm AIVITA Biomedical has completed patient enrolment in a Phase II clinical trial of AV-GBM-1 for the treatment of glioblastoma.
AV-GBM-1 is an investigational immunotherapy designed to target autologous tumour-initiating cells associated with the growth and proliferation of cancer.
The immunotherapy is said to require short-term cell culture and a successful leukapheresis for the production of the final treatment product.
In the eight-site, single-arm Phase II trial, the company is assessing the clinical efficacy of the drug candidate as a monotherapy and in combination with PD-1 inhibitors in around 55 patients.
The primary endpoint of the study is overall survival. The company also intends to develop the therapy as a maintenance treatment to address recurrence.
AIVITA Biomedical chief medical officer Bob Dillman said: “An extremely high manufacturing success rate combined with a very low cost of goods makes this approach highly desirable from both a clinical and commercial viability perspective.
“We’re already exploring new ways to further increase efficiency and expand the applicability of this approach.”
The company is currently performing two other trials of its platform immunotherapy in the US.
The Phase II double-blind trial is enrolling 99 ovarian patients who will be given the autologous tumour-initiating immunotherapy or autologous monocytes.
Meanwhile, an open-label, single-arm Phase Ib study is being conducted to investigate the safety of administering the tumour-initiating immunotherapy plus anti-PD1 monoclonal antibodies in treating metastatic melanoma. This trial study is designed for 14-20 patients and is yet to begin enrolment.
AIVITA secured US Food and Drug Administration (FDA) approval earlier this month to conduct the Phase Ib study.
In addition, the company is working to obtain conditional commercial approval for its melanoma treatment in Japan.