AIVITA Biomedical Announces U.S. Food And Drug Administration Clearance Of IND For Phase II Glioblastoma Multiforme Trial

Trial Will Investigate Company’s Platform Cancer Immunotherapy in Patients with The Deadliest Form of Brain Cancer

AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase II clinical trial investigating the Company’s ROOT OF CANCER technology in patients with glioblastoma multiforme. This will be the third investigation of AIVITA’s platform cancer immunotherapy, which is currently the subject of a Phase II clinical trial in ovarian cancer in the USA, and a commercialization effort in melanoma in Japan.

AIVITA’s single-arm, open-label trial calls for approximately 55 patients with newly diagnosed glioblastoma multiforme to be enrolled with the intent to receive the Company’s ROOT OF CANCER treatment. The treatment consists of the patient’s own dendritic cells loaded with tumor antigens from the patient’s own tumor-initiating cells. The treatment will be administered in a series of injections along with standard care, which may include surgery, chemotherapy and radiation, as well as checkpoint inhibitors should they eventually be approved as standard care.

“We are delighted with this opportunity to help glioblastoma multiforme patients, who face the most aggressive form of brain cancer,” said Dr. Hans Keirstead, AIVITA’s Chief Executive Officer. “This approval reflects the platform nature, the safety and the manufacturing efficiency of our novel technology.”

The University of California, Irvine will be the study’s first site, with additional sites to follow.