AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial

IRVINE, Calif., June 20, 2018 /PRNewswire/ -- 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.

About Glioblastoma Multiforme

Glioblastoma Multiforme is the most aggressive and most common form of malignant brain tumor. Median survival is only nine months, rising to 15?16 months for those receiving standard of care surgery and adjuvant chemoradiation.¹ The cause of most cases is unclear. The National Cancer Institute estimates there will be 23,880 new cases of brain and nervous system cancer in 2018.

[1] Bi, Wenya Linda, and Rameen Beroukhim. "Beating the Odds: Extreme Long-Term Survival with Glioblastoma." Neuro-Oncology 16.9 (2014): 1159?1160. PMC. Web. 18 June 2018.

About the ROOT OF CANCER GBM trial

AIVITA's treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA's AV-GBM-1 trial please visit: https://clinicaltrials.gov/ct2/show/NCT03400917

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its commercial line of skin care products and therapeutic pipeline. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

SOURCE AIVITA Biomedical