IRVINE, Calif. – August 14, 2018 – AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the initiation of its first clinical site for the Company’s ROOT OF CANCER Phase 2 trial in patients with newly diagnosed glioblastoma (GBM). The University of California, Irvine (UCI)’s Comprehensive Brain Tumor Program and the UCLA-UCI Alpha Stem Cell Clinic (ASCC) have received IRB approval to begin recruiting patients to receive AIVITA’s platform ROOT OF CANCER treatment. Patients will receive autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor cells as an adjunctive therapy following primary surgery plus concurrent chemoradiation.

AIVITA’s single-arm, open-label GBM trial calls for approximately 55 patients with newly diagnosed glioblastoma to be enrolled with the intent to receive the Company’s ROOT OF CANCER treatment. Under the direction of UCI neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD, the treatment will be administered in a series of injections along with standard care, which may include surgery, chemotherapy and radiation.

“We are honored to be launching this trial with Dr. Bota and her very capable team,” said Dr. Bob Dillman, AIVITA’s Chief Medical Officer. “With a 100% product manufacturing success rate and a world-class team, we are fully enabled to supply multiple clinical trial sites and get to definitive data quickly.”

Dr. Daniela Bota said, “I am delighted to have the opportunity to offer my patients a new treatment that has already demonstrated remarkable improvements in survival rates during previous trials treating other cancer types.”

AIVITA’s ROOT OF CANCER technology is also currently the subject of a Phase 2 clinical trial in ovarian cancer in the USA and a commercialization effort in melanoma in Japan. Of the 10 patient tumor samples received thus far in AIVITA’s ROOT OF CANCER ovarian trial, short-term tumor cell lines have been successfully established for all 10.

About Glioblastoma

Glioblastoma (GBM) 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 able to receive aggressive 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 any solid tumor type and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells, which means the cells have to be self-renewing as a cell line.

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 Karnofsky Performance Status 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.

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