AIVITA Biomedical Enrolls First Patient in Phase 2 Glioblastoma Trial

IRVINE, Calif., Oct. 25, 2018 /PRNewswire/ -- AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today the enrollment of its first patient in the Company's Phase 2 clinical trial for newly diagnosed glioblastoma. The single-arm, open-label trial is expected to enroll approximately 55 patients to receive the Company's ROOT OF CANCER treatment, an immunotherapy which targets the tumor-initiating cells that are responsible for cancer proliferation and metastasis.

The trial's first patient was enrolled by the University of California, Irvine (UCI) Comprehensive Brain Tumor Program and will be treated under the direction of UCI Health neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD. A second clinical site in San Diego is scheduled to open in late October, with additional clinical sites expected to be added in the coming months.

The treatment, autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor cells, is administered as an adjunctive therapy following primary surgery plus concurrent chemoradiation.

"We are proud to work with Dr. Bota to provide this next-generation immunotherapy to patients in need," said Dr. Robert Dillman, AIVITA's Chief Medical Officer. "This is the first of many sites that will participate in our Phase 2 clinical trial, permitting fast patient recruitment and return of clinical data."

AIVITA's ROOT OF CANCER technology is also the subject of an active Phase 2 clinical trial in ovarian cancer in the USA. The Company is pursuing commercialization of the platform treatment for melanoma patients in Japan.

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.

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: www.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, Inc.