AIVITA Biomedical Attains Japanese PMDA Milestone for ROOT OF CANCER Technology

IRVINE, Calif., Oct. 12, 2018 /PRNewswire/ -- AIVITA Biomedical announced today the successful completion of the manufacturing quality consultation and clinical safety consultation for its patient-specific cancer immunotherapy with the Japanese regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). PMDA approval allows AIVITA to move forward to the final round of discussions focused on the clinical protocol, in the Company's efforts to obtain conditional approval to market their product in Japan.

"Japan's regenerative medicine clinical approval process is the most advanced in the world, allowing expedited commercialization of stem cell-based technologies," said Dr. Hans S. Keirstead, Chairman and CEO of AIVITA Biomedical. "Their manufacturing and safety approval is a highly qualified validation of our ROOT OF CANCER program."

AIVITA's treatment consists of autologous dendritic cells loaded with autologous antigens from the patient's tumor-initiating cells. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. The first Phase 2 trial demonstrated a 72% 2-year survival rate and a 54% 5-year survival rate. The second randomized Phase 2 trial demonstrated similar results, with a significantly longer median survival compared to the control arm.

AIVITA's ROOT OF CANCER technology is also the subject of two ongoing Phase 2 trials, in patients with advanced ovarian cancer and in patients with newly diagnosed glioblastoma in the USA.

About ROOT OF CANCER

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.

AIVITA's ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA's AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA's glioblastoma Phase 2 single-arm study is active and will enroll approximately 55 patients to receive the treatment candidate.

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 therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

SOURCE AIVITA Biomedical

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