Manufacturing, quality and safety data deemed acceptable by Japanese regulatory agency in AIVITA’s effort to commercialize ROOT OF CANCER technology

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.


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.

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).