Regenerative medicine company AIVITA Biomedical said on Friday that the Japanese regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA), has approved and validated its manufacturing, quality and safety data for the commercialisation of its ROOT OF CANCER programme.

Following the PMDA approval, the company will now move forward to focus on the clinical protocol to obtain conditional approval to market its product in Japan.

The company's ROOT OF CANCER programme utilises autologous dendritic cells loaded with autologous antigens from the patient's tumor-initiating cells. The treatment is applicable to most solid tumor types.

Previously, the ROOT OF CANCER treatment was earlier 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 longer median survival, added the company.

Through its ROOT OF CANCER technology, the company said itwill now focus on advanced ovarian cancer and newly diagnosed glioblastoma in the US. Its ovarian Phase 2 double-blind study is active and enrolling 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. Its glioblastoma Phase 2 single-arm study is active and will enroll 55 patients to receive the treatment candidate.