AIVITA Highlights Ovarian Cancer Therapy at Cancer Stem Cell Conference 2016

Chief Medical Officer Dr. Robert O. Dillman describes benefits of novel treatment to be used in upcoming double-blind phase 2 trial

IRVINE, Calif. – September 20, 2016 – AIVITA Biomedical today announced that it will present details on its autologous cancer immunotherapy, subject of an upcoming Phase 2 clinical trial in ovarian cancer, at the National Center for Regenerative Medicine’s Cancer Stem Cell Conference 2016. The talk, to be delivered by AIVITA Chief Medical Officer Robert O. Dillman, M.D., will take place Thursday, Sept. 22 at 5:40 p.m. EDT.

Dr. Dillman’s oral presentation, titled “Autologous dendritic cells loaded with antigens from autologous ovarian cancer stem cells as an adjunctive treatment for advanced ovarian cancer,” will highlight the unmet clinical need for non-toxic adjunctive therapies such as AIVITA’s, as well as the benefits of AIVITA’s approach which uses autologous dendritic cells loaded with tumor-associated antigens from autologous cancer stem cells. AIVITA’s treatment targets the specific antigenic signature of the patient’s own tumor initiating cells, a type of cell which has recently been discovered to be the engine of the disease. The AIVITA treatment will be adjunctive to standard therapy for newly diagnosed advanced ovarian cancer.

“We are confident that the upcoming Phase 2 ovarian trial will bear out notable improvements in overall survival, a precedent which has already been set by two independent Phase 2 trials in advanced melanoma using a related approach,” said Dr. Dillman.

“The pairing of clinical data with patient tumor and blood data has put us in a unique position in the immunotherapy field”, said AIVITA’s Chief Executive Officer Dr. Hans S. Keirstead, “Rarely has a Phase 2 trial been initiated with such confidence of efficacy, and with as deep an understanding of mechanism of action. This trial will allow us to validate several predictions from our mechanistic studies, including synergistic efficacy with checkpoint inhibitors, surrogate markers of efficacy and potency assays”.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,280 new diagnoses in 2016 and 14,240 deaths. The median age at diagnosis is 63, with a 46% survival rate amongst all those who have been afflicted. More than 70% of diagnoses are stage III or IV at the time of diagnosis. Patients with stage III or IV ovarian cancer have a 5-year survival rate of approximately 35%. Current standard of care includes surgical debulking and several courses of chemotherapy.

About AIVITA Biomedical

AIVITA Biomedical is advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high-purity differentiation, AIVITA Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of its curative and regenerative medicines. For more information, visit www.aivitabiomedical.com.