HOUSTON, (November 20, 2023) —Diakonos Oncology Corporation (“Diakonos”), a clinical-stage immuno-oncology company, announced today that Ian H. Bellayr, Ph.D., a regulatory expert with the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH), has joined the company as its Chief Regulatory Officer.
“Dr. Bellayr’s regulatory expertise arrives at a crucial time for Diakonos as we conclude our Phase 1 glioblastoma trial,” said Mike Wicks, Chief Executive Officer of Diakonos. “His extensive experience in regulatory strategies and operations will be a critical component as we initiate the remaining clinical trials and ultimate commercialization of DOC1021.”
Before joining Diakonos, Dr. Bellayr was a regulatory product reviewer and staff scientist in the FDA’s Center for Biologics Evaluation and Research, Division of Cellular and Gene Therapies, Tumor Vaccines and Biotechnology Branch. He was also a senior regulatory affairs specialist with the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases and a regulatory affairs specialist with National Institute of Allergy and Infectious Diseases. Dr. Bellayr earned his Ph.D. in Bioengineering from the University of Pittsburgh and his Bachelor of Science in Biomedical Engineering from the University of Virginia.
“Treatments for late-stage and aggressive cancers still remain a critical unmet need,” said Dr. Bellayr. “Diakonos has a unique technology that allows for a personalized cell therapy that is unbiased in its potential to effectively treat multiple indications. I look forward to helping Diakonos move DOC1021 forward through clinical development, creating new treatments that are safe and effective for the most dangerous cancers.”
Diakonos’ dendritic cell vaccine, DOC1021, is made with a patient’s dendritic cells and a sample of their tumor. This unique approach allows targeting of the complete cancer antigen profile without any genetic modification of the patient’s immune cells. Based on a discovery on how dendritic cells detect viral threats, DOC1021 harnesses a natural immune response that targets and eliminates cancer cells as if they were virally infected.
Diakonos research indicates that this approach not only generates a strong killer T cell response, but also stimulates immunological memory aimed at preventing the cancer’s recurrence.
Two other differentiating elements are the convenience of administration for patients and the rapid stimulation of the immune system. There are only three injections over six weeks proximal to the patient’s deep cervical lymph nodes enabling a faster, more robust immune response than traditional IV or intramuscular administrations.