Diakonos Oncology Gets FDA Fast Track for Pancreatic Cancer Vaccine; Adds Dr. Daniel D. Von Hoff to Advisory Board

Diakonos Oncology Corporation, a clinical-stage company specializing in immuno-oncology, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel dendritic cell vaccine (DCV) aimed at treating pancreatic ductal adenocarcinoma. The company also welcomed Dr. Daniel D. Von Hoff to its Scientific Advisory Board. Dr. Von Hoff, a Distinguished Professor at both the Translational Genomics Research Institute (TGen) and City of Hope, is renowned for his extensive research in pancreatic cancer.

Mike Wicks, CEO of Diakonos, expressed enthusiasm about the FDA's decision, noting that this is the second Fast Track designation granted to the company for its dendritic cell vaccines. The first was for a vaccine targeting glioblastoma multiforme (GBM), which has shown promising results in its Phase 1 trials, significantly improving 12-month survival rates for patients compared to standard treatments. Wicks emphasized the potential of this cutting-edge immunotherapy to treat some of the deadliest cancers.

Dr. Von Hoff, who has been instrumental in the development of numerous anticancer agents now standard in clinical treatment, has a primary research focus at TGen on therapies for advanced pancreatic cancer. He co-founded ILEX Oncology, later acquired by Genzyme, and holds prestigious positions such as the Virginia G. Piper Distinguished Chair for Innovative Cancer Research at HonorHealth Clinical Research Institute. Additionally, he is a Professor of Medicine at the Mayo Clinic in Scottsdale, AZ.

Dr. Von Hoff commented on the promising nature of Diakonos's dendritic cell vaccine, which has already shown encouraging results in glioblastoma, a disease notorious for lacking effective treatments. He expressed his eagerness to contribute to the development of this technology for pancreatic cancer, a field in desperate need of new therapeutic options.

The FDA's Fast Track designation is intended to expedite the development and review of drugs showing early promise in treating severe or life-threatening conditions. Pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, is the third leading cause of cancer-related deaths in the U.S. Its incidence is rising, and the National Institutes of Health report an average five-year survival rate of less than 13%. Projections for 2024 indicate that approximately 66,440 new cases will be diagnosed and 51,750 individuals will succumb to the disease.

Diakonos’s dendritic cell vaccines are produced using a patient's own dendritic cells combined with a sample of their tumor. These vaccines are designed to activate strong cytotoxic T1 cell signaling pathways, triggering a natural immune response to target and destroy cancer cells. This approach avoids genetic modification of the patient’s immune cells, simplifying the manufacturing process and reducing costs compared to leading cell therapy methods.

Headquartered in Houston, TX, Diakonos Oncology is committed to transforming cancer immunotherapy, focusing on challenging conditions like glioblastoma and pancreatic ductal adenocarcinoma. Their DOC1021 treatment platform is also in early-stage clinical trials for angiosarcoma.