On July 15, 2024 Diakonos Oncology Corporation ("Diakonos"), a clinical stage immuno-oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s unique dendritic cell vaccine (DCV) for pancreatic ductal adenocarcinoma (Press release, Diakonos Oncology, JUL 15, 2024, View Source [SID1234644881]). In addition, the company has named to its Scientific Advisory Board, Daniel D. Von Hoff, M.D., Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, AZ, and City of Hope, and an experienced investigator against pancreatic cancer.
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"This second FDA Fast Track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgement of the incredible potential of this innovative immunotherapy for treating the most deadly cancers," said Mike Wicks, Diakonos CEO. "We are thrilled to have Dr. Von Hoff join us as an advisor as we pursue clinical development of our vaccine in this deadly disease," Mr. Wicks added. "The first designation was for our lead vaccine for glioblastoma multiforme (GBM) which successfully completed dosing for the Phase 1 trial and has significantly improved 12 month survival in those patients to well over what would be expected with the standard of care." (See the press release)
Dr. Von Hoff is an internationally recognized physician and scientist whose research has contributed to the development of many anticancer agents that are routinely used in clinical practice. His research at TGEN focuses on development of therapies for patients with advanced pancreatic cancer. He also was a founder of ILEX Oncology which was acquired by Genzyme.
In addition to his work with TGEN, Dr. Von Hoff holds the Virginia G. Piper Distinguished Chair for Innovative Cancer Research at HonorHealth Clinical Research Institute, and is Professor of Medicine at the Mayo Clinic, Scottsdale, AZ.
"Diakonos’s unique dendritic cell vaccine has shown encouraging results in treating glioblastoma, a terrible disease with few effective treatments. Pancreatic cancer patients also need additional treatment options," said Dr. Von Hoff. "I look forward to working with Diakonos to help develop effective treatments for patients with pancreatic cancer with the same targeted technology."
About FDA Fast Track:
FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions. Pancreatic ductal adenocarcinoma is the most common pancreatic cancer. It is the third leading cause of cancer deaths in the U.S. and the number of cases is growing. According to the National Institutes of Health, the average five-year survival rate is less than 13%, and in 2024 an estimated 51,750 people will die and 66,440 will be newly diagnosed.
About Diakonos’ DCV Technology:
The company’s DCVs are made with a patient’s dendritic cells and a sample of their tumor. These highly differentiated double-loaded dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that initiate a natural immune response to target and eliminate cancer cells. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches.