Pancreatic Cancer Dendritic Cell Vaccine Candidate Awarded Fast Track Designation

Diakonos Oncology Corporation announced 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.

On July 15, 2024, the Houston-based company confirmed that DCVs are made with a patient’s dendritic cells and a tumor sample.

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 compared to leading cell therapy approaches.

“This second FDA Fast Track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgment of the incredible potential of this innovative immunotherapy for treating the most deadly cancers,” said Mike Wicks, Diakonos CEO, in a press release.

Pancreatic ductal adenocarcinoma is the most common pancreatic cancer. In 2024, an estimated 51,750 people will die, and 66,440 will be newly diagnosed.

FDA Fast Track designation is intended to speed the development and review of drugs that show early clinical promise in treating severe or life-threatening conditions.