FDA Fast Tracks Pancreatic Cancer Vaccine

A novel pancreatic cancer vaccine is being reviewed by the Food and Drug Administration.

The Food and Drug Administration (FDA) has granted a fast track designation to a dendritic cell vaccine for the treatment of patients with pancreatic ductal adenocarcinoma.

Immuno-oncology company Diakonos Oncology Corporation announced the designation in a news release, noting that it was the second such designation received by one of the company’s dendritic cell vaccines.

“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 Diakonos CEO Mike Wicks in the news release.

“The first designation was for our lead vaccine for glioblastoma multiforme, 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,” Wicks said.

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Interim findings from the phase 1 trial of patients with glioblastoma multiforme (a type of brain cancer), announced earlier this year at the American Association for Cancer Research Annual Meeting, displayed a 12-month overall survival (the time a patient lives, regardless of disease status) rate of 88%, while at 12.9 months’ follow-up the median overall survival time had not yet been reached, meaning more than half of the patients in the study were still alive, Diakonos announced in April. The company also noted that a phase 2 trial of the dendritic cell vaccine, COD1021, was expected to begin within the next year.

The fast track process, according to the FDA’s website, is “designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.”

“Diakonos' unique dendritic cell vaccine has shown encouraging results in treating glioblastoma, a terrible disease with few effective treatments. [Patients with] pancreatic cancer also need additional treatment options,” said Dr. Daniel D. Von Hoff, distinguished professor at the Translational Genomics Research Institute in Phoenix and City of Hope, and a new member of Diakonos’ Scientific Advisory Board. “I look forward to working with Diakonos to help develop effective treatments for patients with pancreatic cancer with the same targeted technology.”

Dendritic cells, according to the National Cancer Institute, are immune cells that are found in tissues and boost immune responses. A dendritic cell vaccine, according to the Moffitt Cancer Center, is akin to a cross between a vaccine and a cell therapy. “These dendritic cells are like immune system factories and make other molecules that activate critical parts of the innate and adaptive immune system,” Moffitt Cancer Center states on its website.

According to Diakonos, the company’s dendritic cell vaccines are made with a patient’s own dendritic cells and a sample of their tumor, initiating a natural immune response to target and kill cancer cells. Because this is done without genetically modifying a patient’s immune cells, the manufacturing process is simplified and the cost is reduced compared to other cell therapies, the company stated in its news release.

Pancreatic ductal adenocarcinoma, according to the Mayo Clinic, begins in the cells that line the ducts of the pancreas. According to the National Cancer Institute, pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer, comprising more than 80% of cases. Pancreatic cancer, the National Cancer Institute stated, is the fourth most common cause of cancer-related death worldwide and is nearly always fatal.

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