Pancreatic Cancer Dendritic Cell Vaccine Receives FDA Fast Track Designation
The technology from Diakonos Oncology initiates a natural immune response that targets and eliminates cancer cells by activating cytotoxic TH1 cell signaling pathways.
A dendritic cell vaccine for the treatment of pancreatic ductal adenocarcinoma has received fast track designation from the FDA, biotech company Diakonos Oncology said in news release.1 The vaccine technology also previously received both fast track and orphan drug designations for glioblastoma multiforme.
Pancreatic Cancer Dendritic Cell Vaccine Receives FDA Fast Track Designation / guerrieroale - stock.adobe.com
The company’s dendritic cell vaccine technology initiates a natural immune response that targets and eliminates cancer cells by activating cytotoxic TH1 cell signaling pathways. The vaccines use a patient’s own dendritic cells and a sample of their tumor, and does not involve any genetic modification of immune cells. This simplifies the manufacturing process, resulting in reduced costs compared to other cell therapies.
READ MORE: GLP-1s Lead to Weight Loss, Improved CVD Outcomes in Breast Cancer
“Diakonos’s unique dendritic cell vaccine has shown encouraging results in treating glioblastoma, a terrible disease with few effective treatments,” Daniel D. Von Hoff, MD, distinguished professor at the Translational Genomics Research Institute, said in a release.1 “Pancreatic cancer patients also need additional treatment options. I look forward to working with Diakonos to help develop effective treatments for patients with pancreatic cancer with the same targeted technology.”
Diakonos is currently conducting a phase 1, first in man, dose escalation study (NCT04157127) of the dendritic cell vaccine to evaluate the safety, toxicity and feasibility in adult patients with pancreatic adenocarcinoma. The study has enrolled 43 patients who will undergo standard treatment and then receive 3 doses of the vaccine via perinodal injection within 3 months of treatment completion.
The primary study outcomes are maximum tolerated dose of dendritic cell vaccine and number of patients who experience dose limiting toxicities. Key secondary outcomes include time to recurrence of pancreatic adenocarcinoma and overall survival.
At the 2024 American Association for Cancer Research’s annual meeting, Diakonos presented data from an interim analysis of a phase 1 trial (NCT04552886) evaluating the safety and feasibility of the dendritic cell vaccine in adult patients diagnosed with glioblastoma. The study showed that the therapy significantly increased survival beyond the expected median overall survival of 12.7 months for patients receiving the standard of care.2
The study included 17 adult patients with glioblastoma (GBM) who underwent neurosurgical tumor resection and had a neuropathological diagnosis. Patients received 4 doses of the vaccine following standard of care of chemotherapy and radiation. The primary study outcome was safety and toxicity. Key secondary endpoints included overall survival and progression-free survival.
“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,” Mike Wicks, CEO at Diakonos, said in a release.1
READ MORE: Oncology Resource Center
Don’t get left behind: Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.
