Last month, the company presented ‘encouraging’ overall survival and immunological biomarker data from its phase 2 clinical trial.
The study reported an estimated survival rate of 71.4% at both 24 and 36 months in patients who received 2 or 3 injections of CAN-2409, plus prodrug regimen, together with chemoradiation prior to surgery.
However, patients treated without CAN-2409, with just chemoradiation prior to surgery, saw an estimated survival rate of 16.7% over the same period.
In parallel, the immunological changes observed in the resected pancreatic tissue after CAN-2409 administration suggested that this investigational treatment can activate an effective immunologic antitumoral response in this otherwise ‘cold’ tumor.
“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter, CEO and president of Candel.
“This milestone follows our first interim data report from the randomized phase 2 clinical trial in patients with borderline resectable PDAC that showed prolonged and sustained survival after experimental treatment with CAN-2409, especially when compared to real-world data on patients receiving radiotherapy treatment."
Pancreatic cancer is a highly lethal malignancy and is the fourth leading cause of cancer-related death in the United States among both men and women.
According to the National Cancer Institute, pancreatic cancer is expected to account for 3.3% of all new cancer cases, with an estimated 64,050 new cases and estimated 50,550 deaths in 2023.
Peter added that Candel remains on track to release updated overall survival data from the interim analysis of the ongoing clinical trial in the second quarter of 2024.
