Candel Therapeutics shares gained more than 37% after the biopharmaceutical firm announced that its pancreatic cancer therapeutic has received US Food and Drug Administration (FDA) Fast Track Designation.
Candel’s lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) is targeting the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.
The Fast Track Designation comes after the company reported interim data from a Phase 2 study which showed the drug led to prolonged and sustained survival in patients with borderline resectable PDAC compared to real-world data on patients receiving radiotherapy.
Patients who received two or three injections of the drug plus standard-of-care neoadjuvant chemoradiation saw an estimated survival rate of 71.4% at 24 and 36 months, compared to an estimated survival rate of 16.7% at 24 and 36 months for patients treated with chemoradiation prior to surgery alone.
The Massechusetts-based company is also set to release updated overall survival data from the interim analysis of the trial data in the second quarter of 2024.
“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” Candel CEO Paul Peter Tak said in a statement.
Shares of Candel had added 37.2% at US$1.15 on Tuesday morning.