Candel Receives FDA Fast Track Designation For CAN-2409 Plus Prodrug

(RTTNews) - Candel Therapeutics, Inc. (CADL) on Tuesday announced that it has received Fast Track Designation from the FDA for their lead investigational asset called CAN-2409 plus prodrug (valacyclovir).

This asset is being developed to improve overall survival in patients with pancreatic ductal adenocarcinoma (PDAC).

Candel's CEO, Paul Peter Tak, MD, PhD, FMedSci, stated that this news comes following an interim data report regarding the phase 2 clinical trial of CAN-2409 involving patients with borderline resectable PDAC which has shown promising results so far.

The data revealed that CAN-2409 extended and maintained patient survival, particularly when compared with real-world radiotherapy data, with an estimated 71.4% survival at 24 and 36 months for patients receiving 2 or 3 injections of the CAN-2409 plus prodrug regimen, together with SoC chemoradiation before surgery.

CADL is trading up by 68.37% at $0.57 per share in the pre-market trade on the Nasdaq.