FDA Grants Fast Track Designation to CAN-2409 For Pancreatic Cancer

The Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational adenovirus CAN-2409 plus prodrug Valtrex (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma, according to a news release from biopharmaceutical company Candel Therapeutics, the manufacturer of CAN-2409.

In a phase 2 clinical trial evaluating CAN-2409 plus Valtrex and standard-of-care chemoradiation followed by resection (surgical removal) for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC; 13 patients), there was an estimated survival rate of 71.4% at 24 and 36 months, versus 16.7% for patients who received presurgical treatment with standalone standard-of-care chemoradiation as of an Aug. 21, 2023 data cutoff, as Candel previously detailed in a presentation at the Society for Immunotherapy of Cancer Annual Meeting, according to the company.

“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” Dr. Paul Peter Tak, president and CEO of Candel, stated in the news release. 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.”

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Candel plans to release updated data regarding overall survival (the time a patient lives regardless of disease status) from the trial in the second quarter of 2024, Tak stated in the release.

The Fast Track Designation, as the FDA explained on its website, is part of a process that is intended to “facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”

There will be an estimated 64,050 new cases of pancreatic cancer in 2023, making up 3.3% of all new cancer cases, as well as 50,550 deaths from pancreatic cancer, or 8.3% of all cancer deaths, in 2023 according to the National Cancer Institute, which stated that the five-year relative survival rate from 2013 to 2019 was 12.5%. Approximately 90% of pancreatic cancer cases are adenocarcinomas, according to the Pancreatic Cancer Action Network.

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The PDAC Fast Track Designation follows a prior Fast Track Designation for CAN-2409 plus Valtrex in combination with Keytruda (pembrolizumab) with the intention of improving survival or delaying progression among patients with stage 3 or 4 non-small cell lung cancer (NSCLC) that is resistant to first-line anti-PDL-1 therapy and who do not have activating molecular driver mutations or who have progressed on directed molecular therapy.

CAN-2409, as Candel explained in the news release, is “designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the disease,” with the manufacturer noting that due to the therapy’s versatility it has the potential to treat a broad range of solid tumor types.

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