Tuesday, April 16, 2024

Candel Therapeutics’ Pancreatic Ductal Adenocarcinoma Treatment Granted FDA Fast Track Status

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The FDA has granted Fast Track Designation to Candel Therapeutics, Inc.’s CAN-2409 along with valacyclovir for pancreatic ductal adenocarcinoma (PDAC) treatment. The therapy, administered through localized injection, aims to offer a safety advantage over standard systemic treatment for this patient group.

Dr. Paul Peter Tak, Candel Therapeutics’ President and CEO, expressed contentment with the FDA’s decision, citing promising interim data from a Phase II trial in borderline resectable pancreatic ductal adenocarcinoma patients. The trial showcased prolonged survival with CAN-2409 compared to real-world radiotherapy data.

CAN-2409 is an adenoviral construct encoding the herpes simplex virus (HSV) thymidine kinase gene. Once inside tumor cells, it expresses HSV-thymidine kinase, converting prodrugs into a toxic form. Studies suggest this leads to cell apoptosis while provoking a CD8+ T cell–mediated response due to adenoviral protein signals.

Pancreatic Ductal Adenocarcinoma

New Hope for Pancreatic Ductal Adenocarcinoma Patients: CAN-2409 and Valacyclovir Combination

Also, a study has revealed that the combination of aglatimagene besadenovec (CAN-2409) with valacyclovir for PDAC treatment displayed a significant 71.4% survival rate at 24 and 36 months compared to the control group’s 16.7%.

Currently, a Phase II trial (NCT02446093) is investigating CAN-2409 with valacyclovir as neoadjuvant therapy alongside standard chemoradiation and surgery for borderline resectable or locally advanced nonmetastatic PDAC. Enrollment criteria involve administering standard induction chemotherapy before random assignment to either the investigational cohort (receiving CAN-2409, prodrug, and chemoradiation) or the control cohort (receiving standard chemoradiation and surgery).

Resource: Pharmexec, January 03, 2023

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