FDA grants fast track designation to Candel’s immunotherapy in pancreatic cancer
13 Dec 2023
Clinical ResultFast TrackImmunotherapyPhase 2Radiation Therapy
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Source: PMLiVE
The US Food and Drug Administration (FDA) has granted fast track designation to Candel Therapeutics’ investigational viral immunotherapy for pancreatic cancer.
The candidate, CAN-2409, has specifically been granted the designation for use alongside prodrug valacyclovir to improve overall survival in patients with pancreatic ductal adenocarcinoma (PDAC).
CAN-2409 will now benefit from the FDA’s fast-track process, which is designed to improve the efficiency of product development and accelerate the review of treatments for serious conditions.
Pancreatic cancer is associated with a poor prognosis and is the fourth leading cause of cancer-related death in the US, accounting for approximately 3.3% of all new cancer cases.
Surgical resection offers the only chance of cure and the addition of adjuvant chemotherapy has been shown to only slightly improve survival rates, Candel said, adding that immunotherapy with PD-1 antibodies with or without CTLA-4 antibodiesCTLA-4 antibodies has been “uniformly unsuccessful” in PDAC patients.
The company recently announced positive results from a mid-stage trial of CAN-2409 plus prodrug together with standard of care chemo-radiation followed by resection in patients with borderline resectable PDAC.
The interim results shared in November demonstrated an estimated survival rate of 71.4% at months 24 and 36 months in patients who received the CAN-2409 regimen prior to surgery, compared to 16.7% in those receiving chemo-radiation alone.
Five out of seven patients who received CAN-2409 were still alive at the time of the data cut-off, with two patients surviving more than 45 months from enrolment, while only one patient randomised to control chemotherapy remained alive at the data cut-off.
A “consistent and robust activation of immune response" was also observed after dosing with CAN-2409, the company said, and the candidate was associated with a “favourable tolerability profile”.
Paul Peter Tak, Candel’s president and chief executive officer, said: "This milestone follows our first interim data report from the randomised phase 2 clinical trial… that showed prolonged and sustained survival after experimental treatment with CAN-2409, especially when compared to real-world data on patients receiving radiotherapy treatment."
Tak added that the company "remains on track” to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024.
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