Candel (CADL) Up as Pancreatic Cancer Drug Gets Orphan Drug Tag
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Candel Therapeutics, Inc. CADL announced that the FDA has granted orphan drug designation to its lead investigational adenovirus immunotherapy candidate, CAN-2409, for the treatment of pancreatic ductal adenocarcinoma (PDAC). Shares of the company rallied 42.8% on Apr 12, following the news.
The FDA grants the orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States. The orphan drug designation will grant Candel market exclusivity for CAN-2409 in the treatment of PDAC for a predefined time period, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval.
Per management, the orphan designation grant reaffirms the potential of Candel’s CAN-2409 to treat rare and difficult-to-treat forms of cancer. Please note that last year, the FDA also granted the Fast Track designation to CAN-2409 for the same indication.
The Fast Track designation facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
Year to date, shares of Candel have skyrocketed 395.2% against the industry’s 6% decline.
Image Source: Zacks Investment Research
We remind the investors that earlier this month, CADL reported positive interim data from the phase II study evaluating CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable PDAC.
The updated interim data from the ongoing mid-stage study showed that experimental treatment with CAN-2409 led to notable improvements (more than doubled) in the estimated median overall survival of 28.8 months compared with only 12.5 months in the control group in the PDAC patient population.
If successfully developed, followed by a potential approval for CAN-2409, it could present a significant commercial opportunity for Candel. There is a high unmet medical need for effective new treatments, given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC.
Apart from pancreatic cancer, CADL expects key data readouts for CAN-2409 in non-small cell lung cancer later in the second quarter of 2024, while top-line data in prostate cancer is expected in the fourth quarter of 2024.
In the absence of a marketed product, the successful development of its pipeline candidates remains the key focus for this clinical-stage biopharmaceutical company.