Candel Therapeutics, Inc. (NASDAQ: CADL) experienced a significant surge in its stock valuation on the preceding trading day, showcasing an impressive increase of 42.75% and concluding at $7.28 by the market close. This notable escalation in CAL shares was instigated by the granting of regulatory approval.
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In a recent announcement, Canndel Therapeutics (CADL) unveiled that CAN-2409 has been designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA). CADL considers this compound to be the best candidate for advanced multimodal biological immunotherapy targeted at pancreatic cancer.
Data from the phase 2 randomized clinical trial of CAN-2409 in patients with pancreatic cancer that is borderline resectable were recently released by Candel Therapeutics. The results showed that the median overall survival increased by more than threefold when CAN-2409 was added to the usual treatment regimen as opposed to when standard therapy was used alone.
The FDA subsequently granted Candel Therapeutics Fast Track and Orphan Drug designations for this development, highlighting the company’s efforts to transform the pancreatic cancer treatment landscape. Securing Orphan Drug Designation signifies a momentous milestone for Candel Therapeutics, as the company persists in advancing CAN-2409 for pancreatic cancer therapy.
The FDA designation will further bolster CADL’s endeavors in developing remedies for less common yet formidable-to-treat cancers. The evidential foundation for CAN-2409 continues to expand, with ongoing clinical trials exploring its efficacy in patients afflicted with challenging-to-treat cancers, such as recent assessments in pancreatic ductal adenocarcinoma and non-small cell lung cancer slated for later in the current quarter.
Earlier this month, Candel Therapeutics furnished updated data on overall survival from the ongoing randomized phase 2 clinical trial of CAN-2409 administered alongside valacyclovir (prodrug) and standard chemoradiation therapy, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Analysis conducted as of a March 29, 2024 cutoff date unveiled a significant enhancement in the estimated median overall survival, with the experimental treatment yielding 28.8 months compared to 12.5 months in the control group. Notably, at the 24-month mark, the survival rate stood at 71.4% for patients treated with CAN-2409, in contrast to a mere 16.7% in the control group post-chemoradiation.
