Milestone Achievement Enhances Development Efforts for Multimodal Biological Immunotherapy
Candel Therapeutics (CADL) has achieved a significant milestone in its fight against pancreatic cancer with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to CAN-2409, the company’s advanced multimodal biological immunotherapy candidate.
CAN-2409 has demonstrated promising results in a phase 2 randomized clinical trial for borderline resectable pancreatic cancer, showing a notable improvement in median overall survival when combined with standard of care. The FDA’s recognition through Orphan Drug Designation underscores the therapeutic potential of CAN-2409 in addressing the unmet medical needs of patients battling this challenging disease.
“We are thrilled by the FDA’s decision to grant Orphan Drug Designation to CAN-2409, further validating our commitment to advancing innovative therapies for pancreatic cancer,” stated Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel Therapeutics. “This designation, coupled with Fast Track Designation, underscores the urgency and importance of our mission to redefine the treatment landscape for pancreatic cancer.”
Orphan Drug Designation provides Candel with valuable financial incentives and potential marketing exclusivity, empowering the company to accelerate the development of CAN-2409 and bring hope to patients fighting this rare and devastating form of cancer. With ongoing positive clinical trial results, Candel remains dedicated to leveraging CAN-2409’s multimodal approach to combat pancreatic cancer and other challenging-to-treat cancers.
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