Candel Therapeutics Inc (NASDAQ:CADL) has provided a corporate update, highlighting anticipated milestones for this year building upon significant achievements in 2024.
Updated overall survival data from phase 2a trials of its lead candidate CAN-2409 in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) are expected in the first quarter of 2025.
Candel is preparing a Biologics License Application (BLA) for CAN-2409 in prostate cancer, with a submission planned for the fourth quarter of 2026.
Phase 3 clinical trial data for CAN-2409 in prostate cancer will be presented at upcoming scientific conferences.
The company anticipates reporting overall survival data from its Phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG) by the fourth quarter of 2025.
Candel ended 2024 with approximately $103 million in cash and cash equivalents, which it expects will fund its operations into the first quarter of 2027.
Dr Paul Peter Tak, Candel CEO, said the company is entering 2025 with “clear momentum,” with its focus on achieving BLA readiness for CAN-2409 in prostate cancer.
“If approved, we believe that CAN-2409 has the potential to become a first-line treatment, as an addition to radiation therapy to reduce the risk of recurrence of prostate cancer, and to redefine the current standard-of-care for prostate cancer patients,” Tak said.
“In the upcoming months we look forward to collaborating closely with the FDA to ensure alignment in preparation for our BLA submission which, if approved, would enable us to deliver this much-needed therapy to patients.”
In December 2024, the company announced positive results from a Phase 3 trial of CAN-2409 in localized prostate cancer, demonstrating a significant improvement in disease-free survival.
Topline data showed a 30% reduction in prostate cancer recurrence or death with CAN-2409 treatment, alongside an improved pathological complete response rate.
FDA designations, including Fast Track and Orphan Drug status, support the regulatory pathway for CAN-2409 in multiple indications.
Positive results from the Phase 2a trial of CAN-2409 in PDAC showed improved survival rates compared to standard care.
At the 2024 ASCO Annual Meeting, CAN-2409 demonstrated favorable overall survival in NSCLC patients inadequately responding to immune checkpoint inhibitors.
Preclinical and clinical development of CAN-3110, including its application in rHGG and melanoma, continues to show encouraging results.
The company also highlighted advancements in its enLIGHTEN discovery platform, which is driving the development of novel viral immunotherapies.