Candel Therapeutics Inc (NASDAQ:CADL) CEO Paul Peter Tak expressed optimism for a "paradigm shift" in prostate cancer treatment as the biopharmaceutical company moves closer to phase 2b and phase 3 trial data releases for its lead therapy, CAN-2409.
Tak stated the data, expected in the fourth quarter of 2024, could pave the way for new regulatory approvals for CAN-2409 in non-metastatic, localized prostate cancer.
The CEO’s statements accompanied the release of Candel’s financial results for the third quarter, which showed the biopharmaceutical firm finished the quarter with a cash position of $16.6 million as of September 30.
The firm reported a net loss of $10.6 million, compared to $8.4 million in the same period last year, reflecting increased clinical development costs and a change in warrant liability, as the company continued to advance its immunotherapy pipeline, including a phase 1b trial for CAN-3110 in recurrent high-grade glioma.
“We hope we will deliver the data and regulatory approvals to enable a paradigm shift in how these patients will be treated in the future,” Tak said in a statement.
Candel presented promising clinical and biomarker activity for CAN-3110, which demonstrated survival benefits and immune responses in high-grade glioma patients. Tak noted that this data supports possible applications of CAN-3110 beyond glioma, as preclinical findings showed antitumor activity in melanoma models, with tumor regression observed in a subset of cases.
CAN-3110 has also been granted orphan drug designation by the US Food and Drug Administration.
Research and development costs were down 7% to $5.4 million due to lower payroll costs following a corporate restructuring, while clinical expenses related to CAN-2409 continued to rise.
In addition to the CAN-2409 and CAN-3110 programs, Candel continues to leverage its enLIGHTEN Discovery Platform, which aims to develop immune-activating therapies for solid tumors. The platform's latest asset, a viral therapeutic candidate, demonstrated robust immune cell activation and tumor regression in early studies, according to the firm.
Upcoming milestones include additional data for non-small cell lung cancer and pancreatic cancer trials expected in the first quarter of 2025, following the anticipated prostate cancer data later this year.