CAN-2409 shows extended survival in pancreatic cancer trial

NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a clinical stage biopharmaceutical company with a current market capitalization of $467.66 million, announced updated results from its phase 2 clinical trial for CAN-2409, an experimental treatment for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). The final data, which includes an additional nine months of follow-up, reveals a significant increase in median overall survival when compared to the control group. The announcement comes as the company’s stock has shown remarkable momentum, with InvestingPro data showing a 526% return over the past year.

Patients treated with CAN-2409 plus standard of care (SoC) therapy showed a median overall survival of 31.4 months after enrollment, markedly higher than the 12.5 months observed in patients receiving SoC alone. Notably, three out of seven patients in the CAN-2409 group are still alive, with survival times post-enrollment of 66.0, 63.6, and 35.8 months, respectively. These figures are considerably higher than the expected median overall survival for pancreatic cancer with standard treatments. According to InvestingPro analysis, analysts have set price targets ranging from $15 to $25, reflecting optimism about the company’s potential. Subscribers can access 10+ additional ProTips and comprehensive financial metrics to better understand CADL’s investment potential.

In addition to the increased survival rates, the study highlighted the potential of CAN-2409 to induce a sustained immune response. Patients in the CAN-2409 arm who experienced disease recurrence responded to salvage chemotherapy and continued to show extended survival at the data cut-off date of February 20, 2025.

The safety profile of CAN-2409 was also favorable, with no dose-limiting toxicities or cases of pancreatitis reported. The therapy has previously received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of PDAC.

Candel’s Chief Medical (TASE:BLWV) Officer, W. Garrett Nichols, MD, MS, emphasized the significance of these results for patients with a typically dismal prognosis. CAN-2409 is designed to work as an in situ vaccine against the patient’s tumor, potentially controlling the disease and prolonging survival.

The promising outcomes of the trial have prompted Candel Therapeutics to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC. The company’s broader goal is to develop off-the-shelf multimodal biological immunotherapies to elicit individualized anti-tumor immune responses in cancer patients.

This news report is based on a press release statement from Candel Therapeutics. Investors should note that the company’s next earnings report is scheduled for March 27, 2025. While current InvestingPro Fair Value analysis suggests the stock is slightly overvalued, the company’s strong price momentum and positive clinical trial results have contributed to its recent market performance.

In other recent news, Candel Therapeutics has captured attention with several key developments. The company announced positive results from a Phase 3 clinical trial for its lead asset, CAN-2409, in treating localized prostate cancer. The trial, conducted under a Special Protocol Assessment with the FDA, showed a 14.5% relative improvement in disease-free survival at 54 months, which could potentially lead to regulatory approval. Citi initiated coverage with a Buy rating and a $25 price target, while H.C. Wainwright upgraded their price target from $11 to $19, maintaining a Buy rating. Candel also announced a public offering to raise approximately $80 million to advance its product candidates, including the preparation of a Biologics License Application for CAN-2409.

The offering includes 10 million shares of common stock and pre-funded warrants, with Citigroup (NYSE:C) and BofA Securities among the joint bookrunning managers. The funds are intended to support ongoing clinical trials and corporate purposes. Additionally, Candel is progressing with its second program, CAN-3110, in a Phase 1b trial for recurrent high-grade glioma, with updates expected in 2025. These recent developments highlight the company’s efforts to advance its pipeline of cancer immunotherapies and potentially bring new treatment options to patients.

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