Candel Therapeutics to Present Prostate Cancer Trial Data

NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a biopharmaceutical company specializing in biological immunotherapies with a current market capitalization of $226 million, announced its participation in the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, slated for May 30 to June 3, 2025, in Chicago. The company’s stock has experienced significant volatility this year, down about 45% year-to-date, though InvestingPro data suggests the stock is currently trading near its Fair Value. The company will present phase 3 clinical trial data for its leading candidate, CAN-2409, targeting localized prostate cancer.

Theodore DeWeese, M.D., will deliver the oral presentation, titled "Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy for newly diagnosed localized prostate cancer," on Tuesday, June 3, 2025. Dr. DeWeese, who is not affiliated with Candel beyond his role as the national principal investigator for the trial, will present at McCormick Place Convention Center.

CAN-2409 is a multimodal biological immunotherapy designed to induce a systemic immune response against cancer. The treatment uses a replication-defective adenovirus to deliver a herpes simplex virus gene into the tumor, which then converts a prodrug into a toxic compound to kill cancer cells and potentially trigger a broader immune response.

The phase 3 trial data builds on previous positive results from phase 2a trials in non-small cell lung cancer and pancreatic ductal adenocarcinoma, as well as a pivotal phase 3 trial in prostate cancer. In December 2024, Candel reported that CAN-2409 met its primary endpoint, showing a significant improvement in disease-free survival in patients with intermediate-to-high-risk localized prostate cancer when combined with standard radiation therapy. Analysts maintain a strong bullish stance on the company’s prospects, with price targets ranging from $15 to $25 per share, according to InvestingPro data.

The FDA has granted CAN-2409 Fast Track Designation for several cancer types, including localized prostate cancer, and Orphan Drug Designation for pancreatic ductal adenocarcinoma. The phase 3 prostate cancer trial was conducted under a Special Protocol Assessment agreement with the FDA.

Candel Therapeutics continues to explore the potential of its immunotherapy candidates, with ongoing trials for CAN-3110 in recurrent high-grade glioma and a systematic discovery platform for new viral immunotherapies.

This news article is based on information provided in a press release statement. Full details of the ASCO presentation will become available on the Candel website following the event.

In other recent news, Candel Therapeutics has reported several promising developments in its cancer treatment studies. The company announced positive results from a Phase 1b trial for high-grade glioma, showing a favorable safety profile and potential survival benefits when combining CAN-2409 with nivolumab. Additionally, a Phase 2a trial for advanced non-small cell lung cancer (NSCLC) revealed that patients receiving CAN-2409 experienced a median overall survival of 24.5 months, significantly surpassing typical outcomes with standard chemotherapy. Candel’s CAN-2409 has also shown success in a Phase 3 study for prostate cancer, achieving a 30% reduction in disease recurrence and an 80.4% pathological complete response rate. The firm has partnered with IDEA Pharma to enhance its commercial strategy for CAN-2409, particularly in preparation for a Biologics License Application submission. H.C. Wainwright has maintained a Buy rating for Candel Therapeutics, highlighting the company’s progress in prostate and pancreatic cancer studies. The analysts at H.C. Wainwright see potential upside in the company’s ongoing Phase 2a trial for NSCLC, emphasizing the importance of upcoming results. These recent developments underscore Candel Therapeutics’ continued advancements in the field of cancer immunotherapy.

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