Candel’s phase 3 trial for prostate cancer therapy shows promise

NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a biopharmaceutical company specializing in biological immunotherapies trading at $5.42 per share with a market capitalization of $272 million, announced today that their phase 3 clinical trial for a prostate cancer treatment met its primary and secondary endpoints. The company’s stock has shown strong momentum with a 7% gain over the past week, according to InvestingPro data. The trial results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting in Chicago.

The study focused on aglatimagene besadenovec (CAN-2409) combined with valacyclovir and standard of care radiation therapy, aiming to improve disease-free survival (DFS) among patients with localized prostate cancer. The trial demonstrated a statistically significant 30% reduction in the risk of recurrence or death in patients treated with CAN-2409 compared to the placebo group. InvestingPro analysis shows the company maintains a healthy financial position with more cash than debt and a strong current ratio of 4.64, indicating robust liquidity to support its clinical programs.

This marks the first multicenter, randomized phase 3 trial in over two decades to meet such endpoints in localized prostate cancer, potentially redefining treatment for patients seeking curative therapy. Dr. Glen Gejerman, Co-Director of Urologic Oncology at Hackensack Meridian Health and a principal investigator of the study, highlighted the clinical significance of the improvement in DFS.

The findings also included a higher rate of pathological clinical response in two-year biopsy samples for patients treated with CAN-2409, suggesting microscopic elimination of cancer. The treatment was generally well tolerated, with most CAN-2409-related adverse events being mild-to-moderate and self-limited.

Paul Peter Tak, President and CEO of Candel, expressed the company’s commitment to advancing regulatory preparations for submitting a Biologics License Application for CAN-2409, with the goal of addressing the unmet needs of patients with intermediate-to-high-risk localized prostate cancer.

Candel’s CAN-2409 is an off-the-shelf, replication-defective adenovirus designed to induce a systemic immune response against tumors. The FDA has granted Fast Track Designation for CAN-2409 for several cancer treatments, including pancreatic adenocarcinoma and non-small cell lung cancer.

The company’s broader portfolio includes other multimodal biological immunotherapy platforms and an ongoing phase 1b clinical trial for recurrent high-grade glioma. Candel is also advancing its enLIGHTEN™ Discovery Platform to create new viral immunotherapies for solid tumors.

This report is based on a press release statement.

In other recent news, Candel Therapeutics reported positive results from multiple clinical trials involving their lead candidate, CAN-2409. The company announced favorable outcomes from a phase 3 trial in localized prostate cancer, where CAN-2409 demonstrated a significant improvement in disease-free survival when combined with standard radiation therapy. Candel is also advancing the development of CAN-2409 for non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma, with the FDA granting Fast Track Designation for these indications. Additionally, Candel shared promising data from a phase 2a trial in advanced NSCLC, showing a median overall survival of 24.5 months, surpassing typical outcomes with standard chemotherapy. The company has entered a strategic partnership with IDEA Pharma to enhance the commercial strategy for CAN-2409, particularly following its successful phase 3 results in prostate cancer. Analysts at H.C. Wainwright have maintained a Buy rating on Candel Therapeutics, citing the robust activation of an immune response by CAN-2409 and its potential to improve survival in various cancers. Candel’s recent phase 1b trial in high-grade glioma also indicated a favorable safety profile and potential survival benefits, though CAN-2409 is not currently prioritized for this indication. These developments highlight Candel’s ongoing efforts to explore and expand the therapeutic potential of their immunotherapy candidates.

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