Candel Therapeutics Advances Localized Prostate Cancer Treatment

Candel Therapeutics Advances Localized Prostate Cancer Treatment

Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL) is making significant strides in the fight against cancer with their innovative approach to prostate cancer treatment. The company recently announced promising results from a phase 3 clinical trial of their investigational drug, aglatimagene besadenovec (CAN-2409), aimed at patients with intermediate-to-high-risk localized prostate cancer. These results will be presented at a major oncology meeting, showcasing the Company's ongoing commitment to enhancing treatment outcomes for patients.

Understanding CAN-2409 and Its Mechanism

CAN-2409 is a multimodal biological immunotherapy designed to activate the body’s immune system against cancer. This treatment uses a specific type of modified adenovirus to deliver therapeutic genes directly to tumor cells, encouraging an immune response. By combining CAN-2409 with the prodrug valacyclovir and standard radiation therapy, researchers aimed to improve disease-free survival rates among patients seeking curative treatment for newly diagnosed localized prostate cancer. The primary goal was to assess if this combination could effectively reduce the risk of cancer recurrence, which is a significant concern for many patients.

Trial Highlights and Results

The phase 3 trial achieved its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS). The results indicated a 30% reduction in the risk of prostate cancer recurrence or death in patients treated with CAN-2409 compared to those receiving a placebo. This remarkable outcome is a milestone, marking the first time in over two decades that a multicenter, randomized phase 3 trial has shown such positive results for this patient group.

Significant Findings from the Research

During the trial, several key findings were highlighted:

• The treatment group saw a DFS improvement when compared to the control group, with favorable statistics (p=0.0155).
• Patients who received CAN-2409 exhibited better pathological responses in biopsy samples taken two years post-treatment, suggesting the drug's effectiveness in eliminating cancer cells at a microscopic level.
• Notably, the safety profile of CAN-2409 was favorable, with a low incidence of serious adverse events, indicating that while effective, it was well tolerated by patients.

Positive Feedback from the Medical Community

Dr. Glen Gejerman, a lead investigator, expressed optimism regarding the results, emphasizing the clinical significance of improved disease-free survival rates. Additionally, Paul Peter Tak, Candel’s President and CEO, highlighted the urgent need for better treatment options for patients with this type of cancer. His remarks resonated with the collective hope that CAN-2409 could provide a viable solution for those facing high recurrence rates after conventional therapies.

Looking Ahead: Future Prospects for CAN-2409

Candel Therapeutics is gearing up to submit a Biologics License Application (BLA) for CAN-2409 in the near future, with eyes on securing FDA approval to broaden therapeutic options for patients with localized prostate cancer. The study’s outcome positions Candel at the forefront of innovative cancer treatments, setting a path for further research and application.

Broader Implications in Cancer Therapy

The encouraging results from the phase 3 trial extend beyond prostate cancer. Candel is also evaluating CAN-2409 in other challenging conditions, including non-small cell lung cancer and pancreatic cancer. The versatility and potential effectiveness of this immunotherapy could lead to broader applications in oncology, potentially transforming cancer treatment modalities.

Frequently Asked Questions

What are the main findings of the CAN-2409 phase 3 trial?

The trial found a significant improvement in disease-free survival for patients receiving CAN-2409 compared to the placebo, indicating a promising step forward in prostate cancer treatment.

How does CAN-2409 work?

CAN-2409 uses a modified adenovirus to deliver genes to tumor cells, stimulating an immune response that targets and destroys cancer cells, especially when combined with valacyclovir and radiation therapy.

What are the next steps for Candel Therapeutics?

Candel anticipates submitting a Biologics License Application for CAN-2409, aiming for FDA approval to offer new treatment options for localized prostate cancer patients.

What is the safety profile of CAN-2409?

The treatment was generally well tolerated, with low rates of serious adverse events, indicating a favorable safety profile for patients.

What is the significance of the trial results for prostate cancer treatment?

This trial is significant as it marks the first positive phase 3 results in localized prostate cancer in over 20 years, potentially redefining standard treatment protocols for patients.

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