Candel Shares Rise Following Positive Prostate Cancer Trial Results
On Wednesday, Candel Therapeutics, Inc. (NASDAQ:CADL) shares saw a significant increase of 150% following the release of positive results from the company's Phase 3 clinical trial evaluating the CAN-2409 viral immunotherapy alongside radiation therapy for intermediate to high-risk localized prostate cancer. The therapy achieved its primary endpoint, demonstrating statistically significant and clinically meaningful benefits.
The Phase 3 trial, conducted under the FDA's Special Protocol Assessment, enrolled 745 patients to assess the efficacy of CAN-2409. The results indicated a significant improvement in disease-free survival for patients receiving CAN-2409 in conjunction with standard care compared to those receiving only standard care. The safety profile of CAN-2409 was consistent with previous studies, and no new safety concerns emerged.
CAN-2409 is designed to elicit a tumor-specific immune response by inducing immunogenic cell death in tumor cells. This effect is expected to be synergistic with radiation therapy. With over 100,000 men diagnosed with localized prostate cancer in the U.S. annually and significant treatment stagnation for over 20 years, the successful trial presents a promising new treatment option in a market potentially valued at over $10 billion.
Key findings from the study included a 14.5% relative improvement in disease-free survival at month 54 in the treatment group, an increase in the number of patients achieving low prostate-specific antigen levels, and a higher rate of pathological complete response in post-treatment biopsies. The median follow-up time was 50.3 months, with the primary outcome measure being the evaluation of post-treatment biopsies for tumor recurrence.
Candel also shared results from a Phase 2 clinical trial where CAN-2409 was used as a monotherapy. These results showed improvements in the time to radical treatment and the percentage of patients with negative biopsies, although these results were not statistically significant. The safety profile in this trial was similar to that of the Phase 3 study.
The company plans to contact the FDA to discuss the regulatory pathway for CAN-2409 and hopes to obtain approval for this new treatment option. Candel aims to present detailed data from both trials at upcoming medical conferences.