Candel shares surge on positive prostate cancer trial

On Wednesday, Candel Therapeutics, Inc. (NASDAQ:CADL) experienced a significant 150% increase in its stock value following the announcement of promising results from a phase 3 clinical trial. The trial evaluated the company's CAN-2409 viral immunotherapy in combination with radiation therapy for treating intermediate-to-high risk, localized prostate cancer. The therapy met its primary endpoint by showing a statistically significant and clinically meaningful benefit.

The phase 3 trial, which was conducted under a Special Protocol Assessment with the FDA, enrolled 745 patients to assess the effectiveness of CAN-2409. The results demonstrated a notable improvement in disease-free survival for patients receiving CAN-2409 combined with standard care compared to standard care alone. The safety profile of CAN-2409 was consistent with prior studies, presenting no new safety concerns.

CAN-2409 is designed to induce a specific immune response against the tumor by causing immunogenic cell death of tumor cells. This effect is expected to be synergistic with radiation therapy. With more than 100,000 men diagnosed with localized prostate cancer annually in the United States, and a lack of significant treatment advancements in over two decades, the successful trial brings hope for a new treatment option in a market potentially worth over $10 billion.

The study's significant findings include a 14.5% relative improvement in disease-free survival at 54 months for the treatment arm, an increase in patients achieving a low prostate-specific antigen level, and a higher rate of pathological complete responses in post-treatment biopsies. The median follow-up period 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 of CAN-2409 as a monotherapy, which showed improvement in time to radical treatment and the percentage of patients with negative biopsies, though 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 engage with the FDA to discuss the regulatory pathway for CAN-2409, with hopes of obtaining approval for this new treatment option. Candel intends to present detailed data from both trials at upcoming medical conferences.

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Source: Investing.com