Candel Therapeutics to File for FDA Approval After Cancer Drug Shows 39% Survival Benefit

Candel Therapeutics is moving toward commercialization of its lead cancer therapy, buoyed by strong late-stage trial results that significantly improve patient outcomes.

Candel Therapeutics (NASDAQ:CADL) plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration by the end of 2026 for its lead drug candidate, aglatimagene besadenovec. The decision follows the release of new data from its Phase III trial showing the treatment significantly improved outcomes for patients with localized prostate cancer, a market the company estimates could be worth up to $16 billion annually in the United States.

"The data was extremely well-received," Candel CEO Dr. Paul Peter Tak said, referencing a presentation at the American Urological Association annual meeting. He described aglatimagene as a form of gene therapy designed to destroy cancer locally and train the patient's immune system to recognize and kill tumor cells throughout the body. The company is partnered with MilliporeSigma for manufacturing and Eversana for its potential U.S. commercial launch.

The pivotal Phase III study evaluated aglatimagene in patients with intermediate- and high-risk localized prostate cancer. After a median follow-up of 58 months, the results demonstrated a 39% improvement in prostate cancer-specific disease-free survival compared to placebo, with a hazard ratio of 0.61 and a p-value of 0.0031. The trial also showed a lower incidence of and longer time to metastases in patients receiving the therapy.

This viral immunotherapy could challenge the current standard of care, which primarily consists of prostatectomy and radiotherapy—treatments that carry risks of recurrence in about 30% of patients. Candel's approach, an off-the-shelf product administered via injection in a 20-minute outpatient procedure, aims to improve those odds. The FDA has already granted the therapy Regenerative Medicine Advanced Therapy (RMAT) designation based on the data.

Analyst Targets Rise on Clinical Success

Wall Street has responded positively to the clinical developments, with Candel's stock surging 90% over the past six months. BofA Securities raised its price target on the stock to $9.00 from $7.00, increasing its penetration estimate for the drug and citing data that supports "meaningful clinical benefit." The firm maintained a Neutral rating, waiting for a clearer commercialization path.

In a more bullish assessment, H.C. Wainwright reiterated a Buy rating on Candel, maintaining a $23 price target. The firm's optimism also extends to Candel's pipeline, having previously highlighted promising survival data from a Phase II trial of aglatimagene in patients with advanced non-small cell lung cancer (NSCLC).

Expanding the Pipeline Beyond Prostate Cancer

While the immediate focus is the BLA submission for prostate cancer, Candel is preparing to launch a global Phase III trial for aglatimagene in second-line NSCLC. The study will enroll about 500 patients to evaluate the drug in combination with Merck's KEYTRUDA versus the standard chemotherapy docetaxel. The company's earlier Phase II data showed at least a doubling of expected median overall survival compared to historical results for docetaxel.

Candel's pipeline also includes another candidate, CAN-3110, an oncolytic herpes simplex virus being studied for recurrent high-grade glioma. With a balance sheet showing more cash than debt, Dr. Tak stated the company is in a "very stable financial position" with a cash runway that could extend into commercialization, positioning it to advance its multiple late-stage programs. The main hurdle for the year-end BLA filing remains the chemistry, manufacturing, and controls (CMC) work, according to the company.

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