Candel's cancer therapy meets late-stage trial goal, shares soar
Adds details from conference call in paragraphs 2,3,10, background throughout
By Mariam Sunny and Kamal Choudhury
Dec 11 (Reuters) -Candel Therapeutics' CADL.O experimental immunotherapy for prostate cancer significantly improved the time patients lived before their disease returned, helping the company's shares more than double in value in early trading.
The immunotherapy, CAN-2409, in combination with radiation therapy, helped 75.2% patients live without any sign of the cancer after 54 months of treatment, the company said on Wednesday.
That compares to the 65.7% patients who received only radiation in the late-stage trial, which enrolled 745 participants.
More than 100,000 men are diagnosed with prostate cancer every year in the U.S., the company said. According to American Cancer Society, it is the second-leading cause of cancer death in American men.
The currently available treatments for the advanced forms of the disease include Johnson & Johnson's JNJ.N Zytiga and Novartis' NOVN.S Pluvicto.
U.S. drugmaker Merck MRK.N has scrapped at least three late-stage studies testing combination treatments including its blockbuster immunotherapy Keytruda for advanced forms of prostate cancer.
Candel's therapy is being developed to treat newly diagnosed patients with intermediate-to-high-risk localized prostate cancer. It is a viral immunotherapy designed to teach the patient's immune cells to recognize and kill cancer cells.
The most common treatment-related side effects, including fever and chills, were mild to moderate, the company said.
It plans to hold regulatory discussions with the U.S. Food and Drug Administration and present full data from the study at upcoming medical meetings.
Candel also intends to file for regulatory approval in the U.S. by the fourth quarter of 2026.
However, a separate mid-stage study testing CAN-2409 as a monotherapy in patients with low-to-intermediate risk localized prostate cancer did not significantly improve the time they lived without the disease getting worse, the company said.
H.C. Wainwright analyst Vernon Bernardino estimates peak annual sales of $818 million for the therapy in prostate cancer alone by 2033.
Shares of Candel were up about 122% at $10.22.
Reporting by Kamal Choudhury and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Shilpi Majumdar
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