Candel Gets FDA Fast-Track Designation for CAN-2409 in Non-Small Cell Lung Cancer

By Colin Kellaher

Candel Therapeutics Inc. on Monday said the U.S. Food and Drug Administration granted fast-track designation to CAN-2409, the clinical-stage biopharmaceutical company's lead asset, in certain patients with non-small cell lung cancer.

The Needham, Mass., company said the designation covers CAN-2409 plus valacyclovir in combination with pembrolizumab in order to improve survival or delay progression in patients with stage III/IV non-small cell lung cancer who are resistant to first-line PD-(L)1 inhibitor therapy and who don't have activating molecular driver mutations or have progressed on directed molecular therapy.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for about 80% to 85% of cases.

Candel said there is a significant unmet need for patients with lung cancer who have an inadequate response to standard-of-care immune checkpoint inhibitors.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 17, 2023 08:32 ET (12:32 GMT)

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