Candel Therapeutics get FDA’s RMAT designation for prostate cancer therapy
Last updated: 10:53 28 May 2025 EDT, First published: 09:32 28 May 2025 EDT
Candel Therapeutics Inc (NASDAQ:CADL) said on Wednesday the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead immunotherapy candidate, CAN-2409, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease.
The RMAT designation is intended to expedite the development and review of regenerative therapies for serious conditions where preliminary evidence suggests the drug may address unmet medical needs.
The designation offers companies enhanced guidance from the FDA and eligibility for accelerated approval pathways, including rolling and priority reviews.
“Receiving the FDA’s RMAT designation underscores the critical unmet need in patients with early, localized prostate cancer and validates the promising clinical activity observed with CAN-2409,” said CEO Paul Peter Tak in a statement.
“Our aim is to introduce a new treatment option for patients at the early stages of prostate cancer, a disease that has seen minimal innovation over the past two decades.”
Candel’s therapy, also known as aglatimagene besadenovec, previously received Fast Track status from the FDA for the same indication.
The designation was based on data from a Phase 3 randomized, placebo-controlled trial, which showed that CAN-2409, when combined with valacyclovir and standard-of-care radiation, significantly improved disease-free survival in patients with localized, intermediate- to high-risk prostate cancer.
In results announced in December, the therapy reduced the risk of cancer recurrence or death by 30% compared with placebo. It also improved prostate-specific disease-free survival by 38%, and a higher proportion of patients reached a PSA nadir of less than 0.2 ng/ml compared to those in the placebo arm.
Biopsies conducted two years after treatment showed an 80.4% pathological complete response rate in patients receiving CAN-2409, compared with 63.6% in the control group.
Candel expects to submit a biologics license application by the end of 2026.
The update was welcomed by investors, with shares of Candel trading up 8% on Wednesday morning.
