Candel Therapeutics Secures RMAT Designation for Prostate Cancer Treatment, Focused on Gene Therapy Programs.

Candel Therapeutics has secured RMAT designation for its gene therapy program CAN-2409 in prostate cancer, following its primary endpoint achievement in early localized prostate cancer. The company is also expanding into non-small cell lung cancer and pancreatic cancer, with orphan designation from the EMA for pancreatic cancer. Its second program, CAN-3110 for glioblastoma, has shown a doubling in median survival and has received fast track and orphan designations from the FDA. The company anticipates a pivotal 2026 and has secured funding through Q1 2027.

Title: Candel Therapeutics Advances Gene Therapy Program CAN-2409 in Prostate Cancer

Candel Therapeutics, Inc. (Nasdaq: CADL) has made significant strides in its gene therapy program, securing a Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate CAN-2409 in prostate cancer. The company announced the designation following the successful primary endpoint achievement in early localized prostate cancer during its oral presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The RMAT designation from the FDA recognizes CAN-2409 as a promising therapy for intermediate-to-high-risk localized prostate cancer. This designation, coupled with the company's positive clinical trial results, positions Candel to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer by the end of 2026.

Candel Therapeutics is also expanding its therapeutic portfolio into non-small cell lung cancer and pancreatic cancer. The company has received orphan designation for CAN-2409 from the European Medicines Agency (EMA) for the treatment of pancreatic cancer. This designation provides Candel with access to certain regulatory and financial incentives to support the development of this novel therapy.

In addition to CAN-2409, Candel's second program, CAN-3110, has shown promising results in glioblastoma. The company reported a doubling in median survival with CAN-3110, which has received Fast Track and Orphan Drug Designations from the FDA. The initial results of CAN-3110 were published in Nature, highlighting the potential of this gene therapy in treating therapy-resistant conditions.

Candel's financial results for the second quarter ended June 30, 2025, reflect a net loss of $4.8 million, compared to a net loss of $22.2 million in the same period last year. The company's cash position remains robust, with $100.7 million as of June 30, 2025, sufficient to fund operations into Q1 2027. The company expects to submit the BLA for CAN-2409 in prostate cancer by the end of 2026, further underscoring its commitment to advancing its pipeline.

Looking ahead, Candel anticipates a pivotal 2026, marked by key regulatory milestones and clinical data presentations. The company's strategic focus on multimodal biological immunotherapies positions it well to address unmet medical needs in various solid tumors.

References:
1. [1] https://finance.yahoo.com/news/candel-therapeutics-reports-second-quarter-120500771.html