CADL Candel Therapeutics

Candel Therapeutics Appoints Martine Zimmermann to Board of Directors

Candel Therapeutics announced the appointment of Martine Zimmermann to its Board of Directors. Her expertise in regulatory and quality matters is expected to strengthen the Board as the company prepares for a planned Biologics License Application (BLA) submission for aglatimagene besadenovec in Q4 2026 and potential commercial readiness.

Candel plans Q4 2026 BLA submission for aglatimagene in prostate cancer

The company announced it is advancing pre-BLA readiness activities, including CMC process validation, and plans to submit a BLA for aglatimagene besadenovec in localized, intermediate- to high-risk prostate cancer in Q4 2026. The submission timeline is supported by the prior publication of pivotal Phase 3 data in The Lancet Oncology and extended follow-up data presented at AUA 2026.

Candel to present Phase 3 aglatimagene data at ASTRO 2026

An abstract on quantitative digital pathology immune activation data from the completed Phase 3 trial of aglatimagene besadenovec in localized prostate cancer has been accepted for poster presentation at the ASTRO 2026 Annual Meeting. The presentation is scheduled for September 29, 2026, in Boston.

Candel initiates global Phase 3 AURORA trial of CAN-2409 in NSCLC

Candel has opened the first site of its global pivotal Phase 3 AURORA trial (NCT07660094) evaluating aglatimagene besadenovec plus valacyclovir plus continued pembrolizumab versus docetaxel in metastatic non-squamous NSCLC progressing after ICI and platinum therapy. The trial is randomized 1:1 across >150 sites worldwide with overall survival as the primary endpoint. Parexel International has been engaged to support execution.

Candel: Phase 3 aglatimagene + RT beats placebo in localized prostate cancer

The Lancet Oncology published the pivotal Phase 3 trial showing a statistically significant 30% improvement in disease-free survival (HR 0.70, p=0.016) and 38% improvement in prostate-cancer-specific DFS (HR 0.62, p=0.0046) with aglatimagene plus radiotherapy versus placebo. The data also demonstrated an 80% vs 63% pathological complete response rate (p=0.0018) and a favorable safety profile. These results underpin the planned BLA submission in Q4 2026.

Candel reports Phase 3 DFS benefit for aglatimagene besadenovec in prostate cancer

Extended follow-up data from the randomized Phase 3 trial (n=745) show aglatimagene besadenovec plus prodrug plus standard-of-care radiotherapy significantly improved prostate cancer-specific disease-free survival versus placebo (HR 0.61, p=0.0031). The company also observed longer time to salvage therapy, biochemical failure, and metastasis in the active arm.

Candel plans Q4 2026 BLA submission for aglatimagene in prostate cancer

Candel announced its intent to file a BLA for aglatimagene besadenovec in localized, intermediate- to high-risk prostate cancer in Q4 2026. The company is advancing pre-BLA activities including CMC process validation and clinical study reports. A commercial partnership with EVERSANA was also announced to support a potential U.S. launch.

Candel plans BLA submission for aglatimagene in prostate cancer in Q4 2026

The company announced its plan to submit a Biologics License Application (BLA) for aglatimagene besadenovec in localized, intermediate-to high-risk prostate cancer in Q4 2026. This follows ongoing pre-BLA readiness activities including CMC work and preparation of clinical study reports and BLA modules. The submission timeline is supported by process validation activities planned for Q2 2026.

Candel Therapeutics R&D Day 2025 – CAN-2409 prostate cancer program

Company hosted a virtual R&D Day on December 5, 2025 to present clinical progress and regulatory plans for CAN-2409 in localized prostate cancer. The event outlined the target product profile, mechanism of action, and Phase 3 trial design but did not disclose new clinical data or regulatory decisions.

Candel plans BLA submission for CAN-2409 in prostate cancer in Q4 2026

The company announced it will submit a BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer in Q4 2026. The filing will be supported by the positive phase 3 trial data showing a statistically significant improvement in prostate cancer-specific DFS (HR 0.62, p=0.0046) and by ongoing CMC and regulatory preparation activities.