- Novel systemic immune data demonstrated T-cell activation following local administration of aglatimagene. Together with recently disclosed evidence of persistent local immune remodeling, these findings provide mechanistic support for the long-term clinical outcomes, including disease-free survival and prolonged time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy, observed in this patient population
- Biodistribution and shedding data from the PrTK05 phase 2 trial remain on track for inclusion in the planned Q4 2026 Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for localized prostate cancer
NEEDHAM, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced novel immunological biomarker data from the ongoing phase 2 PrTK05 trial (NCT07332000) in patients with intermediate-risk localized prostate cancer. These data, together with histologic and clinical data from the intermediate-risk prostate cancer subgroup of the PrTK03 phase 3 trial (NCT01436968) (635 patients, 85% of the intention-to-treat population), are expected to be presented at a future scientific meeting. Intermediate-risk prostate cancer represents the largest group of patients with localized disease treated with curative-intent external beam radiation therapy (EBRT), accounting for approximately 65,000 patients annually in the United States. Despite radiotherapy, disease recurrence, local and metastatic progression, and the need for salvage anti-cancer therapies that can be associated with substantial toxicity and impaired quality of life remain important unmet needs. This underscores the need for new treatments designed to enhance local tumor control and reduce the risk of disease progression.
PrTK03 Clinical Outcomes
With follow-up through March 15, 2026 (median, 58.0 months), the phase 3 trial showed that patients with intermediate-risk disease (635 patients) treated with aglatimagene plus EBRT experienced a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death versus placebo plus EBRT (HR 0.59; 95% CI 0.41–0.84; p=0.0034).
Additional exploratory, descriptive analyses showed 52% improvement in the time to biochemical failure (HR 0.48; 95% CI 0.22–1.03), a 90% improvement in the time to metastasis (HR=0.10; 95% CI 0.01–0.85), and a 49% reduction in the time to salvage anticancer therapy (HR 0.51; 95% CI 0.24–1.10).
PrTK03 Pathologic and Biomarker Data
Centrally reviewed biopsies from patients with intermediate-risk disease obtained 22–26 months after treatment demonstrated a substantial improvement in rate of negative biopsies, defined as the absence of tumor cells in a standard-of-care diagnostic prostate biopsy. Among 277 evaluable patients with intermediate-risk disease:
- 76.6% (144/188) in the aglatimagene arm had negative biopsies versus 60.7% (54/89) in the control arm
- Positive biopsies were observed in 20.7% of the aglatimagene arm and 38.2% of the control arm (stratified CMH p = 0.0034; chi-square p = 0.0026). Six undetermined biopsies were included in the total number of biopsies analyzed and are part of the denominator.
Building on the AI-enabled histologic analysis presented at ASTRO, exploratory digital pathology analyses showed:
- Increased lymphocytic infiltration after treatment in both arms (p