The Studio at Kendall: Candel and IDEA Pharma CEOs on mindset and communication in biotech innovation

The Studio at Kendall: Candel and IDEA Pharma CEOs on mindset and communication in biotech innovation.

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At ASCO 2025, BiotechTV sat down with Paul Peter Tak, MD PhD FMedSci, CEO of Candel Therapeutics, to discuss the firm’s pivotal Phase 3 prostate cancer data and the future outlook for its viral immunotherapy platform.

What is CAN-2409?

CAN‑2409 is an off‑the‑shelf adenovirus-based immunotherapy, a replication-deficient viral vector engineered to deliver cytotoxic gene therapy directly within tumours. Designed to synergize with standard radiotherapy, CAN‑2409 aims to enhance local tumour control and systemic immune activation.

Key Prostate Cancer Data from ASCO

• The Phase 3 trial evaluated CAN‑2409 plus radiotherapy versus radiotherapy alone in localised non-metastatic prostate cancer.
• The primary endpoint, disease-free survival (DFS), showed a 30% reduction in risk of recurrence or death (hazard ratio ≈ 0.70), a statistically significant improvement even in patients with age-related non-cancer deaths factored in.
• Cancer-specific DFS, excluding non-cancer deaths, demonstrated an even stronger benefit (~38% risk reduction).
• Two-year biopsies revealed that over 80% of patients on CAN‑2409 had pathological complete responses, compared to ~64% with radiotherapy alone.

These data mark a milestone in prostate cancer treatment, addressing a critical gap in improving curative outcomes beyond standard modalities.

Development Path & Regulatory Strategy

Tak explained that the Phase 3 study was conducted under an FDA Special Protocol Assessment (SPA), ensuring alignment on design and endpoints with regulatory expectations. Looking ahead, the team is actively preparing for BLA submission and scaling manufacturing to support commercial readiness across indications beyond prostate cancer.

The Bigger Picture: Pipeline Expansion

Beyond prostate cancer, Candel is advancing CAN‑2409 in borderline-resectable pancreatic cancer and therapy-resistant non‑small cell lung cancer, where unmet needs remain significant. Tak underscored the importance of building a pan–solid tumor immunotherapy pipeline, leveraging viral delivery to tackle difficult-to-treat cancers with limited therapeutic options.