Month: August 2024

In this interview, Paul Peter Tak, President & CEO of Candel Therapeutics, offers a deep dive into the company’s viral immunotherapy platform, CAN‑2409, its strategic development journey, and how disruptive science is reshaping prostate cancer care.

What makes CAN-2409 unique

• AN‑2409 is not a traditional oncolytic virus but a viral-mediated in vivo gene therapy. A replication-defective adenovirus delivers the HSV‑tk gene directly into the tumor.
• Patients receive oral valacyclovir, which the HSV‑tk enzyme converts into a toxic agent, causing local cell death and releasing tumour antigens-triggering a CD8+ T-cell–mediated immune response, both locally and systemically.
• This in situ “vaccination” approach harnesses each patient’s unique tumor antigen profile for a finely targeted immune response.

Competitive Advantage & Platform Strength

• Unlike checkpoint inhibitors, which induce broad immune activation, CAN‑2409 is patient-specific and off-the-shelf, offering precision without complex personalized manufacturing.
• The therapy is supported by preclinical proof-of-concept and data from Phase 2a and Phase 3 trials in prostate, NSCLC, pancreatic, and glioblastoma settings.
• As Tak explains, viruses are “very good at delivering genes to cells”, leveraged here to initiate potent inflammation and immune activation at tumour sites.

Phase 3 Results & Regulatory Momentum

• CAN‑2409 achieved its primary endpoint in the Phase 3 PrTK03 trial, showing a 30% reduction in disease recurrence or death (HR ~0.70; p=0.0155) in prostate cancer patients when combined with radiation versus radiation alone.
• 38% reduction in prostate cancer-specific recurrence or death (HR ~0.62; p=0.0046).
• 80% of treated patients reached pathological complete response at two years, compared to ~64% in the control arm.
• Safety profile remains favorable, with no new safety signals identified and mostly mild, self-limited adverse events like flu-like symptoms and fever.
• CAN‑2409 has received FDA Fast Track and RMAT designations, and the Phase 3 protocol was aligned under a Special Protocol Assessment (SPA).
• The company anticipates filing a BLA by Q4 2026 with expedited review opportunities via FDA pathways.

Company Resilience & Strategic Agility

• Facing financial strain in late 2023, Candel took decisive measures, staff and manufacturing cuts, to extend its runway and reach key clinical milestones.
• Despite those hardships, Phase 3 data success triggered a 200% surge in stock price, followed by a $92M public offering that fueled ongoing development efforts.
• Tak emphasizes disciplined investment, avoiding premature manufacturing scale-up until impactful clinical data emerged, preserving resources for high-probability programs.