Candel Therapeutics, a clinical-stage biopharmaceutical company, is advancing its pipeline of multimodal biological immunotherapies, with key milestones expected in 2025. The company's lead candidates, CAN-2409 and CAN-3110, are showing promise in treating various cancers, including prostate cancer, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and recurrent high-grade glioma (rHGG).
CAN-2409: Advancing Towards BLA Submission for Prostate Cancer
Candel Therapeutics is prioritizing the preparation of a Biologics License Application (BLA) for CAN-2409 in prostate cancer, with submission anticipated in Q4 2026. Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, stated that CAN-2409 has the potential to become a first-line treatment for prostate cancer, potentially redefining the standard of care when combined with radiation therapy to reduce the risk of recurrence.
In December 2024, Candel reported positive topline data from its Phase 3 clinical trial of CAN-2409 in intermediate-to-high-risk localized prostate cancer. The study met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS) in patients who received CAN-2409 plus valacyclovir combined with standard of care external beam radiation therapy compared to standard of care alone (p=0.0155). The data also showed an 80.4% pathological complete response rate in 2-year post-treatment biopsies in the CAN-2409 arm versus 63.6% in the control arm (p=0.0015).
The FDA has granted Fast Track Designation for CAN-2409 in prostate cancer, and the Phase 3 trial was conducted under a Special Protocol Assessment (SPA) with FDA agreement on key aspects of the study design.
CAN-2409: Ongoing Trials in Pancreatic and Lung Cancer
Updated overall survival data from the Phase 2a clinical trials of CAN-2409 in borderline resectable PDAC and stage III/IV NSCLC are expected in Q1 2025.
In April 2024, the company announced positive updated survival data from the Phase 2a trial of CAN-2409 plus valacyclovir with chemoradiation in borderline resectable PDAC. The data showed an estimated median overall survival (mOS) of 28.8 months in the CAN-2409 arm versus 12.5 months in the control group. The FDA has granted Fast Track and Orphan Drug Designations for CAN-2409 in this indication.
At the 2024 ASCO Annual Meeting, Candel presented topline overall survival data from the Phase 2a trial of CAN-2409 plus valacyclovir in combination with immune checkpoint inhibitor (ICI) therapy in stage III/IV NSCLC patients inadequately responding to ICI therapy. The data showed a mOS of 20.6 months in patients with progressive disease despite ICI treatment.
CAN-3110: Advancing Clinical Development in Recurrent High-Grade Glioma
Candel anticipates reporting overall survival data from its Phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG) in Q4 2025. The company presented updated clinical and biomarker activity data at the IOVC in October 2024, with investigators reporting improved survival compared to historical controls.
CAN-3110 has received FDA Fast Track and Orphan Drug Designations for the treatment of rHGG.
enLIGHTEN Discovery Platform
Candel's enLIGHTEN Discovery Platform is generating novel viral immunotherapies for solid tumors. Data on a new multimodal viral therapeutic candidate encoding IL-12 and IL-15 were presented at the 2024 IOVC, demonstrating the ability to induce expansion and activation of natural killer and CD8+ T cell populations.
Financial Stability
Candel Therapeutics reported cash and cash equivalents of approximately $103 million as of December 31, 2024, which is expected to fund operations into Q1 2027.
