Candel Therapeutics, Inc. (Nasdaq: CADL) announced its financial results for the third quarter of 2024, alongside key updates on its clinical programs. The company is on track to release topline data from its Phase 2b and Phase 3 trials of CAN-2409 for localized prostate cancer in the fourth quarter of 2024. Additionally, Candel highlighted promising clinical data for CAN-3110 in recurrent high-grade glioma and preclinical data supporting its potential in melanoma.
Financial Overview
For Q3 2024, Candel reported a net loss of $10.6 million, compared to $8.4 million in Q3 2023. Research and development expenses decreased slightly to $5.4 million from $5.8 million year-over-year, while general and administrative expenses increased to $3.3 million from $3.0 million. As of September 30, 2024, the company’s cash and cash equivalents totaled $16.6 million, expected to fund operations through the first quarter of 2025.
CAN-2409 in Prostate Cancer
Candel's focus remains on the development of CAN-2409, with topline data expected in Q4 2024 from a Phase 3 trial in intermediate/high-risk localized prostate cancer and a Phase 2b trial in low/intermediate-risk localized prostate cancer. Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, expressed hope that the data and subsequent regulatory approvals could "enable a paradigm shift" in how these patients are treated.
CAN-3110 in Recurrent High-Grade Glioma
Significant clinical data was presented for CAN-3110 in recurrent high-grade glioma, with investigators reporting improved survival compared to historical controls. Specifically, 3 out of 6 patients in the Phase 1b trial remained alive more than one year after the initiation of experimental treatment, with survival times of 12.2, 13.0, and 18.7 months, respectively. The data also suggested radiologic pseudo-progression, with biopsies showing a near absence of tumor cells and dense lymphocyte infiltrates following CAN-3110 administration.
In November 2024, the FDA granted orphan drug designation to CAN-3110 for the treatment of recurrent high-grade glioma.
CAN-3110 Expansion into Melanoma
Preclinical results presented at the Society for Immunotherapy of Cancer’s 39th Annual Meeting highlighted the therapeutic potential of CAN-3110 in melanoma. In vivo mouse studies demonstrated dose-dependent inhibition of tumor growth, with regression observed in a subset (3 of 8) of tumors treated with a high dose of CAN-3110. Cytotoxic activity in melanoma-bearing mice was associated with systemic immune activation, including increased activation and proliferation of circulating T cells.
enLIGHTEN™ Discovery Platform
Candel continues to leverage its enLIGHTEN™ Discovery Platform to identify new viral immunotherapies for solid tumors. The latest asset from this platform, a multimodal viral therapeutic candidate encoding IL-12 and IL-15, has shown the ability to induce expansion and activation of natural killer and CD8+ T cell populations, resulting in significant tumor growth inhibition and regression in preclinical models.
Anticipated Milestones
Candel anticipates topline data from the Phase 2b trial of CAN-2409 in low-to-intermediate-risk prostate cancer and the Phase 3 trial in intermediate/high-risk prostate cancer in Q4 2024. Updated overall survival data from ongoing CAN-2409 Phase 2 trials in NSCLC and pancreatic cancer are expected in Q1 2025.
