Valerio Therapeutics S.A. announced the completion of dosing for the first cohort of subjects in its Phase 1/2 trial of lead candidate, VIO-01, a pan-DDR decoy for the treatment of solid tumors. VIO-01 is the next-generation DNA decoy generated from Valerio Therapeutics' proprietary PlatON platform. An optimized product with modifications for increased half-life, plasma stability and tumor targeting, VIO-01 is a potent pan-DDR trapper capable of abrogating multiple DNA damage pathways including homologous recombination and non-homologous end joining.

The pan trapping nature of VIO-01 allows for treatment of a wide range of potential solid tumor indications rather than restrictions to BRCA1/2 mutations or HRD positivity as with other DNA damage inhibitors. The VIO-01-101 Phase 1b portion of the trial aims to determine to recommended phase 2 dose and/or pharmacologically active dose in patients with selected solid tumors including, HRD+ Ovarian cancer, BRCA1/2 mutant Breast Cancer, HRR mutated prostate cancer, and solid tumors with HRR mutations. The dose escalation to clinically relevant exposures and safety expansion is expected to continue through 2024.