Gradalis

Gradalis is a private, late-stage biotech advancing Vigil, a personalized cancer immunotherapy platform. Its lead program has demonstrated a significant survival benefit in a subset of ovarian cancer patients in a Phase 2b trial, with data published in a peer-reviewed journal. The company is positioning Vigil as a potential treatment for various solid tumors, either as a monotherapy or in combination with other regimens, representing a targeted approach in the immuno-oncology space.

Vigil platform: a fully personalized immunotherapy created from a patient's resected tumor tissue. It uses bi-shRNAi to knockdown TGFβ1/β2 and expresses GM-CSF to stimulate an immune response against patient-specific tumor neoantigens.

Gradalis competes in the personalized cancer vaccine space against large mRNA players (BioNTech, Moderna) and other biotechs, and more broadly against all immuno-oncology therapies. Its whole-cell, TGFβ-knockdown approach is a key differentiator, but it must prove superior efficacy or a better cost-to-benefit profile.