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A Phase1 trial was completed to evaluate the safety and efficacy of DNX-2401 in pediatric patients with Diffuse Intrinsic Pontine Glioma (DIPG). Patients who are less than 18 years old with newly diagnosed DIPG were eligible.
DNX-2401 has been granted Fast Track and Orphan designation by the FDA, Orphan and PRIME designation by the EMA, and Promising Innovative Medicine designation by the MHRA.
A Phase 1 trial was completed evaluating DNX-2401 as a monotherapy treatment for adults with recurrent glioblastoma (GBM). The full results of this study are published here [Lang 2018].
The Phase 2 CAPTIVE trial was conducted in collaboration with Merck to evaluate the efficacy and safety of DNX-2401 in combination with pembrolizumab (KEYTRUDA), Merck’s anti-PD-1 therapy. Adult subjects diagnosed with GBM or gliosarcoma who experienced disease progression after initial treatment were eligible.
The full results of this study are published here [Nassiri 2023].
DNX-2401 has been granted Fast Track and Orphan designation by the FDA, Orphan and PRIME designation by the EMA, and Promising Innovative Medicine designation by the MHRA.