DNAtrix will report data from an ongoing Phase 1 trial of DNX-2401 in pediatric patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPG), which indicated efficacy through a prolonged survival rate.
Today in a press release, DNAtrix reported that data from an ongoing Phase 1 trial of DNX-2401 in pediatric patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPG) will be presented at the Biennial Congress of the European Society for Pediatric Neurosurgery in Bonn, Germany on May 6-9, 2018.
Results from the study will be revealed in an oral presentation by the lead author, Sonia Tejada, MD, PhD, neurosurgeon and investigator at Clínica Universidad de Navarra.
“The results of this trial will be a big step toward new treatments for this incurable disease,” said Dr Tejada. “All the children treated so far have tolerated the virus infusion perfectly well, which indicates that DNX-2401 could be a viable therapy for DIPG.”
DIPG is a highly aggressive and rare infiltrative tumor of the brainstem; it has the worst prognosis of any pediatric cancer. As of this writing, there are not any approved therapies available, and novel treatment approaches are needed.
DNX-2401 is an investigational oncolytic immunotherapy engineered to treat cancer by setting off a chain reaction of tumor cell killing by selectively replicating within cancer cells (but not normal cells), causing tumor destruction and further spread of the oncolytic virus to adjacent tumor cells. This action then triggers an immune response directed against the tumor. In patients with glioblastoma, DNX-2401 has been well tolerated and prolonged survival rate compared to other therapies.
Preliminary findings of the Phase 1, single-center, uncontrolled trial show that DNX-2401 can be safely injected during a biopsy procedure with minimal side effects. Additionally, later in the trial, a tumor biopsy will be performed through the cerebellar peduncle after which DNX-2401 will be immediately injected. Radiotherapy and chemotherapy will also follow in 2 to 6 weeks.
The main objective of the trial is to evaluate the safety, tolerability, and toxicity of an injected oncolytic adenovirus (DNX-2401) into the cerebellar peduncle in pediatric patients with DIPG as well as to collect tumor samples of this type of tumor.
According to preliminary findings, DNX-2401 has demonstrated that it can be safely injected during a biopsy procedure with minimal side effects. Evidence for clinical activity has been observed and will be reported. In pediatric patients, this is the first use of the oncolytic virus DNX-2401.
"Effective therapies for children with DIPG are urgently needed," said Frank Tufaro, PhD, CEO of DNAtrix. "The DNAtrix virus has been shown to trigger anti-tumor immune response in adult patients with glioblastoma. We are encouraged by these early results."
The data will be presented on May 9th.