DNAtrix announced the intratumoral delivery of DNX-2401 to the first pediatric patient in a Phase 1 study for diffuse intrinsic pontine glioma (DIPG).

DIPG is a highly aggressive, infiltrative tumor of the brainstem that typically affects children aged 4-11 years. There is no effective treatment, and due to the anatomical location of the tumor, surgical resection is often not possible.

The open-label, dose-escalating study is evaluating the safety and efficacy of single dose DNX-2401 for pediatric patients with newly diagnosed DIPG at the Clínica Universidad de Navarra in Pamplona, Spain.

DNX-2401, a potent oncolytic adenovirus, induces tumor-specific cell killing and initiates an antitumor immune response to cancer cells, while leaving normal cells intact. Clinical studies of a single dose of DNX-2401 in adults with recurrent glioblastoma have demonstrated prolonged survival while maintaining a favorable safety profile compared to approved therapies.

"There is a critical need for innovative therapeutic strategies to treat DIPG," said Joanna Peterkin, MD, MS, Chief Medical Officer of DNAtrix. "Our mission is to develop breakthrough treatments for children and adults with life-threatening brain tumors that result in better outcomes for patients and their families."

DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer. DNX-2401 sets 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 process then triggers an immune response directed against the tumor. DNX-2401 has been well tolerated in patients with recurrent glioblastoma and survival has been prolonged compared to other therapies.