On November 22, 2021 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported that data from the Phase 1 study of DNX-2401 in diffuse intrinsic pontine glioma (DIPG) was presented in an oral presentation at the 26th Annual Meeting and Education Day of the Society for Neuro-oncology (SNO), which was held from November 18-21, 2021 in Boston, MA (Press release, DNAtrix, NOV 22, 2021, View Source [SID1234595934]). DNX-2401 is an adenovirus-based immunotherapy that is engineered to selectively kill tumor cells and trigger a robust anti-tumor immune response. It has received FDA Fast Track and Rare Pediatric Disease designations for DIPG.
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"DIPG is a rapidly progressing tumor with the worst prognosis of any pediatric cancer," said Jeffrey Knapp, chief executive officer of DNAtrix. "Patients receiving conventional radiation therapy typically have a median overall survival of between eight and eleven months, with less than ten percent of the patients reaching the two-year survival mark. The preliminary overall survival data from the DNX-2401 Phase 1 study show a median survival of close to 18 months, with three patients still in follow-up. This is a significant and remarkable impact on overall survival in this difficult-to-treat tumor type, and we look forward to completing the study."
The Phase 1 study evaluated DNX-2401 followed by conventional radiation therapy in 12 newly diagnosed DIPG patients. Tumor reductions were reported for 9 patients (75%), including 3 confirmed (25%) responses per RAPNO criteria. As of the data cutoff, median overall survival was 17.8 months with follow-up ongoing for three patients. No dose-limiting toxicities were observed, and the treatment regimen was well-tolerated.
Oral Presentation Details:
Title:
Safety, efficacy, and survival results from a Phase 1 study of the oncolytic adenovirus DNX-2401 followed by standard of care radiotherapy for newly diagnosed diffuse intrinsic pontine glioma (DIPG)
Abstract Number:
CTIM-08
Presenter:
Jaime Gallego Perez-Larraya, M.D.
Date/Time:
November 21, 2021 at 12:00PM EST
About DNX-2401
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and directly kill cancer cells, as well as elicit a broader anti-tumor immune response. DNX-2401 is currently being evaluated as a potential treatment for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children. Clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 has been granted Fast Track for recurrent glioblastoma and Orphan designation by the FDA and PRIME and Orphan designation by the EMA for high grade glioma, as well as Fast Track and Rare Pediatric Disease designations by the FDA for DIPG.
About DIPG
Diffuse intrinsic pontine glioma (DIPG), also known as diffuse midline glioma, is a rare and highly aggressive infiltrative tumor of the brainstem with the worst prognosis of any pediatric cancer. No effective treatments are available and novel treatment approaches are needed.