DNAtrix Announces Oral Presentation of Positive Overall Survival Data with DNX-2401 in DIPG at the Society for Neuro-oncology (SNO) Annual Meeting
SAN DIEGO, Nov. 22, 2021 /PRNewswire/ — DNAtrix, a biotech company promoting virus-mediated immunotherapies for cancer, announced today that data from the phase 1 study of DNX-2401 in diffuse intrinsic pontine glioma (DIPG) was presented in an oral presentation at the Society for Neuro-oncology (SNO) 26th Annual Meeting and Education Day, held Nov. 18-21, 2021 in Boston, MA. DNX-2401 is an adenovirus-based immunotherapy designed to selectively kill tumor cells and elicit a robust anti-tumor immune response. It has received FDA Fast Track and Rare Pediatric Disease designations for DIPG.
“DIPG is a rapidly progressing tumor with the worst prognosis of childhood cancer,” said Jeffrey Knapp, DNAtrix chief executive officer. “Patients receiving conventional radiation therapy typically have a median overall survival of between eight and 11 months, with less than ten percent of patients achieving two-year survival. Preliminary overall survival data from the DNX-2401 Phase 1 study shows a median survival of almost 18 months, with three more patients in follow-up. This is a significant and remarkable impact on the overall survival of 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 by RAPNO criteria. As of the data cut-off, the 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:
Safety, Efficacy, and Survival Results of a Phase 1 Study of Oncolytic Adenovirus DNX-2401 Followed by Standard Radiotherapy for Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Jaime Gallego Perez-Larraya, MD
November 21, 2021 at 12:00 PM EST
DNX-2401 is an oncolytic adenovirus specifically designed to infect, replicate and directly kill cancer cells, as well as elicit a broader immune response against tumors. 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 demonstrated that DNX-2401 was well tolerated and prolonged survival in patients with recurrent glioblastoma. DNX-2401 has received Fast Track for recurrent glioblastoma and FDA orphan designation and PRIME and EMA orphan designation for high-grade glioma, as well as FDA Fast Track and Rare Pediatric Disease designation for 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 childhood cancer. There are no effective treatments available and new treatment methods are needed.
DNAtrix is a privately held biotech company developing virus-mediated immunotherapies for the treatment of cancer. The proprietary adenovirus platform is based on an engineered version of the common cold virus designed to selectively infect and kill cancer cells, while leaving healthy cells unharmed. The company’s lead product candidate is DNX-2401, which will participate in a global pivotal Phase 3 clinical trial for patients with relapsed glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study in diffuse intrinsic pontine glioma, for which the FDA has received Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical trials in patients with colorectal and other cancers with liver metastases. The company’s investors include Morningside Ventures and Mercury Fund. For more information, visit the company’s website at www.DNAtrix.com.
Investors and media contacts:
Wheelhouse Life Science Advisors
Wheelhouse Life Science Advisors
SOURCE DNAtrix, Inc.