“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.”

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“We are thrilled to welcome Dave to the executive leadership team at DNAtrix,” said Jeffrey Knapp, chief executive officer of DNAtrix. “Dave has expertise in developing products that elicit immune responses against targets of interest through various therapeutic modalities, including viral-based vaccines. His deep experience leading oncology drug development programs for innovative, young, as well as established biopharmaceutical companies ­­– such as Amgen — will prove invaluable as we advance our pipeline with multiple product candidates being studied in several tumor types and two programs in pivotal stage development.”

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The data demonstrate that the oncolytic immunotherapy, DNX-2401 (tasadenoturev; Delta-24-RGD), induces a potent anti-tumor immune response, hinders the development of disseminated disease, and leads to longer survival in these difficult-to-treat tumors. 

“These preclinical data for DNX-2401 show encouraging signals of anti-tumor activity against devastating CNS cancers that we had not previously studied,” said Jeffrey Knapp, chief executive officer of DNAtrix. “We now have preclinical and clinical data of DNX-2401’s efficacy across a range of difficult-to-treat adult and pediatric tumors, thus further establishing the activity of this potent immunotherapy. We look forward to the continued advancement of DNX-2401, as well as our pipeline of other oncolytic immunotherapies being developed for the treatment of solid tumors.”

A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.

DNX-2440 is engineered from DNAtrix’s highly potent oncolytic adenovirus, DNX-2401 (tasadenoturev), which has already demonstrated the ability to selectively kill tumor cells and trigger a powerful immune response directed against the tumor in several clinical studies. In addition to these mechanisms, DNX-2440 expresses OX40L, a critical costimulatory molecule known to enhance antitumor immune responses.

Learn more about DNAtrix’s Oncolytic Virus Expressing OX40 Ligand Treats First Patient in Recurrent Glioblastoma Clinical Trial.

Glioblastoma and gliosarcoma are the most common and aggressive forms of malignant brain tumor in adults and can be resistant to conventional therapies. The purpose of the CAPTIVE / KEYNOTE-192 study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered directly into the tumor followed by intravenous administration of the immune checkpoint inhibitor pembrolizumab.

Learn more about Interim Phase II Results of DNX-2401 + Pembrolizumab for Glioblastoma Shows Remarkable Results.