DNAtrix Announces First Patients Treated in Phase 2 Trial with DNX-2401 and KEYTRUDA
Houston, TX – November 1, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced that the first patients have been treated in a multicenter Phase 2 trial investigating its oncolytic adenovirus, DNX-2401, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent glioblastoma.
The CAPTIVE trial is evaluating the potential effect of DNX-2401 and KEYTRUDA in patients with recurrent glioblastoma, a disease for which there is neither a cure nor adequate treatment. Leading medical centers in the United States and Canada are participating.
DNX-2401 is a potent conditionally replicative oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response.
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. This activity enhances the T cell response and leads to effective tumor destruction. KEYTRUDA is currently approved in the United States for advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and advanced head and neck squamous cell cancer (HNSCC).
“Glioblastoma is a difficult disease to treat with conventional therapies,” said Frank Tufaro, Ph.D., Chief Executive Officer of DNAtrix. “Based on remarkable preclinical data, we anticipate that the addition of KEYTRUDA to DNX-2401 therapy will provide even more benefit to patients with recurrent disease.”
For more information about the CAPTIVE trial, visit the website ClinicalTrials.gov and search for the identifier NCT02798406.
DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer, with glioblastoma as the initial indication. Glioblastoma is the most aggressive form of brain cancer, which has a median survival of 15 months following a patient’s initial diagnosis. DNX-2401 sets off a chain reaction of tumor cell killing by selectively replicating within glioblastoma cells (but not normal cells), causing tumor destruction and further spread of the oncolytic virus to adjacent tumor cells. This process can also trigger an anti-tumor immune response. DNX-2401 is currently being investigated in several clinical studies and has been well tolerated in all settings. Compelling results from clinical studies in recurrent glioblastoma indicate that DNX-2401 can (1) replicate in human brain tumors for a period of weeks to months, (2) trigger immune cell infiltration into the tumor, (3) cause ongoing tumor destruction and (4) induce durable responses to therapy. In these studies, patient survival has been prolonged, including in those achieving a complete response.
DNAtrix is a privately held, clinical stage, biotechnology company developing virus-driven immunotherapies for cancer. DNAtrix’s lead product, DNX-2401, is a conditionally replicative oncolytic virus being studied in clinical trials for recurrent glioblastoma, a brain cancer for which there is neither a cure nor adequate treatment. The company is backed by Morningside Ventures and Mercury Fund, and has been awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit the company website at www.DNAtrix.com.
Imran Alibhai, Ph.D.
SVP Business Development