Oncolytic virus cancer therapeutics(DNAtrix, Inc.)

HOUSTON, March 4, 2021 /PRNewswire/ --DNAtrix, Inc. a biotech company advancing virus-driven immunotherapies for cancer, today announced the treatment of the first patient in a Phase 1 dose-escalation and dose-expansion study of DNX-2440, an OX40 ligand encoding oncolytic adenovirus, in patients with resectable liver metastasis. Expression of OX40 ligand on the surface of tumor cells is expected to enhance anti-tumor immune responses by providing costimulatory signals to T cells within the tumor microenvironment. "We are excited to clinically explore the potential of one of our immunotherapy drug candidates, which is based on our proprietary adenovirus platform technology, in additional cancer indications," said Jeffrey Knapp, chief executive officer of DNAtrix. "Our preclinical work with DNX-2440 has demonstrated that infection of human tumor cell lines with this agent leads to viral replication, high level expression of OX40 ligand on tumor cells and effective tumor cell killing. Mouse tumor models showed specific anti-tumor immune memory, abscopal effect, and improved survival. This two-part clinical study is designed to directly demonstrate the activity of DNX-2440 and potential as therapy for colorectal cancer, as well as data with other tumor types where liver metastases occur." The Phase 1 clinical trial of DNX-2440 will be conducted in 24-30 patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have liver resection with curative-intent. Patients will receive two sequential (2 weeks apart) intra-tumoral injections of DNX-2440 into a liver metastasis prior to surgery for liver resection to evaluate safety and biological endpoints. The first part of the Phase 1 study is a dose-escalation phase evaluating three different dose levels of DNX-2440 in 12-18 patients with liver metastasis from tumors of various origins. Following the completion of dose-escalation, the selected dose will be further evaluated in an expansion phase where DNX-2440 will be administered using the same schedule to 12 patients with colorectal cancer liver metastasis. The primary endpoint of the study is to establish safety and identify a maximum tolerated dose. Secondary endpoints include evaluating tumor cell killing of injected and uninjected tumors, determining viral replication in the injected tumor and measuring local and systemic anti-tumor immune responses. Daniel A. Anaya, M.D., FACS, head of the Hepatobiliary Group and chief of the Division of GI Surgery in the Department of Gastrointestinal Oncology at the Moffitt Cancer Center, and principal investigator of the study, added, "DNX-2440 is an innovative therapy that has shown promising preclinical results, including durable tumor responses. As a leading cancer center, we are committed to providing cutting-edge treatment approaches in our fight against cancer and are pleased to launch this collaborative clinical study." About DNX-2440 DNX-2440 is an oncolytic adenovirus expressing the immune modulator OX40 ligand, a powerful costimulatory molecule known to enhance T cell responses directed to tumors. DNX-2440 is in Phase 1 clinical testing following the demonstration of anti-cancer activity in preclinical studies, including tumor reductions, immune memory, and abscopal effect. About DNAtrix DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at . Investor and Media Contacts: Sylvia Wheeler Wheelhouse Life Science Advisors swheeler@wheelhouselsa.com Alexandra Santos Wheelhouse Life Science Advisors asantos@wheelhouselsa.com

HOUSTON, Feb. 11, 2021 /PRNewswire/ -- DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, today announced preclinical data evaluating the use of DNX-2401 against the pediatric brain malignancies atypical teratoid/rhabdoid tumor (AT/RT) and primitive neuroectodermal tumors (PNETs) was published in Clinical Cancer Research. 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." The administration of DNX-2401 resulted in extended overall survival in early and advanced PNET and AT/RT mouse models, including models of disseminated disease. Importantly, DNX-2401 also generated a proinflammatory environment at tumor sites by boosting anti-tumor immune responses and inducing the secretion of damage-associated molecular patterns (DAMPs) into the extracellular medium by infected tumor cells. Marta Alonso, Ph.D., associate professor at the Clinic University of Navarra-CIMA in Pamplona, Spain, added, "AT/RTs and CNS-PNETs are aggressive pediatric brain tumors that are associated with poor survival and have few therapeutic options. Based on promising clinical data of DNX-2401 in adult glioblastoma and pediatric diffuse intrinsic pontine glioma (DIPG), we evaluated its activity in AT/RT and CNS-PNET. These preclinical data demonstrate in vivo efficacy of DNX-2401 in established models that recapitulate important features of these tumors, including models for disseminated AT/RT lesions and in immunocompetent humanized mice. These data underscore the therapeutic potential of DNX-2401 and provide a strong foundation for translation to the clinical setting for these indications." 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 and Orphan designation by the FDA and PRIME and Orphan designation by the EMA. About DNAtrix DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at . Investor and Media Contacts: Sylvia Wheeler Wheelhouse Life Science Advisors swheeler@wheelhouselsa.com Alexandra Santos Wheelhouse Life Science Advisors asantos@wheelhouselsa.com