Immunovaccine Signs Agreement for Phase I/II Clinical Trial of DPX-0907 in Breast and Ovarian Cancer Patients
First Clinical Trial in Europe with DepoVax-based Cancer Vaccine
Halifax, Nova Scotia; January 30, 2013 – Immunovaccine Inc. (TSX-V: IMV), a clinical stage vaccine company, today announced the signing of an Investigator-Initiated Study Agreement for the ongoing evaluation of its DPX-0907 cancer vaccine at the Busto Arsizio Hospital in Italy. Marco Bregni, M.D., head of the Oncology Unit of the Hospital of Busto Arsizio, will serve as the principle investigator for the Phase I/II DPX-0907 clinical trial in patients with breast and ovarian cancer. Immunovaccine expects the Phase I/II study to be initiated during the fourth quarter of 2013.
DPX-0907, which incorporates Immunovaccine's DepoVax™ adjuvanting technology, is a unique multi-targeted therapeutic vaccine designed to train the immune system to recognize and attack cancer cells. A completed Phase I trial of the vaccine therapy in breast, ovarian and prostate cancer patients showed DPX-0907 to be safe and well-tolerated while generating specific polyfunctional T cell responses and triggering increases in antigen targeted CD8 T cells. These positive results were published in the peer-reviewed Journal of Translational Medicine in August 2012.
"We are excited to have the opportunity to continue the clinical evaluation of DPX-0907 and build on results from previous clinical research that showed this unique immunotherapy is capable of generating polyfunctional T cell responses in multiple tumor types," stated Dr. Bregni. "With this new study, we are eager to examine the possibility of utilizing specific T cell responses generated by DPX-0907 in an adoptive immunotherapy setting, and assess the potential of vaccine combined with lymphoablative therapy and T cell reinfusion in inducing immune response in patients with different tumor types."
"The promising results achieved to date with our DPX-0907 program, particularly those related to safety and immune response, have positioned us to confidently advance this program to the next phase of clinical development," said John Trizzino, chief executive officer of Immunovaccine. "We are pleased to be collaborating with Dr. Bregni and the team at Busto Arsizio Hospital on this important study and look forward to generating additional data that will inform our continued work with this exciting cancer vaccine program."
DPX-0907 combines seven tumor associated antigens (TAAs) with Immunovaccine's novel DepoVax adjuvanting delivery platform, allowing for the creation of a depot effect upon vaccination that presents the antigens and adjuvant to the immune system for a prolonged period of time. Treatment with DPX-0907 is designed to train the body's T cells, sophisticated white blood cells that play a key role in fighting cancer, to recognize the antigens incorporated into the vaccine. In doing so, the T cells become programmed to specifically target and attack cancer cells, while leaving normal healthy cells unharmed. By incorporating multiple target antigens, DPX-0907 attempts to attack cancer cells through multiple avenues and potentially minimize the cancer cells' demonstrated ability to edit and escape the impact of individual antigens.
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the capability for single-dose effectiveness. The DepoVax platform possesses impressive flexibility, allowing it to work with a broad range of target antigens in various therapeutic applications. The technology is also commercially scalable, with potential for years of stability and ease of use in the clinic.
Immunovaccine Inc. applies its novel adjuvanting platform to the development of vaccines for cancer therapy, infectious diseases and animal health. The Company's DepoVax™ platform is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system. Immunovaccine has advanced two DepoVax-based cancer vaccines into Phase I human clinical trials. The Company is also advancing a broad infectious disease pipeline including vaccines in such indications as malaria, respiratory syncytial virus (RSV) and anthrax. In addition to the Company's human health vaccine strategy, it continues to capture value from animal health vaccine applications. Immunovaccine has key partnerships in the animal health sector including an agreement with Pfizer Animal Health. Connect at www.imvaccine.com.
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release.
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