Halifax, Nova Scotia; June 4, 2012 – Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX-V: IMV), a clinical stage vaccine company, today announced positive results from a Phase I clinical trial highlighting targeted multi-functional immunotherapeutic responses induced by the Company's DPX-0907 vaccine in a poster presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO). Data indicated that 61 percent (11/18) of the study's evaluable cancer patients, and more specifically in 89% (8/9) of evaluable study patients with breast or ovarian cancer, experienced the desired targeted T cell responses against one or more of the seven key cancer-specific antigens contained in DPX-0907.
T cells are sophisticated white blood cells that play a critical role in the body's fight against cancer. They can recognize cancer cells with high specificity and actively infiltrate tumors. Importantly, T cells can have immunological memory with the potential to provide durable anti-cancer responses. Immunotherapies aim to activate these T cells with the intent to induce durable clinical responses in cancer patients.
The presented findings demonstrated that the antigen specific T cells triggered by DPX-0907 treatment often secreted multiple type 1 cytokines, suggesting the T cells possess the multifunctional activity that is believed to be important in controlling cancer. As previously reported, the study met the primary objective of safety with overall results demonstrating that DPX-0907 is generally well tolerated by all patients and is considered safe at both dose levels with no vaccine related serious adverse effects reported.
DPX-0907, a targeted therapeutic vaccine designed to train the immune system to recognize and attack cancer cells, combines seven tumor associated antigens (TAAs) with Immunovaccine's novel DepoVax™ adjuvanting delivery platform. T cells that have been trained to recognize the antigens are expected to specifically target cancer cells, leaving normal healthy cells unharmed. DPX-0907 leverages the DepoVax platform to create a depot effect upon vaccination that presents the antigens and adjuvant to the immune system for a prolonged period of time.
Immunovaccine's poster presentation (abstract #2588) included additional encouraging data on the trial's observed immune responses in advanced stage ovarian, breast and prostate cancer patients. Study results indicated that DPX-0907 possesses favorable immune induction potential as 73 percent of immune responders generated a response following the first vaccination. Further, in 83 percent of responders, the responses were detected at ≥ two time points following vaccination and 64 percent maintained a persistent response at one month following a third vaccination. To view poster click here.
The open-label, dose-escalating Phase I trial was conducted at five centers in the U.S. with patients receiving three injections (0.25 mL or 1 mL doses) of the active immune therapy DPX-0907, three weeks apart. Safety was assessed in eleven patients in the 0.25 mL dose group and eleven patients in the 1 mL dose group. The immunogenicity results were based on an analysis of nine evaluable patients in the 0.25 mL dose group and nine evaluable patients in the 1 mL dose group.
"The ability to train the immune system to generate specific multi-functional T cells is a key milestone for the DPX-0907 clinical program," said Marc Mansour, Ph.D., Immunovaccine's chief science officer. "Also encouraging is the fact that these results were achieved across multiple cancer types, suggesting broad potential applications for this targeted immunotherapeutic."
Immunovaccine Inc. applies its novel vaccine delivery platform to the development of vaccines for cancer therapy and infectious diseases. The company's DepoVax™ platform is a patented lipid delivery system that presents antigens plus adjuvant to the immune system for a prolonged period and has the potential to enhance immune responses. Immunovaccine has advanced its platform technology and proprietary cancer vaccine into Phase I human clinical trials and has demonstrated both safety and immunogenicity potential. The Company is also capitalizing on the broad potential of its delivery platform by creating new DepoVax-based vaccines through multiple development collaborations. In addition to the Company's human health vaccine strategy, it continues to capture value from animal health vaccine applications. Immunovaccine has several key partnerships in the animal health sector including an agreement with Pfizer Animal Health, which has licensed the Company's delivery technology platform to develop vaccines for livestock. 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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