All Patients Treated to Date with Vaccine Therapy Produced Targeted, Dose-Related Immune Responses
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Halifax, Nova Scotia; October 9, 2012 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX-V: IMV), a clinical stage vaccine company, today announced positive interim results from the Company’s Phase I clinical trial of DPX-Survivac, an ovarian cancer vaccine candidate. The ongoing Phase I study is evaluating the potency, safety and tolerability of DPX-Survivac alone or in combination with low dose oral cyclophosphamide. Interim results showed that, to date, all nine patients receiving DPX-Survivac in combination with cyclophosphamide produced a targeted immune response following only one or two vaccine administrations. Patients receiving a higher dose (0.5 mL) of DPX-Survivac in combination with cyclophosphamide (n=3) produced immune responses after only one vaccination and generally exhibited higher antigen specific immunity than those receiving the combination with a lower (0.1 mL) DPX-Survivac dose (n=6), suggesting dose-related activity. Importantly, patients in the two cohorts experienced consistent immune responses that were detected at two consecutive time points. Specifically, the first three patients enrolled in the 0.5 mL dose cohort in combination with low dose cyclophosphamide demonstrated an average stimulation factor of 350 times (350x) following the second vaccination, and in one patient greater than 850 times (850x), over baseline responses.
Additional results from the interim analysis showed that patients receiving DPX-Survivac without cyclophosphamide were capable of producing antigen specific immune responses. The interim analysis also showed the vaccine to be safe and well tolerated with no systemic side-effects or dose limiting toxicities reported to date. Adverse events were limited to expected local reactions at the site of vaccination. Final results from the study, including a more extensive safety and immunogenicity analysis of all cohorts, are expected by the end of the year.
“These interim results provide important support for the ongoing DPX-Survivac development program as they clearly demonstrate that the vaccine can activate the desired immunity in our target patient population,” said Marc Mansour, chief science officer of Immunovaccine. “This offers further support of the fundamental advantages and potential of our DepoVax platform as a powerful vaccine adjuvanting technology.”
The ongoing Phase I DPX-Survivac trial is a multi-center, open-label, dose-ranging study in previously diagnosed ovarian cancer patients who have been treated by surgery and chemotherapy. Under the study protocol, these patients each receive a total of three DPX-Survivac vaccinations three weeks apart. A lead-in cohort of three patients received DPX-Survivac alone. Two additional cohorts of six patients each received a low dose or a high dose of vaccine concurrent with a low dose of oral cyclophosphamide. The trial’s primary objective is to evaluate the safety of the vaccine with and without the presence of metronomic cyclophosphamide as an immune modulator. A secondary endpoint is the evaluation of the immune response produced by the vaccine therapy.
Immunovaccine has already received clearance from U.S. FDA and Health Canada for the initiation of a Phase II trial of DPX-Survivac immediately following the completion of the ongoing Phase I study. The Phase II trial will be a randomized, double-blinded, placebo-controlled study with a single vaccine dose selected based on the Phase I results. The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively and specifically search for and destroy tumor cells. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.
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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Dr. Marc Mansour, Chief Science Officer, Immunovaccine, Inc.
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Tim Brons, Vida Communication (media)
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Stephanie Diaz, Vida Communication (investors)
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