HALIFAX, NOVA SCOTIA--(Marketwired - Oct. 13, 2016) - Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced positive topline results from its Phase 1 trial evaluating the safety and immunogenicity of DPX-RSV, its DepoVax™-based, small B cell epitope peptide vaccine candidate for respiratory syncytial virus (RSV). The results six months or more after vaccination confirmed earlier-reported interim data on the ability of DepoVax™- formulated antigens to generate a relevant, durable immune response. Specifically:
- The vaccine had a positive safety profile and was well tolerated with no serious adverse events among all study participants.
- Antigen-specific immune responses were detected at least six months after the last vaccination in 93 percent (15/16) of patients receiving DPX-RSV, in both low-dose (8/8 participants) and high-dose (7/8 participants) cohorts.
"Recent clinical developments in the field have highlighted the challenges that can arise due to the complex nature of RSV prevention. We believe that a truly novel approach is needed to achieve the desired outcomes," said Frederic Ors, Immunovaccine's Chief Executive Officer. "We are thrilled with these results, as they go beyond our initial expectations. We see an immune response that could be sustained for at least six months based on a small B cell epitope peptide. We believe that our differentiated approach, along with this topline data, position DPX-RSV to address a significant unmet medical need in the RSV market."
Principal Investigator Joanne Langley, BA, MD MSc FRCPC, led the study, which was conducted at the Canadian Center for Vaccinology (CCfV), based at Dalhousie University, the IWK Health Centre and the Nova Scotia Health Authority, and funded in an industry-academic collaboration by the Canadian Institutes of Health Research and Immunovaccine. The DPX-RSV trial included 40 healthy older adult volunteers and two dose cohorts, with 20 subjects in each cohort. Investigators analyzed the safety and immune response data of all participants up to study day 236.
Earlier this week, researchers from VIB and Ghent University presented a summary of previously announced findings at the World Vaccine Congress in Barcelona, which indicated that the antibodies generated after vaccination with DPX-RSV were functional and could trigger the mechanism of action for the proprietary Immunovaccine target-the exposed part of the RSV Small Hydrophobic (SH) protein.1 A link to the presentation can be found on the Immunovaccine website.
DPX-RSV is a prophylactic, small B cell epitope peptide targeting the SH antigen of RSV. Typical RSV vaccination approaches target the F and G antibodies associated with RSV. A level of F and G antibodies is already circulating in the general population, but it may not be adequate to provide protection against the complication of RSV infections-particularly among vulnerable populations that include the elderly and immuno-compromised.1 Complications that may result in prolonged illness and hospitalizations occur when infected cells are shed into the lower respiratory tract and are unable to be cleared by the immune system.
"Immunovaccine's approach is focused on the SH antigen-for which there is no or very limited pre-existing immunity in the general population-and on reducing complications and hospitalizations by targeting infected cells in the lungs," stated Marianne Stanford, PhD, Vice President, Research, at Immunovaccine. "To the best of our knowledge, no other company or institution working on RSV prevention has programs able to address RSV in this way. We believe that this data supports the rationale behind our strategy, and that the novel mechanisms of action of our DepoVax™-based antigen formulation may enable our vaccine candidate to mitigate hindrances seen in other RSV clinical programs."
Currently, there is no vaccine available for RSV. Immunovaccine has an exclusive worldwide license on applications that target the SH ectodomain antigen in RSV and is in discussions with multiple potential partners to identify the best possible path forward for the further clinical development of DPX-RSV. As previously announced, a complete summary of the data for this clinical trial will be presented later this month during IDWeek.
Respiratory syncytial virus ("RSV") is a common virus that infects the lungs and breathing passages. While it usually leads to mild, cold-like symptoms, it can be severe in the elderly, infants and patients with compromised immune systems. It is second only to influenza as the most commonly identified cause of viral pneumonia in older persons. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths. There is no vaccine currently available to prevent RSV.
DPX-RSV is Immunovaccine's vaccine candidate designed specifically to address the unmet medical needs in respiratory syncytial virus ("RSV"). Scientists from VIB and Ghent University (Belgium) demonstrated the protective potential of the ectodomain of the small hydrophobic (SH) protein of RSV as a vaccine antigen.1 Combined with the Company's proprietary DepoVax™-based platform, it is believed to be the first vaccine candidate in development that targets specifically the SH antigen, which may provide additional immunogenic benefit over traditional approaches for high risk populations, including infants and the elderly. In addition, the concentrated dosage enabled by the DepoVax™ delivery system may help mitigate injection site point-of-pain, which has been a limitation for other potential treatments. The Company recently released interim Phase 1 data for DPX-RSV, which indicated that the vaccine demonstrated a tolerable safety profile and robust immune response in healthy adult volunteers. Immunovaccine holds exclusive worldwide license on applications that target the SH ectodomain antigen in RSV from VIB and Ghent University.
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 potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability. Fully synthetic, off-the-shelf DepoVax™-based vaccines are also relatively easy to manufacture, store, and administer. This would enable Immunovaccine to pursue vaccine candidates in cancer, infectious diseases and other vaccine applications.
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company's DepoVax™ platform, a patented delivery agent that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1/1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as part of a triple combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline, including innovative vaccines for respiratory syncytial virus (RSV), and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
Immunovaccine Forward-Looking Statements
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 of the Company 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 results and 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 except as required by applicable law.
1 Schepens B et al., (2014) Protection and mechanism of action of a novel human Respiratory Syncytial Virus vaccine candidate based on the extracellular domain of Small Hydrophobic protein. EMBO Mol. Med., 6:1436-1454. DOI: DOI: 10.15252/emmm.201404005