Immunovaccine Announces Positive Phase 1 Topline Data for DepoVax™-based Respiratory Syncytial Virus Vaccine Candidate
• The vaccine had a positive safety profile and was well tolerated with no serious adverse events among all study participants.
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.
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.
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1Schepens 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