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Vaccine Demonstrated Tolerable Safety Profile, Induced Measurable Immunogenic Response in 100 Percent of Study Participants in Higher Dose Cohort
Trial Provides Immunovaccine’s First Clinical Immunogenicity Demonstration in Infectious Disease Applications
Halifax, Nova Scotia; July 6, 2016 – Immunovaccine Inc. (“Immunovaccine” or the “company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that a team of investigators has completed an interim analysis of the safety and immunogenicity of its DepoVax™ prophylactic respiratory syncytial virus (RSV) vaccine candidate (DPX-RSV) in a Phase 1 clinical trial in healthy older adult volunteers. The safety analysis indicates that the DPX-RSV was well tolerated among all study participants, with no serious adverse events (SAEs) recorded. Furthermore, immunogenicity data supported DPX-RSV’s ability to generate a relevant immune response; the vaccine candidate obtained antigen-specific antibody responses in 75 percent of subjects vaccinated with the lower dose, and 100 percent of those vaccinated with the higher dose.
“Having the interim DPX-RSV data in hand marks a critical milestone for Immunovaccine. It represents our first clinical demonstration, outside of cancer trials, of the ability of DepoVax™-based vaccines to generate relevant immune responses in humans,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Deploying DepoVax™ in key areas of infectious disease remains a cornerstone of our strategy. We are encouraged by this data and look forward to continuing to explore the ways in which DepoVax™ can positively impact treatment developments in areas of unmet medical need in infectious diseases, including RSV.”
Principal Investigator Joanne Langley, BA, MD MSc FRCPC, led the study, which was conducted at the Canadian Center for Vaccinology (CCfV) 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 84.
Immunovaccine’s vaccine delivery approach focuses on targeting the ectodomain of the SH protein of RSV. Ectodomains are the parts of the protein exposed on the surface of the cell or virus. Prior preclinical research related to this study conducted by VIB and Ghent University scientists showed that the SH ectodomain was protective in animal models1.
Targeting the SH antigen is a significant differentiator from other RSV vaccine programs for two reasons:
- Typical RSV vaccine efforts are focused on targeting the F and G proteins of the virus. However, people can remain susceptible to RSV infection even when they exhibit high levels of antibodies that target the F and G antigens.2
- During RSV infection, infected cells are shed into the respiratory tract. If not cleared by the immune system, this process can cause airway obstruction and complications that linger post-infection. Immune responses targeting SH antigen were able to recognize the target protein on the virally infected cells, and were functional in activating immune mechanisms that may act to clear infected cells from the airways.
“We are pleased that the interim data from this study indicates that DPX-RSV is generally well-tolerated, and induces a robust immune response,” said Dr. Langley. “To the best of our knowledge, this is the first clinical-phase demonstration of a vaccine targeting the SH antigen and we believe that this analysis provides the rationale to continue clinical testing DPX-RSV in future human trials.”
“It is very rewarding to see that the basic research findings for an RSV vaccine candidate that was developed in my group at VIB and Ghent University contributed to this first-in-man study,” said Dr. Saelens, group leader at VIB and Ghent University (Ghent Belgium). “SH ectodomain-specific antibody responses can clearly be induced in humans by DPX-RSV and our results suggest that these antibodies can exert an anti-RSV effect.”
“This is a validating study for Immunovaccine,” stated Marianne Stanford, PhD, Director of Research at Immunovaccine. “It indicates that our first infectious disease vaccine candidate, DPX-RSV, exhibits unique features that both address unmet medical need related to the RSV virus, and also overcomes limitations of other vaccine candidates in development. This creates a potential benefit for future patients as well as a competitive advantage that will drive value to our investors.”
Immunovaccine has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV.
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”). Generated by 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.
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. develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented formulation 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 2 study with its lead cancer vaccine therapy, DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to enter additional Phase 2 clinical studies in ovarian cancer and glioblastoma (brain cancer). In collaboration with commercial and academic partners, Immunovaccine is also expanding the application of DepoVax™ as an adjuvanting platform for vaccines targeted against infectious diseases. Immunovaccine’s goal in infectious diseases is to out-license its DepoVax™ platform to partners to generate earlier revenues. 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 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 except as required by law.
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1Schepens B, Sedeyn K, Vande Ginste L, De Baets S, Schotsaert M, Roose K, Houspie L, Van Ranst M, Gilbert B, van Rooijen N, Fiers W, Piedra P, Saelens X. 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. 2014 Oct 8;6(11):1436-54.2Schepens, Bert, Michael Schotsaert, and Xavier Saelens. “Small Hydrophobic Protein of Respiratory Syncytial Virus as a Novel Vaccine Antigen.” Immunotherapy 7.3 (2015): 203-06. DOI: 10.2217/IMT.15.11