Immunovaccine Initiates Clinical Trial with DPX-RSV Vaccine
Halifax, Nova Scotia; June 30, 2015 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that it has enrolled the first healthy adult volunteer in a Phase 1 clinical study of its respiratory syncytial virus (RSV) vaccine.
The Phase 1 study will evaluate the safety and immune response profile of the DPX-RSV vaccine candidate in healthy adults. The study, conducted at the Canadian Center for Vaccinology (CCfV) in Halifax and led by Joanne Langley, M.D., will enroll 40 healthy adults who are 50 to 64 years of age. The vaccine will be tested at two different vaccine dose levels and study investigators will assess the vaccine’s safety and immune response profile following one or two immunizations of each dose level. Immunovaccine and the Canadian Institutes of Health Research (CIHR) are co-funding the trial.
“We are pleased to initiate this clinical trial in older adults, a largely underserved population for RSV,” said Dr. Langley. “By using a vaccine candidate formulated in DepoVax™, we are hoping to generate strong immune responses in older individuals.”
RSV is a respiratory virus that infects the lungs and breathing passages and most commonly affects the elderly, infants and patients with compromised immune systems. It can be severe in some patients and is the second most commonly identified cause of viral pneumonia in older persons, next to influenza. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths.
The Immunovaccine RSV vaccine candidate contains a unique target, a viral protein expressed on the surface of infected cells. Professor emeritus Walter Fiers and Xavier Saelens, Ph.D. at Ghent University discovered the target, which was exclusively in-licensed to Immunovaccine for use in DPX-RSV from VIB, a non-profit life science research institute based in Flanders, Belgium. It is believed that an immune response to this target will limit the severity of RSV infection in susceptible patient populations.
"We developed this novel human RSV vaccine candidate in our laboratory at Ghent University and VIB, and published those findings in an international scientific journal in 2014,” said Dr. Saelens. “We are very excited to see Immunovaccine engage in this clinical trial to further advance the vaccine."
“Currently, there is no vaccine available for the prevention of RSV, creating both a significant unmet medical need and a large vaccine market,” stated Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. “A novel and effective vaccine formulated in a strongly immunogenic platform like DepoVax™ offers great potential for success, and we look forward to the data that will be generated in this clinical trial.”
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.
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). The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV) and anthrax.
The Canadian Center for Vaccinology (CCfV) in Halifax, Nova Scotia, is an integrated collaborative interdisciplinary vaccine research team. The Center’s 20,000 sq. ft. facilities include laboratories for microbiological and molecular research, ambulatory clinical trial facilities, data analysis, and training. CCfV unites the biomedical and clinical sciences with the social sciences and humanities to span the research continuum from basic discovery, to translation into useful vaccines. www.centerforvaccinology.ca
VIB is a non-profit research institute in life sciences. About 1,400 scientists conduct strategic basic research on the molecular mechanisms that are responsible for the functioning of the human body, plants, and microorganisms. Through a close partnership with four Flemish universities − UGent, KU Leuven, University of Antwerp, and Vrije Universiteit Brussel − and a solid funding program, VIB unites the forces of 74 research groups in a single institute. The goal of the research is to extend the boundaries of our knowledge of life. Through its technology transfer activities, VIB translates research results into products for the benefit of consumers and patients and contributes to new economic activity. VIB develops and disseminates a wide range of scientifically substantiated information about all aspects of biotechnology. More information: www.vib.be.
About Ghent University
After more than twenty years of uninterrupted growth, Ghent University is now one of the most important institutions of higher education and research in the Low Countries. Ghent University yearly attracts over 35,000 students, with a foreign student population of over 2,200 EU and non-EU citizens. Ghent University offers a broad range of study programs in all academic and scientific fields. With a view to cooperation in research and community service, numerous research groups, centers and institutes have been founded over the years. For more information www.UGent.be.
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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.
Contacts for Immunovaccine:
Michael Beyer, Sam Brown Inc.
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Contacts for VIB/Ugent:
Xavier Saelens, PI VIB/UGent
T: +32 9 331 36 20 E: Xavier.Saelens@vib-Ugent.be