First Clinical Study in Infectious Disease Indication with a DepoVax-Based Vaccine
Immunovaccine Inc. (“Immunovaccine” or “IMV” or “the company”) (TSX-V: IMV), a clinical stage vaccine and immunotherapy company, today announced today announced that it has received clearance from Health Canada to conduct a Phase I clinical study of its respiratory syncytial virus (RSV) vaccine in healthy adults.The RSV vaccine is formulated in Immunovaccine’s proprietary DepoVax™ adjuvanting platform and is initially being developed to protect the elderly population from infection. In preclinical studies, the DepoVax-based vaccine demonstrated the ability to protect animals against RSV, a potentially severe respiratory virus that predominantly affects the elderly and infants. Immunovaccine plans to initiate the Phase I trial in the first half of 2015, with initial data expected later this year.
The Phase I study, which will be the first clinical trial of a DepoVax-based vaccine in an infectious disease indication, will evaluate the safety and immune response profile of the RSV vaccine candidate in healthy adults. The study, conducted at the Canadian Center for Vaccinology in Halifax and led by Joanne Langley, M.D., will enroll 40 healthy adults 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. The trial is being co-funded by Immunovaccine and the Canadian Institutes of Health Research (CIHR).
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, with 160,000 deaths. Importantly, there is currently no vaccine available for the prevention of RSV and the World Health Organization (WHO) has designated RSV as a high-priority target for vaccine development.
“There is a significant need for an effective vaccine capable of offering protection to those individuals that are most at risk for contracting RSV. We are interested in evaluating this vaccine candidate based on the promising results that we have seen with Immunovaccine’s DepoVax platform and this vaccine candidate in particular,” said Dr. Langley.
“This trial is a significant milestone for Immunovaccine as it represents the first clinical use of DepoVax for the prevention of an infectious disease in healthy people. We expect the results from this study to demonstrate the clinical applicability of DepoVax that could be extended to other infectious disease applications,” stated Dr. Marc Mansour, chief executive officer of Immunovaccine.
In addition to its program in RSV, Immunovaccine is advancing programs in other infectious disease applications. The Company is currently conducting proof of concept animal studies with DepoVax-based vaccine candidates in both anthrax and Ebola in collaboration with the United States National Institutes of Health (NIH).
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 I human clinical trials. Lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase II clinical studies in both 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 and Ebola.
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, including information regarding the use of proceeds of the financing, 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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Halifax, Nova Scotia, January 20, 2015