Immunovaccine’s Vaccine Candidate for Respiratory Syncytial Virus Is Well Tolerated in Volunteers in Phase 1 Clinical Trial
Safety Review Committee Approves Higher-Dose Cohorts, Enabling DPX-RSV to Progress to the Next Phase of Clinical Program
Halifax, Nova Scotia; October 29, 2015 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that safety data from a Phase 1 clinical study showed that its DepoVax™ prophylactic Respiratory Syncytial Virus vaccine candidate (“DPX-RSV”) was well tolerated in the Phase 1 study’s first 20 volunteers, of whom 8 subjects received the DPX-RSV vaccine. This data marks an important milestone for Immunovaccine as it provides the first safety profile of the DepoVax™-based vaccines for infectious diseases in healthy adults. Based on the vaccine candidate’s safety and immunogenicity demonstrated in the study, the independent Safety Review Committee (“SRC”) has allowed the study to proceed to its next step, which includes vaccinating volunteers with DPX-RSV at a higher dose.
The randomized, controlled, blinded Phase 1 study is evaluating the safety and immune response profile of DPX-RSV vaccine in 40 healthy adults who are 50 to 64 years of age. 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 and 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.
“To date the data indicate that the study vaccines have been generally well tolerated in all participants,” said Joanne Langley, M.D., the study’s principal investigator. “Preliminary blinded immunogenicity data has also indicated that participants are able to generate antigen-specific immune responses to the RSV antigen. We are very pleased that these results have enabled DPX-RSV to move to the next part of its clinical testing program. ”
The SRC reviewed the safety data from the study’s first 20 volunteers, who were given either a low-dose DPX vaccine, a low-dose vaccine with alum (control) or a placebo. The next step will be vaccinating volunteers with a higher dose of DPX-RSV (25 micrograms). Study investigators will assess the vaccine’s safety and immune response profile following two doses of the study vaccine.
“Older adults are a largely underserved population and have a significant unmet need for a strongly immunogenic platform like DepoVax™,” said Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. “This early data indicate a tolerable safety profile, which is a crucial milestone for an adjuvanting vaccine platform. We believe that these initial study results not only validate the platform in this population, they also open up potential opportunities for further collaborations and partnerships in the infectious disease field.”
Immunovaccine and the Canadian Institutes of Health Research (“CIHR”) are co-funding the trial, which is being conducted at the Canadian Center for Vaccinology (“CCfV”) in Halifax. The study’s primary endpoint is the safety and tolerability of DPX-RSV; secondary endpoints include long-term safety, immunogenicity and persistence of immune responses. The RSV vaccine candidate was developed by Bert Schepens and Walter Fiers at Ghent University and VIB (Ghent, Belgium) in the group of Xavier Saelens.
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.
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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.
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