Company Joins Global Race to Find Vaccine; Previous Data Support Potential of Immunovaccine's DepoVax™ Platform Against Other Major Health Threats, Including RSV, Anthrax and Ebola Virus
Halifax, Nova Scotia; March 3, 2016 – Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced it will begin a research project towards development of a vaccine formulated in its DepoVax™ platform against the mosquito-borne Zika virus and infection, which may be linked to neurological birth defects in infants.
The Company said the program will build upon promising results of earlier research with DepoVax™-based vaccines for Ebola virus, anthrax and respiratory syncytial virus (RSV).
"Immunovaccine's unique oil-based delivery system has produced elevated and durable immune responses with a consistent safety profile in several disease areas," said Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. "Successful preclinical proof-of-concept studies will allow us to move quickly towards clinical trials as we join the global effort to develop a vaccine against this disease that has the potential to spread rapidly in previously unaffected populations."
Results from the first human clinical trial of the DepoVax™ delivery system in an infectious disease are expected to be released this spring. The trial involves the Company's vaccine candidate for RSV, which is DPX-RSV. Work on the Ebola virus vaccine came to an end as the recent epidemic waned. The Company's technology has been licensed to PharmAthene Inc. for clinical and commercial development of an anthrax vaccine program.
Zika virus has erupted as an international health emergency as the mosquito borne illness has spread north from Brazil since late last year.
Immunovaccine's proprietary DepoVax™ adjuvanting delivery platform has been shown in multiple studies to produce a strong, high-quality immune response that has a specific and sustained immune effect with the potential for single-dose effectiveness. The platform has been shown to extend exposure of the immune system to practically any antigen and can be readily combined with other vaccine development strategies. Immunovaccine has identified an antigen for Zika virus and expects to establish collaborations with manufacturers to produce the antigen for formulation into a new vaccine.
"We are hopeful about the potential of our technology across a number of immunotherapy and infectious disease targets," said Frederic Ors, Immunovaccine Chief Business Officer. "In the second quarter of this year, we will have Phase 1 clinical data for a DepoVax™-based preventive vaccine for DPX-RSV. These data will support and complement the Zika research program as we select partners to provide the identified antigen for clinical trials."
Because its vaccines contain no water, the Company's product candidates have shown extended stability in various storage conditions and long shelf-life at room temperature. "Our ability to manufacture vaccines quickly and easily could make it possible to speed product to market," said Leeladhar Sammatur, Immunovaccine Director of Product Development. "If it becomes necessary to inoculate large populations quickly, these characteristics of our vaccines could be very advantageous."
"We have previously worked with the National Institutes of Health (NIH) in the U.S. to formulate vaccines that promise to provide fast-acting and long-lasting single-dose protection against anthrax and Ebola virus. This new program will extend that work," said Marianne Stanford, Ph.D., Immunovaccine Director of Research. "The single-dose, rapid-response potential of DepoVax™ will be particularly useful when immunizing populations against Zika virus, as repeated immunizations can be logistically difficult to implement and can significantly delay protection."
Potential of Vaccines Formulated in DepoVax™ Shown in RSV, Anthrax and Ebola Virus
Immunovaccine has developed a DepoVax™-based preventive vaccine for respiratory syncytial virus (RSV), DPX-RSV. There is currently no vaccine for RSV, which causes severe respiratory illness in the elderly and young children. Immunovaccine is conducting its first infectious disease trial with a Phase 1 study of DPX-RSV in healthy adult volunteers, 50 to 64 years of age, to evaluate safety and activity. Topline data is anticipated in the second quarter of 2016.
In collaboration with the NIH, Immunovaccine has also demonstrated single-dose protection in animal studies to a rapid-response anthrax vaccine, DPX-rPA. DPX-rPA contains recombinant anthrax protective antigen (rPA), delivered on the DepoVax™ platform. Immunovaccine licensed DepoVax™ to PharmAthene in 2015 to pursue development and commercialization of the single-dose anthrax vaccine for humans.
In August 2014, Immunovaccine announced positive results for a vaccine formulated in its DepoVax™ technology in an Ebola virus challenge study performed by the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH. All subjects vaccinated with the DepoVax™-based vaccine survived exposure to a lethal dose of the wild-type Zaire strain of the virus, while the unvaccinated animals perished.
Key Facts about the Zika Virus
According to the World Health Organization, the Zika virus disease is caused by a virus transmitted by Aedes mosquitoes. People with Zika virus disease usually have symptoms that can include mild fever, skin rashes, conjunctivitis, muscle and joint pain, malaise or headache. These symptoms normally last for 2 to 7 days. However, there is a growing body of evidence linking Zika infection in pregnant women with an increased risk of a severe congenital complication at birth called microcephaly. Normally a rare condition, microcephaly results in an abnormally small head impairing brain development. There is no specific treatment or vaccine currently available for the Zika virus. To date, the best form of prevention is protection against mosquito bites. The virus is known to circulate in Africa, the Americas, Asia and the Pacific.
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.
Contacts for Immunovaccine:
Mike Beyer, Sam Brown Inc.
T: (312) 961-2502 E: mike[email protected]
Kimberly Stephens, Chief Financial Officer
T: (902) 492-1819 E: [email protected]