A new strain of highly contagious canine influenza (flu) has been spreading across the U.S. since March 2015 when more than 1,000 dogs, 5 of which died, were diagnosed in Chicago. By year-end the virus was confirmed in more than 40 states with thousands more dogs affected. Reports indicate that the virus spreads like “wildfire” in kennels, rescues and shelters from sneezing and coughing. Fears of a widening epidemic prompted the USDA to rush marketing approval of two vaccines whose applications for approval had been pending. There are no other vaccines for this new virus strain. The virus is continuing to rapidly spread while the new vaccines are being manufactured and distributed to veterinarians. The flu is treatable, but particularly dangerous to dogs under age 1 or over age 7 or for those susceptible to pneumonia. During outbreaks among fully susceptible dogs in close contact (e.g., in kennels), the infection rate may approach 100%, and clinical signs in 60-80% of the dogs is not unusual. Treatment can cost several thousand dollars if the animal has to be hospitalized in isolation.

 Current Unmet Medical Need
Current vaccines are ineffective because:

-The period of protection is limited because of the drift and shift of the virus (influenza virus strains are constantly mutating and changing to evade host immune responses)
-The duration of antibody response is limited (antibodies wane over time and protection is lost; hence, the need for repeated annual vaccines
-The efficacy or level of protection of the vaccines is insufficient
-The H3N2 vaccine is not effective for the H3N8 strain; therefore vaccination for both is required

PAH Medical Solution and Competitive Advantage
IMT504 has the potential to provide a canine influenza vaccine that has:

-Better cross-protection against other strains of influenza (heterologous protection)
-Vastly greater levels of protection (much higher antibody levels and longer duration of antibody protection)
-Significant antigen sparing per dose; leads to lower production costs and better safety profile.