Viral Disease Program
Vaccine for Elderly
Our viral disease program is unique as it focuses on providing protection against viral disease in the elderly, whereas competitive vaccine programs are designed mostly for younger individuals with strong immune systems. In particular, our Alloprime® viral disease program targets respiratory viral infections, which adversely affects the quality of life as we age and contributes a significant economic burden to society. Age-related changes in the immune system (immunosenescense) hampers successful prophylactic viral vaccination in the elderly population. Even if a vaccine for viral infection becomes available or is eventually developed for diseases such as COVID19, as is the case for influenza vaccines, protection in the elderly tends to be sub-optimal as compared to healthy younger individuals. Accordingly, vaccines tailored to the needs of the aging immune system are a high priority for development and represents an unmet medical need.
Our AlloPrime® universal anti-viral immunomodulatory vaccine is designed to provide protective immunity in elderly adults that prevents the serious progression of respiratory viral infections. It is well established that the frequency and severity of infectious diseases increase with age. Respiratory viral infections in the elderly, in particular, carry a substantial risk of severe illness, loss of independence, disability, and death.
The unique “universal anti-virus” feature of our novel anti-viral immunomodulatory vaccine technology is the ability of one treatment course to provide protection against any type of viral threat, both threats from known viruses and unknown viruses, including viruses such as SARS-CoV-2 (COVID-19), and any variants or mutations, as well protection from any future newly emergent viruses, naturally occurring or bio-weaponized, with pandemic potential. This universal viral protection can be provided even if at the time of vaccination, the virus is unknown and structure uncharacterized.
We utilize our novel AlloPrime® technology to remodel the senescent immune systems of the elderly so that they can respond to viral infections in the same manner as healthy youthful immune systems. Our AlloPrime® protocols are reversed engineered from the study of the immune mechanisms of the young and healthy. The youthful immune system is capable of clearing respiratory viral infections prior to onset of severe symptoms. The study of this mechanism together with the study of the mechanisms which contribute to the failure of the senescent immune system to respond adequately in response to viral infection; and, the viral mechanisms which enable viruses to evade immune elimination provides the background for design of a novel anti-viral protocol. This AlloPrime® protocol imprints a newly engineered youthful immune system upon the elderly immune system which is pre-programmed to rapidly respond to any viral infection in order to clear the infection, avoiding serious progression of viral diseases.
Our AlloPrime® Universal Anti-Viral immunomodulatory vaccine is designed to protect elderly adults from the progression of respiratory viral infections to pneumonia and more serious symptoms. Respiratory diseases, particularly those linked to pneumonia are a leading cause of serious illness in the elderly and in individuals with co-morbidities. Viral respiratory tract infections can lead to primary viral pneumonia and also predispose to secondary bacterial pneumonia. This is most pronounced for influenza virus infections. Seasonal influenza epidemics affect about 1 billion of the global population and cause up to half a million deaths every year (WHO). Direct and indirect annual costs associated with influenza viral respiratory tract infections is estimated to be around $87 billion in the USA [cite]. Other viral infections add another up to $40 billion annually in the USA [cite].
Community-acquired pneumonia (CAP), defined as a lower respiratory tract infection acquired outside of a hospital or long-term care setting, is a leading cause of morbidity, mortality, and economic burden worldwide. Pneumonia is widely recognized as a disease of the elderly (age ≥65 years). In the United States, CAP affects approximately 5.6 million patients annually, and is the sixth leading cause of death in people aged ≥65 years.
The annual incidence of hospitalization for CAP among adults ≥65 years old is approximately three times higher than the general population and indicates that 2 percent of the older adult population will be hospitalized for CAP annually.
AlloPrime® immunomodulatory vaccine is designed to correct the immune dysfunction that occurs as the immune system declines with age, enabling rapid innate immune response to eliminate viral infections. The decline of immune responsiveness that occurs as we age is known as “immunosenescence”. Immunosenescence has been generally associated with an increased susceptibility to infectious pathogens and poor vaccine responses in older adults.
The severity of viral and bacterial infections (e.g., influenza, herpes zoster, pneumococcal disease) is notably increased among older adults compared to younger individuals, and more acute and long-term sequelae often develop as a result. Vaccination serves as the main strategy for preventing such infections, yet primary vaccine responses are often lower in older adults, frequently failing to induce long-term protective immunity and placing these individuals at further risk for subsequent disease.
AlloPrime® is a novel solution to the problem of immunosenescence, remodeling the immune system to increase the availability of non-exhausted Th1 memory cells and cross-reactive killer T-cells (CTL). Non-exhausted Th1 memory cells that are non-specifically activated upon exposure to virus release interferon-gamma, creating a cascade of events that create an “anti-viral state”. Cross-reactive CTL and NK cells are activated in the anti-viral state and act to kill viral infected cells. The killing of viral infected cells in the context of interferon-gamma and released endogenous heat shock proteins and danger signals provide the conditions for an in-situ vaccination, leading to viral-specific sterilizing immunity and memory to prevent re-infection.
Alloprime® is an advanced mechanism used to imprint a youthful immune response capability upon the immune system of the elderly. Alloprime® harnesses the power of an immune concept called “heterologous immunity” to provide “universal” viral protection. The ability of an individual to respond to a new pathogen is influenced by its past exposure history to viruses, bacteria and fungi. Heterologous immunity occurs when the induction of an immune response to the new pathogen is influenced by the past exposure of the immune system to an unrelated pathogen/antigen.
Previous exposure to pathogens leads to induction of innate and adaptive immune responses, which result in establishing a substantial pool of memory immune cells which persist long after the pathogen has been eliminated. These memory cells provide a fast and efficient protective response upon re-exposure to the same pathogen/antigen. These memory cells provide a fast and efficient protective response upon re-exposure to the same pathogen/antigen. However, these memory cells also form a pool of “ready-to-respond” Th1 immune cells and cross-reactive killer cells that have low stimulation requirements. The low stimulation requirements of these memory cells permit them to be activated non-specifically by cytokines and cross-reactivity of antigen recognition.