Caption: Immunovative scientists working in clean rooms prepare the experimental drug AlloStim for use in human clinical trials. To download image, click here.

Mirror Biologics, Inc. (“MBI”), the commercial development arm of Israel-based Immunovative Therapies, Ltd. (“ITL”) together with the Hadassah-Hebrew University Medical Center’s Center for Immunotherapy and Immunobiology Research today announce the publication of a manuscript describing the scientific rationale for a new approach for vaccine development for the elderly. The patent-pending technology called “AlloPriming” is designed so that a series of injections of bioengineered cells, called “AlloStim®, could provide protection from any future viral infection, including COVID-19, influenza and any future mutations of these viruses or an outbreak of a new novel virus. The technology proposes to prime the elderly immune system to respond to viruses in the same manner as a healthy younger adult immune system would respond.

The manuscript entitled: “ALLO-PRIMING AS A UNIVERSAL ANTI-VIRAL VACCINE: PROTECTING ELDERLY FROM CURRENT COVID-19 AND ANY FUTURE UNKNOWN VIRAL OUTBREAK” was published on-line in the peer-reviewed Journal of Translational Medicine (JTRM). The manuscript can be viewed by following this link: JTRM link. A Phase I/II clinical protocol has been prepared for testing this concept in healthy adults over 50yo and is currently under review by the US FDA.

Dr. Francisco Maricola, editor-in-chief of the Journal of Translational Medicine commented: “The novel allo-priming mechanism described in the manuscript has the potential to become an important new tool in our fight against the current pandemic and preparedness against any future pandemic. This technology is especially unique in that it targets modification of the elderly immune system which tends to respond poorly to immunotherapy and vaccines. The manuscript also suggests that the successful remodeling of the aging immune system to respond to viral infections may have the additional benefit of re-setting the elderly immune system to prevent the type of chronic inflammation which is correlated with age-related diseases, such as cancer, neurodegenerative disorders and cardiovascular disorders.”

The “Universal” anti-viral protection mechanism could assure ongoing protection against diseases like COVID-19 even if the virus should mutate or change. At the same time, this technology has potential to eliminate the need for mass vaccination campaigns for influenza each year or new campaigns for each new virus that might emerge or for current known viruses that change in a manner that defeats an existing vaccine.

Prof. Reuven Or, co-author and Director of Hadassah-Hebrew Medical Center’s Cancer and Immunobiology Research Center stated: “Allo-priming is a concept that proposes a novel mechanism for preparing the immune systems of elderly adults to respond to viral infections, especially respiratory infections, in the same manner as healthy younger persons. A youthful immune response is believed to be most capable of clearance of viral infections before the infection progresses to serious disease. Protection of our vulnerable elderly population is a high priority, especially as the world begins to ease restrictions imposed due to the COVID-19 pandemic.” 

NEED FOR AN ALTERNATIVE VACCINE APPROACH 
There remain many possible technical obstacles using traditional vaccine technology to address the COVID-19 pandemic. Therefore, there is a need to pursue alternative strategies concurrent with traditional vaccine development efforts. The major focus for vaccine development against viruses are strategies that introduce inactivated whole viruses, or pieces of viruses, or viral genetic material to teach the immune system to make antibodies which bind to the virus. The aim is to elicit antibodies which “neutralize” the virus by blocking entry into host cells. 

While these approaches have been successful in providing protection against many childhood diseases, they have not been successful in protecting against many emergent viruses, such as HIV, hepatitis C, Zika, dengue and the pandemic SARS and MERS coronaviruses. One strategic mutation in the virus and the neutralizing activity of a vaccine can be avoided. Therefore, there is risk that current vaccine technology platforms may not timely produce a protective vaccine against COVID-19 or could result in a vaccine that becomes obsolete after a viral mutation.

Further, there is evidence that vaccines that elicit an antibody response to a virus sometimes can make the disease WORSE via a mechanism known as antibody dependent enhancement (ADE). This phenomenon has been observed with influenza vaccines. ADE occurs in West Nile virus infection and dengue fever. There is also evidence that COVID-19 patients with the most severe symptoms have the highest antibody levels, suggesting that an ADE mechanism may also occur with the novel coronavirus. Additionally, vaccines which enhance antibody responses often alter the immune system in a manner that promotes a type of immunity known as Th2 immunity. Th2 immunity has been correlated with serious respiratory diseases, allergies and lung pathology. 

A UNIVERSAL VACCINE technology allows the body’s immune system to continually adapt to viral changes. Allo-priming enhances the cellular part of the immune system, rather than the antibody part, so does not risk the complications associated with antibody-eliciting vaccines.

Dr. Michael Har-Noy, lead author stated: “While there is great optimism regarding current clinical trials investigating protective vaccines against COVID-19, there is a very real possibility that none of the vaccine candidates under investigation will prove to provide long-term protection from COVID-19, and some vaccine candidates may even make symptoms worse. Even in the event that an effective vaccine is timely developed, such a vaccine likely would not be as effective in providing protective immunity in the elderly. If allo-priming is proven to work as designed, a single series of shots could protect against the current pandemic as well as any future pandemic.” 

ABOUT MIRROR BIOLOGICS, INC.
Mirror Biologics, Inc. (MBI) is a private Delaware corporation and a sister company to Immunovative Therapies, Ltd (ITL). MBI owns the exclusive development and commercialization rights to technology and products developed by ITL and to patents pending on the allo-priming technology for universal vaccine protection of the elderly. MBI is headquartered in Phoenix, AZ and has clinical development offices in Bangkok, Thailand, Kuala Lumpur, Malaysia and Taipei, Taiwan. 

ABOUT IMMUNOVATIVE THERAPIES, LTD.
Immunovative Therapies, Ltd. (ITL) is a private Israel corporation that spun out from Hadassah-Hebrew University Medical Center in Jerusalem in 2004. ITL specializes in the reverse engineering of proven immune mechanisms to develop immunotherapies for cancer and infectious diseases where the active ingredients are living immune cells. ITL has over 200 granted patents worldwide protecting this immunotherapy platform technology known as the “Mirror Effect”. ITL operates GMP cell manufacturing facilities in Jerusalem and a blood donor center in Phoenix, AZ USA. www.immunovative.com