New ‘Pan-Viral’ Vaccine Aims to Protect Elderly from All Respiratory Viral Infections, Including COVID-19

The US Food and Drug Administration (FDA) has granted clearance for Phase I/II trial of a universal vaccine designed to protect elderly adults from all respiratory viral infections, including COVID-19, influenza and any future mutations or novel viral outbreaks.

Mirror Biologics, Inc., the commercial development arm of Immunovative Therapies, Ltd. (Jerusalem, Israel), has received clearance from the FDA for a Phase I/II universal virus vaccine clinical trial under the company's second active Investigational New Drug (IND) application enabling use of its lead experimental drug, AlloStim, for testing as an anti-viral prophylaxis drug. AlloStim is an off-the-shelf, non-genetically manipulated, patented living immune cell with multiple immunodulatory properties, currently being tested under a separate IND as a therapeutic vaccine for chemotherapy-refractory metastatic cancers.

The universal viral protection mechanism has been reversed engineered from the immune response that results in asymptomatic viral clearance in youthful individuals. Using a novel, patent-pending technology called "allo-priming", the youthful immune response is imprinted upon the elderly immune system so that it can be ready to be activated upon encounter with any virus. The mechanism creates conditions for an "in-situ" vaccine providing viral-specific protection and memory to prevent re-infection from the same virus.

The Phase I/II trial is believed to be the first anti-viral vaccine in clinical development that is specifically targeted to protect the elderly and will accrue 40 healthy adults over age 65. Volunteers will receive five intradermal injections of AlloStim over 14 days. Blood samples will be collected prior to injection and at 30 days, six months and one year after injection. The blood will be challenged in the laboratory with a panel of live viruses, including the COVID-19 virus and influenza viruses in order to determine if the remodeled immune system can suppress the propagation of these viruses in cultures of human endothelial cells from the respiratory tract.

“We are pleased to have FDA clearance of our novel universal viral vaccine clinical trial targeted to healthy adults over 65 years old. There is a large unmet need to protect the elderly from the devastating effects of respiratory viral infection. If we can protect the elderly from COVID-19, economies can open safely and herd immunity can be allowed to develop without an alarming increase in death rate,” said Dr. Michael Har-Noy, founder and CEO. “Even if a COVID-19 vaccine is developed, it is likely, as with influenza vaccines, that it will be less effective in the elderly where protection is most needed. In addition, a successful COVID-19 vaccine is vulnerable to weakening upon mutation of the virus and will not protect against future novel viral outbreaks. Our universal vaccine technology is designed to protect against any type of viral infection without the requirement to have prior knowledge of the viral structure and is specifically designed to work in the weakened senescent immune systems of the elderly and frail.”

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