The strength and frequency of COVID variants have created a whack-a-mole approach for pharmaceutical companies trying to provide effective pre-exposure protection and therapies for both the general public and immunocompromised individuals. A new variant pops up, and doctors must essentially go back to the drawing board to develop new monoclonal antibodies to counter the new variant effectively.
Tonix Pharmaceutical’s (NASDAQ: TNXP) CEO Seth Lederman, MD told the audience at the 2023 Biotech Showcase earlier this month in San Francisco that a new class of more mutant-resistant pre-exposure antibody therapies for patients at high-risk of Covid-19 is urgently needed and their development is within reach of Tonix’s technology.
For immunocompromised individuals, SARS-CoV-2 is especially a real and dangerous threat. People who are immunocompromised are more likely to get COVID, could be sick for an extended period of time and have higher rates of hospitalization.
Due to these increased comorbidity factors, pharmaceutical companies came out with therapeutic and pre-exposure monoclonal antibody-based medicines for people with higher risk factors. However, with the onslaught of new variants almost all of the monoclonal antibody drugs have become obsolete. Currently, the only monoclonal antibody therapy remaining on the market is EVUSHELDTM, which is the pre-exposure drug that can be taken every six months to help prevent COVID.
“Although four therapeutic monoclonals and one preventative monoclonal were approved under the FDA’s Emergency Use regulations, the four therapeutic monoclonal antibodies are no longer marketed in the U.S. because SARS-CoV-2 variants have rendered them ineffective. Only the single preventative monoclonal remains on the market, Now that remaining antibody drug, EVUSHELD, appears to be nearing the end of its utility because of new variants,” Dr. Lederman said.
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