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12 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com SHUO - STOCK.ADOBE.COM N ucleic acid-based therapeutics have been stepping up into the spotlight following the deployment of messenger RNA (mRNA) COVID-19 vaccines in 2021 and the rise in clin- ical development programs for gene therapies. These ar- eas of development may just be the surface of the types of therapeutic applications where nucleic acid-based therapeutics can come into play. Tackling the develop- ment challenges of these therapeutics can potentially benefit more expansive areas of unmet medical need, particularly in difficult-to-treat patient populations. Current failures in biotherapies Current immune therapies in development may often fail or not work for everyone. The result of these fail- ures, in par t, is what may be driving the R&D en- gine for alternative modalities, including nucleic acid-based therapeutics. "We do not yet fully understand why current im- mune therapies are highly efficacious in some pa- tients while other patients fail to respond, but re- search scientists are exploring several hypotheses. With cancer immunotherapies, it is impor tant to remember that tumors are highly heterogeneous, in respect to the expression of tumor antigens and their effects on the immune system that enable tumor cells to escape immune surveillance," explains John Lewis, CEO of Entos Pharmaceuticals. Lewis points out that some cancers may not re- spond to current immuno-oncolog y (IO) drugs be- cause these cancers do not express the target protein, or because they suppress immune surveillance and inhibit T-cell responses. Mutational burden, which is the number of mutations present in a cancer cell, may also play a role in response to IO therapies, especially checkpoint inhibitors, he adds. Nucleic Acid-based Therapeutics Are Stepping into the Spotlight Feliza Mirasol is science editor for BioPharm International. The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.