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Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinicaldevelopment, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.
Delivery of therapy is being evaluated through injections of DNA and RNA encoding IL-12, viral vectors, and other exploratory platforms designed to bring IL-12 in close proximity to the tumour and avoid excessive IL-12 in systemic circulation. Ultimately, our goal is for this approach to yield an enhanced cancer fighting response.
Several viral vectors are being used currently, in addition to non-viral vectors, such as oligonucleotides, naked DNA, and lipoplexes and polyplexes. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinicaldevelopment. Asia, and Europe.
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