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The agency granted accelerated approval based on the vaccine's ability to prevent HPV-related anogenital disease, but a 6,000-patient study will assess its ability to prevent oral cancer.
PRGN-2009 showed anti-tumor activity in preclinical studies and now will be evaluated in humans as a monotherapy and in combination with a bifunctional fusion protein.
Researchers are making improvements to viral-DNA detection methods and are exploring applications not just for screening but also disease monitoring.
The test will guide clinical decision making related to Inovio's DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus.