NEW YORK – Germantown, Maryland-based biopharmaceutical company Precigen said on Monday that it dosed the first patient in its Phase I/II trial investigating immunotherapy PRGN-2009 in HPV-positive solid tumors.
The US Food and Drug Administration accepted Precigen's investigational new drug application for PRGN-2009 in April allowing for the start of this Phase I/II trial. The trial will be conducted at the NIH Clinical Center, a hospital dedicated to clinical research at the National Institutes of Health's Bethesda, Maryland campus.
The Phase I portion of the trial will evaluate PRGN-2009 as a monotherapy to determine the ideal Phase II dose. The Phase II portion of the trial will evaluate the safety of PRGN-2009 as a monotherapy or in combination with an investigational bifunctional fusion protein in patients with newly diagnosed stage II/III HPV16-positive oropharyngeal cancer and in patients with recurrent or metastatic HPV-associated cancers.
In pre-clinical studies, PRGN-2009 was able to control the growth of HPV-positive head and neck cancers in mice and increase CD8-positive T cell infiltration into the tumor.
PRGN-2009 is a first-in-class, off-the-shelf investigational immunotherapy developed using the company's UltraVector and AdenoVerse platforms and is designed to stimulate the immune system to recognize and target HPV-positive tumors. The therapy is being developed through a Cooperative Research and Development Agreement between Jeffrey Schlom of the Laboratory of Tumor Immunology and Biology, the Center for Cancer Research, and the National Cancer Institute.