NEW YORK – Biopharmaceutical company Precigen said on Monday that the US Food and Drug Administration accepted its investigational new drug application for PRGN-2009, which allows the company to start a Phase I/II trial in patients with HPV-positive solid tumors.
PRGN-2009 is a first-in-class, off-the-shelf investigational immunotherapy that was developed using the company's UltraVector and AdenoVerse platforms to optimize HPV antigen design. The drug works to stimulate the immune system to recognize and target HPV-positive tumors.
In the Phase I portion of the trial, PRGN-2009 will be administered 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.
Bifunctional fusion proteins have previously been used to target HPV-associated cancers. 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.
According to Precigen, high-risk HPVs cause nearly 5 percent of all cancers, and there are approximately 570,000 women and 60,000 men diagnosed with HPV-related cancers each year. Precigen CEO Helen Sabzevari said in a statement that "advancements are critically needed to better target HPV-positive tumors across multiple patient groups, and we have been encouraged by the promising preclinical data for PRGN-2009 in potentially targeting this patient population."
During pre-clinical trials, 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 after treatment.