Precigen gets FDA orphan drug status for PRGN-2012 in RRP

Precigen has secured orphan drug designation (ODD) for PRGN-2012 from the US Food and Drug Administration (FDA) in recurrent respiratory papillomatosis (RRP).

PRGN-2012 is an investigational off-the-shelf (OTS) AdenoVerse immunotherapy.

In January 2021, Precigen was given clearance by the FDA to launch a phase 1 study of PRGN-2012 AdenoVerse immunotherapy in adults having recurrent respiratory papillomatosis.

PRGN-2012 is a therapeutic vaccine candidate with optimized antigen design that incorporates gorilla adenovector technology, which is part of the company’s AdenoVerse platform.

The vaccine candidate has been designed to cause immune responses targeted against cells infected with HPV 6 or HPV 11, said Precigen, a biopharma company based in Maryland.

Recurrent respiratory papillomatosis is a rare, hard to treat, and at times fatal neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11.

Precigen gets FDA orphan drug status for PRGN-2012 in recurrent respiratory papillomatosis. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

In preclinical models, PRGN-2012 had shown robust and specific immune response against the two human papillomavirus strains.

Helen Sabzevari – President and CEO of Precigen said: “This regulatory designation underscores the critical medical need for new therapies to treat this devastating and sometimes fatal disease.

“As the first regulatory designation for our proprietary AdenoVerse platform, this orphan drug designation will help to advance PRGN-2012 with important incentives that support delivery of this medicine as rapidly as possible to patients suffering from RRP.”