Germantown’s Precigen Inc. got the regulatory nod necessary to take an immunotherapy candidate for a rare respiratory disorder to the clinic.
The local biopharmaceutical company said Tuesday the Food and Drug Administration has given the go-ahead to start a phase 1 clinical trial of PRGN-2012, the company’s candidate for adults with recurrent respiratory papillomatosis, or RRP— a disease caused by human papillomavirus in which growths develop in the respiratory tract, in some cases obstructing airways and causing other complications.
“For patients with RRP there is an urgent need for adjuvant treatment options to reduce the number of devastating repeat surgical procedures to remove papillomatous lesions,” said Precigen President and CEO Helen Sabzevari in a statement.
The early-stage study aims to demonstrate safety and tolerability, and dosing for a subsequent phase 2 trial. The therapeutic uses Precigen’s proprietary technology to elicit immune responses against the infected cells.
Precigen has advanced PRGN-2012 through a research and development agreement with the National Cancer Institute’s Center for Cancer Research. It’s the company’s second candidate to reach the clinic through work with NCI; the other is for candidate PRGN-2009 in patients with recurrent or metastatic HPV-associated cancers. The FDA cleared that investigational new drug application in March 2020, giving Precigen the green light to start those trials.
Precigen’s (NASDAQ: PGEN) share price was down more than 12% to $9.61 just before 2 p.m. Tuesday.
Precigen reported $83.8 million in 2020 revenue for the first three quarters of 2020, up 14% from $73.7 million for the same period of 2019, according to filings with the Securities and Exchange Commission. The company also reported that it suffered a net loss of $102.8 million for the first nine months of 2020, less than its net loss of $132.7 million the year prior.
The Montgomery County biopharma, which specializes in gene and cell therapies, has a handful of candidates in phase 1 clinical trials including three immune-oncology candidates: for ovarian cancer, acute myeloid leukemia (cancer of the blood and bone marrow) and myelodysplastic syndrome (a group of blood cell disorders). The company also has a candidate for type-1 diabetes in phase 2 studies, among other candidates for solid tumors and infectious diseases in early stage trials.
Precigen, formerly Intrexon Corp., rebranded under its current name at the start of 2020. That came after Intrexon set out to position itself as a health care company, first initiated with a split of its business units in April 2019. Intrexon, founded in 1998, formed Precigen as a subsidiary in 2017. That entity opened a new 5,000-square-foot manufacturing facility in Germantown in spring 2019, where the new company is now based.
