The Food and Drug Administration (FDA) recently granted accelerated approval for VOCERYQ, a DNA-based immunotherapy developed by Plymouth Meeting-based INOVIO.
The drug reduces the frequency of surgery f in adults with recurrent respiratory papillomatosis, a debilitating disease caused primarily by HPV-6 and/or HPV-11. The disease causes wart-like growths in the respiratory tract. The standard treatment is surgery, but this can permanently damage the vocal cords.
VOCERYQ generates an immune response using DNA plasmids that encode for HPV-6 and HPV-11 antigens. It has shown to be well tolerated, and a confirmatory study is expected to be conducted. By the end of the year, INOVIO must submit a draft protocol to the FDA for the study. INOVIO expects full field deployment during the first quarter of 2027.
“With the approval of VOCERYQ, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option,” Dr. Jacqueline Shea, INOVIO president and CEO, said. “VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP”
The FDA approved VOCERYQ was in combination with CELLECTRA 5PSP, INOVIO’s proprietary DNA medicine delivery device.