Summary
- COVID vaccine INO-4800 is just one piece of the Inovio (INO) puzzle.
- Addressing the Human Papilloma Virus remains a high priority for Inovio.
- Results from the PHI and PHII VGX3100 trials are promising in the fight against HPV types 16 and 18.
- INO-3107 is granted "Orphan Drug Designation" by the US Food and Drug Administration. Is there more to follow?
Human Papilloma Virus
While the eyes of the world anxiously await to hear the news of an approved vaccine that is safe, effective and can maintain a durable response for use in the fight against COVID, Inovio continues to plow forward with other indications for urgent health needs in their pipeline such as Anal Dysplasia, Vulvar Dysplasia, Cervical Dysplasia and Recurrent Respiratory Papillomatosis.
Each one of these diseases are a direct result due to exposure and infection to the human pappiloma virus (HPV). The virus is primarily a sexually transmitted disease and all four of the diseases could lead to pre-cancerous lesions which if not treated, can leave a patient with no choice but to undergo various disfiguring surgical procedures. Furthermore, if not treated, these diseases can also lead to cancer and in the most serious cases, death. Inovio's pipeline is addressing the need for a therapeutic vaccine to address these infections caused by (HPV) and investors should be excited about the potential value to Inovio if and when they bring these candidates to market.
Recurrent Respiratory Papillomatosis (RRP)
On Wednesday, July 29, 2020, Inovio announced that they had been granted 'Orphan Drug Designation' for INO-3107 to treat a rare disease known as Recurrent Respiratory Papillomatosis (RRP) caused by the presence of HPV 6 or the HPV 11 virus. Orphan Drug Designation is critical to advancing drug development for rare disease indications, such as RRP.
Orphan drug designation is intended to advance drug development for rare diseases. FDA grants orphan drug status to medicines intended for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the United States annually.
RRP obstructs patient's airways with primarily benign tumors that can grow in size in the larynx rather quickly requiring invasive surgical procedures and in rare cases, result in cancer. RRP is presently incurable and the courses of treatment include recurrent surgery to remove the tumors as frequently as every few weeks to every few months or the use of antiviral drugs. Regardless of the procedures chosen, living with this incurable disease can result in social isolation as it often comes with a change in voice, hoarseness and difficulty breathing and in the most severe cases, patients opt to insert a permanent tracheotomy.
