Inovio Pharmaceuticals Inc (NASDAQ:INO) has received the green light to proceed with the initial Phase 1 study of its Zika vaccine drug candidate GLS-5700 in humans. With the latest development, Inovio has effectively jumped ahead of Sanofi SA (NYSE:SNY), which is also working on a potential Zika vaccine. Several other drug companies including Pfizer, Inc. (NYSE:PFE), GlaxoSmithKline plc (NYSE:GSK) and Merck & Co., Inc. (NYSE:MRK) are also said to be weighing their options regarding entering the Zika vaccine research ring.
Inovio Pharmaceuticals’ candidate GLS-5700 is a product of collaboration with South Korea’s GeneOne and academic researchers in the U.S. and Canada. The approval for human trial of GLS-5700 now increases pressure on Inovio’s rivals who are also working on Zika virus medicines.
A global health concern
Zika virus outbreak is said to have spread to about 58 countries and territories. Given the threat of the virus and how rapidly it is spreading, the World Health Organization (WHO) has declared it a global public health emergency. Zika virus has been linked to severe birth defects where babies are born with abnormally smaller head, a condition that is medically known as microcephaly. The condition arises when a pregnant woman is infected by the virus. In other people, Zika infection causes fever, joint pain, conjunctivitis and rash.
The rapid spread of Zika infection and the birth defects it causes has increased the urgency in developing a treatment for the virus to keep global populations healthy. Among pharmaceutical companies that have thrown their hat in the Zika ring, Inovio Pharmaceuticals appears to be taking the lead with human trial of its compound GLS-5700.
Success in animals
According to Inovio, success with GLS-5700 vaccine has already been seen in animal trials. As such, the company hopes that it will also hit success in humans. Dosing of GLS-5700 in humans is expected to begin in the coming weeks with topline results from the human Phase 1 trial expected later in the year.
Human study of GLS-5700
Inovio Pharmaceuticals’ Phase 1 human trial will enroll 40 healthy subjects. The idea will be to evaluate the immunogenicity, safety and tolerability of GLS-5700.