The first-in-human clinical trial will evaluate Inovio’s Zika DNA vaccine (GLS-5700), a synthetic vaccine developed in partnership with GeneOne Life Science, a South Korea-based DNA vaccine developer and contract manufacturer.
The study was previously approved by the US Food and Drug Administration (FDA) in June and has also been approved by Health Canada’s Health Products and Food Branch. In preclinical studies, the vaccine induced robust antibody and T cell responses in both small and large animal models.
The open-label, dose-ranging study includes 40 healthy adult volunteers and is being conducted at sites in Miami, Philadelphia, and Quebec City.
The company expects to complete subject dosing and report interim phase I results later this year.
On being the first
According to Joel Maslow, PhD, MD, Chief Medical Officer at GeneOne, the biggest challenge in developing the vaccine was having almost no knowledge of how Zika caused disease.
“To be able to get a vaccine into production in time for human trials meant that the pre-clinical laboratory research would need to be done in parallel,” Maslow told Outsourcing-Pharma.com. “We were helped as we had developed and tested vaccines for West Nile Virus, Yellow Fever, and Dengue which are other related flaviviruses.”
“To be honest, being the 1st to bring a vaccine into clinical trials still seems a bit surreal,” added Maslow.
“Although we had developed a 5 month time schedule to enable us to complete the many, many steps necessary to gain FDA approval– the fact that we were able to maintain this schedule and address the many hurdles encountered to bring this to fruition is still a bit unbelievable,” he said.
Maslow explained that the company’s goal is to move forward rapidly through the stages of clinical development while maintaining “a very tight and stringent view towards patient safety.”
“It is important to quickly expand the studies to geographies to be able to test the vaccine to prevent Zika virus infection,” he added, explaining that "the speed of developing a vaccine for Zika virus has not resulted in any minimization of safety considerations."
On manufacturing
Texas-based VGXI, Inc., the wholly-owned subsidiary CMO of GeneOne, is manufacturing the vaccine.
"VGXI has both the capability and experience to provide the gram-scale quantities of clinical grade DNA that are needed for therapeutic applications, such as for this Zika DNA vaccine," VGXI's VP of Operations, Dorothy Peterson, told us. "In particular, VGXI’s proprietary AIRMIX® Technology allows for efficient and reliably scalable production of very high purity, high concentration DNA products."
Maslow explained that the proprietary system enables the production of supercoiled DNA vaccines at high concentrations and purity.
“The need for supercoiled DNA, the form that naturally occurs in the body, is critical for efficient and effective production of the proteins encoded by the DNA plasmids,” explained Maslow. “It is the proteins made from the DNA that serve to prime the immune system against the invading virus.”
Looking forward, Maslow said it is still premature to focus on demand for a vaccine that is still in Ph I of clinical testing, but the company has had to consider how to provide large scale vaccine production for other products in clinical development and have looked forward to match demand at the time of approval.
"The recognized safety and efficient manufacturing process for DNA vaccines enabled the rapid progress of GLS-5700 from initial conception to first human testing," added Peterson.