Wednesday, April 8, 2020
CORONAVIRUS / GOOD NEWS SAN DIEGO LAB BEGINS HUMAN TESTING FOR COVID-19 VACCINE
Note: During coronavirus pandemic the San Diego Union-Tribune is providing free coverage as a service to its community.
GUEST BLOG / By Mike Freeman, reporter, San Diego Union-Tribune--Inovio Pharmaceuticals, which developed a potential vaccine for COVID-19 at its San Diego lab, has begun an early Phase 1 human trial for the drug involving 40 healthy adult volunteers in two states.
The first wave of volunteers received doses Monday. The trial is occurring at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and at the Center for Pharmaceutical Research in Kansas City, Mo.
Each volunteer will receive two doses of the DNA-based vaccine four weeks apart, with immune response and side-effect data expected by late summer or early fall.
Depending on the results, Inovio plans a much larger Phase 2 trial with 1,000 or more participants — though the exact timing is unclear.
The small biotech firm is one of about a dozen pharmaceutical companies and research labs working on a vaccine for COVID-19. It is the second to begin human trials, following Moderna, which launched Phase 1 testing last month.
While Inovio is using a relatively novel DNA-based approach to trigger an immune response to COVID-19, Moderna is tapping more established messenger RNA-technology with its vaccine to prevent coronavirus.
An approved vaccine probably won’t be available for a while, however. Experts predict it could take 12 to 18 months to get through the necessary safety and effectiveness testing to bring a vaccine to market.
Inovio has 15 DNA-based medicines in development for a variety of diseases, including Middle East Respiratory Syndrome, or MERS. To date, none has received regulatory clearance.
While the company is based near Philadelphia, its research lab is in San Diego. Local scientists developed Inovio’s COVID-19 vaccine shortly after Chinese health officials published the genetic code of the virus online.
The Coalition for Epidemic Preparedness and Innovation, a public-private foundation based in Norway, provided $9 million to Inovio for COVID-19 vaccine development. The company also received $5 million from the Bill and Melinda Gates Foundation.
The U.S. Food and Drug Administration recently approved Inovio’s application for Phase 1 human trials. As part of its submission to the FDA, the company provided pre-clinical data from animal studies that showed “promising” immune responses from its vaccine.
Over the past 10 weeks, Inovio has manufactured thousands of COVID-19 doses to support Phase 1 and Phase 2 trials. It plans to have one million doses available by year-end for additional trials and emergency use, subject to regulatory clearance and funding.
Inovio’s shares ended trading Monday up 9 percent at $8.44 on the Nasdaq exchange.