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.
mike.freeman@sduniontribune.com
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