The novel corona virus (COVID-19), first noted in December in China, is moving close to home. After months of news about the highly contagious disease abroad, it has been identified in cities in the United States.
And the message is clear – it is bound to spread. Public health officials assure us that staying calm and washing our hands is the best remedy. No vaccine in sight, at least not for a while.
Pharmaceutical labs around the world are seeking to develop a vaccine – some of the labs are on our doorstep – using what they know about imunotherapy and applying that knowledge to possible virus-fighting products.
Inovio is one of the companies developing a vaccine. With corporate headquarters in Plymouth Meeting and a manufacturing plant in San Diego, it is well-placed to respond to national and international pharmaceutical needs.
A scientist with roots in Bucks County was willing to talk this week about Inovio’s “Immuno-ingenuity.” Dr. Ami Shah Brown, who grew up in Yardley, is Inovio’s senior vice president for regulatory affairs. Her background is in science and public health and it’s her job to shepherd a drug through the gates it has to pass, in development, testing and government approval.
According to the Inovio website, the company specializes in “DNA-based immunotherapy in cancer and infectious diseases, pairing a revolutionary design process with a groundbreaking delivery system to help combat two of the most pressing needs in global health.”
Brown explained that the company had already done research on the corona virus – COVID-19 is just one of many viruses of the group, which includes MERS. Members of the family have similar qualities.
When Chinese researchers shared the DNA sequence for COVIC-19 on Jan. 10, “we were able to utilize an algorithm to generate what we think might be effective treatment,” Dr. Brown said.
“Inovio was proactive. As soon as the sequence became known we had the power of our platform to begin designing of a vaccine.” The company had a head start on developing a vaccine.
A timeline on the Inovio website shows that DNA vaccine INO-4800 was designed “in three hours after receiving the genetic sequence using its proprietary DNA medicines platform technology. INO-4800 was designed to precisely match the DNA sequence of the virus.”
Inovio scientists rushed to begin preclinical testing and on Jan. 23, with the epidemic growing, Inovio received a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which is based in Norway, to fund ongoing preclinical and initial clinical development of the vaccine.
Preclinical testing, which usually takes up to a year, continued through February, and human clinical trial design began. In March, the human clinical trials will be finalized and 3,000 human trial doses will be prepared for trials in the United States, China and South Korea.
In April, human clinical trials will begin in 30 healthy volunteers in the U.S. and other human clinical trials will begin in China and South Korea.
By the end of 2020, Novio should produce a million doses of INO-4800 COVID-19 DNA vaccine.
“We’re looking at a broad coalition of organizations to work with us,” Dr. Shah Brown said. “There are a lot of moving parts. We are learning at the same time we develop tools to meet the challenge.” The company is establishing partners, finding ways to make more doses of the vaccine because it’s not just design and testing but also manufacturing capacity needed.
Experts so far agree that many unknowns are lurking in COVD-19 and we don’t know how or where the virus will strike. But we do know that work is under way to control it.
Development of a vaccine, experts cannot be rushed.