With Inovio Pharmaceuticals Inc.’s coronavirus vaccine, INO-4800, having just entered Phase 1 of clinical trials, you won’t find the company’s Senior Vice President, R&D, Kate Broderick slowing down. Broderick leads a diverse team of researchers discovering and developing DNA medicines.
She described her workstyle, “My husband says I am like a pit bull, once I get something in my jaws, I’m just not letting go. I can’t let go of this one. I’m working 24-7; this, literally, impacts everyone on the planet. For me, it is complete and utter focus — dedication to the matter at hand — which probably applies to everyone working on COVID-19 at the moment.”
Inovio Pharmaceuticals is a biotechnology company focused on bringing to market precisely designed DNA medicines. It is based in Plymouth Meeting (Philadelphia) and has labs and manufacturing facilities in San Diego.
“This (Phase 1) is a significant step forward in the global fight against COVID-19,” said J. Joseph Kim, INOVIO’s president and CEO. “Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing. Our dedicated team of staff, partners and funders have been mobilized since the genetic sequence of the virus became available in early January and continue to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials,” Kim said.
DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body
In Phase 1, immunogenicity and safety of INO-4800are being tested on up to 40 subjects, who are healthy volunteers. Broderick expressed her confidence on the safety front, “We’ve tested our DNA medicine vaccines in thousands of people over the course of our experience. So, we have a good handle on how these vaccines react in the clinic, and we’re very comfortable with that. We are very, very comfortable with safety database we have collected so far.
“What Phase 1 also does is gives us an early read out on immune responses (antibodies and T-cells) we will expect to see in humans and that helps us to be prepared for efficacy trials”
Broderick doesn’t miss a chance to express gratitude for everyone from volunteers for trials to researchers. “We are so grateful to all our volunteers who have come forward and wanted to be part of this trial,” Broderick said. “The participation is absolutely moving.”
Public interest has been great. “There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible,” said Pablo Tebas, MD, infectious disease specialist and professor of medicine at the Hospital of the University of Pennsylvania and principal investigator of the study.
Tebas administered the first dose of the study to a participant on April 6.
Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
If Phase 1 is successful, the trials would move to Phase II to answers questions of efficacy, with anywhere from hundreds to thousands participating, Broderick said.
A key part of the vaccine is the delivery system, CELLECTRA, which is made entirely at Inovio’s manufacturing plant in San Diego. The vaccine is produced in Texas and a few other locations
“We’ve been working on delivery technology for many years,” Broderick said. “We came up with a smart device, bringing vaccines into the 21st century. We’ve been using syringes for 300 years. With the syringe injection, you just get into the tissue. One of our key needs is to get in the cell. That’s what our device does. Each device has lifecycle of 5,000 uses and could probably go longer than that.”
INOVIO said it is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.
Shortly after Inovio got the sequencing of the coronavirus, it had a vaccine which raised questions from some skeptics. Broderick said it was the nature of work.
“One of our strengths is to move extremely fast, Broderick said. “On Jan. 10, we get the sequencing, three hours later we have a vaccine. One of the differentiating factors is that DNA medicine can be manufactured very quickly. It allows us to get into the clinic in a few short months as we have done.”
A Time for Collaboration
The world has been working on a cure and often working together. “We have some amazing collaborations globally,” Broderick said, emphasizing the teamwork. “We are working with professor David Weiner’s lab, fantastic collaborations in Canada, Public Health England an institution in Australia.
“One positive that came out of the situation is unprecedented level of solidarity seen across the scientific community, genuinely coming together, working together. And by sharing information, I truly believe we will get to a solution faster.”
Asked about the difficulties the coronavirus brings, Broderick paused.
“I have worked on these viral outbreaks my entire career,” Broderick said. “COVID-19 is different situation. It is unprecedented. Never in my wildest nightmares could I imagine we’d be shutting down the U.S., essentially the whole globe, for a viral outbreak. Yet, here we are today. This is such a different situation than one I have ever experienced. It’s almost…it’s hard to get my head around that we’re developing a vaccine …while people are dying from the outbreak.”
Broderick compared her leadership with a soccer manager. “A good soccer manager doesn’t have to be the best player,” Broderick said. “They just have to put players in the right positions. Seeing where the player excels and putting them in that positon to excel. I am extremely lucky with my incredibly bright and dedicated team. I am lucky to work with them every day.”
Broderick stressed that everyone needs to learn from this and be ready when the next pandemic arrives.
For now, she stresses social distancing and following the guidelines not only to help ourselves but to help the medical workers on the front lines of this fight.