Interview: How This Homegrown Philly Biotech Co. Is Leading the World On a Zika Vaccine

Zika virus micrograph image via CDC

The Zika virus is showing no signs of slowing down.

Most recently, the virus has caused an uptick in the number of women seeking abortions in Latin America and has given some people doubts about attending this summer’s Olympic Games in Rio de Janeiro, Brazil, where the World Health Organization has reported some of the highest incidences of microcephaly, a fetal neurological abnormality linked to the virus.

As of June 15th, 60 countries and territories report continuing mosquito-borne transmissions. Philadelphia announced its first case of the Zika virus in February, and Chester County just confirmed its first case on Wednesday.

While there is currently no vaccine or therapy for the Zika virus, a homegrown Philadelphia biotechnology company is leading the effort to get one on the market. On Monday, Inovio Pharmaceuticals announced that it was approved to test its vaccine on humans.

BizPhilly spoke with Inovio’s founder and CEO, Joseph Kim, about the vaccine, a timeline for the human study, and the implications of being a small biotech firm that’s leading the way for a solution to the infectious disease.

The news broke on Monday that Inovio can now initiate the first phase of testing the experimental Zika vaccine, GLS-5700, in humans. Can you talk about how Inovio got approval from the U.S. Food and Drug Administration to begin testing?

Inovio has built a product vaccine and an immune therapy product development platform. It’s quite revolutionary where we can develop the products much faster than the traditional viral vaccine developers could. We started working on the Zika program late last year, and within about six months from starting the animal testing of our Zika vaccine, we were able to complete all the tasks required to get the FDA approval for our first human study.

In the world, Inovio’s product is the first to get approval for human study. We are very proud of that and we look forward to completing this first study and moving on to the next one. We want to move as rapidly as possible to bring this vaccine to the market, to the patients who need it.

Can you speak more about the technology Inovio used to develop the vaccine?

One of the reasons why we can develop such a vaccine rapidly and effectively is that our technology doesn’t involve ever touching the virus. Rather, instead of using the virus as a vaccine where typically the vaccine makers do, we use DNA code, a genetic code for part of the Zika virus that can generate the immune responses in the vaccine recipients. It’s all genetic DNA codes instead of any infectious materials. Our products are designed to be safer than the typical vaccine and perhaps more effective and that allows us to apply the 21st century technology against such an infectious agent as the Zika virus.

And how was this technology applied in animal testing trials?

We designed our vaccine on the computer using the genetic database of the Zika virus, and then we made the vaccine synthetically. Then we tested the vaccine first in small animals, laboratory mice, just to see if it can generate the right level of immune responses in these animals against Zika from our vaccine. Then we tested it on other animal species like rabbits and monkeys to generate the sufficient data to get FDA approval. A lot of work has gone in, in the last six months.

What did Inovio learn about the vaccine from the animal testing?

We learned that our vaccine can generate the right level of immune responses in these animals and that allows us to be very hopeful and optimistic that we will see similar responses in the human subjects that will volunteer for our clinical studies.

We’ve also learned from our vaccine products that we’ve developed previously for Ebola and HIV. We have developed a lot of experience in applying our technology in the last several years. This is really a culmination of putting together our revolutionary technology that can really bring the right level of science to rationally developing a vaccine as quickly and as effectively as possible.

When will the first trial begin and what exactly are you testing in this first phase?

Right now, because all of the federal regulatory approvals have been given, we will begin testing in the next few weeks. We are working on paperwork for the recruitment process and because of the focus Zika has in our public minds, we’ll be able to get the recruitment done pretty quickly. We’re confident we will have some data from the first study by the end of this year.

We are going through the various cities where we will be recruiting 40 volunteers in the United States and Canada. We will have two sites in the United States. Philadelphia is one of them. We will bring in about 10 to 15 subjects from Philadelphia. The second site is in Miami. The third site in Canada has not been disclosed yet.

This trial will test safety and the vaccine’s ability to generate the right immune responses against the Zika virus. Those responses are antibodies and T-cells against Zika virus parts.

If this first phase of testing with 40 subjects shows promising results, what’s next?

Following this first trial, we will do another study that typically takes a few hundred people, and we will be looking for a signal of effectiveness along with additional safety and human responses.

And let’s say the testing is successful with those few hundred people. How will Inovio move forward?

At that point it really depends on the urgency and how dire the need for the human vaccine. If the data looks good from the first couple of studies, we will work with the regulatory agencies to find the best way to bring the vaccine to the market. And those things can take a few months to several years. It also depends on how safe the vaccine is in those studies along with the medical and market need for such a vaccine. As we look at Latin America and the Caribbean and the U.S. Territory of Puerto Rico, it’s clear the disease is spreading very fast. It’s clear there is a medical need for the vaccine Inovio is developing.

Can you talk about the significance of Inovio being ahead of the race? What does this mean for Inovio and for the region?

Where we are with the Zika vaccine is very significant for the region and for Inovio. Inovio is a company that started out of Philadelphia. I started the company with my PhD professor out of the University of Pennsylvania medical school about 15 years ago.

This is a homegrown company and so is the technology. I’ve grown it from a one-person startup to almost a billion dollar market cap, NASDAQ listed, biotech company with over a hundred scientists and vaccine developers working in the business. Inovio is a locally started business, employing local folks, and bringing breakthrough technology that can really develop these important vaccines and therapies.

Our current collaborators include the University of Pennsylvania and especially the biomedical Wistar Institute in Philadelphia.

Are you anxious about anything as you move into this first phase of human trials?

We just need to hurry. There are millions who have been infected in South America. There are hundreds of thousands of Americans, Puerto Ricans projected to get infected in the next several months. We want to make sure we can develop our vaccine as fast as possible. We have a very dedicated group of scientists and vaccine developers who are really devoted to making this happen.

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