More than four billion people in the world have a form of herpes, and yet the standard of care for the disease is limited to acyclovir-related antiviral drugs that have failed to prevent the spread of herpes or curb the symptoms of herpetic disease in many patients. That inspired Agustin Fernandez III, an Oscar-winning producer known for films such as Falling Awake and Badge of Honor, to put his skills to use as a pharma company CEO. Together with William Halford, PhD, he started Rational Vaccines with the goal of offering better solutions to stop the spread of herpes.
Agustin Fernandez III: I really have a passion for eradicating this disease as friends and loved ones have suffered from it. Though it’s funny that everybody sees it as a big switch, running a film is a lot like running a small startup. You take an IP that you like, then you develop it, raise money around it, hire an extensive team, execute on that IP, market it, and sell it.
So they’re very similar, and I don’t feel like I’ve abandoned movies forever. This is just a bigger project. I haven’t written my great script yet, or directed my great movie. But this is my opus. I’m getting to work with Dr. William Halford, a really brilliant scientist who devoted his life to helping people.
How did the two of you come together?
I did a lot of research on the herpes virus and I realized that his approach is the only one that made sense to me, and it seemed to make sense to the scientific community. Of all alphaherpesviruses, three are most well-known: herpes simplex virus types 1 and 2—otherwise known as “herpes”—and what we call the chickenpox, varicella zoster virus. And an attenuated live viral vaccine known as the VZV Oka vaccine has been used successfully for decades against the chickenpox.
The scientist who developed that vaccine was Japanese and his son was really suffering from chickenpox. At the time, he was based in the U.S., but when he saw the regulatory landscape in the U.S. was too difficult to navigate, he went to Japan. Many years later, Merck quietly bought it and brought it back to the States.
That vaccine is based on the same principle as Dr. Halford’s ICP0–mutant vaccines, which is, you take a live virus and you attenuate it. There’s never been a properly attenuated live vaccine that hasn’t worked to eradicate its corresponding virus.
So when I heard that Dr. Halford had the same approach, and he has 20 years of research involving lots of animal trials with guinea pigs that correlate well with humans, I just started trying to convince him to form a company with me, and luckily, he agreed.
One of the big hurdles with starting a pharma company is the regulations. How have you adjusted to overcome these hurdles?
For me, eradicating this virus is a passion and mission—I don’t care how long it takes. I don’t care how much money it costs. Dr. Halford is the same way. So I think it just comes down to stamina. Whereas a film may only take one or two years of your life, this is something you have to commit to long term. A lot of pharma companies don’t commit—an average CEO’s life in a company is only four years.
So you’ve got to hunker down and really keep pushing. To start, we’ve developed a creative strategy that may not be super novel, but we recognized that there are more progressive regulatory environments in the world that are more willing to give us a chance. That is why we are aggressively moving forward with trying to get approval in countries outside the U.S. (see sidebar).
One of the keys to getting a startup off the ground is funding. How did you raise money for Rational Vaccines?
Initially, it was my money. Then I approached my friends, family, and Dr. Halford’s family. We raised about $700,000 to do the phase I human trial. It was a little bit different than usual. Most people want to raise a lot of money and go experiment to see if they can figure something out. But since Dr. Halford had already injected himself and his family with this vaccine to prove its safety, we felt we already had something figured out—we just needed to prove it through studies.
Since we announced the phase I trial, a lot of people have been interested in investing. I’ll tell you a little anecdote. We had an investor, actually a venture capitalist, who donated $50,000 to us. When I asked him why not just invest, he said, “I don’t want to invest. It’s not my space. But I want to give you this money because my sister committed suicide because she had genital herpes, and I know your cause is important.”
I am also being very proactive on a Series A round right now, and we hope to close with a top tier venture capitalist soon that I think will be a great strategic partner.
Rational Vaccines’ Three-Pronged Mission
Rational Vaccines wants to solve all aspects of the herpes problem—beyond just developing better treatments.
The company is working on a new line of therapeutic and prophylactic HSV vaccines, including TheravaxHSV and ProfavaxHSV. According to Fernandez, they are preparing a phase II trial in the Caribbean and a phase I trial in Mexico. “We want to tackle all of the phases in Mexico, where we think we can get to market very quickly. Then we want to start passing some of the regulatory hurdles in the U.S. right after Series A.”
“The current standard of diagnosis of herpes is so bad that the U.S. government has given it a D score on a rating of A to D,” Fernandez explains. Dr. Halford developed a new flow cytometry-based diagnostic test called ABVIC, which measures antibody binding to virus-infected cells. The ABVIC Test includes a background control, is 100 times more sensitive than currently available tests, can shorten diagnosis time to four to six weeks, and has the potential to detect 100% of HSV-1 and/or HSV-2 specific antibodies.
Rational Vaccines is also committed to improve the accuracy of information that scientists, clinicians, and patients rely upon to discuss genital herpes as well as identify solutions to improve the diagnosis, management, and prevention of herpetic disease. “There is a lot of misinformation out there,” Fernandez says. “We’re probably lacking in doing more about this right now, but it is part of our mission and I think we’ll do more of a campaign when we finish our Series A round.”