By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Oscar winning producer Agustin Fernandez III wanted to make a difference in healthcare. But, he didn’t want to be someone who disrupts the industry, he wants to be a transformative force in the lives of people suffering from genital herpes.
The founding of the company didn’t just happen. Agustin did some homework into therapies for genital herpes, which lead him to William Halford, an associate professor of Microbiology and Immunology at Southern Illinois University School of Medicine in Springfield, Illinois. Halford has studied the herpes simplex virus for 25 years and in 2006 became interested in trying to develop a vaccine for HSV-2, one of the genital herpes strains. Agustin learned of Halford’s research and approached him, but did not get very far—at first. After “badgering” Halford for several years, Agustin said the two finally meshed and formed Rational Vaccines.nal
“This is a scientist who had dedicated his life to curing herpes. He’s a man who has brain cancer and is still devoting his time to develop this cure,” Agustin said of Halford in an exclusive interview with BioSpace. “I’m honored to be able to help him with this.”
In October, Rational announced the successful completion of its Phase I trial for Theravax, a live vaccine for treatment of HSV-1 and HSV-2 for patients who suffer with recurrent genital herpes. The trial treated 17 patients with three doses of the vaccine and each of the patients indicated Theravax was “was more effective in reducing their genital herpes symptoms than antiviral drugs,” according to a company statement. Current treatment for an outbreak of genital herpes is antiviral medications.
Agustin said they are still poring over the data from the Phase I trial. Through nine months, some of the patients are still seeing symptoms, but outbreaks have lessened from monthly to about once every four months, he said.
Agustin said the company is planning to initiate another Phase I trial in Mexico, as well as a Phase II trial in that country and in St. Kitts, an island in the West Indies. Agustin anticipated that the majority if clinical trials will be performed outside the United States. He said the U.S. Food and Drug Administration can take too long in its approval process and does not have a favorable view of live vaccines.
In the U.S., it is estimated that about one out of every five people have genital herpes, according to the Center for Disease Control. Most people do not have symptoms, but some outbreaks can be acute and lead to severe problems. When it comes to global statistics, the World Health Organization indicates that approximately 67 percent of the world population, more than 3.7 billion people, are infected with HSV-1. With numbers like that, Agustin called herpes a pandemic, but said so far Halford’s work indicates there is hope a vaccine can be developed for people.
Although Agustin is the first to admit he is not a scientist, he said the movie industry was the perfect training ground for running a pharma startup. Agustin said the film industry requires a lot of outside-the-box thinking to take a story from the script to the screen. It’s the same way in running what he calls a non-traditional pharmaceutical company.
Agustin won the Oscar as the executive producer of the 2013 short film “The Lady in Number 6: Music Saved my Life,” the story of Alice Herz-Sommer, who at the time, was the world’s oldest survivor of the holocaust. She died in 2014, 10 days before her story won the Oscar.
Although Agustin provided much of the financing for the Phase I trial, he said the company was preparing to go into a Series A round of financing. He said the vaccine is generating a lot of interest from potential investors and expects to make an announcement sometime in late March or early April.
“The more word gets out about what we’re doing, the more people are reaching out,” Agustin said.
One area that excites Agustin about the potential effect of the vaccine is the number of people who could benefit from the vaccine through compassionate use sales.
But, it isn’t just about developing a vaccine for herpes that drives Agustin, he also wants to eradicate the social stigmas attached to the disease.
“It’s easy to say don’t talk about it and let people live in shame. That has to stop,” Agustin said. “When you meet these good people suffering in silence it’s almost impossible not to devote every waking moment to help them.”
Rational Vaccines currently employs five people. However, Agustin said he and Halford are not taking a salary.
“We are mission before margin,” he said. “We look at money and we raise money only in how it can keep us viable and sustainable. We don’t need to make billions of dollars. The bigger picture for us is how to defeat a disease.”