Before he co-founded Provention Bio, Ashleigh Palmer worked on inhaled nitric oxide for infants with respiratory failure. After the company was sold for $1.2 billion to a Baxter-led consortium, Palmer noticed there was apprehension about conducting clinical trials with neonates. He was concerned that the inhaled NO assets were slated to fall to the wayside.
“I had seen blue babies turn pink,” Palmer told Drug Delivery Business News. He went on to spin out the technology into a new company, INO Therapeutics.
“What I saw was the industry’s propensity to avoid unusual drugs, unusual therapies, things that are outside of the box,” he said. “That vision has always stayed with me. What else is out there that is being under-developed?”
Although Provention Bio could be considered a rogue in the pharmaceutical industry, it’s backed by some big-name investors – including Johnson & Johnson (NYSE:JNJ) and JDRF. Strategic partnerships within the industry is what helps drive Provention Bio’s pipeline, according to Palmer.
“We started up Provention last year to create a vehicle to win licenses, assets that the pharmaceutical industry may not have a priority to develop directly themselves, but still didn’t want to out-license outright and still have some strategic interest,” he said.
The company, which landed $28.4 million in a Series A round in June, focuses on technology that helps to “intercept and prevent” immune-mediated diseases. Earlier this month, Provention licensed a vaccine technology from Finnish biotech Vactech Oy that it believes could prevent the onset of Type I diabetes.
“I don’t think that people realize that Type I diabetes is an autoimmune disease, like rheumatoid arthritis or celiac or psoriasis, and it’s our own immune system that is killing those precious insulin-producing cells,” Palmer said.
The team at Provention was working with scientists in Finland on a different therapy, when something else caught their attention. There is a high prevalence of Type I diabetes in Finland, according to Palmer, and the government funded epidemiological studies showing a link to a virus caused by the coxsackievirus B pathogen.
Working with the Finland-based scientists, Provention embraced the notion that Type I diabetes could be stopped with a vaccine against CVB infection. Previous work has shown that CVB infection could be responsible for as many as 50% of Type I diabetes cases worldwide, according to the company.
“People are starting to understand that there are a number of reasons why people get autoimmune disease. One factor is genetic susceptibility. In addition, there has to be another trigger that reprograms your immune system to start attacking cells,” chief medical officer & COO Dr. Leni Ramos told us. “In our case, it’s a virus that triggers an infection that leads to some people developing the autoimmune disease.”
Ramos, a 20-year pharma industry veteran, also pointed to data showing that mothers who were previously infected with the CVB virus had children with a lower risk for developing Type I diabetes, since they already had antibodies against the infection.
The company’s diabetes program is still early in development. They are working to finish a toxicology package, file an IND and launch first-in-human studies for the vaccine within the next year, according to Palmer. Provention also has a Phase II asset involving Crohn’s disease, an treatment for ulcerative colitis and a technology for emerging viral infections in its pipeline.
In the meantime, Palmer said the company is “evaluating our options” while they look for a partner to manufacture the CVB vaccine.
“A diabetes program, where you can really prevent and intercept so early, is probably one of the most exciting programs that we have,” Ramos said.
“We do this because we believe that there are patient needs that are being unmet by the traditional industry,” Palmer added. “We really believe that we can be compensated well ourselves if we focus on that need and do a good job and bring therapies to patients that are in need – therapies that are a little outside the box, which the industry wouldn’t otherwise be prioritizing themselves.”