The biopharmaceutical company, lead by co-founder & CEO Ashleigh Palmer, is developing a number of products that aim to prevent or stop the spread of immune-mediated diseases, including Lupus, Crohn’s disease and Type I diabetes.
Provention Bio’s strategy is to find drugs that have been developed by other pharmaceutical companies and take them through the clinical development process. But Palmer draws a clear distinction – the company is not “sifting through the trashcan of big pharma.”
“We’re going carefully through the attic of these organizations,” he told Drug Delivery Business News. “If we were sifting through the trashcan, we’d be in discussions with the business development functions basically bidding for stuff that they were getting rid of and making up-front payments. We’re not doing that.”
Instead, Palmer and his team work directly with industry scientists in the context of a partnership.
“We’re developing partnerships with the organizations to learn from the work that was done by the original sponsors. We work in collaboration with them, in many instances having access to their technology, to their biomarkers, to their skills to be able to interpret the data. We reposition and reevaluate these assets in a different context,” Palmer explained.
Going public was always a part of the company’s strategy, the chief executive added.
“These assets require significant amounts of capital and are not necessarily ideally suited to ongoing venture capital investment. So we’d always intended to get to the public markets as soon as possible to access the type of capital that would be required to fund an intermediate stage clinical development program,” Palmer said.
Provention Bio has five products in its pipeline: a Phase III monoclonal antibody designed to halt Type I diabetes, two Phase II immunology candidates for inflammatory bowel diseases, a Phase I candidate for auto-antibody mediated diseases like lupus, and an IND-enabling-stage vaccine for acute coxsackie B virus infection that could potentially prevent the onset of Type I diabetes.
All five of Provention Bio’s pipeline candidates are geared toward preventing or stopping the spread of a disease, according to co-founder & CSO Dr. Fransisco Leon.
“What we are trying to do is to identify assets which go after upstream targets – upstream either in the pathophysiology of the disease or upstream in the temporal disease process, meaning early disease,” he said.
In order to prevent or halt a disease, scientists need to know what triggers a patient’s immunological cascade. Figuring out what sets off a disease, Fransisco said, is no easy task.
“Sometimes the trigger takes place very early in life, within the first months of life. And there are just a handful of diseases for which those triggers are fully understood. In the cases where we cannot identify the trigger for prevention, then we have to go to the next most upstream event that we know,” he said.
Now that the company has stepped into the public markets, Provention Bio is gearing up for a Phase III study of its anti-CD3 monoclonal antibody in people with Type I diabetes.
The group is also expecting to see top-line data from studies of its drugs designed to treat Crohn’s disease and ulcerative colitis in the second half of 2019, according to COO & CMO Dr. Leni Ramos.
Ramos also noted that the team is finalizing the preclinical program for its CBV vaccine and readying for a first-in-human study.
“We anticipate [that study will begin] no later than the beginning of 2020,” she said.
“It’s so exciting working with individuals like Leni and Francisco,” Palmer said. “All of us come from backgrounds of frustration. We’ve tasted success and we’ve experienced failures. Francisco and Leni have experienced the roller coaster ride of developing assets within big pharma and development-stage biotech companies.”
Alongside its industry partners, Provention Bio works with patient advocacy groups like the JDRF to help keep the team grounded in the ultimate goal of drug development.
“We’re reminded every day of just how important it is for us to push these programs forward as quickly as possible and try to get interventions, interceptions and prevention to patients to avoid suffering a lifetime of autoimmune disease,” he said.