Next-gen hepatitis C drugs, notably Gilead’s Sovaldi and Harvoni, have cured many patients in the last few years, but we’re still short of a prophylactic vaccine. Hoping to change that are scientists at the University of Maryland, who have secured funding from the NIH to work on a new candidate.
The National Institutes of Health awarded the school's Institute for Bioscience and Biotechnology Research (IBBR) $6 million to work on a hep C vaccine from so-called structure-based design over the next five years.
Like many viral and bacterial pathogens, hep C mutates and evolves rapidly to evade the human immune system, a feature that poses major challenges for vaccine development, explained Thomas Fuerst, Ph.D., director of IBBR and lead principal investigator on this NIH-supported study. These so-called smart viruses could develop immunology decoys to trick the body while hiding some critical features deeper inside. By re-engineering vaccine immunogens at the atomic level, structure-based design could stabilize the antigen, expose its key epitopes and disable other distracting features, thus achieving optimal responses, Fuerst told FiercePharma.
The multidisciplinary team includes experts in human immunology, vaccinology, structural biology, computational modeling, protein engineering, and immunoadjuvant and formulation chemistry. Over the past 10 years, the team, in collaboration with Stanford University School of Medicine, has been focusing on identifying human monoclonal antibodies—from “millions and billions” of them—that could kill diverse strains of the hepatitis C virus. The group then used them to guide selection of an appropriate antigenic site as the vaccine target, Fuerst said.
Now, they have produced several candidates to be examined in upcoming tests in monkeys to determine a lead product for clinical development. Fuerst said they expect to finish the preclinical study in 2018.
The project was previously funded by the “MPowering the State” initiative, a partnership between the university’s College Park and Baltimore campuses designed to expand research collaborations and promote innovation.
Besides the $6 million injection from the NIH, Fuerst said his team is also looking for an additional $5 million to $10 million to advance into human testing. Moving forward, the team expects to license the product out to a biopharma company, Fuerst said.
The IBBR’s Structure-based Vaccine Design team is also leading development of vaccines against pan-filoviruses—Ebola included—using the same technology, and is collaborating with other institutions on its application in an HIV vaccine. Last August, the University of Maryland’s Institute of Human Virology received a $14.4 million grant from the NIH for work on creating an effective HIV vaccine.
The hepatitis C drug market, on the other hand, is already crowded with competition. Major players Merck & Co., which has Zepatier; AbbVie, which sells Viekira Pak; and Gilead Sciences, which owns Sovaldi, Harvoni and Epclusa, are experiencing sales woes as the number of patients cured rises and the pool of untreated patients shrinks.