First patient dosed in ISA Phase 1 immunotherapy trial for chronic hepatitis B

ISA Pharmaceuticals announced that the first patient has been treated in a first-in-human Phase 1 trial of its novel immunotherapeutic agent designed to provide a “functional cure” for patients with chronic hepatitis B virus infection.

The HEP-PEP trial will examine the safety, tolerability and efficacy of three ascending doses of ISA Pharmaceuticals’ synthetic long peptide immunotherapy vaccine ISA104 compared with placebo in patients with HBV.

“We are excited about the progress of this first-in-human trial and are eager to understand the potential impact that ISA104-based therapies may have in patients with chronic hepatitis B virus infection,” the researchers said. Dr. Sonia Bushaw, and Dave Sprengers, MD, PhD, said the Erasmus MC University Center in Rotterdam, the Netherlands, in an ISA Pharmaceuticals press release.

They added: “This study will allow us to determine the relationship between safety issues and immune responses and incidental problems in patients treated with ISA104, and deepen our understanding of this promising new treatment, HBV-directed immune responses and understanding of novel HBV biomarkers. ”

According to the company, the drug ISA104 is designed to generate a strong and specific immune response against hepatitis B virus “with the goal of functionally curing patients with chronic infection.” ISA Pharmaceuticals has previously demonstrated the efficacy of its immunotherapy using synthetic long peptides derived from HPV to treat patients chronically infected with HPV16.

“We are pleased to announce that the first patient in the HEB-PEP clinical study has been treated with ISA104, marking an important milestone in our mission to develop effective treatments for patients with chronic hepatitis B virus infection, chronic hepatitis B virus Infections are a huge global health burden and part of our mission. “The Clear Cause of Liver Cancer,” Leon Hoffman, MD, ISA Pharmaceuticals chief medical officer said in a press release. “This study will provide important information about the safety and potential efficacy of ISA104 as we continue to advance our clinical program with a focus on improving patient outcomes.”