ISA Pharmaceuticals announced that the first patient has been treated in its first-in-human phase 1 trial of its novel immunotherapeutic agent, which is intended as a “functional cure” for patients with chronic hepatitis B virus (HBV) infection. The HEP-PEP trial aims to examine the safety, tolerability, and efficacy of three escalating doses of ISA Pharmaceuticals’ synthetic long peptide immunotherapy vaccine, ISA104, in comparison to a placebo among patients with HBV.
Leon Hooftman, MD, expressed his delight at this significant milestone in their mission to develop an effective treatment for chronic hepatitis B virus infection. Study investigators from Erasmus MC University Center in Rotterdam, Sonja Buschow, PhD, and Dave Sprengers, MD, PhD, highlighted their anticipation to understand the potential impact of the ISA104-based therapy on patients with chronic HBV. They emphasized that this study would deepen their understanding of this promising new therapy and its effects on HBV-directed immune responses and novel HBV biomarkers.
Furthermore, ISA Pharmaceuticals has previously shown the efficacy of its immunotherapy treatment using synthetic long peptides derived from HPV to treat patients chronically infected with HPV16. Leon Hooftman, MD, chief medical officer at ISA Pharmaceuticals, reiterated the importance of this clinical study in their ongoing efforts to address the global health burden of chronic hepatitis B virus infection and its link to liver cancer.