Pharma Focus Europe

First Patient With Chronic Hepatitis B Receives Initial Dose of ISA104 in Phase 1 Clinical Study

Friday, September 01, 2023

ISA Pharmaceuticals B.V., a clinical-stage biotech firm dedicated to developing novel immunotherapies for cancer and serious infectious diseases, has announced the initiation of the HEB-PEP study. This significant phase 1 trial, known as first-in-human (FIH), marks a substantial leap in chronic Hepatitis B (HBV) treatment. The study focuses on ISA104, an innovative therapy aiming to achieve a functional cure for Chronic Hepatitis B patients. The first patient has successfully received treatment at the Liver Unit of Erasmus Medical Center in Rotterdam, the study's sponsor.

The primary objective of the HEB-PEP study is to evaluate the safety, tolerability, and efficacy of various doses of ISA104 compared to a placebo, in the context of chronic HBV patients. Those seeking more details about the study can refer to, using identifier NCT05841095. ISA Pharmaceuticals is collaborating closely with experts from the Gastroenterology & Hepatology department of Erasmus MC in Rotterdam, the Netherlands. Co-funding is provided by a PPP Allowance from Health~Holland, Top Sector Life Sciences & Health, aimed at fostering public-private partnerships.

Hepatitis B is a severe liver infection posing a global health challenge, leading to chronic infection in patients who cannot clear the virus, becoming carriers. This condition significantly increases the risk of liver cancer, failure, and cirrhosis. Effective curative treatments for these consequences are currently lacking. An estimated two billion people worldwide have encountered the hepatitis B virus, with about 1.5 million new infections annually. Approximately 300 million individuals continue to endure chronic effects of this ailment.

ISA Pharmaceuticals has collaborated with Erasmus MC to utilize their Synthetic Long Peptide (SLP®) technology in developing ISA104 immunotherapy. This innovative treatment is designed to generate a potent and precise immune response against HBV, with the goal of achieving a functional cure for patients with chronic infection. Previously, ISA Pharmaceuticals demonstrated the efficacy of SLP immunotherapy in patients with human papillomavirus type 16 (HPV16).

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals, expressed enthusiasm, stating, "We are excited to initiate patient enrollment with ISA104 in the HEB-PEP clinical study. This is a pivotal moment in our mission to develop an effective treatment for patients with chronic hepatitis B virus infection—a pressing global health issue associated with liver cancer. Insights gained from this study will help us understand ISA104's safety and potential efficacy, driving us to enhance patient outcomes."

Drs. Sonja Buschow and Dave Sprengers, Principal Investigators from Erasmus MC's Department of Gastroenterology & Hepatology, shared their anticipation about the study's progress. They look forward to understanding the potential impact of ISA104-based therapy on patients with chronic hepatitis B virus infection. The study aims to determine the relationship between safety issues, immune responses, and chance occurrences among patients receiving ISA104. Additionally, the study offers the opportunity to deepen understanding of the novel therapy's effects, HBV-directed immune responses, and innovative HBV biomarkers.

ISA104 is the latest addition to ISA Pharmaceuticals' expanding pipeline, entering clinical development after the company's lead program, ISA101b. The latter is in advanced stages of clinical development for treating HPV16-induced cancers.

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