First patient with chronic hepatitis B treated with ISA104 in first-in-human Phase 1 study

Erasmus MC study marks first clinical development milestone for ISA104 immunotherapy to treat chronic hepatitis B infection

UGSTGEEST, The Netherlands , Aug. 31, 2023 /PRNewswire/ — ISA Pharmaceuticals, a clinical-stage biotechnology company developing immunotherapies to treat cancer and serious infectious diseases, is pleased to announce that the first patient has been dosed in the HEB-PEP study. This first-in-human (FIH) Phase 1 study investigated the use of ISA104, a novel treatment designed to achieve functional cure in patients with chronic hepatitis B. Dosing was performed at the Department of Hepatology at the Erasmus Medical Center in Rotterdam, the sponsor of this dose-escalation study.

The HEB-PEP study will compare the safety, tolerability and efficacy of different doses of ISA104 compared with placebo in patients with chronic HBV. Details of the study can be found at ClinicalTrials.gov with identifier NCT05841095. The study was conducted in collaboration with researchers from the Department of Gastroenterology and Hepatology at the Erasmus Medical Center in Rotterdam, the Netherlands, and was co-funded by a PPP grant from the top life sciences and health sector Health~Holland to stimulate public- Private Partnership.

Hepatitis B is a severe liver infection that is a global health threat caused by the development of chronic infection in some patients who are unable to clear the virus and become carriers. It increases a person’s risk of liver cancer, liver failure, and/or cirrhosis, for which there are currently no effective treatments. Two billion people worldwide are infected with hepatitis B virus, and approximately 1.5 million people are newly infected every year. Approximately 300 million people suffer from chronic sequelae of this disease.

ISA collaborated with Erasmus MC to develop ISA104 immunotherapy using ISA’s Synthetic Long Peptide (SLPĀ®) technology. ISA104 is designed to generate a robust and specific immune response against hepatitis B virus, with the goal of functionally curing patients with chronic infection. ISA has previously shown that SLP immunotherapy is effective in patients chronically infected with human papillomavirus type 16 (HPV16).

Leon Hooftman, chief medical officer of ISA Pharmaceuticals, said: “We are pleased to announce that the first patient has been enrolled in the HEB-PEP clinical study with ISA104, This is an important milestone in our mission to develop effective treatments for patients with chronic hepatitis B virus infection, a huge global health burden and a well-established cause of liver cancer. This study will provide important information about the safety and potential efficacy of ISA104 as we continue to advance our clinical programs focused on improving patient outcomes. “

The study’s principal investigators, Dr. Sonja Buschow and Dr. Dave Sprengers of the Department of Gastroenterology and Hepatology at the Erasmus Medical Center, commented: “We are excited about the progress made in this first-in-human trial and are eager to understand the potential impact that ISA104-based therapies may have in patients with chronic HBV infection. This study will allow us to identify safety issues and how to address this “Immune responses in patients receiving ISA104 are associated with incidental immune responses and deepen our understanding of this promising new therapy, HBV-directed immune responses and novel HBV biomarkers”

ISA104 is the latest pipeline project of ISA to enter clinical development. Its previous leading project ISA101b is in the late clinical development stage for the treatment of cancers induced by HPV16.

For more information, please contact us at info@isa-pharma.com. For more information, please visit us at isa-pharma.com.

About ISA Pharmaceuticals

ISA Pharmaceuticals is an immunotherapy company developing treatments for a variety of cancers and infectious diseases. ISA has state-of-the-art technology to stimulate and activate the body’s immune system, specifically T cells, to fight diseased or infected cells. Its lead asset, ISA101b, is in late-stage clinical trials for human papillomavirus type 16 (HPV16)-induced cancer in partnership with biotech company Regeneron. Additional assets are in preclinical development, including immunotherapies to treat patients with cancers that overexpress PRAME, chronic hepatitis B, or SARS-CoV2 infection. For more information, please visit www.isa-pharma.com.

About Erasmus MC and its Department of Gastroenterology and Hepatology

Erasmus MC is the largest university medical center in the Netherlands. Our primary goal is population health. Nearly 13,000 employees work every day to provide exceptional care, promote world-class education and conduct pioneering research. The Department of Gastroenterology and Hepatology within the Erasmus Medical Center has one of Europe’s leading liver centers, receiving more than 1,200 new patients every year, and the largest liver transplant center in the country. The department conducts innovative translational and clinical research and is internationally recognized for its experience in viral hepatitis. Achieve visible progress and lead in the fields of complexity, innovation and acute care through collaboration with others: these are the main goals of Erasmus MC.

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