Grant accelerates clinical development of immunotherapy to treat chronic hepatitis B virus infection

Oegstgeest, 20 July 2021 – ISA Pharmaceuticals B.V. is pleased to announce that a consortium between the Erasmus MC and ISA has been awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104 to treat hepatitis B in chronically infected patients.

The clinical study, to be conducted in close collaboration with the Gastroenterology & Hepatology department of the Erasmus MC, is entitled the ‘HEB-PEP study’. The project starts in August 2021 and the clinical phase is expected to begin in 2022. It will provide an insight into which dose of ISA104 is safe, tolerable and potentially effective in chronic HBV patients.

ISA104 is an immunotherapy based on ISA’s Synthetic Long Peptide (SLP®) technology designed to direct a strong and specific immune response against the hepatitis B virus (HBV), with the aim to cure chronically infected patients. It will be ISA’s next program to go into clinical development, with its lead program ISA101b in late-stage clinical trials for human papillomavirus type 16 (HPV16) induced cancers.

ISA Pharmaceuticals has previously demonstrated that SLP immunotherapy for HPV16 can eradicate HPV16-induced pre-cancerous lesions^1,2,3. ISA, in collaboration with Erasmus MC, has developed a set of antigenic long peptides to create an SLP vaccine, ISA104, aimed to boost the patient’s immune response to clear cHBV.

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: “We are excited to announce this TKI project which will enable us to bring a next product to the clinic from ISA’s pipeline. It is a new highlight of our long-standing collaboration with Erasmus MC. This project will test the safety and immune-stimulatory capacity of ISA104, by taking an important next step to potentially curing patients with chronic Hepatitis B, a tremendous global health burden.”

Chronic HBV infection affects an estimated 257 million patients worldwide and 20–30% of adults who are chronically infected will develop cirrhosis and/or liver cancer⁴. Currently, no effective curative treatments exist. Therapeutic vaccines harbour great potential to cure chronic HBV aiming to achieve viral control and clearance. SLP immunotherapies act through induction of potent and durable anti-viral adaptive immune responses.

¹Kenter et al., NEJM, 2009
²Welters et al., PNAS, 2010
³van Poelgeest et al., CCR 2016
⁴https://www.who.int/news-room/fact-sheets/detail/hepatitis-b