ISA Pharmaceuticals, in partnership with Erasmus MC, is awarded TKI grant and expands clinical pipeline

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

OEGSTGEEST, Netherlands, July 20, 2021 /PRNewswire/ -- ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, 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, in collaboration with Erasmus MC in The Netherlands.

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
⁴ https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

About ISA Pharmaceuticals

ISA Pharma is an immunotherapy company developing treatments for various cancers and infectious diseases. ISA Pharma has best-in-class technology to stimulate and activate the human 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 a collaboration with US pharmaceutical company Regeneron. Other assets are in preclinical stage development and include immunotherapies to treat patients that suffer from chronic hepatitis B infections, cancers that over-express PRAME, cancers caused by other HPV types than HPV16, or SARS-CoV2 infections. For more information, please visit www.isa-pharma.com.

About Erasmus MC and its Department of Gastroenterology & Hepatology

Erasmus MC is the largest University Medical Center in the Netherlands. Our primary goal is a healthy population. Nearly 13,000 employees devote themselves every day to providing outstanding care, facilitating world-class education and conducting pioneering research. Within Erasmus MC the department of Gastroenterology & Hepatology hosts one of Europe's leading liver centers visited by over 1200 new patients each year and with the nation's largest liver transplant unit. The department performs innovative translational and clinical research and is internationally well-known for its experience in the field of viral hepatitis. Being visibly better and leading the way in the areas of complex, innovative and acute care by collaborating with others: these are key ambitions at Erasmus MC

About Health~Holland, Top Sector Life Sciences & Health PPP Allowance Program

Health~Holland, Top Sector Life Sciences & Health (LSH) supports innovative research and development realised by public-private partnerships (PPPs) of the Dutch LSH sector. The Top Sector brings together stakeholders in a shared, consolidated innovation infrastructure. By means of PPP Allowance, the Top Sector provides a financial instrument to help consortia consisting of research organisations, knowledge institutes, companies, and health foundations to realise their innovative ideas. For more information, please visit https://www.health-holland.com