ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, today announces that a clinical trial using ISA’s novel AMPLIVANT adjuvant technology has started.
The trial, run by partner Scancell Holdings plc (AIM: SCLP, “Scancell”) is a multicentre clinical trial, testing the Moditope vaccine Modi1. This first-in-human clinical trial brings Modi-1 to patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer using the AMPLIVANT adjuvant technology to boost immune response to the therapy.
The main study is an open label clinical trial. The initial part of the trial will assess the safety and immunogenicity of Modi-1. In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumour will be assessed in a neoadjuvant cohort of patients with head and neck cancer treated with Modi-1, randomised to treatment with or without a checkpoint inhibitor, prior to the first surgical resection.
The Modi-1 peptides are linked to AMPLIVANT, a potent adjuvant and toll-like receptor (TLR) 1/2 agonist, which enhances the immune response 10-100fold, resulting in highly efficient tumour clearance, including protection against tumour recurrence, in preclinical models. AMPLIVANT is the subject of a worldwide non-exclusive licensing and collaboration agreement with Scancell for the manufacturing, development, and commercialisation of Modi-1.
Professor Kees Melief, Chief Scientific Officer, ISA Pharmaceuticals, commented: “Adjuvants are crucial components of vaccines which boost efficacy, however there is lack of new, innovative, and effective adjuvants in development to add to a limited armamentarium. As such this is an important achievement and highlights the productive collaboration, we have with Scancell. The trial provides a further opportunity to demonstrate the potent adjuvant properties that AMPLIVANT confers on therapeutic vaccines to potentially benefit patients with a broad range of solid tumours.”
Professor Lindy Durrant, Chief Executive Officer, Scancell, commented: “This is the first time we have taken a product from our Moditope platform into cancer patients and is a major step forward for Scancell and our collaboration with ISA Pharmaceuticals. We are very excited about the prospects for Modi-1 based on the dramatic regression of large tumours in our preclinical models.”