On April 14, 2022 ISA Pharmaceuticals reported that a clinical trial using ISA’s novel AMPLIVANT adjuvant technology has started (Press release, ISA Pharmaceuticals, APR 14, 2022, View Source [SID1234612196]). 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.
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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 10-100 fold, 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."
Amplivant is a registered trademark in Europe