First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer

Scancell, Calculus portfolio company and developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces the enrolment and treatment of the first patient in its multicentre Modi-1 clinical trial (ModiFY) at Imperial College London, Hammersmith Hospital. The study is a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. Modi-1 will be administered alone or in combination with checkpoint inhibitors (CPIs) in patients with head and neck, triple negative breast and renal tumours.

Modi-1 is the first candidate in Scancell’s Moditope® platform. This open label study will recruit up to 108 patients in up to 20 UK clinical trial sites. The objectives of the initial part of the trial are to assess the safety and immunogenicity of two citrullinated vimentin peptides and, if there are no significant side effects, a citrullinated enolase peptide will be added. In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumour will be assessed in a neoadjuvant cohort in which a further 30 patients with head and neck cancer will be treated with Modi-1 with or without CPI, prior to their first surgical resection.

The Modi-1 peptides are linked to AMPLIVANT®, a potent adjuvant which enhanced the immune response 10-100 fold and resulted in highly efficient tumour clearance, including protection against tumour recurrence, in preclinical models. AMPLIVANT® is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development and commercialisation of Modi-1.

As previously announced, the Company expects early safety and immunogenicity data to be available in H2 2022 and efficacy data in 2023.

Prof 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 it is a highly significant milestone for the Company. We are optimistic about the broad clinical utility of Modi-1 and, following safety assessments in the first few cohorts of patients, we intend to rapidly recruit patients across all four cancers.”

Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool, commented: “Moditope® represents an entirely new way of treating cancer and I am delighted to be working with Scancell as the principal investigator for this first-in-human clinical trial.”

Dr David Pinato Medical Oncologist and Principal Investigator at Imperial College London, Hammersmith Hospital commented: “The rationale to treat patients with Moditope® is scientifically attractive, and in clinical practice was very straightforward to administer to our first patient. The study will address many important clinical questions in patients where there is an unmet need.”