First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer and renal cancer
Scancell, a company which specialises in treating cancer and infectious diseases, has announced 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, ovarian, head and neck and renal cancer.
Modi-1 is the first candidate in Scancell’s Moditope platform and the open label study will recruit up to 108 patients across 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 accordingly.
In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumour will be assessed during a cohort in which a further 30 patients with head and neck cancer will be treated with Modi-1 prior to their first surgical resection.
Professor Lindy Durrant, CEO at 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.”
Dr David Pinato, medical oncologist and principal investigator at Imperial College London, Hammersmith Hospital, added: “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.”
Meanwhile, the Modi-1 peptides are linked to Amplivant, a potent adjuvant which enhanced the immune response and resulted in highly efficient tumour clearance, including protection against tumour recurrence, in preclinical models. The therapy is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development and commercialisation of Modi-1.
Scancell expects early safety and immunogenicity data to be available later in 2022 and efficacy data in 2023.
