First patient dosed in Modi-1 Phase 1 trial
13 June 2022
Scancell Holdings plc
("Scancell" or the "Company")
First patient dosed in Modi-1 Phase 1 clinical trial
First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer
Early safety and immunogenicity data expected to be available in H2 2022
Scancell Holdings plc (AIM: SCLP), the 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."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc
+44 (0) 20 3727 1000
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)
+44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Stifel Nicolaus Europe Limited (Joint Broker)
+44 (0) 20 7710 7600
Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment Banking)
Nick Adams/Nick Harland (Corporate Broking)
+44 (0) 20 3727 1000
Simon Conway/Rob Winder/Alex Davis
Scancell is a clinical stage biopharmaceutical company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate novel medicines to treat significant unmet needs in cancer and infectious disease. The Company is building a pipeline of innovative products by utilising its four technology platforms: Moditope® and ImmunoBody® for vaccines and GlyMab® and AvidiMab® for antibodies.
Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs. The Company's unique approach is that its innovative products target modifications of proteins and lipids. For the vaccines (Moditope® and ImmunoBody®) this includes citrullination and homocitrullination of proteins, whereas its mAb portfolio targets glycans or sugars that are added onto proteins and / or lipids (GlyMab®) or enhances the potency of antibodies and their ability to directly kill tumour cells (AvidiMab®).
For further information about Scancell, please visit: https://www.scancell.co.uk/