Scancell Holdings Plc Clinical Advisory Board and Update on Modi-1

TIDMSCLP

Scancell Holdings Plc

10 May 2019

10 May 2019

Scancell Holdings Plc

("Scancell" or the "Company")

Scancell Establishes Clinical Advisory Board and Provides Update on Modi-1 Progress

Appoints six world class clinical oncologists to guide the Moditope(R) clinical development strategy

Modi-1 manufacturing and toxicity testing underway to support anticipated start of Phase 1/2 study in

Q1 2020

Scancell Holdings plc, the developer of novel immunotherapies for the treatment of cancer, today announces that it has appointed six world-leading clinicians to establish its Clinical Advisory Board ("CAB"). The Board will be chaired by Professor Robert Coleman and will provide strategic guidance and support as the Company prepares for its lead Moditope(R) candidate, Modi-1, to enter the clinic in Q1 2020 in multiple tumour types, including head and neck, breast and ovarian cancer.

The CAB comprises: Professor Robert Coleman, Emeritus Professor of Medical Oncology at Weston Park Hospital and the University of Sheffield; Professor Christian Ottensmeier, Professor of Experimental Cancer Medicine at the University of Southampton; Professor Poulam Patel, Professor of Clinical Oncology at the University of Nottingham and Honorary Consultant Medical Oncologist at the Nottingham University Hospitals NHS Trust; Professor Iain McNeish, Professor of Oncology and Head of the Division of Cancer within the Department of Surgery and Cancer, Imperial College London; Professor David Miles, Lead Clinician for breast cancer at Mount Vernon Cancer Centre; and Professor Stephen Chan, Director of Clinical Trials in Breast Cancer and Gynaecological Cancer at Nottingham University Hospital.

The Company also provides an update on progress towards initiating the Modi-1 Phase 1/2 clinical trial.

-- Good Manufacturing Practice (GMP) synthesis of the bulk Modi-1 peptide conjugates is underway at the PolyPeptide Group's facilities in The Netherlands.

-- The Company signed an agreement at the end of April 2019 with AMRI (Glasgow, UK), a global contract and manufacturing organisation, to formulate, manufacture and package the Modi-1 GMP final product for clinical testing.

-- The preclinical toxicity testing programme required prior to the start of the clinical trial commenced in April 2019 and is anticipated to be completed during H2 2019.

Scancell's Moditope(R) platform acts by stimulating the production of CD4 T cells using citrullinated tumour-associated peptide epitopes. This technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Previous pre-clinical data demonstrated that conjugation of the Modi-1 peptides to Amplivant(R) enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour recurrence.

Dr Cliff Holloway, Chief Executive Officer, Scancell, said:

"We are delighted to welcome all six experienced clinicians to our Clinical Advisory Board and the creation of this Board is part of our wider strategy to fully develop and deliver the full potential of the Moditope(R) platform across multiple tumour types. The initial focus of the Board will be to inform the clinical strategy for the planned Modi-1 clinical trial and to ensure the best possible outcome in several solid tumour indications, including ovarian cancer, head and neck cancer, and triple negative breast cancer. Significant progress has been made towards completing the GMP manufacture of the Modi-1 product and the preclinical testing required prior to the anticipated start of the trial early in 2020."

Chair of the Clinical Advisory Board, Professor Robert Coleman said:

"I am pleased to be working alongside Christian, Poulam, Iain, David and Stephen, who collectively have long, established track records in scientific and clinical research in oncology. I am looking forward to chairing the Clinical Advisory Board and working closely with my Board colleagues and the Scancell team to realise the full potential of Scancell's Moditope(R) immunotherapy platform through future clinical development."

Detailed biographies of the Clinical Advisory Board are provided below and will be available at: www.scancell.co.uk

For Further Information:

 
 Scancell Holdings Plc 
 Dr John Chiplin, Chairman                 [phone] 
 Dr Cliff Holloway, CEO 
 
 Panmure Gordon (UK) Limited 
  (Nominated Adviser and Corporate 
  broker) 
 Freddy Crossley/Emma Earl                 [phone] 
 
 FTI Consulting 
  Simon Conway/Natalie Garland-Collins     [phone] 
 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody(R) and Moditope(R) technology platforms.

ImmunoBody(R) vaccines target dendritic cells and stimulate both parts of the cellular immune system. They can be used as monotherapy or in combination with checkpoint inhibitors. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

-- SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.

-- SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK for SCIB2.

Moditope(R) represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope(R) alone, or in combination with other agents, has the potential to treat a wide variety of cancers.

-- Modi-1 is being developed for the treatment of solid tumours including triple negative breast cancer, ovarian cancer and head and neck cancer.

For further details, please see our website: www.scancell.co.uk

Scancell Clinical Advisory Board

Chairman, Professor Robert Coleman MBBS, MD, FRCP, FRCPE

Robert Coleman is Emeritus Professor of Medical Oncology at Weston Park Hospital and the University of Sheffield. He graduated in medicine from Kings College Hospital Medical School and trained in London and Edinburgh before moving to Sheffield where he was instrumental in developing clinical cancer research in the city and establishing an internationally respected bone oncology research team. Professor Coleman held many leadership roles before his recent retirement from the University. He has written more than 450 scientific articles and 60 book chapters, is a past-president of the Cancer and Bone Society and was a trustee for Breast Cancer Now, the largest breast cancer research charity in the UK from 2010-2018. Currently he is a trustee at St Luke's Hospice in Sheffield and the Weston Park Cancer Charity. Since 2014 he has been a part-time Medical Director for the global independent medical education provider, prIME Oncology(TM) developing and delivering both live and on-line educational programmes for oncologists and other providers of cancer care.

Professor Christian Ottensmeier MD, PhD, FRCP

Christian Ottensmeier is Professor of Experimental Cancer Medicine at the University of Southampton. He graduated in Münster, Germany and began his specialist training there. After a 3-year training fellowship in the Dana Farber Cancer Institute in Boston, Massachusetts, he moved to Southampton where he leads the Experimental Cancer Medicine Centre. He has been a consultant in medical oncology since 2000. Clinically his interests are thoracic malignancies, head & neck cancer and melanoma, and he has co-developed a number of national NCRI studies in lung cancer. He is at the forefront of research into cancer vaccines and manages a broad and active clinical trials portfolio, including lung cancer and melanoma.

Professor Poulam Patel MD, PhD, MBBS, FRCP

Poulam Patel is Professor of Clinical Oncology at the University of Nottingham and Honorary Consultant Medical Oncologist at the Nottingham University Hospitals NHS Trust. He combines laboratory research with clinical practice focussing on the development of new treatments for several cancer types including malignant melanoma and renal cancer. He has been principal investigator for many trials of novel therapies, including Scancell's Phase 1/2 clinical trial of SCIB1-001 in melanoma patients. Professor Patel is currently the Chairman of the UK National Cancer Research Institute's Skin Cancer Clinical Studies Group, the multidisciplinary committee charged with developing the national trials portfolio for skin cancer. He has previously been a National Cancer Specialty lead of the NIHR Clinical Research Network, the clinical trials arm of the NHS, and Chairman of the EORTC Melanoma Group, one of the world's largest international melanoma clinical trials networks.

Professor Iain McNeish MD, PhD, FRCP

Iain McNeish is Professor of Oncology and Head of the Division of Cancer within the Department of Surgery and Cancer, Imperial College London. He is also the Director of the Ovarian Cancer Action Research Centre and Cancer theme lead in the Imperial NIHR Biomedical Research Centre (BRC). Externally, he is Chair of the NCRI Gynaecological Clinical Studies Group. His research focuses on ovarian cancer, specifically developing improved therapies through improved understanding of disease biology. He co-leads the BriTROC translational research collaborative and holds a programme grant from Cancer Research UK investigating copy number alterations in ovarian high-grade serous carcinoma as a possible prognostic and predictive biomarker.

Professor David Miles MB, BS, BSc, FRCP, MD

David Miles is a consultant oncologist who specialises in breast cancer treatment, with over 20 years' experience in the field. Professor Miles was head of the Breast Cancer Biology Group at Guy's and St Thomas's, and more recently became Lead Clinician for breast cancer at Mount Vernon Cancer Centre. Professor Miles is the Global Principal Investigator in clinical trials of biological therapies in the treatment of breast cancer and serves on a number of clinical trial steering and independent data monitoring committees for studies of novel therapies for the treatment of breast and other cancers. Professor Miles also advises the National Institute for Health and Clinical Excellence (NICE) on the adoption of new drugs being considered for breast cancer.

Professor Stephen Chan DM, FRCP, FRCR

Stephen Chan is the Director of Clinical Trials in Breast Cancer and Gynaecological Cancer at Nottingham University Hospital. For over two decades he has been at the forefront of researching and treating breast and gynaecological cancer, focussing on specialist treatment areas including chemotherapy, radiotherapy and targeted therapies. Professor Chan qualified at Nottingham University Medical School followed by further research and training at Oxford, Cambridge and London hospitals and universities. Professor Chan leads the Nottingham Personalised Therapy Oncology Research Group and the Breast & Gynaecological Clinical Trial Group with a particular interest in identifying new cancer genes and tests to select the best treatment for individual patients.

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May 10, 2019 02:00 ET (06:00 GMT)