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Pharma Capital
EPIC: SCLP
Market: AIM
52-week High/Low: 16.95p / 9.68p
Sector: Pharma & Biotech
Market Cap: 39.01M

Cancer remains one of the world’s most significant diseases. A key challenge in the fight against cancer is that many tumours continue to grow by successfully evading the body’s own natural defence mechanism - the immune system. Scancell’s mission is to overcome this breach in our defences by developing products that stimulate the immune system to treat or prevent cancer.

Scancell is traded in the NEX Exchange HERE

Scancell Holdings Plc

www.scancell.co.uk

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Big picture - Why invest in Scancell Holdings Plc

Scancell Holdings Plc Snapshot

Cancer remains one of the world’s most significant diseases. A key challenge in the fight against cancer is that many tumours continue to grow by successfully evading the body’s own natural defence mechanism - the immune system. Scancell’s mission is to overcome this breach in our defences by developing products that stimulate the immune system to treat or prevent cancer.

The company, which was founded in 1997 as a spin-out from the University of Nottingham, has secured £17 million funding to date. In December 2006 Scancell sold its pipeline of direct killing monoclonal antibodies to Arana Therapeutics, an Australian biopharmaceutical company. The deal allowed Scancell to focus its efforts entirely on its innovative ImmunoBody® and Moditope® cancer vaccine programmes.

Scancell’s first cancer vaccine, SCIB1, is being developed for the treatment of melanoma and is in Phase I/II clinical trials. The initial results have been highly encouraging and suggest that SCIB1 could have an important future role as first line treatment for patients with resected Stage II or III disease, a key area of unmet medical need for which there are no effective and safe treatment options available.

VIDEO:Campaign for the Centre for Cancer Immunology - Expert panel Q&A

 

Cancer vaccine: SCIB1

Scancell’s first cancer vaccine, SCIB1, is being developed for the treatment of melanoma and is in Phase I/II clinical trials.

SCIB1 is a plasmid DNA which encodes a human antibody molecule engineered to express two cytotoxic T cell epitopes derived from the melanoma antigens Tyrosinase-Related Protein 2 (TRP2) and gp100 plus two helper T cell epitopes. Following immunisation, the engineered antibody is expressed and taken up by dendritic cells, resulting in the development of immune responses against tumour cells expressing the TRP2 and gp100 antigens. The major advantage of the Immunobody® technology is that the Fc component of the engineered antibody will be recognised by the high affinity CD64 receptor present on dendritic cells, leading to a significant enhancement of both the frequency and avidity of the T cell immune response. The induction of high avidity T cells against TRP-2 and gp100 destroys both primary and metastatic tumours, leading to longer progression free survival.


Phase I/II clinical trial of SCIB1

Scancell is conducting  a Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial is being carried out  at clinical sites in Nottingham, Manchester, Guildford, Leeds and Southampton and is still open for recruitment.

The trial is an open label, non-randomised study to determine the safety and tolerability of four doses of SCIB1 administered intramuscularly using an electroporation device (TDS-IM, manufactured by Ichor Medical Systems, USA). The study will also assess immune effects and anti-tumour activity in patients with melanoma. The trial is being conducted in patients with both unresected and resected disease.

Up to 40 patients with Stage III or Stage IV melanoma will be recruited into the study and will receive up to five doses of the SCIB1 vaccine over a 6 month period and may also be invited to enter a long term treatment programme.

The initial results have been highly encouraging.

All 16  patients with resected tumours are still alive and only five  have progressed. The median recurrence-free survival (when 50% of patients  have died) has not been reached; these resected patients have a median survival time of 34 months for Stage III patients (n=9) and 31 months for Stage IV patients (n=7). This compares very favourably with data from historical controls.
These data support the hypothesis that SCIB1 could have an important future role as first line treatment for patients with resected Stage II or III disease, a key area of unmet medical need for which there are no effective and safe treatment options available at present.

For more information please click here

 

Product Pipeline

Scancell is developing a pipeline of ImmunoBody® and Moditope® vaccines, primarily for the treatment of cancer

ImmunoBody® vaccines

SCIB2

Scancell’s Immunobody® immunotherapy platform enhances the uptake and presentation of cancer antigens to harness the high avidity T cell responses that destroy tumours. The platform has been validated both in animals and in the clinic with SCIB1 but many opportunities also exist for the development of additional ImmunoBody® vaccines, both for cancer and chronic infectious diseases.

SCIB2 targets the lung cancer antigen NY-ESO-1. It has been developed to the point at which the product is fully defined and ready for further preclinical development as a potential immunotherapy for any tumour that expresses the NY-ESO-1 antigen such as lung, oesophageal, gastric, ovarian and bladder cancers.

ImmunoBody® vaccines for prostate, liver and colorectal cancer have also been further advanced.

Moditope® vaccines

Modi-1

Scancell’s Moditope® immunotherapy platform is based on exploiting the normal immune response to stressed cells, which is largely mediated by CD4+ T cells, and harnessing this mechanism to eradicate cancer cells. Scancell’s first target for Moditope® is vimentin – a major cytoskeletal protein found in mesenchymal cells. Many epithelial tumours switch from expression of cytokeratin to vimentin during metastasis in a process known as epithelial mesenchymal transition (EMT); this change in phenotype enables the cell to become mobile and metastasize to new locations in the body.

Scancell has now selected two modified vimentin peptides in which the arginine residues have been substituted by citrulline to form the basis of its first Moditope® development candidate, Modi-1. The inclusion of additional modified peptides from other Moditope® target proteins into Modi-1 is currently under review. Animal studies have shown that the two vimentin peptides stimulate potent anti-tumour responses and leads to significant improvements in survival, suggesting that the Modi-1 product could have outstanding potential as a novel immunotherapy. Immune response studies with cells isolated from cancer patients have confirmed that T cell responses were stimulated by both modified vimentin peptides.

Optimisation studies have identified the adjuvant, dose and administration route for testing Modi-1 in the First in Man study. In animal studies, an aggressive tumour cell line confirmed that the two vimentin peptides eradicate tumour cells in a therapeutic, and therefore clinically relevant, setting. Remarkably, these responses were evident when tumours had reached a late stage of development.

Moditope® vaccines have the potential to treat a wide variety of cancers. Scancell is currently further evaluating the initial indications for the first clinical trial with Modi-1 in terms of clinical need and market opportunity.

 

 

ImmunoBody® Vaccines

Generating high avidity T-cell responses for more effective immunotherapy.

Cancer vaccines represent a highly attractive approach to cancer therapy. In contrast to current treatments such as chemotherapy and radiotherapy, small non-toxic doses of a vaccine may be administered to a patient to stimulate an immune response. It is generally accepted that to be effective against cancer, a vaccine needs to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system (known as the CD4-mediated response) which stimulates inflammation at the tumour site; and the cytotoxic T-lymphocyte or CTL response (known as the CD8-mediated response) in which cells of the immune system are primed to recognise and kill specific cells.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive.

Scancell has developed its breakthrough patent protected DNA ImmunoBody® technology to overcome the present limitations of cancer vaccines.

An ImmunoBody® is a DNA plasmid that encodes a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

Unlike current vaccine approaches that rely on a single activation mechanism, ImmunoBody® vaccines activate dendritic cells through two distinctly different and complementary mechanisms that maximize T cell activation and avidity: direct- and indirect/cross-presentation.

 

(a) Direct presentation: ImmunoBody® DNA targets antigen-presenting cells (APCs) directly via transfection.  The DNA is transcribed, translated and the antibody processed.  Tumour-specific T cell epitopes are presented via MHC Class I and II molecules to T cells.

 

 

(b) Cross presentation: ImmunoBody®DNA transfects other (non-APC) cells, which then secrete the antibody protein which targets APCs via the high affinity Fc receptor.

 

 

(c) Dual Mechanism of Action: The combination of direct- and cross-presentation by ImmunoBody®results in amplification of the immune response, inducing high frequency, high avidity T cells that have a potent anti-tumour effect.

As seen above, the ImmunoBody® targets APCs directly via DNA transfection (direct presentation) and by transfecting other cells which then secrete the antibody protein and targets APCs via their high affinity receptor (cross-presentation).  The ImmunoBody® antibody is processed and the tumour-specific T cell peptide epitopes are presented via MHC Class I and II molecules to T cells.

The key to the effectiveness of the ImmunoBody® vaccine is the generation of high avidity CD4+ and CD8+ T cell responses.  T cell avidity is a critical vaccine parameter that is the combination of multiple signals and results in T cells with increased sensitivity and greater cytolytic activity.

By changing the expressed epitopes, the technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Synergy of ImmunoBody® vaccines with checkpoint inhibitors

The “checkpoint pathway” plays a key role in modulating the immune system.  Studies involving the inhibitors of CTLA-4 and PD‐1 have demonstrated promising results in pre-clinical and clinical studies where they alter the tumour microenvironment, making the local environment more permissible for T cells to proliferate and to infiltrate into tumours.

Combining anti‐PD1 therapy with the SCIB-1 ImmunoBody® vaccine significantly enhances survival in a mouse tumour models resulting in 85% survival of immunized mice.

 

Anti-PD1 antibody and SCIB-1 synergise to eradicate tumours in mice with established tumours.

Dr John Chiplin (Executive Chairman)
John is based in San Diego. His recent transaction experience, as a director/CEO, includes Benitec Biopharma (US IPO), Medistem (acquired by Intrexon), Arana (acquired by Cephalon) and Domantis (acquired by GSK). Prior to Scancell John was CEO of Polynoma, a Phase III cancer vaccine company, based in San Diego.

Dr Richard Goodfellow (CEO)
Richard was formerly in senior management at Astra where he ran international clinical trials on Astra’s gastrointestinal and cardiovascular products including omeprazole before becoming Director of international Product Marketing. Thereafter he co-founded  Paradigm Therapeutics (acquired by Takeda) and was a Board Director of Enact Pharma (acquired by Protherics/BTG) before co-founding Scancell with Lindy Durrant.

Professor Lindy Durrant (CSO)
Lindy is an internationally recognised immunologist in the field of tumour therapy, She has worked for over 20 years in translational research, developing products for clinical trials including monoclonal antibodies for diagnostic imaging and therapy and cancer vaccines. She has a personal Chair in Cancer Immunotherapy at the Department of Clinical Oncology at the University of Nottingham.

Dr Sally Adams (Development Director)
Dr Sally Adams was Head of Neurology & Virology at British Biotech and Development Director at Neures Limited before becoming an independent consultant providing drug development and management services within the biotechnology and pharmaceutical sectors, specialising in biological entities.  She has worked on many complex projects over the past 25 years including anti-infective vaccines, cancer immunotherapies and an innovative stem cell treatment for visual dysfunction.  Sally previously  worked as a development consultant to  Scancell, providing guidance on the development  of SCIB1, before her appointment as Development Director in May 2014.

Dr Matthew Frohn
Matthew started his career as a clinical and research scientist before moving to venture capital in 1999. He originally joined Oxford Technology Management making seed investments into start-up and early stage technology companies, predominantly in healthcare. More recently, he co-founded Longwall Venture Partners, an early-stage technology investment company with £70m under management. Matthew has a DPhil in Biochemistry from the University of Oxford.

Kate Cornish-Bowden
Kate is a Chartered Financial Analyst and holds a Masters in Business Administration. She was managing director and head of Morgan Stanley Investment Management’s Global Core Equity Team between 2002 and 2004. Prior to this she was an executive director and senior portfolio manager within the same team at Morgan Stanley. More recently Kate has acted as a consultant providing financial research to private equity and financial training firms and was appointed a director of Investec Structured Products Calculus VCT plc in February 2011.

Dr Alan Lewis
Alan has a proven track record in the US life sciences industry and is currently President and CEO of DiaVacs, a San Diego based clinical stage biotechnology company. He has held senior positions at a number of life science companies including Celgene, Ambit Biosciences, Medistem,  Novocell and Signal Therapeutics. Whilst CEO at Signal Therapeutics Alan oversaw multi-year alliances with leading pharmaceutical companies including Akzo Nobel, Roche Biosciences and Novartis and subsequently managed its $275 million acquisition by Celgene. He is also on the Board of Directors of NASDAQ listed companies Biomarin and Assembly Biosciences.

As at 19th May 2017 the identity and percentage holdings of significant shareholders were: 

 

Ordinary shares at 0.1p each

 

 Number

 Percentage

 Reyker Nominees Limited   

49,422,927

15.84%

 Share Nominees Limited

28,675,439

 9.19%

Hargreaves Lansdown Nominees Limited

24,873,539

7.97%

Scancell Holdings plc directors and related holdings

18,363,875

5.88%

Barclayshare Nominees Limited

18,101,969

5.80%

Nortrust Nominees Limited

16,000,000

5.13%

The Bank of New York Nominees

13,000,000

4.17%

Huntress CI Nominees Limited

11,309.220

3.62%

Lynchwood Nominees Limited

10,968,979

3.52%

 

Address

Scancell Limited
Department of Clinical Oncology
City Hospital
Hucknall Road
Nottingham
NG5 1PB
UK

Telephone
+44 (0) 115 823 1863
Fax
+44 (0) 115 823 1863

 

Company registered address and number:
John Eccles House 
Robert Robinson Avenue
Oxford Science Park 
Oxford
OX4 4GP
Company registration number: 06564638(England and Wales)

Registrar: 
SLC Registrars
Ashley Park House
42-50 Hersham Road
Walton-on-Thames
Surrey
KT12 1RZ
Telephone +44 (0)1372 467 308 
Fax +44 (0)1372 463620

Nominated advisor and Broker:
Panmure Gordon and Co
One New Change
London
EC4M 9AF

Auditor:
Champion Accountants LLP
2nd Floor
Refuge House
33-37 Watergate Row
Chester
CH1 2LE

Solicitor:
Cooley (UK) LLP
Dashwood
69 Old Broad Street
London 
EC2M 1QS

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© biotech Capital 2017

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