Scancell Holdings Regulatory News (SCLP)

18 September 2015

Scancell Holdings Plc

Final Results for the year ended 30 April 2015

Survival data for lead vaccine SCIB1 strengthens; new data demonstrates potential benefits of combining ImmunoBody® vaccines with checkpoint inhibition

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2015.

Highlights during the period:

· Positive data showing highly encouraging survival times from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBodyÒ 

· Adjuvant melanoma* represents a significant new market opportunity for SCIB1

o All 20 resected patients in the Phase 1/2 clinical trial are still alive

o SCIB1 may offer protection from recurrence of melanoma without serious side effects

· Data supporting the rationale for combining Scancell's ImmunoBody® vaccines with checkpoint inhibitors has continued to strengthen

o Pre-clinical data demonstrates that combining SCIB1 and SCIB2 with checkpoint inhibition (PD-1 and CTLA-4 blockade), produced enhanced tumour destruction and longer survival times than when either treatment was used alone

· SCIB2 is ready for further pre-clinical development as a potential immunotherapy for tumours expressing the NY-ESO-1 antigen

· Scancell received US patent for its DNA ImmunoBody® platform technology, following grant of counterparts in Australia, China and Japan

· Modi-1, Scancell's lead vaccine from Moditope® platform, is on schedule to start clinical trials in Q4 2016

· Two new Moditope® protein targets have been identified

· Loss for the year of £2,414,630 (2014: loss £2,222,954) as a result of expected additional expenditure on the SCIB1 clinical trials and the further development of Moditope®

· Group cash balance at 30 April 2015 was £3,059,001 (30 April 2014: £5,566,234)

*Patients without measurable disease following surgery but where there remains a high risk of relapse

Dr. Richard Goodfellow, Joint CEO of Scancell, said: "We continue to make significant progress with both of our platform technologies and pipeline. We remain excited with the data arising from our SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV melanoma. In particular, the increased survival times and low incidence of adverse events in those patients with resected tumour demonstrates that SCIB1 has the potential to be an effective new treatment option in patients with adjuvant melanoma. With recruitment now closed we expect to report headline results from this open label trial around the end of this year. Additionally, evidence is emerging that our ImmunoBody® vaccines may also be effectively deployed as part of a combination therapy to treat late stage melanoma patients. Our second platform technology, Moditope®, has also yielded its first development candidate, Modi-1, which is on track to start clinical trials in 2016 and two further Moditope® protein targets have been identified.

"We remain confident in the prospects for the Company and its differentiated pipeline of cancer immunotherapies as we continue to evaluate all potential opportunities for increasing shareholder value."

For Further Information:

Notes to Editors

About Scancell

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

Scancell's first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Introduction

I am pleased to report the Group's final results for the year ended 30 April 2015.

During the year Scancell continued to make progress with the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV melanoma and closed the trial to further patient recruitment in the third quarter of 2015. SCIB1 continues to deliver strong survival data, especially in patients with fully resected disease. As previously reported, SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to drug-related adverse events. Once the last patient in the main, six-month part of the study has completed the study, the Company will analyse the data and prepare a clinical study report. Patients on long-term continuation treatment will continue to be dosed for up to five years from the end of the main study period.

Financial

Profit and Loss Account

The Group made an overall operating loss for the year to 30 April 2015 of £2,959,995 (2014: loss of £2,497,220). The increased loss for the period has been as a result of additional expenditure on the SCIB1 clinical trials and the further development of Moditope®.

Overall the loss for the year was £2,414,630 (2014: loss £2,222,954).

Balance Sheet

The cash at bank at 30 April 2015 was £3,059,001 (30 April 2014: £5,566,234) and net assets amounted to £6,754,002 (30 April 2014: £9,077,264).

ImmunoBody® platform

Scancell's ImmunoBody® immunotherapy platform enhances the uptake and presentation of cancer antigens to harness high avidity T cell responses that destroy tumours. Each ImmunoBodyÒ vaccine can be designed to target a particular cancer in a highly specific manner, offering the potential for enhanced efficacy and safety compared with more conventional approaches. The platform has been validated both in animals and in the clinic with the Company's first cancer vaccine, SCIB1, and many opportunities also exist for the development of a pipeline of ImmunoBody® vaccines, both for cancer and chronic infectious diseases.

SCIB1 melanoma vaccine

In July, post period-end, the Company announced that it has closed patient recruitment for its SCIB1 ImmunoBody® Phase 1/2 clinical trial in patients with Stage III/IV melanoma.

The Phase 1/2 clinical trial, conducted across six UK centres, is an open label, non-randomised study to determine the safety and tolerability of SCIB1 administered intramuscularly using an electroporation device (TriGrid Delivery System, manufactured by Ichor Medical Systems, USA). Part 1 was a dose-escalation to determine the dose for Part 2. While the primary objective of the study is to assess safety and tolerability, the study is also assessing immune response, anti-tumour activity and the ability of SCIB1 to delay or prevent disease recurrence in patients with resected disease.

In total, 35 patients have now been treated with SCIB1, including ten patients at the higher 8mg dose. Six patients remain on long-term treatment and have received between two and ten additional 4mg or 8mg doses of SCIB1 every three to six months.

As with previously reported data, SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to drug-related adverse events. All 20 patients with resected disease remain alive including the four patients on the 8mg dose. The median observation time in the 16 patients with resected disease who received 2-4 mg doses of SCIB1 is now 37 months and all of these patients have survived for at least 30 months since treatment commenced (range 30-50 months).

Once the last patient in the main, six-month part of the study has completed the study , the Company will analyse the data and prepare a clinical study report. Patients on long-term continuation treatment will continue to be dosed for up to five years from the end of the main study period.

Collaboration

Also in July, the Company announced an agreement with ImmunID to collaborate on a research project aimed at predicting which patients will respond best to SCIB1 treatment. The study uses ImmunID's flagship clinical product, ImmunTraCkeR®, before and during treatment, to assess the immune-modulatory effect of Scancell's SCIB1 ImmunoBody® vaccine in patients with Stage III/IV metastatic melanoma. The ImmunTraCkeR® assay will be used to:

· Understand pre-existing immunity of Stage III/IV metastatic melanoma patients;

· Monitor T cell diversity over time in order to assess immune-modulatory effect of the SCIB1 cancer vaccine;

· Make a preliminary assessment of ImmunTraCkeR® acting as a predictor of response to SCIB1; and

· Identify any other predictive or prognostic clinical value of T cell diversity.

This collaboration will provide an insight into T cell diversity in patients treated with our SCIB1 vaccine and their response to the treatment over time. ImmunID's ImmunTraCkeR® test is expected to deliver valuable data that will provide deeper insight into the strong clinical results we have generated to date with our novel treatment for metastatic melanoma.

SCIB2 vaccine

During the year we announced new data demonstrating that animals treated with a combination of SCIB2, Scancell's ImmunoBody® vaccine in development for the treatment of lung, oesophageal, prostate and other epithelial cancers, and checkpoint inhibition (blockade of the CTLA-4 immune checkpoint pathway), showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

In earlier pre-clinical studies, we have shown that the administration of SCIB2 alone induced potent tumour-specific T cell responses associated with increased T cell infiltration into the tumour and enhanced proliferation of T cells within the tumour resulting in tumour rejection and long-term survival. In our new study, the combination of CTLA-4 with SCIB2 vaccination resulted in a significant survival advantage over the individual treatments. Although patients with a relatively low tumour burden may benefit from SCIB2 alone, for example in the adjuvant setting, these results highlight the potential benefits of combining SCIB2 with immune checkpoint blockade, such as ipilimumab or nivolumab, for the treatment of patients with advanced disease.

Checkpoint inhibitors can enable the host immune system to recognise, attack and destroy cancer cells. However, checkpoint inhibitors will not work on their own if the patient fails to mount an adequate immune response to the tumour. Taking the brake off immunosuppressive T cells with either CTLA-4 or PD-1 blockade, whilst simultaneously pressing the accelerator with active immunotherapies such as SCIB1 or SCIB2, is increasingly regarded as offering potential for overwhelming the disease and increasing efficacy.

The SCIB2 vaccine is a DNA plasmid targeting the cancer antigen NY-ESO-1 which induces high avidity CD8 and CD4 responses in pre-clinical models. In order to enhance its market potential, SCIB2 has been engineered to be effective in over 90% of patients. All future ImmunoBody® vaccines will now be engineered to this new standard.

Patents

During the period, a patent for Scancell's DNA ImmunoBody® technology platform was granted in the United States. The patent is key for the protection of the Company's pipeline of ImmunoBody® vaccines and follows the grant of other patents in Australia, China and Japan.

Moditope® platform

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 plus one modified enolase peptide to form the basis of its first Moditope® development candidate, Modi-1. Enolase is glycolytic enzyme that is overexpressed in various cancers. In all three peptides the arginine residues have been substituted by citrullinine. In animal studies using an aggressive tumour cell line Modi-1 eradicated the tumour in a therapeutic and therefore clinically relevant setting. Remarkably, these responses were evident when tumours had reached a late stage of development. These data, combined with significant improvements in survival, suggest that Modi-1 could have significant potential as a novel immunotherapy.

Optimisation studies have identified the adjuvant, dose and administration route for testing Modi-1 in a Phase 1/2 clinical trial which is expected to start in Q4 2016. 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. 

Board and staff

As the Company seeks to evolve to a later stage development company, the nature and the structure of the Board will evolve to reflect those additional demands. The Board recognises that the progress made over the year would not have been possible without the dedication and determination of all our staff and, on behalf of the Directors, I offer our thanks to them.

Outlook

With the SCIB1 Phase 1/2 melanoma trial coming to a close, we continue to see highly encouraging survival times and melanoma-specific immune responses in patients, especially those with resected tumours. The majority of these patients currently have few treatment options apart from surgery followed by "watch and wait". We believe that SCIB1 will ultimately offer the many thousands of melanoma patients with Stage II and III disease a new treatment option that has the potential to extend life expectancy without significant side effects.

The rationale for combining Scancell's ImmunoBody® vaccines with checkpoint inhibitors is also gathering momentum. Whilst we believe that SCIB2, like SCIB1, will provide effective stand-alone treatment in the adjuvant setting, this data further supports the hypothesis that some patients with later stage disease will benefit from the combination with checkpoint modulation.

Data to date suggests that SCIB1 could have significant value in the treatment of melanoma both in the adjuvant setting and in combination with checkpoint inhibitors. The Board believes that investment in further focused clinical studies to prospectively confirm one or both these hypotheses could add significant further value to the Company and is actively evaluating the possibility of conducting one or more of these studies on its own behalf.

In the meantime the Company is continuing to engage with pharmaceutical and biotechnology companies. These discussions include pursuing partnering opportunities with other oncology companies, especially those seeking a strong immuno-oncology pipeline in order to take advantage of this new paradigm in the treatment of cancer.

EARNINGS PER ORDINARY SHARE (pence)

(note 4)

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

for the year ended 30th April 2015

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

as at 30 April 2015

Current assets

SHAREHOLDERS' EQUITY

CONSOLIDATED CASH FLOW STATEMENT

for the year ended 30 April 2015

NOTES TO THE FINANCIAL INFORMATION

For the year ended 30 April 2015

1 BASIS OF PREPARATION

These financial results do not comprise statutory accounts for the year ended 30 April 2015 within the meaning of Section 434 of the Companies Act 2006. The financial information in this announcement has been extracted from the audited financial statements for the year ended 30 April 2015.

The financial statements have been prepared on the going concern basis on the grounds that the directors have reviewed the funding available and the group's cash flow forecast and are content that sufficient resources are available to enable the group to continue in operation for at least twelve months from the date of approval of these accounts.

The financial information has been prepared in accordance with International Financial Reporting Standards ('IFRS'), as adopted by the European Union, and with those parts of the Companies Act 2006 applicable to companies reporting under IFRS.

The financial statements have been prepared under the historical cost convention and in accordance with applicable accounting standards.

2 OPERATING LOSS

3 TAXATION

Analysis of the tax credit

Factors affecting the tax charge

The tax assessed for the years is lower than the applicable rate of corporation tax in the UK. The difference is explained below:

The Group has tax losses to carry forward against future profits of approximately £9,575,000 (2014: £8,134,000)

A deferred tax asset has not been recognised in respect of these losses as the Group does not anticipate sufficient taxable profits to arise in the foreseeable future to fully utilise them.

The estimated value of the deferred tax asset not recognised measured at a standard rate of 20% is £1,894,300 (2014: £1,597,000)

4 EARNINGS PER SHARE

Basic earnings per share

The earnings and weighted average number of ordinary shares used in the calculation of basic earnings per share is as follows:

Diluted earnings per share

As the Group is reporting a loss from continuing operations for both years then, in accordance with IAS33, the share options are not considered dilutive because the exercise of the share options would have the effect of reducing the loss per share.

5 DELIVERY OF ACCOUNTS

The audited statutory accounts in respect of the prior year ended 30 April 2014 have been delivered to the Registrar of Companies. The auditors issued an unqualified audit opinion which did not contain any statement under section 498(2) or 498(3) of the Companies Act 2006.

6 AVAILABILITY OF ACCOUNTS

This announcement is not being posted to shareholders. Copies of this announcement and copies of the Report and Accounts can be downloaded from the Company's website: www.scancell.co.uk.