Scancell Holdings Regulatory News (SCLP)

30 January 2018

Scancell Holdings Plc

("Scancell" or the "Company")

Interim Results for the six months ended 31 October 2017

Blue chip collaborations validate ImmunoBody® and Moditope® platforms

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, announces its interim results for the six months ended 31 October 2017.

Highlights:

· Dr Cliff Holloway appointed as Chief Executive Officer during the period, succeeding Dr Richard Goodfellow from 10 January 2018 

· £4.7m net proceeds raised in a placing of new ordinary shares in May 2017

o Funds used to initiate the clinical development of Modi-1 and to continue to support the ImmunoBody® platform pipeline

· Investigational New Drug application for SCIB1 Phase 2 checkpoint inhibitor combination study expected to be submitted in H1 2018, with patient enrolment planned to start H2 2018

· Continued progress in the development of Modi-1, our lead product from the Moditope® platform

o Process development work underway for the manufacture of Modi-1 conjugated to an ultra-efficient adjuvant

o First-in-man clinical studies for triple negative breast cancer, ovarian cancer and sarcoma anticipated to commence in H1 2019

· Patent granted in Europe for Scancell's DNA ImmunoBody® technology; counterparts to this patent have already been granted in the US, Australia and Japan

· Loss for the 6-month period of £2.02 million (2016: loss: £1.72 million)

· Group cash balance at 31 October 2017 was £5.0 million (30 April 2017: £2.7 million)

Post Period Highlights:

· Collaboration with BioNTech to investigate T cell receptor based therapeutics for the treatment of cancer, expanding potential therapeutic utility of Moditope® to adoptive T cell therapy

· Clinical development partnership with Cancer Research UK to develop SCIB2 ImmunoBody® for the treatment of patients with solid tumours, including non-small cell lung cancer

· Increasingly impressive 5-year survival data from the SCIB1 Phase 1/2 clinical trial; all 14/16 resected Stage III/IV melanoma patients receiving 2-4 mg doses and who remain alive have now reached their 5-year post-treatment survival time point

Dr Cliff Holloway, CEO of Scancell, said: "We are delighted to have entered into significant collaborations with Cancer Research UK and BioNTech, which provide the first external validation of our ImmunoBody® and Moditope® immunotherapy platforms. Cancer Research UK's world-renowned expertise will be invaluable as SCIB2 is progressed into Phase 1/2 clinical trials, and we are excited to be working with BioNTech in one of the most promising areas of cancer immunotherapy: the development of T cell receptor therapeutics.

"Our lead ImmunoBody®, SCIB1, continues to demonstrate remarkable survival data and we expect to submit an Investigational New Drug application for a Phase 2 study of SCIB1 in combination with a checkpoint inhibitor during H1 2018."

A full copy of the announcement can be found on the Scancell website: www.scancell.co.uk  

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

For Further Information:

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. Data from the Phase 1/2 clinical 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.

CHAIRMAN'S STATEMENT

I am pleased to report the Company's interim results for the six-month period ended 31 October 2017.

The Company started the new financial year with a placing of shares in May 2017 which raised £4.7m net of expenses. These funds are being used to support the Company's clinical development pipeline of novel cancer immunotherapies; in particular, to initiate clinical development of the first product from the Moditope® platform, Modi-1, and to continue to support the pipeline arising from the ImmunoBody® platform.

At the AGM in October we announced the appointment of Dr Cliff Holloway as Chief Executive Officer of Scancell. Cliff succeeds Richard Goodfellow who will remain on the Company's Board of Directors. I would like to thank Richard wholeheartedly for his hard work and substantial contribution to the business, and look forward to continuing working alongside him on the Board of Directors.

Since the six-month period end the Company has announced two exciting collaborations, providing significant external validation of both the ImmunoBody® and Moditope® platforms. In December, a Clinical Development Partnership with Cancer Research UK (CRUK) to fund and manage a Phase 1/2 study with Scancell's second ImmunoBody® vaccine, SCIB2, in combination with a checkpoint inhibitor for the treatment of non-small cell lung cancer (NSCLC) was announced and, earlier this month, a potentially transformational research collaboration on Moditope® between Scancell and BioNTech to develop T cell receptor (TCR) therapeutics offers the potential to enter the lucrative adoptive cell therapy market for the first time.

Both collaborations involved a high level of due diligence, therefore the subsequent signing of these agreements by CRUK and BioNTech points to the significant scientific and commercial potential of both platforms.

ImmunoBody® platform

Scancell's ImmunoBody® immunotherapy platform uses the body's immune system to identify, attack and destroy tumours. This is achieved by enhancing the uptake and presentation of cancer antigens to harness high avidity T cell responses. 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.

SCIB1 melanoma vaccine

SCIB1 is continuing to deliver robust survival data. Currently 18 of the 20 Stage III/IV patients with resected tumours at study entry remain alive. Of the 16 resected patients who received 2/4mg doses of SCIB1, only six patients have had a recurrence of their melanoma and two of these patients have died. Remarkably, all 14 patients in this group who remain alive have now reached their 5-year post-treatment survival time point. Furthermore, 10 of these 16 patients (63%) received no other treatments for their melanoma other than SCIB1 despite having had multiple interventions and recurrences prior to study entry. All four resected patients who received 8mg doses of SCIB1 (recruited after the lower dose cohorts) remain alive.

The Company's Investigational New Drug (IND) application for SCIB1 is expected to be filed with the Food and Drug Administration (FDA) during the first half of 2018. Following the pre-IND meeting in 2017, the FDA suggested that technical data from Ichor's new TriGrid 2.0 clinical device should be submitted 30-60 days prior to Scancell's own FDA submission. Ichor are anticipating making its Master File submission imminently which will mean that patient enrolment is now expected to commence in the second half of 2018, subject to receiving sufficient funding.

The study, which will be a Phase 2 checkpoint inhibitor combination study with SCIB1 in patients with advanced melanoma, will be led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School.

SCIB2 vaccine

SCIB2, Scancell's second ImmunoBody® therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including NSCLC and oesophageal, ovarian, bladder and prostate cancers, as well as neuroblastoma, melanoma and sarcoma.

In December 2017, we announced that we had entered into a Clinical Development Partnership with CRUK to develop Scancell's ImmunoBody® vaccine, SCIB2, for the treatment of patients with solid tumours, including NSCLC.

Under the terms of the Clinical Development Partnership, CRUK will fund and sponsor a UK based Phase 1/2 clinical trial of SCIB2 in combination with a checkpoint inhibitor in patients with solid tumours, focusing on NSCLC in the first instance. The charity's Centre for Drug Development will be responsible for manufacturing the clinical trial supplies of SCIB2, conducting pre-clinical testing, and sponsoring and managing the clinical trial, including the clinical trial timelines.

Following completion of the Phase 1/2 clinical trial, Scancell will have the option to acquire the rights to the data to support further development of SCIB2 itself. If Scancell elects not to exercise the option, CRUK will retain the right to take the SCIB2 programme forward in all indications, in which case any future revenues will be equally shared. The agreement terms provide an excellent opportunity for Scancell to benefit by either developing SCIB2 itself or by the development being taken forward by CRUK.

This collaboration will ensure that this innovative vaccine reaches patients as soon as possible and provides an important validation of Scancell's ImmunoBody® platform from one of the world's foremost cancer charities.

Patents

A patent for Scancell's DNA ImmunoBody® technology was granted in Europe in June 2017. On issuance, this patent extends coverage of Scancell's intellectual property into another important market. Counterparts to this patent have already been granted in the United States, Australia and Japan. The addition of this key European patent for DNA ImmunoBody® significantly bolsters our global intellectual property portfolio as we position the Company for future growth.

Moditope® platform

Scancell's Moditope® immunotherapy platform is a novel immunotherapy that overcomes immunosuppression and delivers unprecedented killer T-helper cell responses. This is achieved by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes which overcome self-tolerance and destroy tumour cells. Pre-clinical studies have shown unprecedented anti-tumour effects can be delivered without requiring checkpoint inhibition.

Modi-1

Modi-1 consists of two citrullinated vimentin peptides and one citrullinated enolase peptide. Vimentin and enolase peptides are highly expressed in triple negative breast cancer (TNBC), ovarian cancer and sarcoma. Pre-clinical data suggests that Modi-1 could be effective in up to 90% of patients with TNBC, up to 95% of patients with ovarian cancer and up to 100% of patients with sarcoma. The Company has recently made substantial progress on the identification of an ultra-efficient adjuvant for Modi-1. This adjuvant, which will be covalently linked to the Moditope® peptides before injection, stimulates potent cancer-killing T cells at up to 100-fold lower doses than could be achieved previously. The Company is currently undertaking process development work on the manufacture of Modi-1 conjugated to the adjuvant with the aim of filing a CTA in the UK for the planned Phase 1/2 clinical trial prior to starting the study in H1 2019.

Collaboration with BioNTech

Earlier this month, Scancell announced that it has entered into a research collaboration with BioNTech for the potential development of innovative, T cell receptor (TCR)-based therapeutics for the treatment of cancer. This research collaboration combines Scancell's Moditope® immunotherapy platform and BioNTech's platform technology for high-throughput cloning and characterisation of naturally selected T cell receptors. 

Under the terms of the agreement, Scancell and BioNTech will enter into an initial research collaboration to discover and characterise T cell receptors specific for citrullinated epitopes from vimentin and enolase. These epitopes form the basis of Scancell's first Moditope® development candidate, Modi-1. Upon completion of these studies, BioNTech will have the exclusive option to enter into a licence agreement for the development of T cell-based therapeutics that are specific to Modi-1 epitopes. 

Modi-2

The Company's second Moditope programme, Modi-2, is currently in pre-clinical development and will address multiple indications resistant to checkpoint inhibitor therapy including oesophageal, gastric, pancreatic and colorectal cancers.

Financial

Profit and Loss Account

The Group made an overall operating loss for the six-month period to 31 October 2017 of £2.39 million (2016: loss of £2.11 million). During the period, development expenditure has increased over the comparative six-month period as costs of the manufacture of new SCIB1 product have been incurred and additional development work has been carried out on Modi-1 and SCIB2. The increase in administrative expenditure is largely due to a significant increase in patent costs as the Company continues to protect and extend its intellectual property portfolio.

Overall the loss for the six-month period was £2.02 million (2016: loss £1.72 million).

Balance Sheet

The cash at bank at 31 October 2017 was £4,961,865 (30 April 2017: £2,672,335) and net assets amounted to £9,206,012 (30 April 2017: £6,499,325).

Share Capital Placing

On 11 May 2017 the Company placed 50,499,999 ordinary 0.1p shares at a price of 10p per share and raised £4.7m net of costs.

Outlook

The Company's collaborations with CRUK and BioNTech provide the first external validation of the ImmunoBody® and Moditope® immunotherapy platforms.

CRUK's world-renowned expertise will be invaluable as SCIB2 is progressed through the clinic. In pre-clinical studies, we have shown that a combination of SCIB2 and checkpoint inhibition produces enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. We believe SCIB2 has the potential to provide a much-needed additional treatment option for patients suffering from lung cancer and a range of other common solid tumours.

We are delighted to be working with BioNTech, one of Europe's new immuno-oncology power-houses to investigate the potential of Moditope® for the development of TCR therapeutics, one of the most exciting areas of cancer immunotherapy.

We are also close to initiating GMP manufacture of Modi-1 for the planned Phase 1/2 clinical trial in TNBC, ovarian cancer and sarcoma, which is planned to start in H1 2019 and will continue to advance Modi-2 in preparation for clinical trials in other solid tumours resistant to checkpoint inhibitor therapy.

The IND submission for the SCIB1 combination trial is expected to be filed during the first half 2018. The commencement of this and other of our internally-funded studies are dependent upon the Company's ability to raise sufficient funds to enable the studies to be completed.

I would also like to welcome Dr Cliff Holloway to Scancell. Cliff's extensive experience and accomplishments speak volumes and his expertise in cancer therapeutics will be invaluable as we drive our immunotherapy products through the clinic and commercialise the assets through partnerships with other companies.

John Chiplin

Chairman

Scancell Holdings plc

Consolidated Profit or Loss and Other Comprehensive Income Statement

for the six-month period to 31 October 2017

Scancell Holdings plc

Consolidated Statement of Changes in Equity

 for the six-month period to 31 October 2017

Scancell Holdings plc

Consolidated Statement of Financial Position

as at 31 October 2017

Scancell Holdings plc

Consolidated Cash Flow Statement

for the six-month period to 31 October 2017

Scancell Holdings plc

Notes to the Interim Financial Statements

for the six-month period to 31 October 2017

1 Basis of preparation

This interim statement for the six-month period to 31 October 2017 is unaudited and was approved by the Directors on 29 January 2018. The financial information contained in the interim report has been prepared in accordance with the accounting policies set out in the annual report and accounts for the year ended 30 April 2017.

The financial information contained in the interim report does not constitute statutory accounts as defined in section 434 of the Companies Act 2006. The financial information for the full preceding year is based on the statutory accounts for the year ended 30 April 2017, upon which the auditors, Champion Accountants LLP, issued an unqualified audit opinion which did not contain any statement under section 498(2) or 498(3) of the Companies Act 2006. The audited statutory accounts for the year ended 30 April 2017 have been lodged with the Registrar of Companies.

As permitted, this interim report has been prepared in accordance with AIM Rule 18 and not in accordance with IAS 34 "Interim Financial Reporting" therefore it is not fully in compliance with IFRS as adopted by the European Union.

2 Earnings per share

Basic earnings per share, from continuing operations, is calculated by dividing the earnings attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding during the year.

The calculations of earnings per share are based on the following losses and numbers of shares.

At 31 October 2017 the Company had 312,058,098 Ordinary Shares of 0.1p in issue.

3 Taxation

Taxation for the six months ended 31 October 2017 is based on the effective rates of taxation which are estimated to apply for the year ended 30 April 2018. 

4 Interim results

These results were approved by the Board of Directors on 29 January 2018. Copies of the interim report are available to the public from the Group's registered office and the Group's website, www.scancell.co.uk.