Landmark four year survival achieved in resected SCIB1 patients
Emerging pipeline of three products across five cancer indications

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 2016.

Read the full document here

Highlights

• SCIB1 continues to deliver significant survival data from the Phase 1/2 clinical trial in patients with Stage III/IV melanoma
  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • Of the 16 patients who received 2-4mg doses of SCIB1
    • Median observation time since entry is 49 months, a landmark survival milestone
    • Only two new incidences of disease progression have been recorded since December 2013
  • Of the four patients who received 8mg doses of SCIB1
    • Median observation time since entry is 18 months
    • None have progressed and none have died
  • As announced on 17 June 2016, treatment for the eight patients in the long-term continued dosing phase has been suspended due to the clinical trial supplies no longer being within the original specification
  • New SCIB1 material being manufactured to support a new study of SCIB1 in combination with a checkpoint inhibitor will also be made available to these continuation patients (subject to regulatory approval)
  • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track, enrolment expected to commence in Q3 2017
  • The final Clinical Study Report will be issued later this year and will support our US IND submission
• Continued progress made in development of lead product, Modi-1, from Moditope® platform
  • Enrolment for first-in-man clinical study in triple negative breast cancer, ovarian cancer and osteosarcoma expected to commence in early 2018
• Strategic collaboration with Karolinska Institutet to explore the role of citrullination in cancer, a key mechanism underpinning the Moditope® platform
• £6.2m (£5.8m net) raised through a firm placing and open offer involving both existing and new shareholders
• John Chiplin appointed Chairman
• Loss for the year of £2,583,273 (2015: loss £2,414,630)
• Group cash balance at 30 April 2016 was £6,527,435 (30 April 2015: £3,059,001)

Post Period Highlights

• Scancell’s executive management team restructured to align expertise with the strategic direction outlined in fundraising
• Dr Alan Lewis appointed to Board as Non-Executive Director
• Opening of new offices in San Diego, US and Oxford, UK to support Company’s growth plans

Dr John Chiplin, Executive Chairman of Scancell, said:

“We have continued to make significant progress in the period, both in terms of the maturing clinical data with SCIB1 and further scientific developments on both the ImmunoBody® and Moditope® platforms. We now have a pipeline of three products across five cancer indications and clinical success with any one of these products could transform the value of the business. The Board believes that further clinical studies could add significant value to the Company and is continuing to explore a number of funding options to ensure that the Company has the resources to progress these programmes further.

“Scancell has arrived at an exciting point in its development. We now have the opportunity to transform the business from a small UK-based and largely scientifically-based enterprise into an international force in immuno-oncology. We remain committed to driving this process forward in the US and elsewhere, and to realising the value that has been accumulating over recent years, both for the benefit of our shareholders and cancer patients.”

For Further Information:

Dr John Chiplin, Executive Chairman	Scancell Holdings Plc	+1 858 900 2646
Dr Richard Goodfellow, CEO	Scancell Holdings Plc	+44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance)	Panmure Gordon & Co	+44 (0) 20 7886 2500
Tom Salvesen(Corporate Banking)	Panmure Gordon & Co	+44 (0) 20 7886 2500
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 3727 1000

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 Tlymphocyte 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.

Peer-­reviewed publication highlights advantages of Moditope® technology platform

Potential to develop completely new class of immuno-­oncology therapeutics

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of an invited review in the scientific journal Autophagy entitled: “Autophagy, citrullination and cancer”, which describes Scancell’s pre-­clinical data that supports the innovation and potential of the Company’s Moditope® platform1.

The review, whose lead author is Professor Lindy Durrant, Scancell’s Chief Scientific Officer, discusses the concept that citrullinated peptides produced during autophagy offer attractive vaccine targets for cancer therapy. Scancell’s Moditope® platform utilises this mechanism to stimulate the production of highly active CD4+ T cells that overcome self-­tolerance and destroy tumour cells.

The data described in the review, and published in the peer-­reviewed journal Cancer Research2, showed that a single immunization with Moditope® peptides, up to 14 days after tumour implant, resulted in long-­term survival in up to 90% of mice, with no associated toxicity.

Professor Lindy Durrant, Chief Scientific Officer of Scancell commented:
 “The interplay between autophagy, citrullination and cancer support the rationale behind our Moditope® platform technology. Moditope® has a unique mechanism of action that overcomes the immune suppression induced by tumour cells, allowing T cells to seek out and kill tumours that would otherwise be hidden from the immune system. We believe this platform has the potential to develop a new class of immuno-­oncology therapeutics and look forward to progressing our first vaccine into the clinic as soon as possible.”

The first clinical trials of Modi-­1, the lead candidate from the Moditiope® platform, are expected to target patients with triple negative breast cancer, ovarian cancer and osteosarcoma.

The full abstract of the review can be found below.

Abstract

Autophagy, citrullination and cancer

A cell needs to maintain a balance between biosynthesis and degradation of cellular components to maintain homeostasis. There are 2 pathways, the proteasome, which degrades short-­lived proteins, and the autophagy/lysosomal pathway, which degrades long-­lived proteins and organelles. Both of these pathways are also involved in antigen presentation or the effective delivery of peptides to MHC molecules for presentation to T cells. Autophagy (macroautophagy) is a key player in providing substantial sources of citrullinated peptides for loading onto MHC-­II molecules to stimulate CD4 T cell responses. Stressful conditions in the tumor microenvironment induce autophagy in cancer cells as a mechanism to promote their survival. We therefore investigated if citrullinated peptides could stimulate CD4 T cell responses that would recognize these modifications produced during autophagy within tumor cells. Focusing on the intermediate filament protein VIM (vimentin), we generated citrullinated VIM peptides for immunization experiments in
mice. Immunization with these peptides induced CD4 T cells in response to autophagic tumor targets. Remarkably, a single immunization with modified peptide, up to 14 days after tumor implant, resulted in long-­term survival in 60% to 90% of animals with no associated toxicity. These results show how CD4 cells can mediate potent antitumor responses against modified self-­epitopes presented on tumor cells, and they illustrate for the first time how the citrullinated peptides produced during autophagy may offer especially attractive vaccine targets for cancer therapy.

1. Lindy G. Durrant, Rachael L. Metheringham & Victoria A. Brentville (2016): Autophagy, citrullination and cancer, Autophagy, DOI: 10.1080/15548627.2016.1166326
2. Victoria A. Brentville, Rachael L. Metheringham, Barbara Gunn, Peter Symonds, Ian Daniels, Mohamed Gijon, Katherine Cook, Wei Zue & Lindy G Durrant (2015): Citrullinated vimentin presented on MHC-­II in tumor cells is a target for CD4+ T cell-­mediated autitumor immunity, Cancer Research 76(3), 548-­560.

For Further Information:

Dr John Chiplin, Executive Chairman Dr Richard Goodfellow, CEO	Scancell Holdings Plc	+1 858 900 2646 +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Maisie Atkinson (Sales)	Panmure Gordon & Co	+44 (0) 20 7886 2500 +44 (0) 20 7886 2905
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 3727 1000

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.

Commentary: Richard Goodfellow

Read More

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY
IN, OR INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF IRELAND, THE RUSSIAN FEDERATION OR SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL.

FURTHER, THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND SHALL NOT CONSTITUTE AN OFFER TO SELL OR ISSUE OR THE SOLICITATION TO BUY, SUBSCRIBE FOR OR OTHERWISE ACQUIRE ANY ORDINARY SHARES OF SCANCELL IN ANY JURISDICTION IN WHICH ANY SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL. THIS ANNOUNCEMENT SHOULD BE READ IN ITS ENTIRETY. IN PARTICULAR, YOU SHOULD READ AND UNDERSTAND THE INFORMATION PROVIDED IN THE "IMPORTANT NOTICES" SECTION AND IN THE APPENDICES.

Scancell Holdings plc (LSE:AIM SCLP) ("Scancell" or the "Company"), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce a proposed new issue to raise approximately £6.8 million, before expenses, at an issue price of 17 pence per New Ordinary Share by way of:
 

• a firm placing of New Ordinary Shares to raise approximately £3 million, which will be conducted by accelerated bookbuild, and in respect of which the Company has received indicative demand for the entire amount; and
• an open offer, for up to 22.4 million New Ordinary Shares, to raise up to £3.8 million, which will provide Qualifying Shareholders with the opportunity to subscribe for New Ordinary Shares on the basis of 1 New Ordinary Share for every 10 Existing Ordinary Shares held by Qualifying Shareholders on the Record Date.

The proposed placing and open offer are within the Company’s existing allotment authorities.

John Chiplin, Chairman of Scancell, commented:

"This placing and open offer will fund important next steps for the pipelines of both of our ImmunoBody® and Moditope® platform technologies as well as strengthening the Board and management as Scancell enters the next chapter in its growth.

“We recently announced that we had put in place a prestigious team of US investigators to lead a Phase 2 checkpoint inhibitor combination study with the ImmunoBody® lead cancer vaccine SCIB1 in melanoma. A proportion of funds raised will be used to accelerate the remaining preparatory work to allow such a trial to begin in a timely manner in 2017.

“We are also excited to be progressing the first pipeline product from our Moditope® platform, Modi-1, into the clinic. Part of the funds raised are earmarked for finishing the necessary work to allow Scancell to file a Clinical Trial Application in the UK for the planned Phase 1/2 clinical trial in triple negative breast cancer/ovarian cancer that we expect to begin next year.”

For further information please contact:

Scancell Holdings Plc Dr Richard Goodfellow, Joint CEO Professor Lindy Durrant, Joint CEO	+44 (0) 20 3727 1000
Panmure Gordon (Nominated Adviser and placing agent) Robert Naylor/Paul Fincham, Corporate Finance Maisie Atkinson, Sales	+44 (0) 20 7886 2500
Lesmoir-Gordon, Boyle & Co. Limited (Sub placing agent) Angus Grierson	+44 (0) 20 7518 9892
FTI Consulting Mo Noonan Simon Conway	+44 (0) 20 3727 1000

 

The Placing is being conducted through an accelerated bookbuild which will be launched immediately following this announcement. Members of the public are not eligible to take part in the Placing.

The Company has received advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme. Although the Company currently expects to satisfy the relevant conditions for EIS and VCT investment, neither the Directors nor the Company gives any warranty or undertaking that relief will be available in respect of any investment in the Company Shares, nor do they warrant or undertake that the Company will conduct its activities in a way that qualifies for or preserves its status.

A circular to shareholders, including further details of the Open Offer will be despatched to shareholders on or around 11 March 2016 and will also be available at this time on the Company's website at http://www.scancell.co.uk.

Panmure Gordon (UK) Limited is acting as Nominated Adviser and placing agent in respect of the Placing. Lesmoir-Gordon, Boyle & Co. Limited is acting as sub placing agent.

Description of Company

Scancell is developing immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Immunotherapy is a form of treatment that may hold the key to keeping patients permanently disease-free. Unlike traditional therapies that attack cancer directly, immunotherapy uses the body’s own internal biological defences to ward off the disease, with the ultimate hope of building up longterm resistance to the cancer.

There is a strong rationale for the development of tumour-specific T cell stimulators to treat patients with cancer. Although some cancer vaccines in clinical development have been able to stimulate an immune response, few have yet been able to demonstrate an overall clinical benefit.
ImmunoBody® 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.

Each ImmunoBody® vaccine can be designed to target a particular cancer in a highly specific manner.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. The results of the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy in stage III/IV (late stage) melanoma patients with resected disease, produced a melanoma-specific immune response; and a highly encouraging survival trend without serious side effects.

Pre-clinical data on a combination of SCIB1 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has also shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

These data suggest that SCIB1 has the potential to become both the first stand-alone adjuvant treatment for early stage metastatic melanoma and an attractive partner with checkpoint inhibitors for later stage disease.

This has set the stage for an expanded clinical trial programme with a highly qualified group of US specialists. Dr Keith Flaherty, M.D., Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School has been named the principal investigator for a multicentre clinical trial, which aims to demonstrate an increase in the response rates when SCIB1 is added to checkpoint inhibitor monotherapy. The trial is expected
to commence in 2017.

Moditope®

Moditope® is a peptide-based vaccine platform that stimulates the production of killer CD4+ T cells that induce anti-tumour activity without toxicity. Although CD8+ T cell responses to tumourassociated antigens have been reported, it is difficult to induce tumour-specific CD4+ T cell
responses due to self‐tolerance against normal CD4+ T cell epitopes. The ability of Moditope®citrullinated peptides to induce CD4+ cytotoxic T cells against tumour-associated epitopes has therefore added a new dimension to the potential of anti‐tumour vaccines.

Publication of the scientific data supporting the Moditope® platform in Cancer Research in December 2015 provides further endorsement of the quality of Scancell’s innovative research and is a tribute to the strength of the Company’s research team.

Reasons for the Firm Placing and Open Offer

The latest survival data on patients treated with SCIB1 combined with the animal data showing the potential value of a SCIB1/checkpoint inhibitor combination, has set the stage for an expanded clinical trial programme in melanoma, starting in 2017.

Further progress has also been made with the Moditope® platform, and it is anticipated that the first product, Modi-1, will be ready for clinical trials for the treatment of triple negative breast cancer and ovarian cancer in 2017.

To support this process, the Board and management will be further strengthened to prepare the Company for its future as a later stage development Company.

This Capital Raising will allow the Company to prepare for further clinical studies on both SCIB1 and Moditope®, which the Board believes could add significant incremental value.

Proposed Use of proceeds

The Capital Raising is expected to raise gross proceeds of approximately £6.8 million (before commission and the costs of the Firm Placing and Open Offer), with the Firm Placing raising gross proceeds of approximately £3 million and the Open Offer expected to raise gross proceeds of up to
approximately £3.8 million, assuming full take up of the Open Offer.
It is expected that the net proceeds from the Firm Placing and Open Offer will be used as follows:
 

• ImmunoBody®: approximately £1.9 million is expected to be used to secure approval of an Investigational New Drug application from the US Food and Drug Administration for the SCIB1 combination study and to complete all of the preparatory work for such a trial in the US, including the manufacture of SCIB1 and conducting suitable toxicology and stability studies;
• Moditope®: approximately £1.4 million is expected to be used to prepare and file a Clinical Trial Application in the UK for the planned Phase 1/2 clinical trial with Modi-1 and to complete all of the preparatory work for such a trial in the UK, including the manufacture of Modi-1 and conducting suitable toxicology and stability studies;
• approximately £0.6 million will be used to build an experienced US focused management team; and
• the remaining balance of the net proceeds is expected to be used for the Company's working capital requirements.

Therapeutic drug development is a long process and the Directors believe that the Company will need additional funding in order to conduct the aforementioned clinical studies and as it moves from its current strong research base to a later stage development company.

This funding will need to be provided either by a development partner, such as a large pharmaceutical company, or by further equity issuance to existing and new shareholders. The Directors believe that delivering the milestones outlined above, enabling the Company to secure approval to conduct clinical trials with SCIB1 in the US and the manufacture of SCIB1 and Modi-1 for both clinical trials, will enhance the value of the Company and prepare it for further later stage fundraising. The Directors also believe that these milestones will ensure wider recognition of the Company both in the United States and Europe for the quality and value of both the ImmunoBody®and Moditope® platforms.

The expected use of proceeds set out above is illustrative of the Directors’ current intentions with regard to the proceeds from the Firm Placing and Open Offer and may be subject to change.

Expected Timetable of Principal Events

Announcement of the Firm Placing and Open Offer	9 March
Record Date for the Open Offer	9 March
Publication of the Open Offer and the Application Form	11 March
Ex-entitlement Date	11 March
Open Offer Entitlements credited to CREST stock accounts of Qualifying CREST Holders	14 March
Recommended last time and date for requesting withdrawal of Open Offer Entitlements from CREST	4.30 p.m. on 21 March
Latest time and date for depositing Open Offer Entitlements into CREST	3.00 p.m. on 22 March
Latest time and date for splitting Application Forms (to satisfy bona fide market claims only)	3.00 p.m. on 23 March
Latest time and date for acceptance of the Open Offer and receipt of completed Application Forms	11.00 a.m. on 29 March
Announcement of result of Open Offer	31 March
Admission and commencement of dealings in the New Ordinary Shares	8.00 a.m. on 5 April
New Ordinary Shares credited to CREST members’ account	5 April
Despatch of definitive share certificates for New Ordinary Shares in certificated form	19 April

The above time and/or dates are subject to change and, in the event of such change, the revised times and/or dates will be notified to Shareholders by an announcement through a Regulatory Information Service.

Definitions

The following definitions apply throughout this announcement, unless the context requires otherwise:
 

“Admission”	the admission of the Firm Placing Shares and the Offer Shares to trading on AIM
"AIM"	the AIM market operated by London Stock Exchange
"AIM Rules for Companies"	the AIM Rules for Companies and guidance notes as published by the London Stock Exchange from time to time governing the admission to, and operation of, AIM
"Application Form"	the personalised application form on which Qualifying Shareholders may apply for New Ordinary Shares under the open offer
"Board" or "Directors"	the directors of the Company
“Capital Raising”	the Firm Placing and the Open Offer, taken together
“Company” or “Scancell”	Scancell Holdings PLC
“CREST”	the computerized settlement system (as defined in the CREST Regulations) in respect of which Euroclear is the operator (as defined in the CREST Regulations), which facilitates the transfer of title to shares in uncertificated form
“CREST member”	a person who has been admitted to CREST as a system-member (as defined in the CREST Regulations)
“CREST Regulations”	the Uncertificated Securities Regulations 2001 (SI 2001/3755) (as amended)
"EIS"	Enterprise Investment Scheme
"EIS Qualifying Shares"	the Firm Placing Shares and the Offer Shares being the New Ordinary Shares that the Board have allocated to investors who are VCTs or wish to receive EIS relief
"Euroclear"	Euroclear UK & Ireland Limited
“Ex-entitlement Date”	the date on which the Existing Ordinary Shares are marked “ex” for entitlement under the Open Offer.
“Existing Ordinary Shares”	the Ordinary Shares in issue on the date of this announcement
“Firm Placees”	The persons who with whom the Firm Placing Shares will be placed pursuant to the Firm Placing
“Firm Placing”	the placing by the Company of the Firm Placing Shares with the Firm Placees, otherwise than on a pre-emptive basis, at the Offer Price
“Firm Placing Shares”	The Ordinary Shares which are the subject of the Firm Placing
“FCA”	the Financial Conduct Authority
“FSMA”	Financial Services and Market Act 2000 (as amended)
“HMRC”	Her Majesty’s Revenue and Customs
“London Stock Exchange”	London Stock Exchange plc
“LGB” or “Lesmoir-Gordon Boyle”	Lesmoir-Gordon, Boyle & Co Limited
"New Ordinary Shares"	the Firm Placing Shares and the Offer Shares
"Offer Price"	17 pence per New Ordinary Share
"Offer Shares"	the Ordinary Shares being made available to Qualifying Shareholders pursuant to the Open Offer
"Open Offer"	the conditional invitation made to Qualifying Shareholders to apply to subscribe for the Offer Shares at the Offer Price
“Open Offer Entitlement”	the entitlement of Qualifying Shareholders to subscribe for Offer Shares allocated to Qualifying Shareholders on the Record Date pursuant to the Open Offer
"Ordinary Shares"	ordinary shares in the capital of the Company
“Panmure Gordon”	Panmure Gordon (UK) Limited
"Overseas Shareholders"	a Shareholder with a registered address outside the United Kingdom
“Qualifying CREST Holders”	holders of Existing Ordinary Shares in uncertificated form on the register of members of the Company at the Record Date
“Qualifying Non-CREST Holders”	holders of Existing Ordinary Shares in certificated form on the register of members of the Company on the Record Date
“Qualifying Shareholders”	Qualifying Non-CREST Holders and Qualifying CREST Holders (other than certain Overseas Shareholders)
“Record Date”	5.00 p.m. on 9 March 2016 in respect of the entitlements of Qualifying Shareholders under the Open Offer
“Regulatory Information Service”	has the meaning given in the AIM Rules for Companies
“Restricted Jurisdiction”	the US, Canada, Australia, New Zealand, the Republic of South Africa, the Russian Federation, Japan or the Republic of Ireland and any jurisdiction where the extension or availability of the Open Offer (and any other transaction contemplated thereby) would breach any applicable laws or regulations and “Restricted Jurisdictions” shall mean any of them
“Scancell ” or “Group”	Scancell Holdings plc and its subsidiaries
“Securities Act”	US Securities Act of 1933 (as amended)
“Shareholders”	the holders of Existing Ordinary Shares
“United Kingdom” or “UK”	the United Kingdom of Great Britain and Northern Ireland
“United States”, “United States of America” or “US”	the United States of America, its territories and possessions, any state of the United States of America and the District of Columbia and all areas subject to its jurisdiction
"VCT"	Venture Capital Trust as defined by section 259 ITA

Scancell focuses on the US in a transformational year

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 2015.

Highlights:

• Completion of the main study period of the Phase 1/2 clinical trial of SCIB1 ImmunoBody® in patients with Stage III/IV melanoma with continued strong survival data
  • All 20 patients with resected disease remain alive
  • Median observation time in 16 patients who received 2-4mg is now 42 months since study entry and 11 remain disease free
  • Median observation time in four resected patients who received 8mg is 10 months and all remain disease free
  • All nine patients currently on long-term treatment remain disease free up to 39 months from start of SCIB1 treatment
  • Final clinical study report expected in H1 2016
• Continued good progress in development of lead product, Modi-1, from Moditope® platform
  • Improvement in peptide components suggest Modi-1 will be effective in up to 95% of patients with triple negative breast and ovarian cancers
  • Clinical studies anticipated to commence in 2017
  • Important paper outlining the scientific basis for the Moditope® platform published in revered cancer journal, Cancer Research
• Loss for the six month period of £1.17 million (2014: loss: £1.34 million)
• Group cash balance at 31 October 2015 was £1.81 million (30 April 2015: £3.06 million)

Post Period Highlights

• Prestigious US scientific team to lead Phase 2 checkpoint inhibitor combination study with SCIB1, expected to commence in 2017
• Results from first pilot study indicate ImmunTraCkeR® has the potential to be used as a companion diagnostic to predict early response to SCIB1. Further studies planned
• John Chiplin appointed Chairman, succeeding David Evans who has stepped down from the role 

Richard Goodfellow, Joint CEO of Scancell, said: “Scancell is in the midst of an exciting transformation. Our focus on the US has resulted in the appointment of Dr Keith Flaherty, one of the world leaders in melanoma
clinical research as Principal Investigator for our planned SCIB1/checkpoint inhibitor combination study. The SCIB1 survival data, especially in patients with resected disease is extremely encouraging. All 20 patients with resected Stage III/IV disease remain alive and only 5 have any evidence of disease progression. The strength of the Moditope® platform has been endorsed by the publication of data supporting its scientific basis in Cancer Research, one of the most influential cancer journals in the world. We have strengthened the clinical development team with the appointment of Dr Peter Brown, former Global Head of Oncology at Teva Pharmaceuticals and recently appointed Dr John Chiplin as Chairman, both of whom are US based. We are attracting renewed interest from both investors and pharmaceutical companies on both sides of the Atlantic. Cancer immunotherapy is becoming one of the most important clinical advances of our generation and I have never been more optimistic about the company, its research and the potential for future growth”.

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

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO
Robert Naylor/Maisie Atkinson	Panmure Gordon	+44 (0) 20 7886 2500
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 3727 1000

 

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.

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 Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells. 

Pre-clinical data on a combination of SCIB1 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has 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 period ended 31 October 2015. During the period the Company has continued to make good progress across all fronts.

• The latest survival and safety data from the Phase 1/2 clinical trial continues to suggest that SCIB1has the potential to become both the first stand-alone adjuvant treatment for early stage metastatic melanoma and an attractive partner with checkpoint inhibitors for later stage disease.
• Results from a pilot study with ImmunID illustrate ImmunTraCkeR®’s potential to be used as a companion diagnostic to predict early clinical response to SCIB1, both during further clinical trials and during subsequent routine clinical use.
• Scancell is to work with leading US melanoma specialists to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1. This pivotal initiative which aims to demonstrate an increase in the response rates to checkpoint inhibitor therapy without additional toxicity is expected to commence in early 2017.
• The Company’s second immunotherapy platform received a significant boost following the publication of a paper in Cancer Research underpinning the scientific basis for the Moditope® platform.
• Progress has been made in the pre-clinical development of Modi-1, the lead pipeline candidate from the Moditope® platform significantly increasing the number of patients with triple negative breast and ovarian cancer eligible for treatment.

Financial

Profit and Loss Account

The Group made an overall operating loss for the six month period to 31 October 2015 of £1.37 million (2014: loss of £1.56 million). The reduced loss reflects a fall in research and development expenditure in the period as the SCIB1 clinical trial reaches completion and includes a reduction in administrative expenditure.

Overall the loss for the six month period was £1.17 million (2014: loss £1.34).

Balance Sheet

The cash at bank at 31 October 2015 was £1,813,718 (30 April 2015: £3,059,001) and net assets amounted to £5,606,941 (30 April 2015: £6,754,002).

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 ImmunoBody® 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 this year 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 was 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 line with previously reported results, 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. The median observation time in the 16 patients with resected disease who received 2-4 mg doses of SCIB1 is now 42 months since study entry and 11 are still disease free. The median observation time for the resected patients on the 8mg dose who were recruited to the study later is 10 months and all are still disease free to date. Patients on long-term continuation treatment will continue to be dosed for up to five years from the end of the main study period. Nine patients are currently on long-term treatment (up to 11 treatments given) and all remain disease free for periods of up to 39 months from the start of treatment.

The main study closed on 29 October 2015. The Company is in the process of analysing the data and preparing a final clinical study report which is expected to be completed during the first half of 2016.

The enhanced survival and safety in our SCIB1 study combined with the novel mechanism of action which delivers high T cell avidity, has re-ignited the interest of pharmaceutical companies, especially in combination with checkpoint inhibitors.

SCIB2 vaccine
Our second ImmunoBody® vaccine, SCIB2 has been designed to be effective in over 90% of patients that over express the cancer antigen NY-ESO-1, including those with lung and other epithelial cancers.

US Clinical Study
The Company has announced the formation of a core US investigator team to lead a checkpoint inhibitor combination study with Scancell’s lead cancer vaccine, SCIB1. The team 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 and will be supported, amongst others yet to be announced, by:

• Dr Paul Chapman (Memorial Sloan Kettering)
• Dr Jennifer Wargo and Dr Michael Davies (MD Anderson)
• Dr Rene Gonzalez (University of Colorado)

The clinical study will assess the impact of adding SCIB1 to checkpoint inhibitors in patients with late stage melanoma. The aim will be to improve the objective response rates of anti-PD-1 (“checkpoint inhibitor”) monotherapy without adding additional toxicity. It is expected that the study will enrol approximately 80 Stage III/IV metastatic melanoma patients and commence in early 2017, with completion approximately 18 months later. We are delighted to have secured the help and support of such a prestigious group of US specialists to undertake this important study.

ImmunID Collaboration
The Company is continuing to work with ImmunID on a research project aimed at predicting which patients will respond best to SCIB1 treatment. This collaboration is providing further insight into T cell diversity in patients treated with our SCIB1 vaccine and their response to the treatment over time. Results from the first pilot study with ImmunTraCkeR® have indicated its potential to be used as a companion diagnostic to predict early clinical response to SCIB1 both during further clinical trials with SCIB1 and during routine clinical use; further studies are planned.

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.

The pre-clinical development of Modi-1, the lead candidate from our Moditiope® platform technology is continuing to progress and the peptide components have now been modified to include an additional enolase peptide. This improvement has meant that the product is expected to be effective in up to 95% of patients with triple negative breast and ovarian cancers. The Company expects to start clinical trials with Modi-1 in 2017.

The Company was also delighted to announce in January the publication of a paper in Cancer Research underpinning the scientific basis for the Moditope® platform. Cancer Research is one of the most highly regarded and widely read cancer journals and publication in this prestigious journal is a tribute to Scancell’s scientific team under the leadership of Prof Lindy Durrant.

Board

Scancell has strengthened its commercial and clinical development expertise with the appointment of Dr Peter Brown as an advisor to the Company and myself to the Board, initially as a senior Non-Executive Director and now as Chairman. David Evans has stepped down as Chairman and the Board would like to thank him for his exemplary leadership and sage advice during his tenure.

Peter is a highly experienced pre-clinical and clinical development consultant to the pharmaceutical industry and his expertise in designing and managing international late stage oncology clinical trials in both small and large pharmaceutical companies will be of enormous help as the Company continues to grow.

Outlook
The latest data on SCIB1, both in terms of the unprecedented survival of Stage III/IV melanoma patients with resected disease, combined with anti-tumour responses in late stage patients and compelling animal data showing the potential value of a SCIB1/checkpoint inhibitor combination, has set the stage for an expanded clinical trial programme with a prestigious group of US specialists.

Progress has also continued to be made with the Moditope® platform and it is anticipated that the first product, Modi-1, will be moving into the clinic in 2017. Publication of the scientific data supporting the Moditope® platform in Cancer Research is also a key milestone and a tribute to the strength of the Company’s research team.

These developments have reignited interest in the Company from all of its stakeholders, including the pharmaceutical industry and potential new investors, especially in the US.

The Board believes that investment in further focused clinical studies on both SCIB1 and Moditope® could add significant value to the Company and is exploring with its advisers a number of funding options to ensure
that the Company has the resources to progress these programmes further.

As part of this process, the Board and management will be further strengthened to prepare the Company for its future as a later stage development company.

I have become Chairman as the Company is poised for an exciting future and I am committed to strengthening our presence in the US and to building the Company into one of the leaders in immunooncology.

John Chiplin
Chairman

Scancell Holdings plc
Consolidated Profit or Loss and Other Comprehensive Income Statement
for the six months to 31 October 2015
 

	Unaudited Six months 31/10/2015 £	Unaudited Six months 31/10/2014 £	Unaudited Six months 30/04/2015 £
Continuing operations
Development expenses	(938,211)	(1,072,984)	(1,998,366)
Administrative expenses	(429,563)	(487,829)	(961,629)
OPERATING LOSS	(1,367,774)	(1,560,813)	(2,959,995)
Interest receivable and similar income	12,011	70,898	131,513
LOSS BEFORE TAXATION	(1,355,763)	(1,489,915)	(2,828,482)
Tax on loss on ordinary activities	180,800	150,000	413,852
LOSS FOR THE PERIOD	(1,174,963)	(1,339,915)	(2,414,630)
Attributable to: Equity holders of the parent company	(1,174,963)	(1,339,915)	(2,414,630)
EARNINGS PER ORDINARY SHARE (PENCE) Note2
Basic	(0.52)	(0.60)	(1.07)
Diluted	(0.52)	(0.60)	(1.07)

 

Scancell Holdings plc
Consolidated Statement of Changes in Equity for the six month period to 31 October 2015

 

 

	Share capital £ Unaudited	Share premium account £ Unaudited	Share option reserve £ Unaudited	Retained earnings £ Unaudited	Total Equity £ Unaudited
At May 2015	224,951	16,036,276	613,726	(10,120,951)	6,754,002
(Loss) for the period				(1,174,963)	(1,174,963)
Share option costs			27,902		27,902
At 31 October 2015	224,951	16,036,276	641,628	(11,295,914)	5,606,941
At 1 May 2014	224,951	16,036,276	522,358	(7,706,321)	9,077,264
(Loss) for the period				(1,339,915)	(1,339,915)
Share option costs			46,867		46,867
At 31 October 2014	224,951	16,036,276	569,225	(9,046,236)	7,784,216
	Audited	Audited	Audited	Audited	Audited
At 1 May 2014	224,951	16,036,376	522,358	(7,706,321)	9,077,264
(Loss) for the year				(2,414,630)	(2,414,630)
Share option costs			91,368		91,368
At 30 April 2015	224,951	16,036.276	613,726	(10,120,951)	6,754,002

 

Scancell Holdings plc

Consolidated Statement of Financial Position as at 31 October 2015

	Unaudited 31/10/2015 £	Unaudited 31/10/2014 £	Unaudited 30/04/2015 £
ASSETS
Non-current assets
Plant and equipment	73,250	100,811	86,504
Goodwill	3,415,120	3,415,120	3,415,120
	3,488,370	3,515,931	3,501,624
Current assets
Trade and other receivables	103,615	78,643	136,785
Income tax assets	590,339	396,652	660,504
Cash and cash equivalents	1,813,718	4,302,052	3,059,001
	2,507,672	4,777,347	3,856,290
TOTAL ASSETS	5,996,042	8,293,278	7,357,914
LIABILITIES
Current liabilities	(389,101)	(509,062)	(603,912)
Trade and other payables
TOTAL LIABILITIES	(389,101)	(509,062)	(603,912)
NET CURRENT ASSETS	2,118,571	4,268,285	3,252,378
NET ASSETS	5,606,941	7,784,216	6,754,002
TOTAL EQUITY
Called up share capital	224,951	224,951	224,951
Share premium account	16,036,276	16,036,276	16,036,276
Share option reserve	641,628	569,225	613,726
Retained earnings	(11,295,914)	(9,046,236)	(10,120,951)
	5,606,941	7,784,216	6,754,002

 

 

Scancell Holdings plc

Consolidated Cash Flow Statement for the six month period to October 2015

	Unaudited Six months 31/10/2015 £	Unaudited Six months 31/10/2014 £	Unaudited Six months 30/04/2015 £
Cash flows from operating activities
Operating (loss) for the period	(1,367,775)	(1,560,813)	(2,959,995)
Depreciation	13,254	14,810	29,117
Share based payment expense	27,902	46,867	91,368
Operating (loss) profit for the year before changes in working capital	(1,326,619)	(1,499,136)	(2,839,510)
(Increase)/decrease in trade and other receivables	33,170	67,871	9,729
(Decrease)/increase in trade and other payables	(214,810)	(28,529)	66,321
Cash generated from operations	(1,508,259)	(1,459,794)	(2,763,460)
Income taxes received	250,965	124,714	124,713
Net cash from operating activities	(1,257,294)	(1,335080)	(2,638,747)
Cash flows from investing activities
Asset acquisition	-	-	-
Grant monies	9,776	5,556	64,668
Other income	2,235	49,725	49,725
Finance income	12,011	15,617	17,121
Net cash used by investing activities		70,898	131,514
Net increase/(decrease) in cash and cash equivalents	(1,245,283)	(1,264,182)	(2,507,233)
Cash and cash equivalents at beginning of the year	3,059,001	5,566,234	5,566,234
Cash and cash equivalents at end of the period	1,813,718	4,302,052	3,059,001

 

Scancell Holdings plc

Notes to the Interim Financial Statements for the period to 31 October 2015

1.Basis of preparation

This interim statement for the six month period to 31 October 2015 is unaudited and was approved by the Directors on 26 January 2016. 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 2015.

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 2015, 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 2015 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.

	Six months to 31/10/2015	Six months to 31/10/2014	Year ended 30/04/2015
Loss after taxation	(1,174,963)	(1,339,915)	(2,414,630)
Weighted average number of shares	224,950,683	224,950,683	224,950,683
Basic earnings per share	(0.52)p	(0,60)p	(1.07)p

 

       

   

At 31 October 2015 the Company had 224,950,683 Ordinary Shares of 0.1p in issue.

3. Taxation

Taxation for the six months ended 31 October 2015 is based on the effective rates of taxation which are estimated to apply for the year ended 30 April 2016.

4. Interim results

These results were approved by the Board of Directors on 26 January 2016. 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.

 

Translating innovative science into ground-breaking new products

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today provide a business and R&D update following the Company’s AGM. Dr Richard Goodfellow and Prof Lindy Durrant, Scancell’s joint CEOs, will present a summary of the latest available data from the SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company’s ImmunoBody® platform. The Company will also provide an update on the latest data and plans for the Moditope® platform.

Highlights

• Maturing survival and safety data from Phase 1/2 clinical trial continues to suggest that SCIB1 has the potential to become the first effective stand-alone adjuvant treatment for early stage metastatic melanoma, a billion US dollar market opportunity
  • All 20 patients with resected tumours at study entry remain alive
    • Of the 16 patients who received 2-4mg doses of SCIB1
      • Median survival since entry is 39 months or 44 months since first diagnosis of metastatic disease
      • Only five patients have progressed
    • Of the four patients who received an 8mg dose (recruited after lower dose cohorts)
      • None have progressed
      • Median survival since entry is 7 months to date
  • Final Clinical Study Report for trial expected H1 2016
• Further animal data has confirmed that SCIB1 offers the potential to be combined with checkpoint inhibition thereby increasing response rates beyond the 25-30% of patients responding to checkpoint inhibitors alone
• Progress in pre-clinical development of Modi-1, lead pipeline candidate from Moditope® platform
  • Modi-1 peptide components broadened to include additional enolase peptide
    • Significantly extends tumour coverage and patient eligibility in triple negative breast and ovarian cancer patient populations
    • First in Man studies in these settings provisionally targeted for Q4 2016
• Roadmap for further clinical development of Immunobody® and Moditope® assets outlined
• Continuing to explore various options for the Company consistent with maximising shareholder value

Prof Lindy Durrant, Joint CEO of Scancell, said: “We continue to be excited by the compelling data emerging from our Phase 1/2 clinical trial in metastatic melanoma with SCIB1, the lead pipeline candidate from our ImmunoBody® platform. In particular the encouraging survival data in patients with resected disease continues to support its potential to become the first effective, stand-alone adjuvant treatment for early stage metastatic melanoma. We have also continued to progress the pre-clinical development of Modi-1, the lead candidate from our second platform technology, Moditope®. The product has been further improved to be potentially effective in up to 95% of patients with triple negative breast and ovarian cancers. We look forward to progressing Modi-1 into the clinic in these indications towards the end of 2016.”

Dr Richard Goodfellow, Joint CEO of Scancell, added: “The commercial launch of the first cancer immunotherapies has cemented the importance of this approach in the treatment of cancer. We continue to believe that Scancell has a complementary and potentially valuable pipeline of immuno-oncology assets that is underpinned by two differentiated technology platforms.

“We look forward to communicating the findings from the final Clinical Study Report from our SCIB1 Phase 1/2 trial during the first half of 2016 and to progressing Modi-1 into the clinic towards the end of that year. While we continue to refine our roadmap for the future development of assets from both our platforms, we also continue to explore various options for the Company that are consistent with maximising shareholder value.”

David Evans, Non-Executive Chairman of Scancell, commented: “Given the strength of the clinical data and product pipeline, the Board believes that investment in further focused clinical studies on both SCIB1 and Moditope® could add significant value to the Company and is actively evaluating the possibility of conducting one or more of these studies on its own behalf alongside other strategic opportunities for realising shareholder value. The Company is poised for an exciting future as one of the leaders in immuno-oncology and we anticipate strengthening both the Board and management as the Company evolves into a later stage development business.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO
Rob Naylor (Corporate Finance)	Panmure Gordon & Co	+44 (0) 20 7886 2714
Maisie Atkinson (Sales)		+44 (0) 20 7886 2905
Mo Noonan/Simon Conway	FTI Consulting	+44 (0) 20 3727 1000

 

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.

Scancell Holdings Plc

Interim Results for the six months ended 31 October 2014

SCIB1 continues to generate highly encouraging survival data; Modi-1 vaccine on track for 2016 entry into clinic

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 2014.

Highlights

• Data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody shows highly encouraging survival times in both Part 1 and Part 2 patient groups
• Pre-clinical data demonstrates that a combination of SCIB1 and checkpoint inhibition (PD-1 blockade) produced enhanced tumour destruction and longer survival times than when either treatment was used alone, supporting use of the combination for later stage disease
• Adjuvant melanoma* represents a significant new market opportunity for SCIB1
• SCIB2 vaccine ready for further pre-clinical development as a potential immunotherapy for any tumour expressing the NY-ESO-1 antigen
• Patent granted in the US for Scancell’s DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan
• Modi-1, lead vaccine from Moditope® platform, is on schedule for clinical trials in 2016
• Two new Moditope® protein targets identified
• Loss for the six month period of £1,339,915 (2013: loss: £1,187,574)
• Group cash balance at 31 October 2014 was £4,302,052 (30 April 2014: £5,566,234)

Richard Goodfellow, Joint CEO of Scancell, said: “We are delighted that our lead ImmunoBody®, SCIB1, continues to show the potential to extend the lives of melanoma patients without serious side effects. This encouraging data makes us increasingly optimistic about the clinical value of SCIB1 as monotherapy, especially in the adjuvant setting, a huge and relatively untapped market. Furthermore, the increased survival times when SCIB1 was combined with PD-1 blockade in pre-clinical studies gives us confidence that SCIB1 also has significant potential in combination with checkpoint inhibitors for late stage disease."

“Our Moditope® platform is progressing well with Modi-1 expected to start clinical trials in 2016. Two additional Moditope® protein targets have also now been identified. The market opportunity for our two innovative technology platforms, ImmunoBody® and Moditope®, is significant and we remain committed to evaluating all available options for the realisation of shareholder value.”

-ENDS-

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

For Further Information:

Dr Richard Goodfellow, Joint CEO Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 3727 1000
Robert Naylor/Maisie Atkinson	Panmure Gordon	+44 (0) 20 7886 2500
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 3727 1000

 

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.

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 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has 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.

Click here to read the full Interim Results Report

Scancell Holdings Plc

AGM research and development update highlights progress in both SCIB1 clinical trial and Moditope® platform

 Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today provide a research and development update following the Company’s AGM. Dr Richard Goodfellow and Prof Lindy Durrant, Scancell’s joint CEOs, will present an update on progress with the new Moditope® platform as well as the ongoing SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company’s ImmunoBodyplatform.

Highlights

• Encouraging survival and safety data from Phase 1/2 clinical trial suggests that SCIB1 has the potential to become the first effective stand-alone treatment for adjuvant melanoma. All 16 patients with fully resected disease are still alive with a median survival of 26 months after starting treatment and only four have shown disease progression
• Adjuvant melanoma represents a significant new market opportunity for SCIB1.
• Combining SCIB1 and PD-1 blockade in animals enhances tumour destruction and extends survival times supporting the use of the combination for later stage disease
• Modi-1 on schedule to be ready for clinical trials in 2016
• Two new Moditope® protein targets identified

Dr Lindy Durrant, Joint CEO of Scancell, comments: “Modi-1 remains on track for start of first-in man clinical trials in 2016. The identification of new targets suggests that Moditope has significant potential as a platform for generating multiple cancer immunotherapeutics. In addition to the reported positive data from SCIB1, our Immunobody® platform continues to make good progress with a second vaccine target for lung cancer and the potential to take the platform into chronic infectious diseases.”

Dr Richard Goodfellow, Joint CEO of Scancell, adds: “Cancer immunotherapy is emerging as one of the most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are currently being evaluated by a number of pharmaceutical companies under a CDA. The encouraging survival data on SCIB1, especially in patients with resected disease, offers an even greater market opportunity for SCIB1 and our pipeline of ImmunoBody® vaccines than was originally envisaged.”

Research and Development Update

SCIB1

We are pleased to announce further encouraging data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with SCIB1. To date, 32 patients have been treated with SCIB1, including seven at the higher 8mg dose. Six patients are currently on long-term treatment and have received between 4 and 6 further doses of SCIB1 every 3-6 months. Although recruitment of patients with advanced disease remains challenging it is expected that enrolment for the study will be completed during 2Q15. A new clinical centre has been established at the Royal Surrey County Hospital in Guildford to accelerate recruitment. SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to adverse events.

Overall, only five of the 27 patients who have received at least three doses of 2-8mg SCIB1 since commencement of the study in 2010 have died. Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 34 months since study entry. This group of patients had 1-year, 2-year and 3-year survival rates of 100%, 67% and 50%, respectively. For the Part 1 8mg cohort of patients, who were recruited later, the median survival time is currently 13 months since study entry. The median survival time since initiating treatment with SCIB1 in Part 2 patients with resected disease (and receiving 4mg doses of SCIB1) is currently 25 months.

Importantly, all 16 patients (two in Part 1 and 14 in Part 2) with fully-resected metastatic disease (nine Stage III and seven Stage IV) are still alive with a median survival time of 26 months since study entry (range 20-39 months) and only four have shown evidence of disease progression. The Stage III patients have a median survival time of 26 months since study entry and two (22%) have progressed. This compares extremely favourably with results from a peptide vaccine trial (Slingluff et al., 2011) where 52% of fully-resected Stage III patients had progressed and 33% had died two years after the start of treatment. The Stage IV patients treated with SCIB1 have a median survival time of 24 months since study entry and two of these patients (22%) have also progressed. In the Slingluff study, 50% of the fully-resected Stage IV patients had progressed and 19% had died after two years of treatment.

These results in patients with resected disease suggest that SCIB1 may have an important role to play as first line treatment in adjuvant melanoma. These are patients who no longer have measurable disease (following surgery) and are often generally quite well. However, they are at a high risk of recurrence and currently have very few, if any, effective treatment options. This represents a significant and as yet untapped market opportunity, including some 360,000 patients in the US alone, of whom around 45% have the MHC antigen HLA-A2 and are therefore suitable for SCIB1 treatment.

Animal data supporting the synergistic effect of combining SCIB1 with PD-1 blockade was announced in August. Any patients that progress following SCIB1 monotherapy, or indeed any patient with more advanced disease, may therefore benefit from the combination of SCIB1 with a checkpoint inhibitor.

ImmunoBody® platform

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 a pipeline of ImmunoBody® vaccines, both for cancer and chronic infectious diseases.

A second ImmunoBody® vaccine targeting the lung cancer antigen NY-ESO-1 (SCIB2) 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. During the past 12 months research on other ImmunoBody® vaccines for prostate, liver and colorectal cancer have also been further advanced.

In addition, Scancell has conducted proof of concept studies with ImmunoBody® constructs expressing antigens from influenza and Epstein Barr virus and is in early discussions with potential partners for the co-development of ImmunoBody® vaccines for the treatment or prophylaxis of infectious diseases.

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 and based upon the possible addition of other peptide targets into the product.

Scancell is considering options for conducting the initial Modi-1 study in both Europe and the US and is designing the development and regulatory strategy to allow for either approach. The development programme will include manufacture plus toxicology and stability testing of the final formulated product. This data will form the basis of a clinical trial application, which is anticipated to be ready for submission in the first half of 2016.

Moditope® platform

Having exemplified the Moditope® platform with modified vimentin peptides, Scancell has been expanding the platform to other citrullinated tumour proteins that could be incorporated into Modi-1 or developed into a pipeline of other multiple-cancer immunotherapeutics. We are therefore pleased to announce today the identification of two further Moditope® protein targets, alpha-enolase and ING4.

Human alpha-enolase is a glycolytic enzyme that is overexpressed by lung, liver and other cancers. We have identified a citrullinated peptide within human alpha-enolase that induces a powerful and specific immune response and that elicits both increased survival and decreased tumour volume compared to control groups in animal models. Analysis of blood samples from donors has indicated that humans have a T cell repertoire that is able to recognise citrullinated alpha-enolase.

The tumour suppressor protein encoded by the ING4 gene plays a role in many cancer related processes. Two citrullinated peptides from human ING4 have been shown to induce specific T cell responses. Further studies are ongoing to evaluate the effect of these citrullinated peptides on tumour volume and survival. Both alpha-enolase and ING4 are believed to offer excellent prospects for future Moditope® immunotherapies.

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Christopher Golden/Stephen Keys	Cenkos Securities	+44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+44 (0) 20 3727 1000

 

 

 

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.

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 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway), has 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.

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of the patent application underpinning the Company’s Moditope® platform.  When granted, this patent will protect the platform to at least 2033.

The patent application, describes how the Moditope® immunotherapy platform harnesses CD4+ T cells to eradicate tumours.  Moditope® deploys certain tumour-associated peptide epitopes as immunotherapeutic agents to overcome self-tolerance and eradicate tumour cells, with no requirement for blockade inhibitors.  Planning is underway for the manufacture, preclinical testing and first-in-man clinical development of the Modi-1, the first Moditope® immunotherapeutic.  The PCT patent application which has a priority date of 7 August 2012 was published on 13 February 2014 as WO2014/023957.

Prof. Lindy Durrant Professor of Cancer Immunotherapy at the University of Nottingham and Joint CEO of Scancell, said:  “The publication of the patent application is another important milestone in the development of a range of novel immunotherapeutics from the Moditope® platform.  Recent data suggests that Modi-1 may exhibit potent anti-tumour effects even against established aggressive tumours, dramatically improving survival rates.  We look forward to a busy and exciting year in which we continue to prepare Modi-1 for clinical trials which are on schedule to start in early 2016.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

 

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 produced a melanoma-specific immune response and promising survival trend. 

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.