Posts in Category: SCIB1

Extension to Ichor Commercial Option

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer is pleased to announce that it has been granted a further extension to its option to licence the commercial use of Ichor Medical Systems’ (“Ichor’s”) proprietary TriGrid® electroporation delivery system with SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma. In exchange, Scancell has granted a partial waiver over the lock-up which prohibited the sale, during the two years following their issue, of ordinary shares in the Company (“Ordinary Shares”) issued pursuant to exercise of the Tranche 2 share options (over 3,184,620 Ordinary Shares), issued as part payment for the licence option, as originally announced 16 July 2009 and extended in July 2014. Subject to exercise of the Tranche 2 share options, Ichor will remain under an orderly market agreement requiring any sale of such Ordinary Shares during that two year period to be effected through Scancell’s brokers.

Under the terms of the agreed extension, Scancell’s licence option, which had been due to expire on 13 July 2016, has been extended until 13 July 2018.

Richard Goodfellow, CEO of Scancell, said:

“Ichor’s proprietary TriGrid® electroporation delivery system remains central to our studies on SCIB1 and in particular, to our upcoming US clinical study of SCIB1 in combination with a checkpoint inhibitor, expected to commence in 2017. We are delighted to have extended the licence option agreement to commercialise their technology on the terms as set out above and we appreciate Ichor’s continued support of our SCIB1 programme as we continue its clinical development as a potential treatment for patients with melanoma.”

Robert Bernard, President & CEO of Ichor, added:

“Scancell has continued to generate outstanding survival data using our TriGrid® electroporation delivery system in conjunction with their lead ImmunoBody® vaccine, SCIB1. We believe that SCIB1 has the potential to be a significant new treatment option for patients with melanoma, and we look forward to continuing to work with Scancell on this exciting product.”

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)

Tom Salvesen (Corporate Broking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

About Ichor and the TriGrid® Delivery System

Ichor is dedicated to the clinical application and commercialization of electroporation technology for the delivery of DNA drugs and vaccines to treat and prevent debilitating or life threatening diseases. They are applying their proprietary TriGri® Delivery System to enable delivery of DNA drugs to address unmet medical needs in areas including therapeutic cancer vaccines, therapeutic proteins and vaccines for serious infectious disease.

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.

SCIB1 continues to deliver compelling survival data in melanoma

Scancell to present update at the Oxford Technology VCT AGM and Proactive Investors One2One Forum

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today provides an update from the SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company’s ImmunoBody® platform and will be presenting at the Oxford Technology VCT AGM and Proactive Investors One2One Forum later this week.

Dr Richard Goodfellow, CEO of Scancell, said: “SCIB1 continues to deliver compelling survival data in patients with resected Stage III/IV melanoma. It is particularly interesting to note that there has only been one new case of disease progression since November 2013 in the resected patients receiving 4mg doses of SCIB1, which gives us hope that SCIB1 might offer curative potential in this currently untreated patient group.”

Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School, commented: “The SCIB1 overall survival and progression free survival data generated to date go well beyond established norms for this group of melanoma patients. We have a lot of enthusiasm for validating these results in subsequent trials.”

SCIB1 Survival Update

As of 27 June 2016, SCIB1 continues to deliver strong survival data:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • One patient who first experienced disease progression in September 2013 died in April 2016, despite additional treatment with checkpoint inhibitors and radiation therapy
  • Of the 16 patients who received 2-4mg doses of SCIB1 Median observation time since entry is 46 months and 52 months since first diagnosis of metastatic disease
  • Only five patients have progressed and one has died
  • Only one new incidence of disease progression has been seen since November 2013
  • Of the four patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
  • Median observation time since entry is 16 months and 21 months since first diagnosis of metastatic disease
  • 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)
  • New SCIB1 material will be ready for use in approximately 9-12 months
  • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track
  • The final Clinical Study Report, which will be issued later this year, will provide safety, immunology and clinical data from all patients up to 29 October 2015 (the date of the last patient’s dose in the main study) to support our US regulatory submission


Investor Events

Proactive One2One Forum, 7 July 2016 – Dr Richard Goodfellow
The event will commence at 6.00pm at the Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair. Attendance is free. Proactive Investors One2One Forums have rapidly gained global recognition for companies to present
to an audience of astute high net worth investors, fund managers, private client brokers and analysts. See Proactive Investors website for more details: http://www.proactiveinvestors.co.uk/register/event_details/65

Oxford Technology VCT AGM, 8 July 2016 – Dr John Chiplin

Scancell will be speaking as part of the portfolio review at the Oxford Technology VCT AGM which commences at 11am at the Magdalen Centre, Oxford Science Park, Oxford OX4 4GA. The Company will provide a corporate presentation and will provide an update on its immunotherapy platform technologies:

  • ImmunoBody® - Best-in-class DNA vaccine technology for use in combination with checkpoint inhibitors or as monotherapy for patients with resected disease
  • Moditope® - Novel immunotherapy that destroys tumours and extends survival without the need for checkpoint inhibition

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 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.

SCIB1 Drug Product Supply

Scancell Holdings Plc, (AIM:SCLP), the developer of novel Immunotherapies for the treatment of cancer, announces that it is suspending dosing with the current clinical trial supplies of SCIB1 with immediate effect.

Ongoing quality control analysis has revealed that the stored drug product is no longer within the original specification. In discussion with the MHRA Clinical Trials Unit, and with patient safety of primary importance, the Company has concluded that it is no longer suitable for further use, although no new side effects have emerged.

The suspension of dosing affects eight patients in the long term extension arm of the Phase 1/2 trial, SCIB1- 001 (out of the 35 patients that have been dosed), investigating SCIB1 as a monotherapy for the treatment of melanoma. All study investigators have been informed and their patients will be notified as soon as possible.

SCIB1-001 was originally started in 2010 with a prospectively planned treatment period of only six months. However, continuing encouraging results and an excellent side effect profile led to successive amendments to the clinical trial protocol to investigate increasing doses of the drug and eventually to examine a long term dosing regimen. As a result, some of the trial materials have now been stored for over 7 years.

The Company is planning to make a fresh batch of SCIB1 and has recently signed an agreement with a new GMP manufacturer. The primary reason for this is to support a new study of SCIB1 in combination with a checkpoint inhibitor, as previously announced. However, the Company also intends to make this material available to patients currently in the long term extension of SCIB1-001 who wish to continue receiving the drug. While it is expected that there will be a delay of approximately 9-12 months before the new SCIB1 material will be available for clinical use, it is anticipated that the anti-tumour response induced by SCIB1 should persist and eliminate any remaining tumour cells. Further doses of SCIB1 have been given for added protection to ensure the immune cells continue to patrol for any emerging cancer cells; subsequent administration of the new SCIB1 material should reactivate these memory immune cells to eliminate any recurring tumours.

Prof Poulam Patel, Chief Investigator for the SCIB1-001 clinical trial and Professor of Clinical Oncology at the University of Nottingham commented: “Results from the SCIB-001 trial to date have been very encouraging and SCIB1 clearly warrants further investigation as a potential treatment for melanoma.

However as patient safety is our primary concern, the deterioration of stored clinical trial material from the original specification necessarily means that dosing of SCIB1 must be suspended until new drug product becomes available.”

Dr Richard Goodfellow, CEO of Scancell added: “Patient safety has always been our primary responsibility. Although we have seen no new adverse events it is unfortunate, but nevertheless appropriate, that we suspend dosing of SCIB1 at this time while we work as quickly as possible to secure new supplies of this promising potential treatment for melanoma. Starting further efficacy studies with SCIB1 is only possible due to the results we have seen so far in the long-running SCIB1-001 study and we would again like to convey our thanks to the patients in that trial for their participation and support over the past 6 years.”

-ENDS-

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
Maisie Atkinson (Sales) Panmure Gordon & Co +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 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.

Result of the Open Offer

On 9 March 2016 the Board of Scancell announced details of a Placing in which it had conditionally raised gross proceeds of £3.4 million by means of a Placing of 20,000,000 Placing shares at 17 pence per share.

In addition, the Company announced that it was providing Qualifying Shareholders with an opportunity to subscribe, at 17 pence per share, for 22,495,068 new Ordinary Shares to raise gross proceeds of up to approximately £3.8 million by way of the Open Offer.

The Company has received subscriptions in respect of 16,048,593 new Ordinary Shares, representing 71.3 per cent. of the new Ordinary Shares available under the Open Offer. All applications made pursuant to the Open Offer including the Excess Shares applied for under the Excess Application Facility have been met in full. The Company has therefore raised gross proceeds of approximately £2.7 million through the Open Offer.

John Chiplin, Non-Executive Chairman of Scancell, said: "We are delighted that, through our Placing and Open Offer, the Company has successfully raised £6.1 million. We would like to thank our existing shareholders for their continued support, as well as welcoming new investors, at this important time in the Company’s evolution. As a result of this fundraising we are now able to accelerate the development of both our ImmunoBody® and Moditope® platform technologies. We will use the money raised to prepare for our SCIB1 ImmunoBody® / checkpoint inhibitor combination study in melanoma, including applying for a US IND later this year, enabling the study to begin in 2017 and also to take our first Moditope® product, Modi-1, into the clinic next year. We will continue to strengthen our Board and management team and increase our focus on the US with the goal of becoming one of the leading cancer immunotherapy companies.”

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

 

Application will be made to the London Stock Exchange for the admission to trading on AIM of the 36,048,593 new Ordinary Shares to be issued under the Placing and Open Offer. It is expected that Admission will occur and that dealings will commence at 08:00 a.m. on 5 April 2015. The total number of Ordinary Shares following Admission will be 260,999,276 with each share carrying the right to one vote. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in Scancell under the FCA's Disclosure and Transparency Rules.

This announcement should be read in conjunction with the full text of the Circular posted to Shareholders on 11 March 2016, copies of which are available on the Company's website at www.scancell.co.uk. Capitalised terms not otherwise defined in this announcement have the meanings given in the Circular.

Scancell’s SCIB1 ImmunoBody® cancer vaccine being presented at the World Vaccine Congress

Scancell’s SCIB1 ImmunoBody® cancer vaccine being presented at the World Vaccine Congress Scancell Holdings plc, (‘Scancell’ or the 'Company’) the developer of novel immunotherapies for the treatment of cancer, announces that Dr Peter Brown, Clinical and Scientific Consultant, Immunotherapeutics, at Scancell, will be presenting an update on the Company’s SCIB1 ImmunoBody® cancer vaccine at the World Vaccine Congress US 2016, 29-31 March 2016, in Washington D.C., US.

The presentation entitled: “SCIB1 ImmunoBody® stimulates a potent T cell response that eradicates tumours and prevents recurrence” will be presented on Wednesday 30 March 2016 at 11:40am EDT.

Scancell’s first ImmunoBody®, SCIB1, is currently being evaluated in a Phase 1/2 clinical trial in patients with Stage III/IV melanoma. The latest data suggests that SCIB1 may have the potential to significantly extend survival times in patients, especially in those with resected disease. The Company is in the process of preparing a final clinical study report. A Phase 2 checkpoint inhibitor combination study of SCIB1 in melanoma is due to commence in 2017.

Richard Goodfellow, Joint CEO of Scancell, commented:

“We are delighted to be presenting an update on SCIB1 at the World Vaccine Congress, alongside some of the most distinguished companies in the immunotherapy field. Funds from the recently announced placing
and the pending open offer will be used to further progress our ImmunoBody® and Moditope® platforms, including helping to fund our expanded SCIB1 clinical trial programme, which will be led by a team of leading US specialists.”


For Further Information:

Dr Richard Goodfellow, Joint CEO

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc + 44 (0) 20 3727 1000

Robert Naylor (Corporate Finance)

Maisie Atkinson (Sales)

Panmure Gordon & Co

+44 (0) 20 7886 2714

+44 (0) 20 7886 2905

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 3727 1000

 

SCIB1 mechanism of action

SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation
with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

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 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.

Proposed Placing and Open Offer

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
   

Interim Results for the six months ended 31 October 2015

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.

 

Early Immune Effect of SCIB1 Cancer Vaccine Observed in Blood by ImmunTraCkeR® Companion Diagnostic

ImmunTraCkeR® to be incorporated into SCIB1’s upcoming Phase II checkpoint inhibitor combination clinical trial
 

ImmunTraCkeR® represents potential companion diagnostic for early detection of patient response to SCIB1 immunotherapy

Nottingham, UK and Grenoble, France, January 11, 2016 - Scancell Holdings plc (‘Scancell’ LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, and immune companion diagnostic developer ImmunID, today released data showing patient immunologic response to cancer vaccine SCIB1 can be demonstrated through monitoring changes in the diversity of T cells found in the blood.


The collaboration between Scancell and ImmunID to predict SCIB1 responders using ImmunTraCkeR® was announced in a press release on 30 July 2015.

“This initial data shows promise for the development of ImmunTraCkeR® as a companion diagnostic for SCIB1 cancer immunotherapy” said Dr Nicolas Pasqual, Co-Founder & Chief Science Officer of ImmunID. “The ability to identify patient responders to immuno-oncology treatments early is a key unmet clinical need which is likely to improve cancer patient outcomes.”

Prof Lindy Durrant, Joint Chief Executive Officer of Scancell, said: “These results provide further evidence that SCIB1 can induce T cell responses that are associated with disease control. ImmunTraCkeR® shows promise as an assay for predicting which patients will benefit most from SCIB1 and we are looking forward to conducting additional research on this during our planned checkpoint inhibitor combination trial.”

Dr Bernhard Sixt, Chairman & Chief Executive Officer of ImmunID, added: “These early but promising results are pointing towards the value ImmunID brings as a partner to biotech companies. We are convinced that ImmunTraCkeR® stratification will help to shorten clinical trial times, accelerate regulatory approval in the field of immuno-oncology and enhance investor confidence.”

The data was generated through a pilot study performed in conjunction with Scancell’s Phase 1/2 trial of the SCIB1 cancer vaccine in patients with resected stage III/IV metastatic melanoma. ImmunID’s ImmunTraCkeR® assay was used to assess T cell diversity in the blood from patients before and during treatment with SCIB1. Results showed variations in T cell diversity kinetics during SCIB1 treatment, underlining the immune-modulatory effect of the vaccine, and indicated that patients had developed an immunological response to SCIB1. Interestingly, data also suggested that patients who relapsed did not have an adequate immunological response to the vaccine. These preliminary results will be confirmed in a larger patient population through an extended collaboration between Scancell and ImmunID.

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Dr Bernhard Sixt, Chairman & CEO ImmunID +33 (0) 4387 85770
Robert Naylor/Maisie Atkinson Panmure Gordon +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

 

Notes to Editors

About Scancell

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

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

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic 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.

SCIB1 mechanism of action

SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

About ImmunID

ImmunID adds precision to the immuno-oncology revolution by personalizing immunotherapy for cancer patients. With its decade-long experience in immune molecular diagnostics, ImmunID provide doctors with clinically meaningful data on the highly complex immune system to select the right therapy for individual patients and to monitor their response. ImmunID’s flagship CE-marked product, ImmunTraCkeR®, evaluates the patient’s immune status based on the T lymphocyte diversity, from a simple liquid biopsy. The company is establishing ImmunTraCkeR® as the general immune companion diagnostic assay for immune checkpoint inhibitors and other immunotherapies. In addition, ImmunID collaborates with pharma and biotech companies to optimize the development of their next-generation immunotherapies. ImmunID is ISO 9001 and ISO 13485 certified and runs a CAP-accredited laboratory in the MINATEC high-tech campus in Grenoble, France.
www.immunid.com - Follow ImmunID on Twitter: @ImmunID

About ImmunTraCkeR®

ImmunTraCkeR® is a proprietary CE-marked immune molecular diagnostics assay, which evaluates a patient’s immune status in the blood based on combinatorial T cell diversity. Unlike most companion diagnostics tests, ImmunTraCkeR® is patient-specific rather than drug- or disease-specific, as it approaches the disease from the patient’s own immune system perspective. ImmunTraCkeR® provides information on the patient’s complex immune profile to evaluate clinical benefit or risk under treatment with immunotherapies. ImmunTraCkeR® may ultimately be used as immune companion diagnostics and answer the urgent medical need for efficient patient stratification tools in melanoma and other solid cancers.

Directorate Change

Scancell Holdings Plc, (AIM:SCLP), today announces the appointment of John Chiplin as Non-Executive Chairman, succeeding current Chairman David Evans who has offered his resignation to the Board in line with his personal decision to reduce his number of Non-Executive Chairman roles. John Chiplin will take on this position with immediate effect.

John Chiplin joined the Board of Scancell as a senior Non-Executive Director on 14 October 2015. John is based in the United States and his appointment as Chairman is in line with the Company’s strategy of increased focus in the US. As previously announced on 18 December 2015, the Company has formed its core US investigator team to lead a Phase 2 checkpoint inhibitor combination study with Scancell's lead cancer vaccine SCIB1.

David Evans joined the Board of Scancell as Non-Executive Chairman in 2007. During his time at the Company, David has played a key role in building Scancell into a clinical stage biotechnology company focused on the discovery and development of novel therapeutics that stimulate the immune system to treat or prevent cancer.

David Evans, outgoing Chairman, said: “I have thoroughly enjoyed my 8 years as Chairman of Scancell and I am proud of its many accomplishments. During this very productive time I have overseen the Company develop two platform technologies at the cutting edge of immuno-oncology. Scancell has also successfully progressed its lead ImmunoBody® product, SCIB1, into the clinic where it has generated compelling data that warrant its further development.

“John has a wealth of international experience in this sector, particularly in the US, and I am confident that he will successfully guide the Board and management team as the Company embarks on the next stage of development and growth.”


Dr Richard Goodfellow and Prof Durrant, joint CEOs, commented: “David’s leadership of our Board has been exemplary and his partnership and sage advice as a colleague and mentor to the management team has been invaluable. His many years of service have ensured a long and strong period of stability for Scancell, despite the challenges we have faced. His wisdom and experience have successfully guided us to the strong position we are in today, with a solid pipeline of development projects. We thank David for his contribution to Scancell and wish him well for the future.

“We are delighted that John will be taking on the role of Chairman. His significant Board experience and strong track record in the life science and technology industries makes him a clear successor and we look forward to working with him at this important time in the Company’s development.”


-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Robert Naylor (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2714
Maisie Atkinson (Sales) Panmure Gordon & Co +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 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.

Scancell to conduct Phase II checkpoint inhibitor combination study with SCIB1 with leading US melanoma specialists

Harvard, MD Anderson, Memorial Sloan Kettering, University of Colorado clinical team to lead checkpoint inhibitor combination trial with SCIB1 

Aim of study will be to improve objective response to anti-PD-1 monotherapy without additional toxicity.

Scancell Holdings Plc, (AIM:SCLP), today announced formation of its core US investigator team to lead a Phase II checkpoint inhibitor combination study with Scancell’s lead cancer vaccine SCIB1. 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. Joining Dr Flaherty are Dr Jennifer Wargo of the Department of Surgical Oncology at MD Anderson, Dr Michael Davies of the Department of Melanoma Oncology at MD Anderson, Dr Paul Chapman in the Melanoma/Sarcoma Service at Memorial Sloan Kettering and Dr Rene Gonzalez of the Division of Medical Oncology at University of Colorado.

Dr Keith Flaherty, Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital said: “Based on the scientific and translational research behind SCIB1, I believe there is a compelling case for further investigation in both the metastatic and adjuvant melanoma settings. Despite meaningful recent advances in the treatment of this disease there still remains a significant unmet medical need. I am very excited to be working with Scancell and my other colleagues in the investigator team to bring this innovative treatment to patients."

Dr Paul Chapman, Dept. of Medicine, Memorial Sloan Kettering Cancer Center added: “SCIB1 represents a potentially important complement to checkpoint inhibitor therapy. Despite the unquestionable clinical utility of anti-PD-1 drugs, only around 30% of patients respond to treatment. Available data supports testing the hypothesis that the use of SCIB1 in combination with these agents may increase the number of patients responding to treatment and prolong progression free survival without the additional burden of significant further side effects.”

Dr Richard Goodfellow, Joint CEO of Scancell, said: “The latest data on SCIB1, both in terms of the unprecedented survival of Stage 3/4 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 regimen sets the stage for an expanded clinical trial programme. We are delighted to have secured the help and support of such a prestigious group of US specialists, led by Dr Flaherty.”

The clinical study will assess the impact of adding SCIB1 to a checkpoint inhibitor 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 trial will enrol approximately 80 Stage 3/4 metastatic melanoma patients and commence in the second half of 2016, ending around 18 months later.

For Further Information:

Dr Richard Goodfellow, Co-CEO Scancell Holdings Plc + 44 (0) 20 3727 1000
Professor Lindy Durrant, Co-CEO    
Robert Naylor/Maisie Atkinson Panmure Gordon & Co +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting +44 (0) 20 3727 1000
David Schull Russo Partners (858) 717-2310
[email protected]

Notes to Editors

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

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

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic 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.