Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it will be presenting at the World Immunotherapy Congress being held on 14-16 November 2016 in Basel, Switzerland and at the Biotech and Money Inv€$tival Showcase on 18 November 2016 in London, UK.

At the World Immunotherapy Congress, Professor Lindy Durrant, Chief Scientific Officer of Scancell, will be presenting: “SCIB1, SCIB2 and Moditope novel cancer vaccines” at 11:25am on 16 November 2016 as part of the Cancer Vaccines segment.

At the Biotech and Money Inv€$tival Showcase, Dr Richard Goodfellow, Chief Executive Officer of Scancell, will be presenting an overview of the Company at 10:45am on 18 November 2016. Dr Richard Goodfellow will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.

For Further Information:

About The World Immunotherapy Congress
Immunotherapy currently offers the brightest hope for cancer treatment. New developments with checkpoint inhibitors and co-stimulatory targets have enabled some stunning breakthroughs and high optimism for the
sector. Recently, there have been some incredibly exciting new therapies in the field.

Our vision is to bring together the full community and provide a single meeting point for the whole value chain. It is where science meets business to make immunotherapy the cornerstone of the fight against
cancer.

The event is new, though the ideas and relationships are not. The event comes out of our discussions with leading clinicians, pharmaceutical companies, biotechs and research institutes held every year at the
successful European Antibody Congress, now in its twelfth successful year.


About The Biotech and Money Inv€$tival Showcase
Biotech and Money connects corporates to capital, and we have partnered with Jefferies for Inv€$tival to showcase the latest investable private and public life science opportunities.

Presenting companies will range from the latest start-ups through to growing public companies, delivering succinct powerful presentations to an audience of global investors and pharma. All companies will also have
their presentations recorded and a corporate interview video produced, forming a full corporate profile on the exclusive Biotech and Money Investor Portal.

For investors, Inv€$tival will help uncover and identify investable opportunities. And all of this in collaboration and with backing from the global investment bank Jefferies, co-located with their annual London Healthcare Conference.

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.

• SCIB2 will be developed for the treatment of non-small cell lung cancer in combination with a checkpoint inhibitor
• Latest SCIB2 data published in peer-reviewed journal OncoImmunology confirms potent antitumour activity was further enhanced by checkpoint blockade
• Extension of clinical application from melanoma to lung cancer highlights potential of ImmunoBody® platform technology to target broad range of cancers

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces its intention to develop its SCIB2 ImmunoBody® for the treatment of non-small cell lung cancer (NSCLC) in combination with a checkpoint inhibitor. Scancell’s Board approved the decision based on the outstanding results from the SCIB1 melanoma clinical trial which extended several years beyond the original completion date due to the unexpectedly long survival times. Planning for Phase I/II clinical trials in NSCLC is currently underway.

The latest data on SCIB2 has recently been published in OncoImmunology^1, a highly regarded journal at the frontier between oncology and immunology. The results confirmed that SCIB2, an ImmunoBody® encoding NYESO-1 epitopes, induced potent anti-tumour immunity which was further enhanced by checkpoint blockade.

Prof Lindy Durrant, Chief Scientific Officer of Scancell, said: “Our clinical experience with the first ImmunoBody®, SCIB1, in the melanoma setting will greatly facilitate planning and execution of our planned lung cancer clinical trials with SCIB2. We believe that success with this clinical programme will highlight that ImmunoBody® has the potential to be applicable to cancers with very different characteristics and underlying genetics.”

Dr Richard Goodfellow, Chief Executive Officer of Scancell, said: “It is recognised that the successful exploitation of novel therapeutic mechanisms, such as that underlying our ImmunoBody® platform, will be critical to further improving the poor mortality rates of patients with lung cancer. The data we have generated to date with the SCIB2 ImmunoBody® suggest that it should be well tolerated and be an ideal complement to existing and emerging portfolios of checkpoint inhibitor therapies in the treatment of NSCLC.”

The Company will now begin to assemble a lung cancer investigator team in the United States to assist in finalising the clinical trial design.

Lung cancer remains one of the most prevalent and difficult to treat cancers in need of novel therapeutic approaches. According to the Bonnie Addario Lung Cancer Foundation, one of the largest philanthropic organisations targeting the disease, more than 228,000 people are diagnosed with lung cancer in the United States alone, and more 160,000 will go on to die. Lung cancer accounts for 27% of all cancer deaths, more than breast, prostate and colon cancers combined.² ImmunoBody® is designed to be used to complement existing treatments in combination approaches, but may also be valuable where current treatments are either unsuitable or unavailable.

¹ SCIB2, an antibody DNA vaccine encoding NY-ESO-1 epitopes, induces potent antitumor immunity which is further enhanced by checkpoint blockade. Xue W, Metheringham RL, Brentville VA, Gunn B, Symonds P, Yagita H, Ramage JM, Durrant LG. OncoImmunology.
2016 Apr 22;5(6):e1169353. doi: 10.1080/2162402X.2016.1169353. eCollection 2016 Jun. PMID: 27471648

² Bonnie J. Addario Lung Cancer Foundation (http://www.lungcancerfoundation.org/about-us/lung-cancer-facts/)

For Further Information:

About ImmunoBody®
ImmunoBody® is an injectable DNA based immunotherapy with a customizable targeting mechanism for multiple specific cancer types. Two additional major practical advantages of ImmunoBody® are a benign toxicity profile and a relatively low cost of manufacture.

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.

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’s ImmunoBody® treatments 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.

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.

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:

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.

Leading DNA plasmid manufacturer Eurogentec appointed to manufacture new SCIB1 material 

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces an agreement with Eurogentec S.A, an FDA inspected CMO specialised in the GMP production of plasmid DNA and recombinant proteins, for the manufacture of new supplies of Scancell’s SCIB1 ImmunoBody® vaccine for use in the US clinical study of SCIB1 in combination with a checkpoint inhibitor, expected to commence in 2017. Upon completion and once fully evaluated, which is expected to take approximately 9-12 months, this clinical trial material will also be available to recommence dosing of patients in the Company’s long-term extension of the Phase 1/2 SCIB1 clinical study in malignant melanoma (subject to regulatory approval).

Eurogentec’s biologics division produces clinical trial and commercial biopharmaceutical material compliant with current Good Manufacturing Practice (cGMP) for all major markets according to US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) requirements. The company is FDA inspected (2011, 2013, 2014) and currently manufactures a biopharmaceutical marketed in the US. In the field of plasmid DNA, Eurogentec is a recognised leading CMO having recently manufactured 150g of plasmid DNA material for a major pharmaceutical company with plans to scale the process to commercial
requirements.

Dr Richard Goodfellow, CEO of Scancell, said: 
“We are delighted to be working with Eurogentec, a world class manufacturer, to provide the new batch of SCIB1 material. As can be seen from the latest data from our Phase 1/2 clinical trial, SCIB1 continues to deliver compelling survival data in patients with resected stage III/IV melanoma. This new supply will not only be used in our upcoming US checkpoint inhibitor combination trial, but also enable us to recommence treating patients in the long-term extension of the Phase 1/2 study.
“Access to Eurogentec’s expertise and proprietary manufacturing processes has the potential to substantially increase the yields of SCIB1 and fast-track the scale-up that will be required for future Phase III and commercial supply.”

For Further Information:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from thePhase 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.

About Eurogentec

Eurogentec S.A., part of Kaneka Corporation, is a leading global supplier of innovative reagents, kits, specialty products and custom services. Through its three inter-related business units, the company provides high quality products to scientists involved in the life science, biotechnology, diagnostic and pharmaceutical markets. Eurogentec is fully ISO 9001, ISO 13485 certified, cGMP accredited by the Belgian Ministry of Health and approved by the US FDA for the commercial manufacturing of a biologic marketed in the US.

www.eurogentec.com

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:

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.

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:

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.

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:

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.

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:

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 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:

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.

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:

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

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: