ImmunoBody® vaccine to be developed for the treatment of glioblastoma multiforme

Research undertaken by scientists at Nottingham Trent University and the University of Portsmouth

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that researchers at Nottingham Trent University and the University of Portsmouth have initiated a new preclinical study aimed at developing a vaccine for the treatment of glioblastoma multiforme (GBM) by utilising Scancell’s ImmunoBody® technology platform.

GBM is the most common and aggressive form of glioma and carries a very poor prognosis. Around 5,000 people are diagnosed with a primary malignant brain tumour in the UK each year and GBM accounts for just over half of them. Treatments are limited and even with intensive chemotherapy patients have an average survival time of just 14 months.

Due to the highly aggressive nature of GBM and the lack of successful curative treatments to date, there is an urgent need for novel therapeutic approaches such as immunotherapy.

By using Scancell’s ImmunoBody® technology platform, scientists at Nottingham Trent University and the University of Portsmouth are aiming to develop a vaccine that stimulates protective immune responses against tumour molecules such as ‘HAGE’ and ‘TRP2’, which are proteins that are expressed in the cancer cells of GBM patients.

The vaccine treatment will be assessed for its ability to generate strong anti-GBM tumour immunity, as well as the ability to reduce and eradicate established tumours.

The researchers will also determine whether the vaccine stimulates HAGE and/or TRP2-specific immune cells in the blood of GBM patients that are capable of recognising the GBM tumours. This will demonstrate the ability of a patient’s immune system to identify and kill the cancer cells, providing insight into the effectiveness of the treatment.

The £95,000 study is being funded by the Headcase Cancer Trust, the only UK charity which dedicates its funding solely to research which aims to find a cure for GBM brain tumours.

Professor Lindy Durrant, Chief Scientific Officer of Scancell commented:

“We are keen to collaborate on this exciting project to add HAGE to our TRP-2/gp100 vaccine to target GBM. It is an aggressive disease and we believe the high avidity T cells generated by ImmunoBody® will be needed to control its growth.”

Dr Stephanie McArdle, a scientist in the John van Geest Cancer Research Centre at Nottingham Trent University, said:

“Vaccines can be extremely powerful when correctly formulated, so we are very hopeful that combining HAGE and TRP-2/gp100 with Scancell’s ImmunoBody® technology will lead to better disease outcomes.”

-ENDS-

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
     
Dave Rogers (Senior Press Officer) Nottingham Trent University +44 (0) 115 848 8782
Helen Breese (Senior Press Officer)   +44 (0) 115 848 8751
     
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Maisie Atkinson (Sales)   +44 (0) 20 7886 2905
     
Mo Noonan/Simon Conway FTI Consulting +44 (0) 20 3727 1000

About Scancell

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

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

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic 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 John van Geest Cancer Research Centre, Nottingham Trent University

Nottingham Trent University’s John van Geest Cancer Research Centre is a unique purpose-built scientific facility. Its aim is to save lives and speed recovery by improving the early diagnosis and treatment of cancer.

The centre focuses on two key approaches to the treatment of patients with cancer:

Improving the diagnosis and management of breast and prostate cancers

Developing effective vaccines and immunotherapies that will significantly improve the survival rates and quality of life for cancer sufferers

Visit the John van Geest Cancer Research Centre website to find out more about its work, or to make a donation towards its vital scientific research.

Scancell Opens US Headquarters in San Diego - Key Management Changes to Support Future Growth

Scancell Holdings Plc, (AIM:SCLP), today announces the opening of new offices in San Diego to support the Company’s ambitious US growth plans together with plans to establish a new base in the Oxford area for its UK corporate and development activities.

In addition, the following changes have been made to the structure of Scancell’s executive management team to optimally align management expertise with the strategic direction outlined in the £6.2m ($9m) fundraising completed in April.

Dr John Chiplin, who is based in the US and is currently Scancell’s Non-Executive Chairman, will assume the role of Executive Chairman. John will be directly involved in raising the corporate profile of the Company in the US. Recent US transaction experience, as a director/CEO, includes Benitec Biopharma (US IPO), Medistem (acquired by Intrexon), Arana (acquired by Cephalon) and Domantis (acquired by GSK). Prior to Scancell John was CEO of Polynoma, a Phase III cancer vaccine company, based in San Diego.

Dr Richard Goodfellow, currently Joint CEO, will become Chief Executive Officer and Professor Lindy Durrant, currently Joint CEO, will become Chief Scientific Officer, allowing her to focus fully on the innovative drug discovery that underpins Scancell’s novel technology platforms.

Dr Sally Adams will remain as Development Director.

Dr John Chiplin, Executive Chairman of Scancell commented: “The Board believes that these changes align management with the strategic direction outlined at the time of our recent £6m fundraising and optimally leverage expertise with the needs of the Company. Scancell’s next generation cancer vaccine platforms, ImmunoBody® and Moditope®, are delivering outstanding results and I am convinced that Scancell will secure wider recognition for its innovative technologies and products in both the United States and Europe over the coming months.”

-ENDS-

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

About Scancell

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

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

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

Amendment to Options

Scancell Holdings Plc (‘Scancell’ LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, announces the grant of a share option to Dr John Chiplin. Further to the announcement of his
appointment as non-executive Chairman of the Company in January 2016, Dr John Chiplin has been granted an option over 3,000,000 ordinary shares, under a one-off option grant.

The option vests over a period of three years in three equal tranches, subject to the achievement of performance criteria as specified by the Remuneration Committee. The exercise price payable in respect of the option is 17p per share; being the price paid by shareholders in the recent Placing and Open Offer.

For Further Information:

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

About Scancell

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

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial.

Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic 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 (2)

On 1 April 2016 the Board of Scancell announced that it had received subscriptions in respect of 16,048,593 new Ordinary Shares of the 22,495,068 new Ordinary Shares available under the Open Offer.

The Company has now received applications for an additional 558,823 new Ordinary Shares, available but not subscribed for by Qualifying Shareholders in the Open Offer, therefore the revised total subscription under the Open Offer is 16,607,416 new Ordinary Shares, representing 73.8 per cent. the new Ordinary Shares available under the Open Offer. The Company has therefore raised gross proceeds of approximately £2.8 million through the Open Offer and £3.4 million through the Placing being approximately £6.2 million in total.

Application will be made to the London Stock Exchange for the admission to trading on AIM of the 36,607,416 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 2016. The total number of Ordinary Shares following Admission will be 261,558,099 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.

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

 

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.