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.

 

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.

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.

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.

Translating innovative science into ground-breaking new products

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

Highlights

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

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

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

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

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

For Further Information:

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

 

About Scancell

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

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

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T- lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces the appointments of Dr John Chiplin to the Board of Scancell as a Non-Executive Director, and Dr Peter Brown as an advisor to the Company, with immediate effect. Their experience from an operational, clinical development and investment perspective will be invaluable as the Company grows.

John, aged 56, has significant international experience particularly in the US life science and technology industries. Most recently, John has been instrumental in the NASDAQ Initial Public Offering of Benitec Biopharma (ASX: BLT; NASDAQ BNTC), the clinical stage biotechnology company, where he has been a Non-Executive Director since 2010. He also serves on the boards of Cynata Therapeutics, Adalta, Batu Biologics, Prophecy, ScienceMedia and the Coma Research Institute. Previously John was President and Chief Executive Officer of Polynoma, a Phase III cancer vaccine company, and from 2006 to 2009 he was Chief Executive Officer of Arana Therapeutics. Prior to this, was head of the ITI Life Sciences investment fund in the UK, where he managed significant negotiations regarding funding with Government Ministers.

Since 2000, John has managed his own investment company, Newstar Ventures, which, over the past decade, has funded over a dozen early stage companies. He has been influential in various other transactions including Intrexon’s acquisition of Medistem, Cephalon’s acquisition of Arana Therapeutics and GlaxoSmithKline’s acquisition of Domantis.

Speaking upon his appointment, Dr John Chiplin said: “I am delighted to be joining the Board of Scancell at such an exciting time in its development. I look forward to working alongside the team as the Company continues to grow into a key player in the immuno-oncology space.”

Peter is a highly experienced pre-clinical and clinical development consultant to the pharmaceutical industry, having most recently served as Vice President & Global Head of Oncology at Teva Pharmaceuticals. Prior to joining Teva, Peter served as Vice President of Clinical Oncology & Experimental Medicine at Cephalon. Here, Peter led the clinical development program for bendamustine and was a key member of the team that completed the NDA submission that led to bendamustine's approval as TREANDA. Peter has designed and conducted global clinical trials in oncology ranging from Phase 1 to pivotal Phase 3, including several first-inhuman studies with novel agents. He has also authored over 60 peer reviewed publications, and has co-authored a number of patents relating to oncology drug development.

Dr Peter Brown commented: “Scancell’s area of research is one of great interest and importance and I look forward to working with the Company as they further progress their product portfolio.”

David Evans, Non-Executive Chairman of Scancell, said: “These changes will help prepare Scancell for its transition into a key player in the rapidly growing immune-oncology sector. We are delighted to welcome both John and Peter to Scancell. John’s wealth of experience in the sector, from both an operational and investment standpoint, especially in the context of the US, the largest healthcare market in the world; and Peter’s expertise in both pre-clinical and clinical development in the oncology space, will be invaluable as the Company continues to grow and as our lead ImmunoBody®, SCIB1, progresses through the clinic.”

Schedule Two information regarding Dr John Chiplin:

Current Directorships
AdAlta Pty (Australia)
Batu Biologics Inc. (US)
Benitec Ltd. (Australia)
Coma Research Institute (US)
Cynata Therapeutics Ltd. (Australia)
Prophecy Inc. (US)
ScienceMedia Inc. (US)

Directorships in the past five years
Medistem Inc. (US)
Polynoma LLC. (US)
Ribomed, Inc. (US)

There are no other disclosures required in relation to Rule 17 or paragraph (g) of Schedule 2 of the AIM Rules for Companies.

For Further Information:

Dr Richard Goodfellow, Co-CEO	Scancell Holdings Plc	+44 (0) 20 3727 1000
Professor Lindy Durrant, Co-CEO	Scancell Holdings Plc
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.

Six scientific presentations at the Progress in Vaccination against Cancer Conference highlight potential of ImmunoBody® and Moditope® platform technologies

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, today announces that six scientific presentations on the Company’s ImmunoBody® and Moditope® immunotherapy platforms will be delivered at the 15th International Conference on Progress in Vaccination against Cancer (PIVAC-15), 6-8 October 2015. The presentations exemplify the growing body of data that are emerging from these platform technologies that suggest that they could be potentially important approaches to delivering effective and complementary immunotherapies to treat a range of cancers.

The six presentations are as follows:

• “Citrullinated vimentin, which is presented on MHC-II on tumour cells, is a novel rejection target for CD4 T cells”1 (Moditope®)
•  “A clinical trial of a DNA vaccine (SCIB1) that targets dendritic cells in vivo in fully resected melanoma patients; a vaccine to prevent disease recurrence?”2 (SCIB1 ImmunoBody®)
•  “SCIB1 DNA vaccination synergises with PD-1 blockade to induce efficient tumour therapy of poorly immunogenic tumours”3 (SCIB1 ImmunoBody®)
•  “SCIB2 targets NY-ESO-1 epitopes to induce potent anti-tumour immunity which is enhanced by Treg depletion or checkpoint blockade”4 (SCIB2 ImmunoBody®)
•  “Adjuvant choice modulates self antigen specific CD4 responses generated by peptide vaccination”5 (Moditope®)
•  “Anti-tumour immune responses to citrullinated enolase”6 (Moditope®)

Prof Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented: “Scancell’s presentations at this important conference exemplify the growing body of exciting data emerging from both our SCIB1 clinical trial and our ImmunoBody®, and Moditope®, immunotherapy technology platforms, and provide a solid foundation for building a broad immuno-oncology franchise in the future.”

All abstracts and posters will be made available for download at 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	Scancell Holdings Plc
Robert Naylor/Maisie Atkinson (Sales)	Panmure Gordon & Co	+44 (0) 20 7886 2500
Mo Noonan/Simon Conway	FTI Consulting	+44 (0) 20 3727 1000

1 Citrullinated vimentin, which is presented on MHC-II on tumour cells, is a novel rejection target for CD4 T cells.
V Brentville, R Metheringham, B Gunn, P Symonds, I Daniels, M Gijon, W Xue and L.G. Durrant.
2 A clinical trial of a DNA vaccine (SCIB1) that targets dendritic cells in vivo in fully resected melanoma patients; a vaccine to prevent disease recurrence?
L.G. Durrant, C Ottensmeier, C Mulatero, P Lorigan, R Plummer, R Metheringham, V Brentville, L Machado, I Daniels, D Hannaman & P.M.Patel.
3 SCIB1 DNA vaccination synergises with PD-1 blockade to induce efficient tumour therapy of poorly immunogenic tumours.
W Xue, V Brentville, R Metheringham, K Cook, P Symonds, I Daniel and L.G. Durrant.
4 SCIB2 targets NY-ESO-1 epitopes to induce potent anti-tumour immunity which is enhanced by Treg depletion or checkpoint blockade.
W Xue, R Metheringham, V Brentville, K Cook, P Symonds, I Daniel and L.G. Durrant.
5 Adjuvant choice modulates self antigen specific CD4 responses generated by peptide vaccination.
V Brentville, W Xue, P Symonds, K Cook, B Gunn, R Metheringham and L.G. Durrant.
6 Anti-tumour immune responses to citrullinated enolase.
K Cook, I Daniels, V Brentville, R Metheringham, W Xue, P Symonds, T Pitt, M Gijon and L.G. Durrant

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.

 

Survival data for lead vaccine SCIB1 strengthens; new data demonstrates potential benefits of combining ImmunoBody® vaccines with checkpoint inhibition

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 2015.

Highlights during the period:

• Positive data showing highly encouraging survival times from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody
• Adjuvant melanoma* represents a significant new market opportunity for SCIB1
  • All 20 resected patients in the Phase 1/2 clinical trial are still alive
  • SCIB1 may offer protection from recurrence of melanoma without serious side effects
• Data supporting the rationale for combining Scancell's ImmunoBody® vaccines with checkpoint inhibitors has continued to strengthen
• Pre-clinical data demonstrates that combining SCIB1 and SCIB2 with checkpoint inhibition (PD-1 and CTLA-4 blockade), produced enhanced tumour destruction and longer survival times than when either treatment was used alone
• SCIB2 is ready for further pre-clinical development as a potential immunotherapy for tumours expressing the NY-ESO-1 antigen
• Scancell received US patent for its DNA ImmunoBody® platform technology, following grant of counterparts in Australia, China and Japan
• Modi-1, Scancell’s lead vaccine from Moditope® platform, is on schedule to start clinical trials in Q4 2016
• Two new Moditope® protein targets have been identified
• Loss for the year of £2,414,630 (2014: loss £2,222,954) as a result of expected additional expenditure on the SCIB1 clinical trials and the further development of Moditope®
• Group cash balance at 30 April 2015 was £3,059,001 (30 April 2014: £5,566,234)

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

Dr. Richard Goodfellow, Joint CEO of Scancell, said: “We continue to make significant progress with both of our platform technologies and pipeline. We remain excited with the data arising from our SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV melanoma. In particular, the increased survival times and low incidence of adverse events in those patients with resected tumour demonstrates that SCIB1 has the potential to be an effective new treatment option in patients with adjuvant melanoma. With recruitment now closed we expect to report headline results from this open label trial around the end of this year. Additionally, evidence is emerging that our ImmunoBody® vaccines may also be effectively deployed as part of a combination therapy to treat late stage melanoma patients. Our second platform technology, Moditope®, has also yielded its first development candidate, Modi-1, which is on track to start clinical trials in 2016 and two further Moditope® protein targets have been identified.

“We remain confident in the prospects for the Company and its differentiated pipeline of cancer immunotherapies as we continue to evaluate all potential opportunities for increasing shareholder value.”

For Further Information:

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

Scancell’s ImmunoBody® platform being presented at the Cancer Vaccines Conference, London

Presentation entitled: ‘‘Peptides or DNA vaccines? Could ImmunoBody® be the answer?”

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, today announces that Dr Stephanie McArdle, Senior Research Scientist from The John van Geest Cancer Research Centre, Nottingham Trent University will be giving a presentation entitled: ‘‘Peptides or DNA vaccines? Could ImmunoBody® be the answer?” at the Cancer Vaccines Conference in London, 16-17 September 2015. The presentation will cover the criteria for designing an effective cancer vaccine, with particular reference to Scancell’s ImmunoBody®.

ImmunoBody® is a DNA plasmid that encodes a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Unlike current vaccine approaches that rely on a single activation mechanism, ImmunoBody® vaccines activate dendritic cells through two distinctly different and complementary mechanisms that maximise T cell activation and avidity: direct- and indirect/cross-presentation.

Scancell’s first ImmunoBody®, SCIB1, is being developed for the treatment of melanoma and is currently being evaluated in a Phase 1/2 clinical trial. The latest data suggests that SCIB1 may have the potential to significantly extend survival times in patients, especially in those with resected disease. The John van Geest Cancer Research Centre is also engaged on collaborative research with Scancell on the development of an ImmunoBody® for the treatment of prostate cancer targeting PAP (prostate acid phosphatase).

Prof Lindy Durrant, Joint Chief Executive Officer of Scancell, said: “Cancer vaccines help boost the immune system to recognise and destroy cancer cells. The design of a cancer vaccine is extremely important and needs to deliver very high avidity T cells in order to be effective. ImmunoBody® delivers high avidity T cells by combining the advantages of DNA and peptide vaccines in one molecule. We are delighted to be working with The John van Geest Cancer Research Centre on this exciting project.”

For Further Information:

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

 

Notes to Editors

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.