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"In our view, the potential for SCIB1 [Scancell's skin cancer treatment], as already demonstrated by the survival data, is remarkable," said one broker recently

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Richard Goodfellow, chief executive of Scancell Holdings Plc (LON:SCLP), tells Proactive Cancer Research UK is to fund and sponsor a Phase I/II clinical trial of their SCIB2 lung cancer vaccine.

Goodfellow says the tie-up is a significant endorsement of their  ImmunoBody platform – the underlying technology behind both SCIB1 and SCIB2 - which helps to prime a patient’s immune system to recognise and kill specific cancer cells.

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Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has now been granted in Europe.
The European patent, number 2134357, granted by the European Patent Office, covers Scancell’s DNA ImmunoBody® platform technology and is key to the protection of the Company’s pipeline of ImmunoBody®vaccines, including lead candidates, SCIB1 and SCIB2.

On issuance, this patent will extend coverage of Scancell’s intellectual property into another important market for Scancell. Counterparts to this patent have already been granted in the United States, Australia and Japan.

The European patent covers the following countries: Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Sweden and Turkey.

Dr. Richard Goodfellow, Chief Executive Officer of Scancell, commented:
“The addition of this key European patent for DNA ImmunoBody® significantly bolsters our global intellectual property portfolio as we position the company for future growth.”

For Further Information:

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

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® an 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. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

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.

Addario Lung Cancer Medical Institute and Scancell Holdings PLC Form Partnership to Advance Lung Cancer Vaccine Clinical Trials

Collaboration builds a world-class network to develop innovative treatment alternatives for lung cancer patients

(January 30, 2017) — The Addario Lung Cancer Medical Institute (“ALCMI”), the Bonnie J. Addario Lung Cancer Foundation (“ALCF”) and Scancell Holdings PLC (“Scancell”) today announce a collaboration to evaluate the use of Scancell’s second innovative cancer vaccine, SCIB2, from its ImmunoBody® platform to treat non-small cell lung cancer (“NSCLC”).

Scancell’s ImmunoBody® cancer vaccine platform is a novel immunotherapy treatment under development that stimulates the immune system to potentially treat and prevent cancer. The Company recently successfully completed a Phase 1/2 clinical trial with SCIB1 in patients with melanoma.

The Addario Advanced Collaboration Program brings patients into clinical trials from ALCMI’s extensive research consortium of international researchers and member institutions and ALCF’s patient support programs. ALCMI plans to assist Scancell in the design and development of a Phase 1/2 clinical trial with SCIB2 in patients with NSCLC which is planned to begin in 2018 and complete approximately 18 months later.

“This partnership enables us to access an important clinical program that could also accelerate the development of this groundbreaking immunotherapy technology,” said ALCMI President and COO Steven Young. “Combining our two foundations’ unique resources will increase patient engagement with the goal to bring new treatment options to non-small cell lung cancer patients,” added Bonnie J. Addario, a 12-year lung cancer survivor and founder and chair of ALCF and founder of ALCMI.

According to the Centers for Disease Control and Prevention, lung cancer accounts for 27 percent of all cancer deaths, more than breast, prostate and colon cancer combined. More than 228,000 people receive a cancer diagnosis in the United States alone and more than 160,000 will not survive. It remains one of the most difficult cancers to treat.

“Immunotherapy has dramatically improved many patients' outcomes across various cancer types. One of the next steps is how we can further enhance the immune response to cancer. Early clinical data on ImmunoBody® suggests it is extremely well tolerated and may significantly improve outcomes, which would be ideal. I'm excited to work with Scancell and hopeful that we will take another important step in the fight against lung cancer,” said Jacob M. Sands, MD, assistant professor, medical oncology, Lahey Hospital & Medical Center in Burlington, Massachusetts.

SCIB2 has the potential to complement existing treatments and has potential value where current treatments either do not work or are not available. By stimulating immune responses to specific lung cancer antigens, SCIB2 should assist the body in targeting and fighting NSCLC, leading to longer survival rates.

“We have generated preclinical data that suggests that SCIB2 could be the ideal complement to existing and emerging checkpoint inhibitor therapies to treat NSCLC and so provide an effective new potential treatment option for patients with this devastating disease,” said Scancell CEO Richard Goodfellow.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

Addario Lung Cancer Medical Institute

Julia Spiess Lewis

Perry Communications Group

+1 916-658-0144 [email protected]

 

Scancell Holdings Plc

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

 

About the Addario Lung Cancer Medical Institute (ALCMI)
The Addario Lung Cancer Medical Institute (ALCMI, voiced as “Alchemy”) was founded by advanced stage lung cancer survivor Bonnie J Addario in 2008 as a nonprofit organization. Working in tandem with our “partner” foundation the Bonnie J. Addario Lung Cancer Foundation (ALCF), ALCMI and ALCF contribute resources and join together to power collaborative, patient-centric initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments and early detection. ALCMI overcomes barriers to collaboration via a world-class team of investigators from 25 institutions in the USA, UK and Europe, supported by dedicated research infrastructures such as centralized project management and biorepositories and data systems. ALCMI directly facilitates research by combining scientific expertise found at leading academic institutions with patient access through our network of community cancer centers – accelerating novel research advancements to lung cancer patients. Byproviding access to critical masses of patient stakeholders, academic, community and industry researchers, ALCMI, in partnership with the ALCF, is making progress towards its goal of transforming lung cancer into a chronically managed disease by 2023.

About the Addario Advanced Collaboration Program
The Addario Advances Collaboration Program accelerates novel therapeutic medical device and diagnostics into patient trials. The program incentivizes the collaboration of the non-profit community and emerging life science companies to reduce development times, improve clinical trial designs, reduce costs and, most critically, accelerates more effective diagnostics and therapies to lung cancer patients globally.

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. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

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, (‘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:

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

 

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:

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

 

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.

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.

 

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.