Posts in Category: Year - 2016

Scancell to present at the World Immunotherapy Congress in Basel and at the Biotech and Money Inv€$tival Showcase in London

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.

Results of AGM

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that all resolutions proposed at the Annual General Meeting held today were duly passed.
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 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 preparing SCIB2 for clinical study in lung cancer

  • 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 OncoImmunology1, 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.

Notice of AGM - Amendment

Scancell Holdings Plc 

Notice of AGM

Amendment

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, will host its Annual General Meeting on Tuesday 18 October 2016.

AGM details are as follows:

Date: Tuesday 18 October, 2016
Time: 2.30pm
Venue: The Kassam Stadium
Grenoble Road
Oxford
OX4 4XP

 

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 Scancell

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

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

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

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

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

Final Results for the year ended 30 April 2016

Landmark four year survival achieved in resected SCIB1 patients
Emerging pipeline of three products across five cancer indications

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2016.

Read the full document here

Highlights

  • SCIB1 continues to deliver significant survival data from the Phase 1/2 clinical trial in patients with Stage III/IV melanoma
    • Currently 19 of the 20 patients with resected tumours at study entry remain alive
    • Of the 16 patients who received 2-4mg doses of SCIB1
      • Median observation time since entry is 49 months, a landmark survival milestone
      • Only two new incidences of disease progression have been recorded since December 2013
    • Of the four patients who received 8mg doses of SCIB1
      • Median observation time since entry is 18 months
      • None have progressed and none have died
    • As announced on 17 June 2016, treatment for the eight patients in the long-term continued dosing phase has been suspended due to the clinical trial supplies no longer being within the original specification
    • New SCIB1 material being manufactured to support a new study of SCIB1 in combination with a checkpoint inhibitor will also be made available to these continuation patients (subject to regulatory approval)
    • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track, enrolment expected to commence in Q3 2017
    • The final Clinical Study Report will be issued later this year and will support our US IND submission
  • Continued progress made in development of lead product, Modi-1, from Moditope® platform
    • Enrolment for first-in-man clinical study in triple negative breast cancer, ovarian cancer and osteosarcoma expected to commence in early 2018
  • Strategic collaboration with Karolinska Institutet to explore the role of citrullination in cancer, a key mechanism underpinning the Moditope® platform
  • £6.2m (£5.8m net) raised through a firm placing and open offer involving both existing and new shareholders
  • John Chiplin appointed Chairman
  • Loss for the year of £2,583,273 (2015: loss £2,414,630)
  • Group cash balance at 30 April 2016 was £6,527,435 (30 April 2015: £3,059,001)

Post Period Highlights

  • Scancell’s executive management team restructured to align expertise with the strategic direction outlined in fundraising
  • Dr Alan Lewis appointed to Board as Non-Executive Director
  • Opening of new offices in San Diego, US and Oxford, UK to support Company’s growth plans

Dr John Chiplin, Executive Chairman of Scancell, said:

“We have continued to make significant progress in the period, both in terms of the maturing clinical data with SCIB1 and further scientific developments on both the ImmunoBody® and Moditope® platforms. We now have a pipeline of three products across five cancer indications and clinical success with any one of these products could transform the value of the business. The Board believes that further clinical studies could add significant value to the Company and is continuing to explore a number of funding options to ensure that the Company has the resources to progress these programmes further.

“Scancell has arrived at an exciting point in its development. We now have the opportunity to transform the business from a small UK-based and largely scientifically-based enterprise into an international force in immuno-oncology. We remain committed to driving this process forward in the US and elsewhere, and to realising the value that has been accumulating over recent years, both for the benefit of our shareholders and cancer patients.”

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen(Corporate Banking) Panmure Gordon & Co +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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

Scancell to present at the 23rd Annual NewsMakers in the Biotech Industry Conference in NYC

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 23rd Annual NewsMakers in the Biotech Industry Conference. The conference is being held on 9 September 2016 at the Millennium Broadway Hotel & Conference Center in New York City, USA.

Dr John Chiplin, Executive Chairman of Scancell, will be presenting an overview of the Company at 15:00 ET in presentation room 311 and will 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

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 NewsMakers in the Biotech Industry Conference


NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each Fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $480 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

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.

Dr Alan J. Lewis appointed as Non-Executive Director

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces the appointment of Dr Alan J. Lewis to the Board of Scancell as Non-Executive Director with immediate effect.

Alan has extensive experience in the US life sciences industry with a proven track record of raising funds and advancing drug discovery and development in both biotechnology and large pharmaceutical companies. Since 2000, as CEO, Alan has successfully led several life sciences companies through rapid growth to a successful exit. At Medistem he oversaw the acquisition by Intrexon in March 2014 for a stock and cash transaction of $26 million. Whilst at Novocell, he supervised the $25.4 million fundraising and was responsible for its multi-year drug discovery collaboration with Pfizer. As CEO of Signal Therapeutics, Alan oversaw multi-year alliances with a number of leading pharmaceutical companies including Akzo Nobel, Roche Biosciences and Novartis, and subsequently managed its $275 million acquisition by Celgene.

Alan has also held senior positions at Celgene, Ambit Biosciences, and the Juvenile Diabetes Research Foundation and initially worked in research at Organon Laboratories (Merck) and Wyeth Laboratories (Pfizer).

He is currently President and CEO of DiaVacs, a San Diego based clinical stage biotechnology company developing products to reverse the onset of autoimmune diseases by re-inducing tolerance into the patient’s immune system to halt the vicious cycle of autoimmunity.

Alan has a B.Sc in Physiology and Biochemistry from Southampton University, UK, a Ph.D in Pharmacology from the University of Wales, UK where he was later made an Honorary Research Fellow in 2008. He has held research fellowships at University of Guelph, Canada and Yale University, USA, and has published over 120 full manuscripts, 100 abstracts as well as written and edited seven books.

Speaking upon his appointment, Dr Lewis said: “I am very much looking forward to joining the Board of Scancell. This is an exciting time for immuno-oncology and I am delighted to be involved in the cutting edge science that underpins the company’s research and development.”

Dr John Chiplin, Executive Chairman of Scancell continued: “We welcome Alan to the Scancell Board. He brings with him a wealth of industry experience, both commercially and financially. Most importantly though,
Alan has extensive experience in drug discovery and development, which combined with his close connections to key players in the sector, will be invaluable to Scancell as it begins to accelerate the development of a range of new products from the ImmunoBody® and Moditope® platforms from next year."


Schedule Two information regarding Dr Alan James Lewis, age 70:

Current Directorships
Assembly Biosciences, Inc. (US)
Batu Biologics, Inc. (US)
Biocom (US)
BioMarin Pharmaceutical, Inc. (US)
Capella Therapeutics (US)
Cellastra, Inc. (US)
DiaVacs, Inc. (US)
Habit Rx (US)
International Association of Inflammation Societies (US)
Neurometrix Rx (US)
The Stem Cell Advisors, Inc. (US)
Targazyme, Inc. (US)


Directorships in the past five years
Ambit Biosciences Corporation (US)
Biotica Technology Ltd. (UK)
Cytochroma (CA)
Medistem, Inc. (US)
Rincon Pharmaceuticals (US)

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

This announcement contains inside information.

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Maisie Atkinson (Sales) Panmure Gordon & Co +44 (0) 20 7886 2905
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

About Scancell

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

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. 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.

Appointment of Eurogentec as SCIB1 manufacturer

Leading DNA plasmid manufacturer Eurogentec appointed to manufacture new SCIB1 material 

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

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

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

For Further Information:

Dr John Chiplin, Executive Chairman

Dr Richard Goodfellow, CEO

Scancell Holdings Plc

+1 858 900 2646

+44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

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

About Scancell

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

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.
Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

About Eurogentec

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

www.eurogentec.com

Extension to Ichor Commercial Option

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

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

Richard Goodfellow, CEO of Scancell, said:

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

Robert Bernard, President & CEO of Ichor, added:

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

For Further Information:

Dr John Chiplin, Executive Chairman

Dr Richard Goodfellow, CEO

Scancell Holdings Plc

+1 858 900 2646

+44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

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

About Ichor and the TriGrid® Delivery System

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

About Scancell

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

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

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

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

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

Publication highlights advantages of Moditope® technology platform

Peer-­reviewed publication highlights advantages of Moditope® technology platform

Potential to develop completely new class of immuno-­oncology therapeutics

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of an invited review in the scientific journal Autophagy entitled: “Autophagy, citrullination and cancer”, which describes Scancell’s pre-­clinical data that supports the innovation and potential of the Company’s Moditope® platform1.

The review, whose lead author is Professor Lindy Durrant, Scancell’s Chief Scientific Officer, discusses the concept that citrullinated peptides produced during autophagy offer attractive vaccine targets for cancer therapy. Scancell’s Moditope® platform utilises this mechanism to stimulate the production of highly active CD4+ T cells that overcome self-­tolerance and destroy tumour cells.

The data described in the review, and published in the peer-­reviewed journal Cancer Research2, showed that a single immunization with Moditope® peptides, up to 14 days after tumour implant, resulted in long-­term survival in up to 90% of mice, with no associated toxicity.

Professor Lindy Durrant, Chief Scientific Officer of Scancell commented:
 “The interplay between autophagy, citrullination and cancer support the rationale behind our Moditope® platform technology. Moditope® has a unique mechanism of action that overcomes the immune suppression induced by tumour cells, allowing T cells to seek out and kill tumours that would otherwise be hidden from the immune system. We believe this platform has the potential to develop a new class of immuno-­oncology therapeutics and look forward to progressing our first vaccine into the clinic as soon as possible.”

The first clinical trials of Modi-­1, the lead candidate from the Moditiope® platform, are expected to target patients with triple negative breast cancer, ovarian cancer and osteosarcoma.

The full abstract of the review can be found below.

Abstract

Autophagy, citrullination and cancer

A cell needs to maintain a balance between biosynthesis and degradation of cellular components to maintain homeostasis. There are 2 pathways, the proteasome, which degrades short-­lived proteins, and the autophagy/lysosomal pathway, which degrades long-­lived proteins and organelles. Both of these pathways are also involved in antigen presentation or the effective delivery of peptides to MHC molecules for presentation to T cells. Autophagy (macroautophagy) is a key player in providing substantial sources of citrullinated peptides for loading onto MHC-­II molecules to stimulate CD4 T cell responses. Stressful conditions in the tumor microenvironment induce autophagy in cancer cells as a mechanism to promote their survival. We therefore investigated if citrullinated peptides could stimulate CD4 T cell responses that would recognize these modifications produced during autophagy within tumor cells. Focusing on the intermediate filament protein VIM (vimentin), we generated citrullinated VIM peptides for immunization experiments in
mice. Immunization with these peptides induced CD4 T cells in response to autophagic tumor targets. Remarkably, a single immunization with modified peptide, up to 14 days after tumor implant, resulted in long-­term survival in 60% to 90% of animals with no associated toxicity. These results show how CD4 cells can mediate potent antitumor responses against modified self-­epitopes presented on tumor cells, and they illustrate for the first time how the citrullinated peptides produced during autophagy may offer especially attractive vaccine targets for cancer therapy.

1. Lindy G. Durrant, Rachael L. Metheringham & Victoria A. Brentville (2016): Autophagy, citrullination and cancer, Autophagy, DOI: 10.1080/15548627.2016.1166326
2. Victoria A. Brentville, Rachael L. Metheringham, Barbara Gunn, Peter Symonds, Ian Daniels, Mohamed Gijon, Katherine Cook, Wei Zue & Lindy G Durrant (2015): Citrullinated vimentin presented on MHC-­II in tumor cells is a target for CD4+ T cell-­mediated autitumor immunity, Cancer Research 76(3), 548-­560.

For Further Information:

Dr John Chiplin, Executive Chairman

Dr Richard Goodfellow, CEO

Scancell Holdings Plc

+1 858 900 2646

+44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Maisie Atkinson (Sales)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2905

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

About Scancell

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

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

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