Posts in Category: SCIB1

AGM Business and R&D Update

Translating innovative science into ground-breaking new products

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

Highlights

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

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

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

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

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

For Further Information:

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

 

About Scancell

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

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

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

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

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

Scancell strengthens operational and clinical development expertise

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

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

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

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

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

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

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

Schedule Two information regarding Dr John Chiplin:

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

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

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

For Further Information:

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

Notes to Editors


About Scancell

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

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

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

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

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

PIVAC Conference Presentations

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.

 

Final Results for the year ended 30th April 2015

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

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2015.

Highlights during the period:

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

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

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

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

For Further Information:

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

 

Notes to Editors

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

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

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

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

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

ImmunoBody Presentation at Cancer vaccines Conference in London

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

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

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

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

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

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

For Further Information:

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

Notes to Editors

SCIB1 mechanism of action
SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

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

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

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

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

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

Scancell and ImmunID announce collaboration to predict SCIB1 responders using ImmunTraCkeR®

Nottingham, UK and Grenoble, France, 30 July 2015 - Scancell Holdings plc (‘Scancell’ LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, and ImmunID, an immune molecular diagnostics company, today announce an agreement to collaborate on a research project aimed at predicting which patients will respond best to SCIB1 treatment.

The study will use ImmunID’s flagship clinical product, ImmunTraCkeR®, before and during treatment, to assess the immune-modulatory effect of Scancell’s SCIB1 ImmunoBody® vaccine in patients with Stage III/IV metastatic melanoma. The ImmunTraCkeR® assay will be used to:

  • understand pre-existing immunity of Stage III/IV metastatic melanoma patients;
  • monitor T cell diversity over time in order to assess immune-modulatory effect of the SCIB1 cancer vaccine;
  • make a preliminary assessment of ImmunTraCkeR® acting as a predictor of response to SCIB1; and
  • identify any other predictive or prognostic clinical value of T cell diversity.

ImmunID has been a pioneer in the field of immune molecular diagnostics for a decade. Its clinical product ImmunTraCkeR® evaluates a patient’s immune status, from a simple liquid biopsy (5ml EDTA blood), based on T lymphocyte repertoire diversity. ImmunID has developed and patented the ImmunTraCkeR® diagnostic assay and is expanding its clinical utility to become the general immune companion diagnostics for all immune therapies and especially immune checkpoint agents.

Scancell’s first ImmunoBody®, SCIB1, is being developed for the treatment of melanoma and is currently being evaluated in a Phase 1/2 clinical trial. The latest data suggests that SCIB1 may have the potential to significantly extend survival times, especially in patients with resected disease.

Dr Richard Goodfellow, Joint Chief Executive Officer of Scancell, said: “We are delighted to be working with ImmunID. This collaboration will provide an insight into T cell diversity in patients treated with our SCIB1 vaccine and their response to the treatment over time. We believe that ImmunID’s ImmunTraCkeR® test will deliver valuable data that will provide deeper insight into the strong clinical results we have generated to date with our novel treatment for metastatic melanoma.”

Dr Bernhard Sixt, Chairman and CEO of ImmunID, added: “We see this collaboration as an opportunity to provide Scancell with a relevant tool to measure the patient’s immune status in the rapidly growing immunooncology field, while also widening the clinical value of our ImmunTraCkeR® assay. Ultimately, ImmunTraCkeR® may be used to predict which patients respond best to treatment.”

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc + 44 (0) 20 3727 1000
Dr Bernhard Sixt, Chairman & CEO ImmunID +33 (0) 4387 85770
Robert Naylor/Maisie Atkinson Panmure Gordon + 44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting  + 44 (0) 20 3727 1000

Notes to Editors

About Scancell

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

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

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

SCIB1 mechanism of action
SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

About ImmunID
ImmunID adds precision to the immuno-oncology revolution by personalizing immunotherapy. With its decade-long experience in immune molecular diagnostics, ImmunID provide doctors with clinically meaningful data on the highly complex immune system to select the right therapy for individual patients and to monitor their response. ImmunID’s flagship CE-marked product, ImmunTraCkeR®, evaluates the patient’s immune status based on the T lymphocyte diversity, from a simple liquid biopsy. The company is establishing ImmunTraCkeR® as the general immune companion diagnostic assay for immune checkpoint inhibitors and other immunotherapies. In addition, ImmunID collaborates with pharma and biotech companies to optimize the development of their next-generation immunotherapies. ImmunID is ISO 9001 and ISO 13485 certified and runs a CAP-accredited laboratory in the MINATEC high-tech campus in Grenoble, France.
www.immunid.com - Follow ImmunID on Twitter: @ImmunID

About ImmunTraCkeR®
ImmunTraCkeR® is a proprietary CE-marked immune molecular diagnostics assay, which evaluates a patient’s immune status in the blood based on combinatorial T cell diversity. Unlike most companion diagnostics tests, ImmunTraCkeR® is patient-specific rather than drug- or disease-specific, as it approaches the disease from the patient’s own immune system perspective. ImmunTraCkeR® provides information on the patient’s complex immune profile to evaluate clinical benefit or risk under treatment with immunotherapies. ImmunTraCkeR® may ultimately be used as immune companion diagnostics and answer the urgent medical need for efficient patient stratification tools in melanoma and other solid cancers.

Patient recruitment completed for SCIB1 Phase 1/2 clinical trial

SCIB1 continues to deliver strong survival data in resected melanoma patients with Stage III/IV disease

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, today announces 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 five 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 designed trial to determine the dose for Part 2. While the primary objective of the study is to access safety and tolerability, the study is also assessing immune response and anti-tumour activity, and the ability of SCIB1 to delay or prevent disease recurrence in patients with resected disease.

In total, 35 patients have now been treated with SCIB1, including ten patients at the higher 8mg dose. Six patients remain on long-term treatment and have received between one and nine additional 4mg or 8mg doses of SCIB1 every three to six months.

As with previously reported data, 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 including the four patients on the 8mg dose. The median survival time in the 16 patients with resected disease who received 2-4 mg doses of SCIB1 is now 35 months.

The last patient in the formal six month study will be dosed in October this year after which the Company will analyse the data and prepare a clinical study report. Patients on long-term continuation treatment will continue to be dosed for up to five years from the start of their treatment regime.

Dr Richard Goodfellow, Joint Chief Executive Officer of Scancell, said: “With the recruitment of the SCIB1 Phase 1/2 melanoma trial coming to a close, we continue to see highly encouraging survival times and melanoma-specific immune responses in patients, especially those with resected tumours. We believe that our ImmunoBody® platform offers melanoma patients a new treatment option that has the potential to extend life expectancy and improve their quality of life. We look forward to reporting the final results of the study in due course.”

For further information:

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

Notes to Editors

SCIB1 mechanism of action
SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

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

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

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

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

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

ASCO Update on Phase 1/2 clinical trial of SCIB1 in Stage III/IV melanoma

Scancell provides positive update on SCIB1 data in resected melanoma patients

Median survival time of 34 and 31 months for Stage III and IV patients Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce further encouraging results from its on-going Phase 1/2 clinical trial of SCIB1, its DNA ImmunoBody® being developed for the treatment of patients with melanoma. Updated data on patients with resected Stage III or Stage IV melanoma was presented in a poster at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Monday 1 June 2015.

The poster entitled: “A clinical trial of SCIB1, a DNA vaccine that targets dendritic cells in vivo, in fully resected melanoma patients: a vaccine to prevent recurrence” by PM Patel et al, demonstrates that the latest clinical data on patients with fully resected tumours is highly promising, and suggests that SCIB1 may uniquely offer protection from recurrence of melanoma with little associated toxicities.

Highlights

  • All 16 patients with resected disease (two in Part 1 and 14 in Part 2) are still alive.
  • Survival times are very encouraging: median survival time for Stage III patients (n=9) and Stage IV patients (n=7) is 34 and 31 months, respectively.
  • Only five patients (31%) have had a recurrence of the disease; all other patients have been disease free for between 27 and 46 months since study entry* (median follow-up of 34 months).
  • The median for disease-free survival and overall survival (when 50% of patients have progressed or died, respectively) have therefore not yet been reached.
  • All 16 patients showed melanoma-specific immune responses.
  • All patients who continued treatment showed strong T cell memory responses following three
  • monthly boosts with SCIB1.
  • SCIB1 was safe and well-tolerated, with no grade 4/5 toxicities observed other than those related to disease progression and one case of pneumonia.

Following the conclusion of the conference the poster will available for download from Scancell’s website at: www.scancell.co.uk

Prof Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented: “We are excited to report this latest clinical data on melanoma patients with fully resected tumours. The on-going positive results from this Phase 1/2 trial gives us confidence that our SCIB1 ImmunoBody® has the potential to become the first non-toxic effective adjuvant treatment for resected melanoma. All 16 participants in this part of the study remain alive, suggesting that SCIB1 may offer protection from tumour recurrence in these patients. Data to date demonstrates that SCIB1 is safe and welltolerated, and the very encouraging survival times suggest a strategy of using SCIB1 in such resected melanoma patients to extend their lives.”

Prof Poulam Patel, Chief Investigator for the trial and Professor of Clinical Oncology at the University of Nottingham, added: “The cancer immunotherapy field is rapidly advancing and although checkpoint inhibitors are continuing to deliver positive results in late stage melanoma, there is an unmet need for non-toxic adjuvant therapy in patients with earlier stage disease. All resected patients in this Phase 1/2 trial with SCIB1 have shown melanoma-specific immune responses and survival times that are extremely promising. These results suggest that SCIB1 could help to prevent recurrence of melanoma and so improve overall outcomes in these patients.”

The Phase 1/2 clinical trial 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). While the primary objective of the study is to access safety and tolerability, the study is also assessing immune response and anti-tumour activity, and the ability of SCIB1 to delay or prevent disease recurrence in patients with resected disease.

Poster overview
The poster summarises current data from a subset of patients in the trial with resected tumours. 16 patients with fully resected Stage III (n=9) or Stage IV (n=7) melanoma were immunised with 4mg of SCIB1 by intramuscular electroporation at 3-weekly intervals, then subsequently at three and six months. Patients tolerating treatment were allowed to continue treatment for up to five further years. Immune responses were assayed by proliferation and Elispot assays.

SCIB1 was safe and well-tolerated
More than 190 doses administered and no CTC grade 4/5 toxicities were reported except those that were disease-related and one case of pneumonia (grade 4). Most common adverse events were injection site reactions (pain, tenderness, bruising, erythema and swelling).

Highly encouraging clinical responses
Impressive clinical responses continue to be seen in these patients. Only five out of 16 patients
(31%) have had a recurrence of disease at one, four, 14, 17 and 18 months, and none have died. All other patients have been disease-free for between 27 and 46 months since study entry. Median survival time for Stage III patients (n=9) and Stage IV patients (n=7) is 34 and 31 months, respectively.

Immune responses generated in all patients
Significant immune responses have also been produced by these patients. All 16 patients showed a SCIB1-epitope specific proliferation response ex vivo and γIFN Elispot responses in vitro after T cell expansion. 12 patients responded to all four epitopes, two patients to three epitopes, one patient to two epitopes and one patient to one epitope. All patients who continued treatment showed strong T cell memory responses following three monthly boosts with SCIB1.

*This compares very favourably with reported data from a peptide vaccine trial in which 48% of Stage III/IV patients had disease progression and 21% had died after three years (Slingluff et al., 2011 J Clin Oncol 29:2924-2932). In addition, a study of untreated Stage IV patients showed that 84% had disease progression and 64% had died after three years (Sosman et al, 2011 Cancer 117(20), 4740-4746).

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




 

SCIB1 mechanism of action 

SCIB1 is a DNA ImmunoBody immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines cross presentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

Overview of the Phase 1/2 trial design
Part 1 of this single arm, open label, Phase 1/2 clinical trial, conducted in five UK centres, was a dose escalation designed to determine the dose for Part 2. Eleven patients, ten with Stage IV and one with Stage III malignant melanoma were given up to five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered by Ichor Medical Systems’ TriGrid™ electroporation delivery device, over a period of six months. One patient in the 0.4mg dose group and one in the 4mg dose group who received only a single dose of SCIB1 were withdrawn from the study due to progressive disease shortly after study entry and were replaced to ensure that at least three patients in each dose cohort could be fully evaluated for immune response.

During the course of the study, regulatory approval was granted to increase the SCIB1 dose from 2mg to 4mg in patients in the 2mg cohort, if the treatment was well tolerated. Two patients in this group received two 4mg doses of SCIB1 and one patient received a single 4mg dose. Regulatory approval was subsequently obtained for treating a cohort of patients with 8mg of drug in Part 1; five patients were enrolled. One patient received three 8 mg doses and one patient received four 8 mg doses of SCIB1. One patient received two doses of 4mg followed by three doses of 8mg and the other two patients both received five 8 mg doses of SCIB1.

In Part 2 of the study, 14 patients with resected Stage III/IV melanoma (nine with Stage III and five with Stage IV) entered the study. One patient was only able to tolerate three doses of 2mg and withdrew from the study. Of the remaining patients, 12 received a full 4mg dose of SCIB1 on five occasions over a period of 6 months and one received four doses of 4mg and one dose of 2mg. In the absence of any serious toxicity in the Part 1 8mg cohort, approval was also obtained to further expand Part 2 to dose up to 13 additional patients with 8mg. Recruitment and dosing of these patients is currently on-going.

During the course of the study, regulatory approval was also granted to continue treating eligible patients for a period of up to five years after they completed the main part of the study. During this period patients can receive further doses of SCIB1 every three to six months. Six patients in Part 2 (five receiving 4mg and one receiving 8mg doses) are currently receiving extended SCIB1 treatment.

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

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

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

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

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

Scancell to provide update on SCIB1 data in resected melanoma patients at 2015 ASCO Annual Meeting

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces that the latest data from the ongoing Phase 1/2 clinical trial of SCIB1, its DNA ImmunoBody® being developed for the treatment of patients with melanoma, will be presented in a poster at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 29 - June 2, 2015. 

An abstract of the poster can be accessed through the ASCO website at: http://abstracts.asco.org/. The summary of the results contained therein relates to data available at the time of abstract submission. A further update on clinical outcomes, including survival time, will be given as part of the poster presentation.

SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. The trial is an open label, non-randomised study to determine the safety and tolerability of SCIB1 administered intramuscularly using an electroporation device (TDS-IM, manufactured by Ichor Medical Systems, USA). The study is also assessing immune response and anti-tumour activity, and the ability of SCIB1 to delay or prevent disease recurrence in patients with resected disease.

The title, timing and location of the poster presentation is as follows:

Abstract: 9035
Title: An adjuvant clinical trial of SCIB1, a DNA vaccine that targets dendritic cells in vivo, in fully resected melanoma patients
Presenter: Prof Poulam M. Patel, MD, PhD
Session: Melanoma/Skin Cancers
Day/Date: Monday 1 June 2015
Session Time: 1:15 PM - 4:45 PM
Location: S Hall A

 

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 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. 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.