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:

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.

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: 

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

Notes to Editors

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

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

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

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

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

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

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

Highlights during the period:

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

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

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

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

For Further Information:

Notes to Editors

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

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

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

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

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

Scancell Holdings Plc

Moditope® citrullinated peptides destroy tumours and extend survival

Poster to be presented at American Association for Cancer Research Annual Meeting

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, today announces that a poster exemplifying the Company’s Moditope® immunotherapy platform has been accepted for presentation at the American Association for Cancer Research Annual Meeting (AACR) in Philadelphia, Pennsylvania, 18-22 April 2015.

The AACR Annual Meeting highlights the latest, most exciting discoveries in every area of cancer research and provides a unique opportunity for investigators from all over the world to meet, interact, and share their insights. This year’s meeting theme - “Bringing Cancer Discoveries to Patients” - underscores the vital and inextricable link between discovery and treatment, and it reinforces the fact that research underpins all the progress being made in the field toward cancer cures.

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

The presentation abstract can be accessed through the AACR website: 

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=0cf4d7d6-5069-4032-996a-  84e0ceb978ef&cKey=c7d3f1c7-31d2-4063-b18e-40db764186e6&mKey=%7b19573A54-AE8F-4E00-9C23- BD6D62268424%7d

For Further Information:

About Scancell

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

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

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

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

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

Scancell Holdings Plc

Interim Results for the six months ended 31 October 2014

SCIB1 continues to generate highly encouraging survival data; Modi-1 vaccine on track for 2016 entry into clinic

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces its interim results for the six months ended 31 October 2014.

Highlights

• Data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody shows highly encouraging survival times in both Part 1 and Part 2 patient groups
• Pre-clinical data demonstrates that a combination of SCIB1 and checkpoint inhibition (PD-1 blockade) produced enhanced tumour destruction and longer survival times than when either treatment was used alone, supporting use of the combination for later stage disease
• Adjuvant melanoma* represents a significant new market opportunity for SCIB1
• SCIB2 vaccine ready for further pre-clinical development as a potential immunotherapy for any tumour expressing the NY-ESO-1 antigen
• Patent granted in the US for Scancell’s DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan
• Modi-1, lead vaccine from Moditope® platform, is on schedule for clinical trials in 2016
• Two new Moditope® protein targets identified
• Loss for the six month period of £1,339,915 (2013: loss: £1,187,574)
• Group cash balance at 31 October 2014 was £4,302,052 (30 April 2014: £5,566,234)

Richard Goodfellow, Joint CEO of Scancell, said: “We are delighted that our lead ImmunoBody®, SCIB1, continues to show the potential to extend the lives of melanoma patients without serious side effects. This encouraging data makes us increasingly optimistic about the clinical value of SCIB1 as monotherapy, especially in the adjuvant setting, a huge and relatively untapped market. Furthermore, the increased survival times when SCIB1 was combined with PD-1 blockade in pre-clinical studies gives us confidence that SCIB1 also has significant potential in combination with checkpoint inhibitors for late stage disease."

“Our Moditope® platform is progressing well with Modi-1 expected to start clinical trials in 2016. Two additional Moditope® protein targets have also now been identified. The market opportunity for our two innovative technology platforms, ImmunoBody® and Moditope®, is significant and we remain committed to evaluating all available options for the realisation of shareholder value.”

-ENDS-

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

For Further Information:

About Scancell

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

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic 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 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

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

Click here to read the full Interim Results Report

Scancell Holdings Plc

AGM research and development update highlights progress in both SCIB1 clinical trial and Moditope® platform

 Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today provide a research and development update following the Company’s AGM. Dr Richard Goodfellow and Prof Lindy Durrant, Scancell’s joint CEOs, will present an update on progress with the new Moditope® platform as well as the ongoing SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company’s ImmunoBodyplatform.

Highlights

• Encouraging survival and safety data from Phase 1/2 clinical trial suggests that SCIB1 has the potential to become the first effective stand-alone treatment for adjuvant melanoma. All 16 patients with fully resected disease are still alive with a median survival of 26 months after starting treatment and only four have shown disease progression
• Adjuvant melanoma represents a significant new market opportunity for SCIB1.
• Combining SCIB1 and PD-1 blockade in animals enhances tumour destruction and extends survival times supporting the use of the combination for later stage disease
• Modi-1 on schedule to be ready for clinical trials in 2016
• Two new Moditope® protein targets identified

Dr Lindy Durrant, Joint CEO of Scancell, comments: “Modi-1 remains on track for start of first-in man clinical trials in 2016. The identification of new targets suggests that Moditope has significant potential as a platform for generating multiple cancer immunotherapeutics. In addition to the reported positive data from SCIB1, our Immunobody® platform continues to make good progress with a second vaccine target for lung cancer and the potential to take the platform into chronic infectious diseases.”

Dr Richard Goodfellow, Joint CEO of Scancell, adds: “Cancer immunotherapy is emerging as one of the most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are currently being evaluated by a number of pharmaceutical companies under a CDA. The encouraging survival data on SCIB1, especially in patients with resected disease, offers an even greater market opportunity for SCIB1 and our pipeline of ImmunoBody® vaccines than was originally envisaged.”

Research and Development Update

SCIB1

We are pleased to announce further encouraging data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with SCIB1. To date, 32 patients have been treated with SCIB1, including seven at the higher 8mg dose. Six patients are currently on long-term treatment and have received between 4 and 6 further doses of SCIB1 every 3-6 months. Although recruitment of patients with advanced disease remains challenging it is expected that enrolment for the study will be completed during 2Q15. A new clinical centre has been established at the Royal Surrey County Hospital in Guildford to accelerate recruitment. SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to adverse events.

Overall, only five of the 27 patients who have received at least three doses of 2-8mg SCIB1 since commencement of the study in 2010 have died. Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 34 months since study entry. This group of patients had 1-year, 2-year and 3-year survival rates of 100%, 67% and 50%, respectively. For the Part 1 8mg cohort of patients, who were recruited later, the median survival time is currently 13 months since study entry. The median survival time since initiating treatment with SCIB1 in Part 2 patients with resected disease (and receiving 4mg doses of SCIB1) is currently 25 months.

Importantly, all 16 patients (two in Part 1 and 14 in Part 2) with fully-resected metastatic disease (nine Stage III and seven Stage IV) are still alive with a median survival time of 26 months since study entry (range 20-39 months) and only four have shown evidence of disease progression. The Stage III patients have a median survival time of 26 months since study entry and two (22%) have progressed. This compares extremely favourably with results from a peptide vaccine trial (Slingluff et al., 2011) where 52% of fully-resected Stage III patients had progressed and 33% had died two years after the start of treatment. The Stage IV patients treated with SCIB1 have a median survival time of 24 months since study entry and two of these patients (22%) have also progressed. In the Slingluff study, 50% of the fully-resected Stage IV patients had progressed and 19% had died after two years of treatment.

These results in patients with resected disease suggest that SCIB1 may have an important role to play as first line treatment in adjuvant melanoma. These are patients who no longer have measurable disease (following surgery) and are often generally quite well. However, they are at a high risk of recurrence and currently have very few, if any, effective treatment options. This represents a significant and as yet untapped market opportunity, including some 360,000 patients in the US alone, of whom around 45% have the MHC antigen HLA-A2 and are therefore suitable for SCIB1 treatment.

Animal data supporting the synergistic effect of combining SCIB1 with PD-1 blockade was announced in August. Any patients that progress following SCIB1 monotherapy, or indeed any patient with more advanced disease, may therefore benefit from the combination of SCIB1 with a checkpoint inhibitor.

ImmunoBody® platform

Scancell’s Immunobody® immunotherapy platform enhances the uptake and presentation of cancer antigens to harness the high avidity T cell responses that destroy tumours. The platform has been validated both in animals and in the clinic with SCIB1 but many opportunities also exist for the development of a pipeline of ImmunoBody® vaccines, both for cancer and chronic infectious diseases.

A second ImmunoBody® vaccine targeting the lung cancer antigen NY-ESO-1 (SCIB2) has been developed to the point at which the product is fully defined and ready for further preclinical development as a potential immunotherapy for any tumour that expresses the NY-ESO-1 antigen such as lung, oesophageal, gastric, ovarian and bladder cancers. During the past 12 months research on other ImmunoBody® vaccines for prostate, liver and colorectal cancer have also been further advanced.

In addition, Scancell has conducted proof of concept studies with ImmunoBody® constructs expressing antigens from influenza and Epstein Barr virus and is in early discussions with potential partners for the co-development of ImmunoBody® vaccines for the treatment or prophylaxis of infectious diseases.

Modi-1

Scancell’s Moditope® immunotherapy platform is based on exploiting the normal immune response to stressed cells, which is largely mediated by CD4+ T cells, and harnessing this mechanism to eradicate cancer cells. Scancell’s first target for Moditope® is vimentin – a major cytoskeletal protein found in mesenchymal cells. Many epithelial tumours switch from expression of cytokeratin to vimentin during metastasis in a process known as epithelial mesenchymal transition (EMT); this change in phenotype enables the cell to become mobile and metastasize to new locations in the body.

Scancell has now selected two modified vimentin peptides in which the arginine residues have been substituted by citrulline to form the basis of its first Moditope® development candidate, Modi-1. The inclusion of additional modified peptides from other Moditope® target proteins into Modi-1 is currently under review. Animal studies have shown that the two vimentin peptides stimulate potent anti-tumour responses and leads to significant improvements in survival, suggesting that the Modi-1 product could have outstanding potential as a novel immunotherapy. Immune response studies with cells isolated from cancer patients have confirmed that T cell responses were stimulated by both modified vimentin peptides.

Optimisation studies have identified the adjuvant, dose and administration route for testing Modi-1 in the First in Man study. In animal studies, an aggressive tumour cell line confirmed that the two vimentin peptides eradicate tumour cells in a therapeutic, and therefore clinically relevant, setting. Remarkably, these responses were evident when tumours had reached a late stage of development.

Moditope vaccines have the potential to treat a wide variety of cancers. Scancell is currently further evaluating the initial indications for the first clinical trial with Modi-1 in terms of clinical need and market opportunity and based upon the possible addition of other peptide targets into the product.

Scancell is considering options for conducting the initial Modi-1 study in both Europe and the US and is designing the development and regulatory strategy to allow for either approach. The development programme will include manufacture plus toxicology and stability testing of the final formulated product. This data will form the basis of a clinical trial application, which is anticipated to be ready for submission in the first half of 2016.

Moditope® platform

Having exemplified the Moditope® platform with modified vimentin peptides, Scancell has been expanding the platform to other citrullinated tumour proteins that could be incorporated into Modi-1 or developed into a pipeline of other multiple-cancer immunotherapeutics. We are therefore pleased to announce today the identification of two further Moditope® protein targets, alpha-enolase and ING4.

Human alpha-enolase is a glycolytic enzyme that is overexpressed by lung, liver and other cancers. We have identified a citrullinated peptide within human alpha-enolase that induces a powerful and specific immune response and that elicits both increased survival and decreased tumour volume compared to control groups in animal models. Analysis of blood samples from donors has indicated that humans have a T cell repertoire that is able to recognise citrullinated alpha-enolase.

The tumour suppressor protein encoded by the ING4 gene plays a role in many cancer related processes. Two citrullinated peptides from human ING4 have been shown to induce specific T cell responses. Further studies are ongoing to evaluate the effect of these citrullinated peptides on tumour volume and survival. Both alpha-enolase and ING4 are believed to offer excellent prospects for future Moditope® immunotherapies.

For Further Information:

About Scancell

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

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic 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 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway), has shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

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

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that Dr Richard Goodfellow, Joint CEO of Scancell, is scheduled to present at the 14th Annual Biotech in Europe Forum for Global Partnering and Investment held in Basel, Switzerland on Tuesday 30 September 2014.

Dr Goodfellow will participate in the Oncology II – Next Generation Immunotherapies panel discussion at 2pm where he will be joined by leading cancer experts to discuss the increasing role of combination and targeted therapies.

In a corporate presentation at 4.30pm, Dr Goodfellow will provide an update on the progress of the SCIB1 clinical programme and the development of both the ImmunoBody® and Moditope® platforms.

The Annual Biotech in Europe Forum is recognised as the leading international stage for those interested in investing and partnering in the biotech and life science industry and is highly transactional. The Forum draws together an exciting cross-section of early-stage/pre-IPO, late-stage and public companies with leading investors, analysts, money managers and pharma licensing executives.

For Further Information:

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 has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

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

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

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2014.

Highlights during the period:

• Orphan drug designation granted by FDA for SCIB1 ImmunoBody® for the treatment of metastatic melanoma
• Positive data from Part 2 and an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 ImmunoBody® in patients with Stage III/IV melanoma
  • Melanoma-specific immune response seen in all Part 2 patients
  • Continuing positive survival trend in Part 1 subjects
  • No serious adverse events reported
  • Completion of patient dosing with 8mg of SCIB1 in Part 1 of on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma
• Planning for preclinical and clinical development of Modi-1, lead vaccine from Moditope® platform underway
  • Provisionally positioned as a novel immunotherapeutic for the treatment of lung, triple-negative breast cancer, ovarian and endometrial cancers
  • Continue to expect first-in-man clinical studies to start in 2016
• Publication of patent application underpinning the Company’s Moditope® platform
• Scancell granted an extension of the Option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1
• Loss for the year of £2,222,954 (2013: loss: £1,901,944)
• Group cash balance at 30 April 2014 was £5,566,234 (30 April 2013: £1,491,320). This increase in cash is attributable to the placing and open offer earlier in the financial year which raised £6.1m, net.

Post period highlights:

• New data demonstrates that a combination of SCIB1 and checkpoint inhibition showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone
• Patent granted in the United States for Scancell’s DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan
• Further positive results from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody®
  • Survival times are highly encouraging in both Part 1 and Part 2 patient groups
  • Melanoma-specific immune responses in 24 of 28 (86%) patients
  • Reduction in the number and size of multiple lung metastases in two patients
  • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said: “The cumulative results emerging from our ongoing Phase 1/2 SCIB1 clinical trial, including the destruction of lung metastases in two patients and the apparent prolongation of survival, continues to add to the evidence that SCIB1 has the potential to extend lives without the burden of serious side effects. The rationale for combining SCIB1 and PD-1 blockade, confirmed in recent animal studies, is also compelling.

“Our ongoing Moditope® research continues to be productive as we continue to prepare Modi-1, our lead vaccine from this platform, for clinical trials which are on schedule to start in 2016.

“Cancer immunotherapy is emerging as one of most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are expected to be of substantial interest to the increasing number of pharmaceutical companies establishing R&D programmes in the area. The Board remains dedicated to realising value for our shareholders as we continue to build upon the excellent data garnered to date.”

Read further information here

For Further Information:

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 has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte 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 Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the appointment of Dr Sally Adams to the Board as Development Director with immediate effect.

Sally Elizabeth Adams, 53, has worked as a consultant alongside Scancell since 2008 providing guidance through the drug development process. With 25 years’ industry experience, Sally has brought to Scancell her expertise in most aspects of drug discovery, including preparation and execution of clinical development plans from research to the clinic, scientific writing, implementation of quality control and documentation systems plus management of the SCIB1 clinical trial itself. She has worked on a number projects in recent years including anti-infective vaccines, cancer immunotherapies and an innovative stem cell treatment for visual dysfunction. Previously, Sally was Head of Neurology & Virology at British Biotech and Development Director at Neures Limited. She has an MA in Genetics from the University of Cambridge and a PhD in Microbiology from Imperial College London.

Richard Goodfellow, Joint CEO of Scancell, said: “Sally has already worked closely with the Scancell team for several years. She has played a key role in the planning and execution of our successful clinical trial of SCIB1 in patients with metastatic melanoma and we are delighted that Sally will be joining our Board at such a pivotal juncture in the Company’s history. With her industry, scientific and drug development knowledge, Sally will continue to play an important role in the development of our ImmunoBody® and Moditope® platforms.”

Schedule Two information:

Sally was a director of Winetraders (UK) Limited until December 2013.

There is no further information required to be disclosed pursuant to paragraph (g) of Schedule To of the AIM Rules for Companies.

 For Further Information:

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 produced a melanoma-specific immune response and promising survival trend. 

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.