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:

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.

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:

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 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:

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 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:

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 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.

Combining SCIB2 with CTLA-4 blockade enhances tumour destruction and extends survival times

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce new data demonstrating that animals treated with a combination of SCIB2, Scancell’s ImmunoBody® vaccine in development for the treatment of lung, oesophageal, prostate and other epithelial cancers, and checkpoint inhibition (blockade of the CTLA-4 immune checkpoint pathway), showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

The data confirming the therapeutic effect of SCIB2 with this second checkpoint pathway follows our previous announcement on 12 August 2014 of SCIB1’s synergy with PD-1 blockade in animal models.

In earlier pre-clinical studies, we have shown that administration of SCIB2 alone induced potent tumour-specific T cell responses associated with increased T cell infiltration into the tumour and enhanced proliferation of T cells within the tumour resulting in tumour rejection and long term survival. In our new study where higher doses of tumour cells were used, the combination of CTLA-4 blockade with SCIB2 vaccination resulted in a significant survival advantage over the individual treatments. Although patients with a relatively low tumour burden may benefit from SCIB2 alone, these results highlight the potential benefits of combining SCIB2 with CTLA-4 blockade, such as ipilimumab, for the treatment of patients with advanced disease.

SCIB2 is a DNA plasmid targeting the cancer antigen NY-ESO-1. It induces high avidity CD8 and CD4 responses in pre-clinical models and unlike SCIB1 which is only suitable for patients with the HLA-A2 subtype (around 50% of patients), SCIB2 has been engineered to be effective in over 90% of immune subtypes, further enhancing the market potential and reducing the need for HLA screening prior to treatment. All future ImmunoBody® vaccines will now be engineered to this new standard.

Checkpoint inhibitors can enable the host immune system to recognise, attack and destroy cancer cells. However, checkpoint inhibitors will not work on their own if the patient fails to mount an adequate immune response to the tumour. Taking the brake off immunosuppressive T cells with either CTLA-4 or PD-1 blockade, whilst simultaneously pressing the accelerator with active immunotherapies such as SCIB1 or SCIB2, is increasingly regarded as offering potential for overwhelming the disease and increasing efficacy.

Prof Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented: “The rationale for combining Scancell’s ImmunoBody® vaccines with checkpoint inhibitors is gathering momentum. Whilst we believe that SCIB2, like SCIB1, will provide effective stand-alone treatment in the adjuvant setting, these data further support the hypothesis that some patients with more bulky disease will benefit from a combination of SCIB2 with CTLA-4 blockade.”

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.

Part 2 patients have median survival time of 28 months since study entry All resected patients are still alive with median survival time of 30 months and 27 months for Stage III and IV patients, respectively

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that Joint CEOs Dr Richard Goodfellow and Professor Lindy Durrant will be making corporate presentations 12-15 January 2015, coincident with JP Morgan’s 33rd Annual Healthcare Conference, San Francisco, CA, USA.

A very encouraging update on clinical outcomes in the Company’s on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody® will be given as part of these presentations. It will be reported that the overall median survival of Part 1 patients with tumour present at trial entry and who received at least three doses of 2-8mg of SCIB1 is 24 months. This compares favourably with first line untreated Stage IV disease where patients with no visceral disease had a median survival of 11 months and patients with visceral disease had a median survival of six months (Sosman et al., 2011 Cancer 117:4740-4706). The status of the patients with resected tumours at study entry is equally promising. The 14 patients in Part 2 of the trial have been on study for 23-32 months (median 28 months) and only three have evidence of disease progression. Of particular note, all resected patients (n=16; two from Part 1 and 14 from Part 2) are still alive and only four have progressed. The median recurrence-free survival (when 50% of patients have died) has not been reached; these resected patients have a median survival time of 30 months for Stage III patients (n=9) and 27 months for Stage IV patients (n=7). This compares very favourably with reported data from a peptide vaccine trial following two years of treatment, in which 50% of Stage III patients had disease progression and 19% had died; while 52% of Stage IV patients had disease progression and 33% had died (Slingluff et al., 2011 J Clin Oncol 29:2924-2932).

Richard Goodfellow, Joint CEO of Scancell, said: “The maturing clinical data from our lead ImmunoBody®, SCIB1, continues to enhance our confidence in the clinical value of SCIB1 as monotherapy, especially in the adjuvant setting, a huge and relatively untapped market.”

-ENDS-

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

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 that Professor Lindy Durrant, Joint CEO of Scancell, is scheduled to present on SCIB1, the Company’s clinical stage ImmunoBody® vaccine for the treatment of melanoma, and the ImmunoBody® technology platform at the following conferences:

Professor Lindy Durrant will also be on the Scientific Advisory Panel and conference co-chair at CAVAD 14.

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.