Posts in Category: Moditope

Final Results for the year ended 30 April 2014

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:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc +44 (0) 20 3727 1000

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc  

Dr Christopher Golden/Stephen Keys

Cenkos Securities Plc

+44 (0) 20 7397 8900

Mo Noonan/Simon Conway FTI Consulting

+44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1 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.

Dr Sally Adams to Join Scancell as Development Director

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:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc + 44 (0) 20 3727 1000

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc  

Camilla Hume/Stephen Keys

Cenkos Securities Plc

+44 (0) 20 7397 8900

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.  Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial.  Data from the trial demonstrate that SCIB1 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.

Publication of Moditope® Patent

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of the patent application underpinning the Company’s Moditope® platform.  When granted, this patent will protect the platform to at least 2033.

The patent application, describes how the Moditope® immunotherapy platform harnesses CD4+ T cells to eradicate tumours.  Moditope® deploys certain tumour-associated peptide epitopes as immunotherapeutic agents to overcome self-tolerance and eradicate tumour cells, with no requirement for blockade inhibitors.  Planning is underway for the manufacture, preclinical testing and first-in-man clinical development of the Modi-1, the first Moditope® immunotherapeutic.  The PCT patent application which has a priority date of 7 August 2012 was published on 13 February 2014 as WO2014/023957.

Prof. Lindy Durrant Professor of Cancer Immunotherapy at the University of Nottingham and Joint CEO of Scancell, said:  “The publication of the patent application is another important milestone in the development of a range of novel immunotherapeutics from the Moditope® platform.  Recent data suggests that Modi-1 may exhibit potent anti-tumour effects even against established aggressive tumours, dramatically improving survival rates.  We look forward to a busy and exciting year in which we continue to prepare Modi-1 for clinical trials which are on schedule to start in early 2016.”

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

 

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. 

Nottingham Technology Grant

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has received a Nottingham Technology Grant Fund (”N’Tech”) of £80,000 from Nottingham City Council. Funded by the Government’s Regional Growth Fund, the grants from N’Tech are awarded mainly to small and medium-sized companies to support business growth and expansion in the Greater Nottingham area. Scancell will use the funds to secure additional staff to develop its groundbreaking new Moditope® technology platform.

Richard Goodfellow, Joint CEO of Scancell, said: “We are delighted to receive this additional funding from Nottingham City Council. This funding will allow us to expand our skill base and boost our productivity at this important juncture in the Company’s history."

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

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 has just completed Phase 1/2 clinical trials which demonstrated that SCIB1 produced a melanoma-specific immune response and promising survival trend.  A further higher dose study of SCIB1 will take place during 2014.

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.

ImmunoBody technology used in prostate cancer protein discovery

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, notes Nottingham Trent University’s announcement that using Scancell’s Immunobody® technology, they have unlocked a protein that could pave the way for future prostate cancer vaccinations.  The full text of Nottingham Trent University’s announcement follows:

 SCIENTISTS UNLOCK PROSTATE CANCER PROTEIN IN MOVE WHICH COULD LEAD TO IMPROVED CANCER VACCINES

UK scientists have identified how a specific region of a prostate-related protein can be used to trigger the body’s immune response against prostate cancer. The study by scientists at Nottingham Trent University – and published in the European Journal of Immunology – could pave the way for new and improved vaccines for prostate cancer.

The work focused on the prostatic acid phosphatase (PAP) protein, which is present in more than 90% of prostate tumours. Scientists were able to develop a new prostate cancer vaccination strategy utilising a portion, or ‘epitope’ of this PAP protein – PAP 114 – which was capable of preventing and reducing tumour growth in pre-clinical trials.

The team believes the study could lead to the development of new vaccines which are able to generate a more specific, more efficient, faster and longer-lasting protective immune response against prostate cancer.

It might also mean that vaccines could be developed at a lower cost than currently, and with fewer potential side effects, say the scientists, who are based in the university's John van Geest Cancer Research Centre.

Prostate cancer is the most common cancer in men in the UK – each year more than 10,000 men will die as a result of prostate cancer and more than 40,000 will be diagnosed with the disease. Cases are rising among men over 50 and the average age for men to be diagnosed is between 70 and 74.

Although cancer vaccines can be formulated in a number of different ways, the approach devised by the scientists for this PAP vaccine would involve a series of injections. 

Dr Stephanie McArdle, lead researcher based in Nottingham Trent University’s John van Geest Cancer Research Centre, said: “Unfortunately for most cancers, the specific targets against which vaccination strategies can be based are sometimes weak and relatively poor at inducing robust, protective anti-tumour immune responses.

“Developing cancer vaccines that can overcome the capacity of tumours to ‘evade’ the immune system and induce protective anti-tumour immunity is therefore essential for the development of new immunotherapies for aggressive disease.

"Our findings demonstrate that PAP-114 is a promising candidate for further development of PAP-based anti-cancer vaccine strategies. It induces characteristics that are consistent with anti-tumour protection; capable of triggering an immune attack against prostate cancer cells and protecting against established prostate tumours."

The epitopes of the PAP protein were delivered to the immune system using Scancell’s proprietary ImmunoBody® technology. 

ENDS

Notes for editors: 

Nottingham Trent University’s John van Geest Cancer Research Centre is a unique purpose-built scientific facility. Its aim is to save lives and speed recovery by improving the early diagnosis and treatment of cancer.

The centre focuses on two key approaches to the treatment of patients with cancer:

  • Improving the diagnosis and management of breast and prostate cancers
  • Developing effective vaccines and immunotherapies that will significantly improve the survival rates and quality of life for cancer sufferers.

Visit the John van Geest Cancer Research Centre website to find out more about its work, or to make a donation towards its vital scientific research.

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

The paper in the European Journal of Immunology can be accessed here.

Press enquiries please contact Dave Rogers, Senior Press Officer, on telephone +44 (0)115 848 8782 or via email, or Therese Easom, Press and Internal Communications Manager, on telephone +44 (0)115 848 8774 or via email.

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

DNA ImmunoBody® Patent Granted in Japan

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has been granted in Japan.  This key patent follows approval in Australia earlier this year and adds to Scancell’s growing body of intellectual property for its ImmunoBody® platform.  Scancell’s protein ImmunoBody® patent has already been approved in the US, Europe, Japan and Australia.

Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:

“This Japanese approval is an important addition as we continue to build a comprehensive IP portfolio for our ImmunoBody® platforms.  With the positive results from our SCIB1 study announced earlier this week and the progress we are making on our Moditope® programme, IP plays an increasingly important role in the value ascribed to Scancell’s technology.  We look forward to building on the momentum of Scancell’s progress in 2014.”

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

 

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 has just completed Phase 1/2 clinical trials which demonstrated that SCIB1 produced a melanoma-specific immune response and promising survival trend.  A further higher dose study of SCIB1 will take place during 2014.

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. 

Unaudited interim results for 6 months ending 31st October 2013

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the six months ended 31 October 2013.

Highlights during the period:

  • Recruitment of 8mg dose patient cohort continues as part of the previously announced  extension to Part 1 of the Phase1/2 study of ImmunoBody® vaccine, SCIB1  in patients with advanced melanoma
  • Planning for preclinical and clinical development of Modi-1, lead pipeline vaccine from Moditope® platform underway
  • Australia becomes first jurisdiction to grant DNA ImmunoBody® technology patent.  Counterpart pending in major territories around the globe
  • Operating loss for the period, £1.31m (2012: loss of £0.99m). Net loss £ 1.19m (2012: loss £0.92m)
  • Cash at bank at 31 October 2013 was £6.40m (30 April 2013: £1.49m), following a Placing and Open Offer of shares in August that raised £6.09 million (net of expenses) 
    • Data anticipated by 2014 calendar year end
    • Provisionally positioned as a novel immunotherapeutic for the treatment of triple-negative breast cancer, ovarian and endometrial cancers
    • First in-man clinical studies are scheduled to start in 2016

Post period highlights:

  • Important positive data from Part 2 as well as an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement)
  • Scancell granted an extension of the Option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1 
    • Melanoma-specific immune response seen in all Part 2 patients
    • Continuing positive survival trend in Part 1 subjects, although patient numbers are small
    • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said:

“We are delighted with the results and progress generated from both our ImmunoBody® and Moditope® platform technologies during the period.  In particular, the immune response data released today from our lead programme, the SCIB1 ImmunoBody® vaccine for advanced melanoma, has exceeded our highest expectations.  We anticipate reporting data from the high dose 8mg arm of this Phase 1/2 trial by 2014 calendar year end.  While treated patient numbers are small, we believe our results to date add to the growing body of evidence that suggests that training T cells to target and control tumour growth could be one of the most promising new ways of treating cancer.  With that in mind, the discovery of the Moditope® platform technology could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immuno-oncology treatments.  We are actively planning the preclinical and clinical development for Modi-1, our lead vaccine arising from this platform, as an immunotherapeutic provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers.

“As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach.  Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is eventually sold.”

For Further Information:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc + 44 (0) 20 7831 3113

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc  

Camilla Hume/Stephen Keys

Cenkos Securities Plc

+44 (0) 20 7397 8900

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

CHAIRMAN’S STATEMENT

I am pleased to report the Company’s interim results for the six month period ended 31st October, 2013. During this period the Group has continued progress with the SCIB1 clinical trials and in August 2013 raised £6.1m (net proceeds) in additional investment through a placing and open offer of shares. These funds will enable the Company to commence work on the pre-clinical development of the first Moditope® immunotherapy product and will provide working capital for the completion of the existing SCIB1 clinical trials as well as enable the Company to recruit the further ten patients for the 8mg cohort of the Phase 1/2 trial.

We have also announced today (see separate release) the extremely encouraging new results from the ongoing Phase 1/2 clinical trial in patients with advanced melanoma. This data from Part 2 of the trial shows that all 14 patients produced a melanoma-specific immune response to treatment and all are still alive. Only three patients have any evidence of disease progression to date. In addition, the four patients from Part 1 of the study who were still alive at the time of the Part 1 report (December 2012) are still alive with a median survival time since treatment commenced of 25 months. Furthermore no serious drug related adverse events have been reported.

Financial

Profit and Loss Account

The Group made an overall operating loss for the six month period to 31st October 2013 of £1,306,556 (2012: loss of £989,981).

Overall the loss for the six month period was £1,187,574 (2012: loss £923,020).

Balance Sheet

The cash at bank at 31 October 2013 was £6,395,927 (30 April 2013: £1,491,320) and net assets amounted to £10,006,318 (30th April, 2013: £5,092,145)

SCIB1 melanoma vaccine

Clinical Trial

Additional encouraging results from the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement).

In Part 1 of the study, 5/6 patients allocated to the 2mg and 4mg dose cohorts and who received at least three doses of SCIB1 produced a melanoma-specific immune response to treatment and 4/6 are still alive. In one of these patients all of the lung metastases showed partial or complete regression during treatment. All four surviving patients from Part 1 are still alive after a further 12 months on study. The median survival time from study entry in these two higher dose groups is now 25 months, although in three of these patients there is evidence of disease progression.

Part 2 of the study was conducted in 14 patients with resected Stage III/IV disease. All 14 patients (100%) produced a melanoma-specific SCIB1-induced T cell response to treatment. Only three patients have experienced progressive disease to date and all patients are still alive. The median survival time since initiating treatment with SCIB1 in Part 2 is currently 15 months and 21 months from diagnosis of metastatic disease. Six of these patients are continuing on extended, long-term treatment with SCIB1.

There have been no serious drug-related adverse events to date.

As a result of the positive results and minimal side effects seen with the 4mg dose, Scancell commenced evaluating an 8mg dose in parallel with Part 2 of the Phase 1/2 study. The higher 8mg dose SCIB1 study has been implemented for two reasons:

Firstly, one of the goals of Part 1 of the Phase 1/2 study was to establish a "maximally tolerated dose" of SCIB1 for use in Part 2. As there were no drug related side effects observed at 4mg, a maximally tolerated dose was not reached and a higher dose could improve the immune response even further.

Secondly, we were pleased to see a significant effect on tumour burden in one late stage patient in the Part 1 study. The Part 2 study, however, is primarily designed to assess immune response in resected Stage III/IV patients and although we will be monitoring the time to disease progression, we will not be able to measure an effect on tumour size. The extended Part 1 study using the 8mg dose is in patients with tumour load and will therefore provide the opportunity to assess whether we can reproduce the valuable data reported from Part 1 in an additional group of patients and at a higher dose. Data from this cohort of patients is expected in by 2014 calendar year end.

Moditope® vaccine technology platform

The Company has developed a new platform technology, Moditope® which has been used to develop the lead product, which will henceforth be described as Modi-1. Planning is underway for the preclinical and clinical development of Modi-1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers. First in-man clinical studies are scheduled to start in 2016. Moditope® harnesses CD4+ cells to eradicate tumours and represents a new class of immunotherapeutic agents. The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors). It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers.

The ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens. As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect. Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers.

Patents

A patent for Scancell’s DNA ImmunoBody® technology has been granted in Australia. This is the first jurisdiction to approve the DNA patent and is a key landmark on the road to comprehensively protecting Scancell’s DNA ImmunoBody® platform technology.

The patent, which covers the DNA ImmunoBody® platform technology and is of importance for the protection of Scancell’s entire pipeline of ImmunoBody® vaccines, has also been filed in the US, Europe and other major markets. The composition of matter patent for SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma, has already been granted in Europe, Turkey and South Africa. Scancell’s protein ImmunoBody® patent has also been approved in the US, Europe, Japan and Australia.

A broad patent for Scancell’s Moditope® has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

Ichor

Scancell signed an agreement with Ichor in July 2009 which provides for the supply and use of the TriGrid™ device for Scancell’s pre-clinical and clinical studies with SCIB1 and gives Scancell an option (‘The Option’) to license TriGrid™ for commercial use on payment of certain undisclosed milestones and royalties. The Option could be exercised at any time up to July 2014. In return, Ichor was granted share options to subscribe for Scancell shares at a subscription price of 4.5p including an option over 1,592,310 shares upon regulatory approval to start clinical trials being granted in the UK.

Since the end of the period, Scancell has been granted an extension of The Option to commercialise Ichor’s proprietary TriGrid™ electroporation delivery system with SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma. Under the terms of the extension, Scancell’s Option, which had been due to expire in July 2014, will be extended until July 2016. In exchange, Scancell agreed to waive the two year lock-in period following the exercise of Ichor’s options over 1,592,310 shares at 4.5p which have been subsequently placed on the market.

Share Capital – Placing and Open Offer

On 1st August 2013 the shareholders of the Company approved resolutions for; (i) the placing of 20,000,000 ordinary 0.1p shares at a price of 22.5p and (ii) an open offer to qualifying shareholders, who had not taken part in the placing, to subscribe for 8,888,888 ordinary 0.1p shares at a price of 22.5p. Following the approval of these resolutions the company raised £6.1m, net of costs.

Outlook

The results released today from Part 2 of the Phase 1/2 study with the SCIB1 vaccine in advanced melanoma support the encouraging results from Part 1 of the study reported last year. Importantly, we have confirmed that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, the results suggest that SCIB1 may be contributing to prolonged survival by controlling tumour growth. We remain confident that, as further long-term data is generated, both in these patients and those treated with the higher 8mg dose, the clinical and commercial potential of Scancell’s ImmunoBody® vaccine approach will be fully apparent. The results from this trial to date have exceeded our highest expectations and support our belief that the highly targeted ImmunoBody® approach is delivering potent T cells that can control malignant disease and adds to the growing body of evidence that suggests that training T cells to target and control tumour growth could be of the most promising new ways of treating cancer. Furthermore, in patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit.

The discovery of the Moditope® platform technology and its ability to induce potent CD4+ T cells against tumour associated epitopes could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immune-oncology treatments.

As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach. Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is sold.

Investor update showcases Moditope® platform and updates SCIB1 trial progress

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today hold an investor update. Following an introduction by Prof. Peter Stern, Institute of Cancer Sciences, University of Manchester, Dr Richard Goodfellow and Prof Lindy Durrant, Scancell’s joint CEOs will present a business update as well an overview of the ImmunoBody® platform and SCIB1 clinical programme, including its current status.  A detailed introduction to the new Moditope® platform will also be given for the first time. 

Prof Durrant will review the SCIB1 clinical trial programme and confirm that the ongoing studies remain on track.  Further results from this trial are expected by the end of 2013.  SCIB1 is Scancell’s first cancer immunotherapy and is a product of the Company’s ImmunoBody® platform.  It is being developed for the treatment of malignant melanoma and is currently in Phase 1/2 clinical trials.  Encouraging results from Part 1 of the study have previously been presented and provide the first clinical evidence that Scancell’s ImmunoBody® immunotherapy approach is producing an immune response in cancer patients which may also be associated with clinical benefit.  Prof Durrant will today add that four out of the six evaluable patients treated with either the 2mg or 4mg dose of SCIB1 still remain alive. The mean survival time in this group of five Stage IV and one Stage IIIb patients is currently 21 months from trial entry. 

In view of the positive results and minimal side effects seen with the 4mg dose (Part 1) of the SCIB1 Phase 1/2 trial, the Company has initiated evaluation of an 8mg dose in up to six patients with measurable tumours.  Five patients have been recruited to date: one patient will no longer be evaluable due to delivery of an incomplete dose of SCIB1 and a further patient was not able to complete dosing within the required timeframe.  A safety review of the data from the 8 mg cohort in Part 1 will be conducted and, if adequate safety is demonstrated, Scancell plans to recruit a further 10 patients with measurable disease into Part 2 of the study.  An amendment has been submitted to the appropriate regulatory authorities to request approval to treat these additional patients at the 8 mg dose.  

Prof Lindy Durrant, the inventor of the Moditope® platform, will present a detailed overview of the technology and its potential.  She will describe how the technology was used to generate the lead product, SCMod1.  Planning is underway for the preclinical and clinical development of SCMod1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers.  First-in-man clinical studies are scheduled to start in 2016.  Moditope® harnesses CD4+ T cells to eradicate tumours and represents a new class of immunotherapeutic agents.  The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors).  It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers.  A broad patent has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

It will be recalled that the ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens.  As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect.  Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers. 

In the second part of the seminar, specialist guest speakers, led by Professor Karol Sikora, Dean of Medicine at University of Buckingham, Medical Director of CancerPartnersUK and honorary Consultant Oncologist at Hammersmith Hospital, will form an interactive panel to discuss the increasing importance of immunotherapy for the treatment of cancer and how Scancell’s technology fits into this emerging landscape. 

Dr. Richard Goodfellow, joint CEO of Scancell, commented:  “We welcome this opportunity to update investors following the recent successful fundraising completed in August.  The SCIB1 clinical programme remains on track and further data is expected by the end of 2013.  Having now filed and exemplified the patents covering our Moditope® technology, we can provide more detail on how this second platform technology has the potential to generate a completely new class of potent and selective immunotherapy agents and which could have a profound effect on the way that cancer immunotherapies are developed.  In particular, the technology may overcome the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors, thereby allowing activated T cells seek out and kill tumour cells that would otherwise be hidden from the immune system.

“In view of the short to medium term licensing and partnership potential that both the Moditope® and Immunobody® programmes now bring to the Company, our strategy requires a more flexible approach.  Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will now consider technology validating and revenue generating deals on each individual platform when and where appropriate in order to enhance the value of the company when it is sold.”

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials.  Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell’s ImmunoBody® immunotherapies 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, Immunobody® and Moditope® are trade marks of Scancell Limited.

Investor Day Agenda

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is to host an Investor Update on Tuesday, 1 October 2013. Details of the event are:

Location  FTI Consulting
Holborn Gate
26 Southampton Buildings
London, WC2A 1PB
10.45 Registration with refreshments
11.00

Introduction David Evans,

Scancell Non-Executive Chairman

11.05

Cancer immunotherapy

Prof Peter Stern, Head of the Immunology Group, Paterson Institute for Cancer Research, University of Manchester

11.20

Scancell corporate update

Dr Richard Goodfellow, Joint CEO of Scancell

11.30

SCIB1 trial update and introduction to Moditope™

Prof Lindy Durrant, Joint CEO of Scancell

11.45 Q&A
12.00

Interactive panel discussion

Led by Prof Karol Sikora, Dean of Medicine , University of Buckingham; Honorary Consultant Oncologist at Hammersmith Hospital

Panellists include:

Prof Lindy Durrant,

Prof Peter Stern,

Dr Steve Chan, Consultant Oncologist, City Hospital, Nottingham University

and Prof Christian Ottensmeier, Dept. of Experimental Medicine, University of Southampton

12.45 Buffet lunch
13.30 Close

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

Investor Day

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is to host an Investor Update on Tuesday, 1 October 2013.

Joint CEO’s, Dr Richard Goodfellow and Professor Lindy Durrant will present an update on Scancell’s SCIB1 trial and an introduction to their new Moditope™ platform.  Specialist guest speakers, led by Professor Karol Sikora, will form an interactive panel to discuss how the natural immune system can be harnessed to eradicate tumour cells and the prospects for this emerging class of immunotherapies as effective treatments for cancer.  The event will be followed by a lunch.

Scancell is developing novel therapeutic vaccines for the treatment of cancer based on its ground-breaking ImmunoBody® and Moditope™ technology platforms.

Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of malignant melanoma and is in Phase 1/2 clinical trials.  Encouraging results from the Phase 1 part of the study provided the first evidence that Scancell’s ImmunoBody® vaccine approach is producing an immune response in cancer patients which may also be associated with clinical benefit.  In view of the positive results and minimal side effects seen with the 4 mg dose (Part 1) the Company has initiated evaluation of an 8 mg dose in parallel with Part 2 of the study. 

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer immune cells that destroy tumours without toxicity.  This Moditope™ platform has the potential to generate a completely new class of potent and selective immunotherapy agents and could have a profound effect on the way that cancer vaccines are developed.  In particular, the technology can overcome the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors), thereby allowing activated T cells seek out and kill tumour cells that would otherwise be hidden from the immune system.

For further details of the event, please contact Mo Noonan or Eleanor Clarke at FTI Consulting.

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0 497
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.