Posts in Category: Moditope

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.

Frankfurt Listing

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the Company’s ordinary shares have been included on the Quotation Board of the Open Market of the Frankfurt Stock Exchange with effect from today.  Scancell has appointed ACON Actienbank AG as Listing Coordinator for providing the quote on the Borse Frankfurt (Frankfurt Stock Exchange) under the symbol “SCP”.

The compliance listing is in addition to Scancell’s existing listing on the AIM market of The London Stock Exchange.

Richard Goodfellow, Joint CEO of Scancell, said: 

“Following meetings earlier in the year and our recent successful fundraising, we have received significant interest in the Company from German investors.  A quotation on the Borse Frankfurt gives these investors the opportunity to trade in Scancell and alongside our London listing.  We anticipate that having this Frankfurt listing will encourage regular trading by German retail investors, enhance liquidity in the Company’s shares and create a broad investor base to allow greater visibility amongst the European investment community.  The coming year is pivotal for Scancell as we await results from clinical trials on SCIB1 in malignant melanoma and the further development of our Moditope™ platform.”

 For Further Information:

Scancell Holdings Plc  Dr Richard Goodfellow, Joint CEO  + 44 (0) 74 2323 0 497 
  Professor Lindy Durrant, Joint CEO   
Cenkos Securities Camilla Hume +44 (0) 20 7397 8900
  Stephen Keys  
FTI Consulting Simon Conway +44 (0) 20 7831 3113
  Mo Noonan  
Dr. Reuter Investor Relations Eva Reuter [+49 251 980 1561]
  Kim von Ahn  

 

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 T cells that destroy tumours without toxicity. The Directors believe that the Moditope™ platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Final Results for the year ended 30 April 2013

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 2013.

Highlights during the period:

  • Successful completion of Part 1 of the SCIB1 Phase 1/2 clinical trial
  • Part 2 of the SCIB1 Phase 1/2 clinical trial fully recruited and on track for completion by the end of 2013
  • Additional 8mg dose study underway, also expected to be completed by the end of 2013
  • Development of new Moditope™ platform
  • Strengthened IP with patents awarded in the US and Japan for protein Immunobody® technology platform
  • Peter Allen appointed as a Director

Post period highlights:

  • Placing and Open offer up to £6.5 million (announced today)

Richard Goodfellow, Joint CEO of Scancell, said:

“We have made excellent progress this year with the successful completion of Part 1 of our Phase 1/2 clinical trial for SCIB1, Part 2 remains on track and our additional 8mg dose study has also commenced. We are delighted that four of the six patients from the 2mg and 4mg dose groups are still alive with one patient remaining disease free two years after initiating treatment.

“We believe our innovative Moditope™ platform has the potential to generate a new class of powerful cancer immunotherapy treatments. We are putting funding in place to identify a lead from this programme and develop it through to the point at which we have secured regulatory approval to start clinical trials, a key value inflexion point. We are confident that such targeted further development of the Immunobody® and Moditope™ platforms will both strengthen Scancell's position as a leading immunotherapy player and allow it to realise an enhanced value for shareholders.”

Click here to read the full news article


For Further Information:

Scancell Holdings Plc   + 44 (0) 74 2323 0 497
Dr Richard Goodfellow, Joint CEO
Professor Lindy Durrant, Joint CEO 

Cenkos Securities    +44 (0) 20 7397 8900
Camilla Hume
Stephen Keys

FTI Consulting    +44 (0) 20 7831 3113
Simon Conway
Mo Noonan

Proposed Firm Placing and Open Offer and Notice of General Meeting

THIS ANNOUNCEMENT IS RESTRICTED AND IT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA, THE REPUBLIC OF IRELAND OR AUSTRALIA OR NEW ZEALAND OR ANY OTHER STATE OR JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Scancell Holdings plc (AIM:SCLP), the AIM-quoted developer of novel immunotherapies for the treatment of cancer, is pleased to announce a conditional Firm Placing and Open Offer to raise up to £6.5 million (before expenses) to enable the Company to commence work on the pre-clinical development of the first Moditope™ immunotherapy product, provide working capital for the completion of the Phase 1/2 SCIB1 clinical trial and for the recruitment of a further ten patients on the 8mg dose. As previously announced the Company expects to announce the preliminary results of the Phase 1/2 trial (excluding the patients on the 8mg dose) by the end of 2013.

The Company announces a conditional Firm Placing of 20,000,000 new Ordinary Shares at 22.5 pence each to raise gross funds of approximately £4.5 million by a means of a Firm Placing with investors in various EIS and VCT funds managed by Calculus Capital. In addition, and in order to provide Qualifying Shareholders with an opportunity to subscribe for new Ordinary Shares at the same price, the Company announces a proposed Open Offer to raise up to a further £2.0 million (before expenses).

Highlights

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

The funds raised in the Firm Placing and Open Offer, together with existing cash resources will enable the Company to:

  • identify a lead product from the Moditope™ platform to take into pre-clinical and clinical development by the third quarter of calendar year 2014. Scancell has provisionally selected triple-negative breast cancer (TNBC), ovarian and endometrial cancers as the initial target indications for the first clinical study which is scheduled to start in 2016;
  • provide working capital for the completion of the existing SCIB1 clinical trial;
  • and enable the Company to recruit a further ten patients for the recently initiated higher dose 8mg cohort of the Phase 1/2 trial.

The Board remains firmly committed to a trade sale at an optimal point where significant shareholder value has been created on both the ImmunoBody® and Moditope™ platforms.

Shareholders should be aware that if the Resolutions are not approved at the General Meeting, the Company will be unable to complete the Firm Placing. The Board is of the opinion that, without completion of the Firm Placing, the working capital currently available to Scancell will not be sufficient for its requirements for the next 12 months following the date of the Circular.

David Evans, Non-Executive Chairman of the Company, said: “We are delighted with the continued strong support for Scancell from its shareholders. Both our Immunobody© and newer Moditope™ technology platforms hold great promise as novel immunotherapy-based approaches for the treatment of cancer. We are committed to realising their potential for the benefit of both patients and shareholders.

“This financing, together with our existing cash resources, will allow Scancell to progress products from both technology platforms to significant value inflexion points in the near and medium term. We remain committed to a trade sale of the Company and while we acknowledge this additional work may delay such plans, we believe it will ultimately result in a markedly improved return to shareholders”

Reasons for the Fundraising

On 15 August 2012 the Company announced the development of a new platform technology (Moditope™). The Moditope™ platform stimulates the production of killer CD4 T cells with powerful anti-tumour activity. CD4 responses to cancer associated antigens have been notoriously difficult to generate whether presented as peptides, proteins or DNA. CD4 cells are vital for effective anti-tumour immunity. Scancell has identified and patented a series of modified epitopes that overcome this limitation. Scancell's Moditope™ technology produces killer CD4 T cells that destroy tumours without apparent toxicity. Tests have shown that not only do these epitopes stimulate CD4 killer T cell responses but that cancer patients can produce an immune response to these epitopes. The Board believes that the Moditope™ epitopes can be used to develop both DNA and peptide vaccines and could become an important component of many therapeutic vaccines in the future, both under development at Scancell and other companies.

The Board is excited about the potential of this innovative discovery and has been actively evaluating the strategic options for Moditope™ to determine which, in the Board’s opinion, will create the greatest value for shareholders. Following a detailed review of the options, the Board believes that significant additional value can be delivered to shareholders by the further development of the new Moditope™ platform technology. Although the Moditope™ platform is currently at an early stage, the Directors believe that the potential of this novel immunotherapy platform is likely to be considerable. Accordingly, the Board plans to identify a lead product to take into pre-clinical and clinical development by the third quarter of calendar year 2014. Scancell has provisionally selected triple-negative breast cancer (TNBC), ovarian and endometrial cancers as the initial target indications for the first clinical study which is scheduled to start in 2016.

In addition, and as previously announced, preliminary results from Part 1 of the Phase I/II clinical trials on SCIB1 have provided the first evidence that Scancell's ImmunoBody® vaccine approach is producing an immune response in cancer patients. In view of the positive clinical results and minimal side effects seen with the 4mg dose, the Company is currently evaluating an 8mg dose in 3-6 patients with evaluable disease. This additional cohort will permit an assessment of the safety and immunogenicity of an increased dose of SCIB1 in addition to the effect of this higher dose on tumour burden. The 8mg cohort is being evaluated in parallel with the second part of the Phase 1/2 study which is primarily designed to assess the effect of the 4mg dose on immune response in patients who have had all tumour removed prior to treatment. Three patients have been recruited to the 8mg dose cohort to date. The Board believes that it will also be important to demonstrate the safety and efficacy of the 8mg dose in a larger number of patients prior to a sale of the Company. As such, the Company intends, provided the 8 mg dose is well tolerated, to seek approval to recruit an additional ten patients with evaluable disease to strengthen the data set on the 8mg dose prior to closing the SCIB1 Phase1/2 programme. The Directors believe that the availability of data from additional patients will position the Company as a more attractive sale opportunity.

Accordingly, the Board believes that the Firm Placing and Open Offer are in the best interests of the Company and Shareholders as the funds raised 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.

Click here to read the full news article

For more information, please contact:

Scancell Holdings Plc
David Evans, Non Executive Chairman +44 (0) 7740084452 
Dr Richard Goodfellow, Joint CEO + 44 (0) 74 2323 0 497

FTI Consulting
Simon Conway/Mo Noonan + 44 (0) 20 7831 3113

Cenkos Securities plc  
Camilla Hume/Stephen Keys +44 (0) 20 7397 8900

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 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 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.

Stimulation of killer CD4 T cells with potent anti-tumour activity

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces the development of a new platform technology (Moditope) that stimulates the production of killer CD4 T cells with powerful anti-tumour activity. The Directors believe that this new discovery could have a profound effect on the way that cancer vaccines are developed. 

CD4 responses to cancer associated antigens have been notoriously difficult to generate whether presented as peptides, proteins or DNA. CD4 cells are vital for effective anti-tumour immunity. Scancell has identified and patented a series of modified epitopes that overcome this limitation. Scancell’s Moditope technology produces killer CD4 T cells that destroy tumours without toxicity 

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: “Not only do these unique epitopes stimulate a CD4 killer T cell response, we have also shown in tests that cancer patients can produce an immune response to these epitopes. The Moditope epitopes can be used to develop both DNA and peptide vaccines and could become an important component of many therapeutic vaccines in the future, both under development at Scancell and other companies” 

Prof Peter Stern, Head of the Cancer Research UK, Immunology Group at the Paterson Institute for Cancer Research, commented: “This novel technology has the potential to transform the therapeutic cancer field. It is increasingly recognised that combining products and technologies will unlock the full potential of cancer vaccines. The Moditope technology offers those developing cancer vaccines, a means to optimise the potency of their immune targets”. 

David Evans, Chairman of Scancell Holdings, commented: "This highly innovative discovery opens up a new approach to the development of cancer vaccines. Whilst currently at an early stage, we are aware that the opportunities could be considerable in addition to Scancell’s existing platform technology. As a result, the Board is actively evaluating its strategic options for this new technology platform and will be consulting with key shareholders in this regard. We are excited by the potential and are resolute in our aim of creating the greatest value for shareholders. The Board will update the market in due course.” 

The Directors of the issuer accept responsibility for this announcement. 

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO  Scancell Holdings Plc  + 44 207 653 9850 
Professor Lindy Durrant, Joint CEO  Scancell Holdings Plc  + 44 207 653 9850 
     
Graham Herring/Heather Armstrong  Newgate Threadneedle  + 44 207 653 9850 
     
Ross Andrews / Tom Rowley  Zeus Capital  + 44 161 831 1512 
     
Jon Belliss/Karen Kelly  Xcap Securities Plc  + 44 207 101 7070