Posts in Category: Regulatory News

Notice of AGM

Scancell announces that the Annual General Meeting ("AGM") relating to the Company's financial year ended 30 April 2013, will be held at 11.00 a.m. on 1 November 2013 at the offices of FTI Consulting, Holborn Gate, 26 Southampton Buildings, London, WC2A 1PB.

The Notice convening the AGM is being sent to shareholders today and will be available on the company's website www.scancell.co.uk

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/Simon Conway FTI Consulting + 44 (0) 20 7831 3113
Kim von Ahn Dr. Reuter Investor Relations [+49 251 980 1561]

 

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 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.

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.

DNA IB Patent in Australia

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 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 been approved in the US, Europe, Japan and Australia.

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

"Our lead ImmunoBody® for melanoma, SCIB1, currently in Phase I/II clinical trials is based on the DNA approach. The approval of this DNA patent is therefore a very important step in the development and commercialisation of our ImmunoBody® platform. Scancell continues to build its growing portfolio of intellectual property in parallel with advancing the clinical trial programme on SCIB1.”

-ENDS-

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  

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.

Holdings in Company - 8 August 2013

The Company has today received notification that Helium Special Situations Fund holds 8,275,000 ordinary shares in the Company representing 3.70% of the Company’s issued voting share capital.

For Further Information:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc + 44 (0) 74 2323 0497

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 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.

 

Result of General Meeting

The Board of Scancell announces that all resolutions put to shareholders at the Company’s General Meeting held earlier today were duly passed.

Application has been made for a total of 28,888,888 new ordinary shares to be admitted to trading on AIM. Dealing is expected to commence in respect of 22,222,222 new ordinary shares at 08:00 on 2 August 2013 and in respect of 6,666,666 new ordinary shares at 08:00 on 5 August 2013.

In conformity with rule 5.6.1 of Disclosure and Transparency Rules, the Board of the Company notifies the market of the following:

The total number of ordinary shares of 0.1p each in Scancell in issue following the admission of the 28,888,888 new ordinary shares will be 223,358,373 with each share carrying the right to one vote. There are no shares held in Treasury. The total number of voting rights in the Company will following admission of the Offer Shares therefore be 223,358,373. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Scancell under the FSA's Disclosure and Transparency Rules.

David Evans, Non-Executive Chairman of Scancell, said: “With funding now secured, we can focus on advancing both of Scancell’s cancer immunotherapy platforms to key value inflection points that we believe will further support their future role in the rapidly growing new approach to cancer treatment. We look forward to providing updates on our progress in due course.”

For Further Information:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc + 44 (0) 74 2323 0 497

David Evans, Non Executive Chairman

Scancell Holdings Plc +44 (0) 77 4008 4452

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.

Result of Open Offer

On 9 July 2013 the Board of Scancell announced details of a conditional Firm Placing in which it had conditionally raised gross proceeds of £4.5 million by means of a Firm Placing of 20,000,000 Firm Placing shares at 22.5 pence per share. In addition the Company announced that it was providing Qualifying Shareholders, who had not taken part in the Firm Placing, with an opportunity to subscribe, at 22.5 pence per share, for an aggregate of 8,888,888 Open Offer Shares to raise gross proceeds of up to approximately £2 million.

The Open Offer has now closed in accordance with its terms and Scancell is pleased to announce that the Open Offer was oversubscribed. The Company has received valid acceptances from Qualifying Shareholders in respect of 8,888,888 Open Offer Shares, representing 100 per cent. of the Open Offer Shares available under the Open Offer. In accordance with the terms and conditions of the Open Offer all applications made pursuant to the Open Offer (other than Excess Shares applied for under the Excess Application Facility) have been met in full and a scaling back exercise has been undertaken in respect of applications for Excess Shares. The Company has therefore raised gross proceeds of approximately £2 million through the Open Offer.

The Open Offer remains conditional, inter alia, upon the passing of the resolutions at the General Meeting on 1 August 2013 and upon First Admission occurring by 08:00 on 2 August 2013 (or such later time as the Company and Cenkos Securities plc may determine).

Application will be made to the London Stock Exchange for the admission of the Offer Shares which are subscribed for to trading on AIM. It is expected that First Admission, being the admission of the EIS Qualifying Shares, will occur and that dealings will commence at 08:00 a.m. on 2 August 2013 and Second Admission, being the admission of the Non-EIS Qualifying Shares, will occur and dealings commence at 08:00 a.m. on 5 August 2013.

This announcement should be read in conjunction with the full text of the Circular posted to Shareholders on 9 July 2013

David Evans, Non-Executive Chairman of Scancell, said: “We would like to thank our shareholders for their continued support. The Company has already delivered substantial shareholder value as SCIB1 progresses through the clinic. We are confident that the expansion of the SCIB1 trial and the further targeted development of the Moditope platform that this additional funding will enable us to undertake will translate into significant tangible benefits for both patients and shareholders in the medium-term.”


For more information, please contact:

Scancell Holdings Plc
David Evans, Non Executive Chairman      +44 (0) 7740 084 452
Dr Richard Goodfellow, Joint CEO             +44 (0) 7423 230 497 

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

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

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.

Director Shareholdings

The Company has been informed that on 22 July 2013 certain Directors of the Company purchased ordinary shares in the Company as follows:

Director No. of Shares purchased Price at which shares purchased No. of shares held pursuant to transaction (% of ISC following transaction)
David Evans 30,000 31.8 pence

5,130,000

(2.6%)

Kate Cornish-Bowden 45,000 32.0 pence

45,000

(0.02%)


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


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.

SCIB1 8mg Study Update

Scancell Holdings plc, ("Scancell" or the "Company") the developer of novel immunotherapies for the treatment of cancer, was informed on 11 July 2013 that one of the three patients recruited into the higher 8mg dose study of SCIB1 will no longer be eligible for evaluation due to delivery of an incomplete dose of SCIB1 following a fault with the electroporation device for that patient. Scancell will recruit a replacement patient as soon as possible in order to complete the initial phase of the 8mg study which is to assess the safety and immune response produced by the 8mg dose prior to expanding the study to include a further ten patients as planned. The initial part of the study is now expected to be completed early next year.

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 3 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 study using the 8mg dose will be 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.

Richard Goodfellow, Joint CEO of Scancell, said:

“With the higher dose study underway, we are now looking to recruit a new patient to ensure adequate safety and immune response data ahead of the extended trial of SCIB1 in patients with tumour load. We firmly believe that the data we gain from this additional trial will add further value to SCIB1 and the ImmunoBody® platform and look forward to reporting the results in due course.”

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

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 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.

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