Posts in Category: Regulatory News

Extension to Ichor Option and Issue of Equity

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer is pleased to announce that it has been granted an extension of its 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 has agreed to waive the two year lock period following the exercise of Tranche 1 share options (over 1,592,310 shares).

The agreement with Ichor, signed in July 2009, 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 as follows: on regulatory approval to start clinical trials in the UK, 1,592,310 share options (“Tranche 1); on starting the first Phase II clinical trial, 3,184,620 share options (“Tranche 2); and on completing the first Phase II clinical trial, 3,184,620 share options (“Tranche 3”). Tranches 1 and 2 have already vested.

On 15 November 2013 Ichor exercised Tranche 1 of the share options. Following this exercise the Company has applied for 1,592,310 ordinary shares to be admitted to trading on AIM (“Admission”). It is expected that Admission will become effective and that dealings will commence in these Ordinary Shares at 21 November 2013.

Following admission of the 1,592,310 new ordinary shares the Company’s share capital will consist of 224,950,683 voting ordinary shares.

The above figure (224,950,683) 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 FCA’s Disclosure and Transparency Rules.

Richard Goodfellow, Joint CEO of Scancell, said:

“Ichor’s proprietary TriGrid electroporation delivery system is central to our current studies on SCIB1. We are delighted to have extended the option agreement to commercialise the technology with the Company beyond July 2014. It enables us to continue to evaluate its potential to effectively deliver our vaccine now that we have decided to expand the Phase1/2 clinical trial on SCIB1 to include a further 13 patients on an 8mg dose and the need to continue treating patients being placed on long term maintenance therapy.”

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 Ichor and the TrigridTM Delivery System

Ichor is dedicated to the clinical application and commercialization of electroporation technology for the delivery of DNA drugs and vaccines to treat and prevent debilitating or life threatening diseases. They are applying their proprietary TriGrid™ Delivery System to enable delivery of DNA drugs to address unmet medical needs in areas including therapeutic cancer vaccines, therapeutic proteins and vaccines for serious infectious disease.

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 Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

Scancell, Immunobody® and Moditope® are trade marks of Scancell Limited.

Results of AGM

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that all resolutions proposed at the Annual General Meeting held today were duly passed.

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 

+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.

Director Share Dealing

The Company has been notified that on 21 October 2013 Lindy Durrant and Richard Goodfellow each sold 100,000 shares in the Company from their respective holdings held jointly with Scancell Employee Benefit Trust at a price of 30 pence per share.

Following these transactions their holdings in the Company are as follows:

Director Name No. of shares held in own sole name post transaction No. of shares held jointly with Scancell Employee Benefit Trust post transaction
Lindy Durrant 1,606,960 8,773,960
Richard Goodfellow 200,000 6,343,840

 

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

Kim von Ahn Dr. Reuter Investor Relations +(0) 49 251 980 1561

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.