Posts in Category: Regulatory News

SCIB1 Phase I Trial Commences - First Patient Treated

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, today announces the enrolment and treatment of the first patient in its multicentre Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial will evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma.

The trial, which is commencing on schedule, will be in nine, Stage IV or inoperable Stage III patients and is being conducted in three UK centres. All patients in the clinical trial will be treated with Scancell’s SCIB1 ImmunoBody® vaccine, delivered by Ichor Medical Systems’ TriGrid™ electroporation delivery device.

ImmunoBody® vaccines generate the high-avidity T-cells* that kill cancer cells, which may overcome the current limitations of most cancer vaccines. In vivo electroporation is widely regarded as an effective method of enhancing the potency of DNA vaccines by up to 100-fold compared to conventional methods of delivery.

Advanced melanoma currently has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately six months. According to the World Health Organisation, 132,000 melanoma skin cancers occur globally each year and the incidence is increasing, especially in the United States, Europe and Australia.

Professor Lindy Durrant, CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented:

“This is the first time we will be taking the SCIB1 ImmunoBody® vaccine into patients with late stage melanoma and follows our very positive research studies with the vaccine against this deadly form of cancer. We are very excited about the prospects for SCIB1 and are very pleased that it has moved a step closer to becoming available for the treatment of cancer patients.”

Professor Poulam Patel, Lead Researcher, commented:

“Advanced melanoma is one of the most deadly cancers we have and there is an urgent need for new treatments. The data from the laboratories looks very promising and we’re very excited to take SCIB1 into the clinic.”

David Evans, Chairman of Scancell Holdings, commented:

“The beginning of enrolment in the Phase I trial for SCIB1 is a key milestone for Scancell and we are delighted that the Company is continuing in its progress.”

The Directors of the issuer accept responsibility for this announcement.

*High avidity T-cells – A type of white blood cell composed of CTL and Helper cells. CTL cells recognise and kill tumour or virally infected cells, Helper cells recognise and secrete molecules to alert the immune system to the presence of a tumour or virally infected cell. Avidity measures the strength of the T-cell interaction.

For further information contact:

Professor Lindy Durrant, CEO  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews/Tom Rowley  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Scancell Enters Strategic Collaboration with ImmuneRegen BioSciences®

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, today announces a strategic collaboration with ImmuneRegen BioSciences, Inc.® (‘ImmuneRegen’), a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC BB:IRBS.OB). Under the agreement, Scancell and ImmuneRegen will work together to investigate the synergy between ImmuneRegen’s Homspera® and Scancell’s ImmunoBody® vaccine technologies.

Scancell‘s first vaccine using its patented ImmunoBody® technology is SCIB1, a novel DNA vaccine being developed for the treatment of melanoma. An advantage of Scancell’s Immunobody® platform is that it specifically targets dendritic* cells, leading to a significant enhancement of the immune response. This enhanced immune response against TRP-2 (a melanoma protein called Tyrosinase-Related Protein 2) is expected to lead to the inhibition and regression of both primary and metastatic melanoma tumor growth. Scancell is on track to commence its Phase I clinical trials for SCIB1 during Q2 2010.

ImmuneRegen’s Homspera® has previously been found to improve the efficacy of a TRP2 cancer vaccine in mice, resulting in persistent and specific immune responses associated with inhibition of melanoma tumor growth. Additionally, previous studies have demonstrated efficacy of Homspera® in enhancing immune responses to infectious disease vaccines, such as influenza.

Hal Siegel Ph.D., ImmuneRegen’s Chief Scientific Officer, commented:

“We are excited to be commencing this relationship with Scancell. As ImmuneRegen and Scancell move towards the clinic independently, we feel this is the ideal time to collaborate on this project, with the goal of evaluating the combination of Scancell’s dendritic cell targeting technology as applied to these melanoma antigens** and ImmuneRegen’s Homspera®, which has shown dendritic cell immunostimulatory activity via dendritic cell responses to TRP2 directed against melanoma tumors. Ideally, we could be creating a combined product that represents the ‘next generation’ of cancer vaccine technology.”

Professor Lindy Durrant, Chief Executive Officer of Scancell, commented:

“Combining Scancell’s revolutionary ImmunoBody® technology with Homspera® might offer the opportunity to further improve the therapeutic potential of SCIB1. We are very much looking forward to collaborating with Immuneregen on this exciting project.”

* A type of white blood cell that initiates an immune response
**A molecule that is recognised by an antibody or T-cell receptor

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran   -  Hansard Communications  -  +44 (0)207 245 1100,  +44 (0)7872 061 007

Ross Andrews  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

About ImmuneRegen BioSciences, Inc.

ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC BB:IRBS.OB-News), is a development-stage biotechnology company focused on the research, development and licensing of Homspera®. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Homspera is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. Additionally, Homspera is being developed for use as a therapeutic for Idiopathic Pulmonary Fibrosis, an indication which ImmuneRegen has recently submitted for Orphan Drug Status. To advance its mission, the Scottsdale, Arizona based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems. For more information, please visit www.immuneregen.com.

National Institutes of Health Licensing Agreement

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce it has signed a worldwide non-exclusive licensing agreement with the National Institutes of Health (‘NIH’), an agency of the United States Department of Health and Human Services, for use of the melanoma antigens TRP-2 and gp100, developed in the laboratory of Steven A. Rosenberg, M.D., Ph.D., at the National Cancer Institute. These antigens will be utilized as key components of Scancell’s lead ImmunoBody® vaccine for melanoma, SCIB1.

Under the agreement, Scancell has agreed to pay the US Public Health Service an undisclosed upfront fee in addition to certain milestone fees and a royalty on future sales of SCIB1. Scancell will have the right to develop and commercialise its ImmunoBody® vaccines for the treatment of melanoma in humans incorporating epitopes from these targets.

ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. Scancell is expected to commence its Phase I clinical trials for SCIB1 in Q2 2010.

David Evans, Chairman of Scancell, commented:

“This agreement strengthens Scancell’s IP position around SCIB1 and enables the Company to move forward towards its proposed clinical trials of the melanoma vaccine.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

David Evans, Chaiman  -  Scancell Holdings Plc  -  +44 (0)774 008 4452

Professor Lindy Durrant, CEO  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews/Tom Rowley  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Placing

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, announces it has raised approximately £24,000 (before expenses) by way of a placing of 53,333 New Ordinary Shares of 0.1p each (‘Placing Shares’) at a price of 45p (the ‘Placing’) with Wilton International Marketing Limited.

Admission and commencement of dealings in the New Ordinary Shares to be issued under the Placing are expected to take place at 8.00 a.m. on 11 May 2010. There will be a total of 15,926,659 Ordinary Shares in issue following Admission of the Placing Shares.

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

David Evans -  Scancell Holdings Plc  -  +44 (0) 774 008 4452

Kirsty Corcoran / John Bick  -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews / Tom Rowley  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Clinical Trial Approval for SCIB1 melanoma vaccine study

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that its proposal to conduct a Phase I clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma, has been approved by the Gene Therapy Advisory Committee (‘GTAC’) and by the Medicines and Healthcare products Regulatory Agency (‘MHRA’) Medicines Division. In addition, Scancell’s partner Ichor Medical Systems (‘Ichor’) has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor’s TriGrid™ electroporation delivery device to administer SCIB1 to patients participating in the trial of SCIB1.

Recruitment for the Phase I clinical trial of SCIB1 is expected to commence shortly at three leading UK hospital centres in Nottingham, Manchester and Newcastle.

SCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell’s patented ImmunoBody® technology for the treatment of melanoma. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. In vivo electroporation is widely regarded as an effective method of enhancing the potency of DNA vaccines by up to 100-fold compared to conventional methods of delivery. Scancell is confident that TriGrid™ will provide the most effective delivery system for its SCIB1 melanoma vaccine as it enters clinical trials.

Advanced melanoma currently has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately six months. According to the World Health Organisation, 132,000 melanoma skin cancers occur globally each year and the incidence is increasing, especially in the United States, Europe and Australia.

David Evans, Chairman of Scancell, commented:

“With the approvals from GTAC and MHRA in place Scancell will commence the Phase I clinical trial of our first therapeutic cancer vaccine SCIB1 during this second quarter which is exactly on track with our programme and marks a significant step for the Company. We look forward to updating shareholders again in due course.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications  -  +44 (0)207 245 1100/+44 (0)7872 061 007

Ross Andrews/Tom Rowley -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine, SCIB1, is being developed for the treatment of melanoma and will enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a DNA vaccine encoding a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of high avidity and high frequency helper and CTL responses.

The ImmunoBody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

About Ichor

Ichor Medical Systems’ TriGrid™ Delivery System is the first integrated and fully automated system for electroporation-mediated DNA administration. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on three continents in a wide range of studies to test the TriGrid™ as an enabling platform for delivery of DNA drugs and vaccines to treat diseases such as pandemic flu, hepatitis, HIV, melanoma, multiple sclerosis, and others. The TriGrid™ is also being tested by the U.S. military as an efficient means of delivering anti-bioterrorism agents.

Placing of New Ordinary Shares

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce it has raised £207,000 (before expenses) by way of a placing of 460,000 New Ordinary Shares of 0.1p each (‘Placing Shares’) at a price of 45p (the ‘Placing’) with the Aspire Fund. The net proceeds of the Placing, together with the proceeds of the Open Offer that was completed on 29 March 2010, will be used to fund the working capital requirements of the Company to take its lead melanoma vaccine, SC1B1, through Phase I and Phase IIa Clinical Trials.

Admission and commencement of dealings in the New Ordinary Shares to be issued under the Placing are expected to take place at 8.00 a.m. on 15 April 2010. There will be a total of 15,873,326 Ordinary Shares in issue following Admission of the Placing Shares.

David Evans, Chairman of Scancell Holdings plc, commented:

“Following the recent successful fundraising, I am delighted that the Aspire Fund has now also decided to become a significant shareholder in Scancell. The investment represents further recognition of the work of our CEO Lindy Durrant in the development of SC1B1.”

Melanie Perkins, Lead Manager of the Aspire Fund said:

“This investment is extremely exciting and we are thrilled to have the opportunity to support such a vital enterprise that may have the opportunity to save so many lives. The Aspire Fund seeks to support and encourage female entrepreneurship and Scancell is an excellent example of women leading the way in diverse and important fields of work.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

David Evans, Chairman  -  Scancell Holdings Plc  -  +44 (0) 774 008 4452

Professor Lindy Durrant, CEO  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

Kirsty Corcoran / John Bick  -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews / Tom Rowley  -  Zeus Capital  -  +44 (0)161 831 1512

About the Aspire Fund (www.capitalforenterprise.gov.uk)

Established in November 2008, the £12.5m Aspire Fund targets support for women-led businesses with an objective to increase the number of successful female entrepreneurs within the UK, ensuring that those with real potential to succeed are not held back through a lack of growth capital. The Fund is able to make investments of between £100k and £1m, providing up to 50% of capital in a funding round alongside other private investors. The Aspire Fund is managed by Capital for Enterprise Ltd (CfEL) on behalf of the Department for Business Innovation and Skills (BIS).

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

The ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Result of Open Offer

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to report the results of the Open Offer that was announced on 5 March 2010. Under the Open Offer, a total of 5,137,775 New Ordinary Shares will be issued at a price of 45 pence per New Ordinary Share to raise approximately £2.31 million, before expenses, to fund the working  capital requirements of the Company.

Results of the Open Offer

  • Existing shareholders have subscribed for 3,770,248 New Ordinary Shares, representing approximately 73.38 per cent. of the total number of New Ordinary Shares to be issued;
  • Helium Special Situations Fund Limited, a new institutional investor, has subscribed for 1,034,194 New Ordinary Shares, representing approximately 20.13 per cent. of the total number of New Ordinary Shares to be issued; and
  • 333,333 New Ordinary Shares have been placed with private investors, representing approximately 6.49 per cent. of the total number of New Ordinary Shares to be issued.

Admission and commencement of dealings in the New Ordinary Shares to be issued under the Open Offer are expected to take place at 8.00 a.m. on 30 March 2010. There will be a total of 15,413,326 ordinary shares in issue following Admission of the New Ordinary Shares.

Directors’ dealings

The Company has been notified of the following dealings:

Mr David Evans, non-executive chairman, has subscribed for 250,000 New Ordinary Shares at 45p per share under the Open Offer. After Admission of the New Ordinary Shares the total holding of David Evans in the Company will amount to 510,000 ordinary shares (representing approximately 3.31 per cent. of the enlarged issued share capital).

Mr Michael Rippon, non-executive director, has subscribed for 55,000 New Ordinary Shares at 45p per share under the Open Offer. After Admission of the New Ordinary Shares the total holding of Michael Rippon in the Company will amount to 250,416 ordinary shares (representing approximately 1.62 per cent. of the enlarged issued share capital).

Mr Matthew Frohn, non-executive director, is also a director of Oxford Technology Management Limited which is the manager for the Oxford Technology VCT plc and the Oxford Technology 3 VCT plc. The Oxford Technology VCT plc has subscribed for 166,667 New Ordinary Shares and the Oxford Technology 3 VCT plc has also subscribed for 166,667 New Ordinary Shares under the Open Offer. After Admission of the New Ordinary Shares the total holding of the Oxford Technology VCT plc in the Company will amount to 833,330 ordinary shares (representing 5.41 per cent. of the enlarged issued share capital) and the total holding of the Oxford Technology 3 VCT plc in the Company will amount to 442,592 ordinary shares (representing 2.87 per cent. of the enlarged issued share capital).

David Evans, Chairman of Scancell Holdings plc, commented:

“We are very pleased that the Open Offer has been so well supported by existing shareholders.

The net proceeds of the Open Offer, together with the existing funds held by or available to the Group, will be used to build on the progress achieved since the Company’s admission to PLUS and will be sufficient to allow completion of the Phase I and Phase IIa Clinical Trial of Scancell’s lead melanoma vaccine, SC1B1.”

The Directors of the issuer accept responsibility for this announcement.

Director's Dealings

The Company announces that it has received notification of the following Director’s dealings made on 9 March 2010.

Mr David Evans, non-executive chairman, purchased 10,000 ordinary shares in the Company at 46p per share.

Following this purchase, the total holding of David Evans in the Company amounts to 260,000 ordinary shares (representing approximately 2.53 per cent. of the issued share capital).

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant, CEO  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews/Tom Rowley  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is expected to enter clinical trials in Q2 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

Open Offer


Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, today announces an Open Offer of 5,137,775 New Ordinary Shares at a price of 45 pence per New Ordinary Share to raise approximately £2.31 million, before expenses, to fund the working capital requirements of the Company. The Directors believe that the net proceeds of the Open Offer, together with the existing funds and facilities available to the Company, will be sufficient to allow completion of the Phase I and Phase IIa Clinical Trial of Scancell’s lead melanoma vaccine, SC1B1, with completion expected in 2012.

An Open Offer Document containing details of the Open Offer is being posted to shareholders later today and will be available on this website.

Highlights:

  • The Open Offer provides an opportunity for all Qualifying Shareholders to participate in the fundraising by acquiring Open Offer Shares pro rata to their current holdings of Existing Ordinary Shares on the basis of 1 Open Offer Share for every 2 Existing Ordinary Shares held on the Record Date.
  • The Issue Price of 45 pence per New Ordinary Share represents a 10.89 per cent. discount to the closing middle market price of 50.5 pence per Existing Ordinary Share on 4 March 2010, the last business day before the announcement of the Open Offer.
  • The Open Offer is underwritten.

David Evans, Chairman of Scancell, commented:

“We are pleased to be able to offer existing shareholders the opportunity to participate in this fully underwritten fundraising. The net proceeds of the Open Offer, together with the existing funds held by or available to the Group, will be used to build on the progress achieved since the Company’s admission to PLUS and will be sufficient to allow completion of the Phase I and Phase IIa Clinical Trial of Scancell’s lead melanoma vaccine, SC1B1.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications  -  +44 (0)207 245 1100

Ross Andrews  -  Zeus Capital  -  +44 (0)161 831 1512

Expected Timetable of Principal Events:

close of business on 3 March 2010 - Record Date for the Open Offer

5 March 2010 - Announcement of the Open Offer

5 March 2010 - Posting of the Open Offer document and the Application Forms

3.00 pm on 24 March 2010 - Latest time and date for splitting Application Forms (to satisfy bona fide Market Claims only)

1.00 pm on 26 March 2010 - Latest time and date for receipt of completed Application Forms and payment in full under the Open Offer

7.00 am on 29 March 2010 - Expected time and date of announcement of results of the Open Offer

8.00 am on 30 March 2010 - Admission and dealings in the New Ordinary Shares commence

View the full Offer details

Clinical Trial Application for SCIB1 melanoma vaccine

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that its proposal to conduct a Phase I clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma, was submitted to the Gene Therapy Advisory Committee (‘GTAC’) on 29 December 2009. In addition, Scancell and its partner Ichor Medical Systems (‘Ichor’) submitted parallel applications to the Medicines Division and to the Devices Division of the Medicines and Healthcare products Regulatory Agency (‘MHRA’) on 29 January 2010 requesting approvals for the clinical trial of SCIB1 and for the use of Ichor’s TriGrid™ electroporation delivery device to administer SCIB1 to participating patients, respectively.

SCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell’s patented ImmunoBody® technology for the treatment of melanoma. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. In vivo electroporation is widely regarded as an effective method of enhancing the potency of DNA vaccines by up to 100 -fold compared to conventional methods of delivery. Scancell is confident that TriGrid™ will provide the most effective delivery system for its SCIB1 melanoma vaccine as it enters clinical trials.

Advanced melanoma currently has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately six months. According to the World Health Organisation, 132,000 melanoma skin cancers occur globally each year and the incidence is increasing, especially in the United States, Europe and Australia.

David Evans, Chairman of Scancell, commented:

“Scancell’s CTA submission and proposal to GTAC to conduct the Phase I clinical trial for our first therapeutic cancer vaccine marks a significant step for the Company and we look forward to reporting on its progress. We are confident that, subject to regulatory and ethical approvals, the Phase I clinical trial for SCIB1 will be on target to commence in Q2 2010.”

For further information contact:

Professor Lindy Durrant  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications  -  +44 (0)207 245 1100/+44 (0)7872 061 007

Ross Andrews  -  Zeus Capital  -  +44 (0)161 831 1512

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine, SCIB1, is being developed for the treatment of melanoma and will enter clinical trials in early 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccine need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a DNA vaccine encoding a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of high avidity and high frequency helper and CTL responses.

The ImmunoBody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

About Ichor

Ichor Medical Systems’ TriGrid™ Delivery System is the first integrated and fully automated system for electroporation-mediated DNA administration. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on three continents in a wide range of studies to test the TriGrid™ as an enabling platform for delivery of DNA drugs and vaccines to treat diseases such as pandemic flu, hepatitis, HIV, melanoma, multiple sclerosis, and others. The TriGrid™ is also being tested by the U.S. military as an efficient means of delivering anti-bioterrorism agents.