Posts in Category: Regulatory News

Holdings in Company - 23 August 2012

The Company announces that it has received notification that Helium Special Situations Fund Limited has a beneficial interest in Scancell Holdings of 11,420,000 ordinary shares of 0.1 pence each which represents approximately 5.87 per cent of the issued capital of the Company.

For further information contact:

Scancell Holdings Plc 

Dr Richard Goodfellow / Professor Lindy Durrant+ 44 (0)20 7653 9850*

Newgate Threadneedle (Financial PR)

Guy McDougall / Heather Armstrong+ 44 (0)20 7653 9850

Zeus Capital - Nominated Adviser/Joint Broker

Ross Andrews /Andrew Jones + 44 (0)161 831 1512

XCAP - Joint Broker

Jon Belliss / Adrian Kirk +44 (0)207 101 7070

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction.

About Scancell 

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® and Moditope™ technology platforms. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is in Phase 2 clinical trials. 

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 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 have a profound effect on the way that cancer vaccines are developed.

Holdings in Company - 20 August 2012

The Company announces that it has received notification that Helium Special Situations Fund Limited has a beneficial interest in Scancell Holdings of 13,370,000 ordinary shares of 0.1 pence each which represents approximately 6.88 per cent of the issued capital of the Company.

For further information contact:

Scancell Holdings Plc 

Dr Richard Goodfellow / Professor Lindy Durrant+ 44 (0)20 7653 9850*

Newgate Threadneedle (Financial PR)

Guy McDougall / Heather Armstrong+ 44 (0)20 7653 9850

Zeus Capital - Nominated Adviser/Joint Broker

Ross Andrews /Andrew Jones + 44 (0)161 831 1512

XCAP - Joint Broker

Jon Belliss / Adrian Kirk +44 (0)207 101 7070

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction.

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® and Moditope™ technology platforms. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is in Phase 2 clinical trials. 

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 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 have a profound effect on the way that cancer vaccines are developed.

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

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

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

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

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

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

The Directors of the issuer accept responsibility for this announcement. 

-ENDS-

For Further Information:

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

 

 

 

 

SCIB1 Trial Update - Approval to dose patients for up to 5 years

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the Gene Therapy Advisory Committee (‘GTAC’) and the Medicines and Healthcare products Regulatory Agency (‘MHRA’) Medicines Division have given their approval to increase the maximum treatment period from 6 months up to a further 5 years in its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The continuation option will be available for patients with stable disease. Approval was also granted to further broaden the study inclusion criteria. 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 for this extended period.

The clinical trial of SCIB1 is being conducted at five leading UK hospital centres in Nottingham, Manchester, Newcastle, Leeds and Southampton.

Prof. Lindy Durrant, Joint CEO of Scancell, commented:

“This approval from GTAC and MHRA provides our Investigators with the opportunity to continue dosing patients whose disease has not progressed whilst receiving the SCIB1 vaccine and will allow the Company to gather longer term data on late stage melanoma patients for whom the prognosis is poor.”

A copy of this announcement is available for download on the Company’s website at www.scancell.co.uk 

-ENDS-

For further information contact:

Professor Lindy Durrant/Dr Richard Goodfellow  Scancell Holdings Plc  + 44 (0)207 653 9850 
Graham Herring/ Heather Armstrong  Newgate Threadneedle  + 44 (0)207 653 9850 
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 in Phase II clinical trials. 

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 Medical Systems 

Ichor Medical Systems’ TriGrid™ Delivery System (TriGrid) i s the first integrated and fully automated device for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on four continents to provide its enabling TriGrid platform as a means for delivery of DNA drugs and vaccines in disease indications such as melanoma, malaria, hepatitis B virus (HBV) infection, human immunodeficiency virus (HIV) infection, melanoma, Alzheimer’s disease, and others. For further info visit www.ichorms.com

Vesting of Ichor Options

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that, further to the commencement of the Phase II clinical trial for SCIB1, the Company’s first cancer vaccine which is being developed for the treatment of melanoma, 3,184,620 options previously granted to ICHOR Medical Systems Inc ('ICHOR') have now vested. 

As announced on 10 July 2010, ICHOR was granted options over a total of 7,961,560 ordinary shares in the Company (as adjusted for the subdivision of the Company’s share capital announced on 30 June 2011). The subscription price payable upon exercise of the options is 4.5p per share. The options were originally granted under a License and Supply Agreement ('the Agreement') dated 13 July 2009 made between Scancell and ICHOR. 

Under the terms of the Agreement, ICHOR agreed to supply its TriGrid™ electroporation device for Scancell's pre-clinical and clinical studies with SCIB1 and gave Scancell an option to license TriGrid™ for commercial use on achievement of certain milestones and payment of royalties. 

In return, ICHOR was granted options to subscribe for ordinary shares in the Company. The options vest as follows: 1,592,310 options vested on regulatory approval being granted to start clinical trials in the UK (which has already occurred); 3,184,620 options vested on starting the first Phase II clinical trial (which has recently occurred); and 3,184,630 options will vest on completing the first Phase II clinical trial. Each tranche of the options may be exercised at any time in the five year period after the relevant vesting date. 

A copy of this announcement is available for download on the Company’s website at http://www.scancell.co.uk/ 

-ENDS-

For further information contact:

Professor Lindy Durrant/Dr Richard Goodfellow  Scancell Holdings Plc  + 44 (0)207 653 9850 
Graham Herring/ Heather Armstrong  Newgate Threadneedle  + 44 (0)207 653 9850 
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 in Phase II clinical trials. 

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 Medical Systems 

Ichor Medical Systems’ TriGrid™ Delivery System (TriGrid) i s the first integrated and fully automated device for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on four continents to provide its enabling TriGrid platform as a means for delivery of DNA drugs and vaccines in disease indications such as melanoma, malaria, hepatitis B virus (HBV) infection, human immunodeficiency virus (HIV) infection, melanoma, Alzheimer’s disease, and others. For further info visit www.ichorms.com. 

SCIB1: First patient treated in Phase II clinical trial

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce the recruitment and treatment of the first patient in the second part of its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The Phase II part of the trial will be conducted in five UK centres in thirteen patients with Stage III/IV disease to further assess the safety of treatment and to assess the cellular immune response induced by SCIB1. Patients will be treated with a 4mg dose of SCIB1 on five occasions over a period of 6 months. The study is expected to take 18 months to complete. 

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

“Although the recruitment of patients to early stage cancer studies can be very challenging, we expect recruitment for the Phase II part of the study to be substantially faster than for Phase I as we will not be constrained by the cohort study design required for dose escalation, there are more patients available and they are likely to have earlier stage disease.” 

For further information contact:

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850* 
Newgate Threadneedle (Financial PR)  Graham Herring / Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk  +44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction. 

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 currently in Phase II clinical trials. 

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. 

SCIB1 Trial Update

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce the completion of recruitment to the Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial is being conducted in five UK centres in patients with Stage III/IV disease, and it is anticipated that Phase II trials will commence in the next few weeks. 

Scancell has obtained approval from the Cohort Review Committee to commence the Phase II study using the 4mg dose, the highest dose used in the Phase I part of the study. The approval is based upon safety data collected after all patients have been treated for 6 weeks. The Phase I patients will continue to be treated and followed up for a total of 6 months. 

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

“The recruitment of patients to early stage cancer studies can be very challenging and it is a tribute to both the dedicated Scancell team and the efforts of our clinical investigators that we have now completed recruitment for the Phase I part of the study. We expect recruitment for Phase II to be substantially faster than for Phase I and hope to treat the first patient in this part of the study within the next few weeks.” 

For further information contact: 

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850*
Newgate Threadneedle (Financial PR)  Guy McDougall / Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk 

+44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction

Holdings in Company

The Company announces that it has received notification that Helium Special Situations Fund Limited has a beneficial interest in Scancell Holdings of 15,556,940 ordinary shares of 0.1 pence each which represents approximately 8.0 per cent of the issued capital of the Company.

For further information contact: 

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850*
Newgate Threadneedle (Financial PR)  Guy McDougall/ Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk 

+44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction

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 entered 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.