Posts in Category: SCIB1

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.

Interim Results for the six month period to 31 October 2009

Scancell (SCLP.PL), the developer of therapeutic cancer and infectious disease vaccines based on its
patented ImmunoBody® platform, is pleased to announce the interim results for the six month period ended 31st October 2009 (‘the period’).

Highlights:

  • Licensing agreement signed with Merck KGaA for two key patents required for further development and commercialisation of protein ImmunoBody® vaccines
  • Agreement signed with Ichor Medical Systems to use Ichor's TriGrid™ electroporation device for the delivery of SCIB1
  • Signed a research agreement with ImmunoVaccine Technologies Inc. to explore IVT’s DepoVax™ delivery system for future use with Scancell’s ImmunoBody® DNA infectious disease and animal health vaccines

Post Period Highlights:

  • GMP production of SCIB1 vaccine completed successfully with excellent yield
  • PharmaNet Development Group appointed to conduct and manage the SCIB1 clinical trial

David Evans, Non-Executive Chairman of Scancell, commented:

“The Company is on track with its clinical programme as outlined in our admission document in 2008, and we look forward to further progress during the current year, as SCIB1 enters Phase I clinical trials.”

A copy of this announcement is available for download at Announcement

The interim financial information is not audited.

For further information contact:

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

Kirsty Corcoran/John Bick  -  Hansard Communications  -  +44 (0)207 245 1100/+44 (0)7515 588 947

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

View the full results 

Scancell Selects PharmaNet Development Group for SCIB1 Clinical Trial

Scancell Holdings Plc, (PLUS:SCLP), the parent company of Scancell Limited (‘Scancell’), the developer of innovative therapeutic cancer vaccines, is pleased to announce that it expects to commence its Phase I/II clinical trial with SCIB in the first half of 2010. PharmaNet Development Group (PharmaNet), a top-ten clinical research organization, has been selected for the conduct and management of the study.

Scancell’s SCIB1 is a DNA ImmunoBody® vaccine for the treatment of melanoma. SCIB1 was developed using Scancell’s patented ImmunoBody® technology. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, overcoming the current limitations of most cancer vaccines. 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.

PharmaNet has extensive oncology experience from more than 200 studies, at over 9600 investigative sites with over 50,000 patients.

David Evans, Chairman of Scancell, commented:

“We are delighted to have selected PharmaNet to manage Scancell’s Phase I/II clinical trial programme with SCIB1. PharmaNet’s extensive experience, particularly in the management of early stage oncology clinical trials, will be of critical importance to Scancell as SCIB1 moves into clinical development.”

Jeffrey McMullen, President and Chief Executive Officer, PharmaNet Development Group, commented:

"This is our first project with Scancell. We are thrilled to work on Scancell’s innovative therapeutic cancer vaccine, SCIB1, and are very pleased that they have entrusted PharmaNet with their study.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

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

Adam Reynolds/Vikki Krause  -  Hansard Group  -  +44 7515 922906

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 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 PharmaNet Development Group, Inc.

PharmaNet Development Group, Inc., a global drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company offers early and late stage consulting, Phase I clinical studies and bioanalytical analyses, and Phase II, III and IV clinical development programs. With approximately 2,300 employees and 40 facilities throughout the world, PharmaNet is a recognized leader in outsourced clinical development. For more information, please visit www.pharmanet.com.

Completion of GMP manufacture for Scancell’s SCIB1 Clinical Trial

Scancell Holdings Plc, (PLUS:SCLP) the parent company of Scancell Limited (‘Scancell’), the developer of therapeutic cancer vaccines based on its patented ImmunoBody® platform, is pleased to announce that the current Good Manufacturing Practice (‘cGMP’) production of Scancell’s SCIB1 DNA vaccine has been successfully completed ahead of the planned clinical trials that are expected to commence on schedule in H1 2010.

SCIB1 is being developed for the treatment of melanoma. The vaccine has been developed using Scancell’s patent-protected ImmunoBody® technology platform that overcomes the current limitations of most cancer vaccines by generating the high-avidity T-cells that kill cancer cells. Melanoma kills over 1,800 people every year in the UK, with over 130,000 new cases of the disease being reported annually worldwide. Advanced melanoma currently has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately 6 months.

The cGMP manufacturing was completed by AIM-Listed Cobra Biomanufacturing Plc (AIM:CBF), the international manufacturer of biopharmaceuticals. The final release of the product for SCIB1 clinical trials is anticipated mid-Q4 2009 and will be undertaken by Cobra’s in-house QP.

David Evans, Chairman of Scancell, commented:

“Cobra Biomanufacturing has done an excellent job manufacturing our SCIB1 DNA vaccine on time and on budget. This is another important step forward towards our goal of starting clinical trials with SCIB1 in the first half of 2010.”

Simon Saxby, Chief Executive of Cobra Biomanufacturing said:

”It has been a pleasure to work with Scancell on the production of their SCIB1 vaccine. The two teams have worked closely together to make this a highly successful project and we wish Scancell every success with their clinical trials. The Cobra team look forward to working with Scancell in the future.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

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

Adam Reynolds/Vikki Krause  -  Hansard Group  -  +44 7515 922906

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 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 Cobra Biomanufacturing Plc:

Cobra Biomanufacturing Plc is a leading international manufacturer of biopharmaceuticals to the lifescience industry. Founded in 1992, Cobra provides innovative manufacturing solutions to the biopharmaceutical industry covering DNA, virus, cellular therapeutics and recombinant protein products. Cobra has developed a range of unique, patented technologies, which underpin a successful revenue generating contract manufacturing business.

www.cobrabio.com

Preliminary Results for the Year Ended 30 April 2009

The Directors of Scancell Holdings plc, the parent company of Scancell Limited (‘Scancell’), the developer of therapeutic cancer and infectious disease vaccines based on its patented ImmunoBody® platform, are pleased to announce the preliminary results for Scancell for the year ended 30th April 2009 (‘the Period’).

Highlights:

  • Admitted to Plus markets and raised £1.559,502
  • Signed deal with Cobra Biomanufacturing Plc to commence Good Manufacturing Practice manufacture of Scancell’s SCIB1 DNA vaccine
  • Awarded £250,000 Grant for Research and Development by the East Midlands Development Agency
  • Preparations for scheduled 2010 Phase 1 clinical trials of Scancell’s first cancer vaccine for melanoma, SCIB1, continued on time and on budget
  • Voted ACQ Magazine Plus Company of the year

Post Period Highlights:

  • Merck Serono: signed licensing agreement for two key patents required for further development and commercialisation of protein ImmunoBody® vaccines
  • Ichor Medical Systems: agreement signed to use Ichor's TriGrid™ electroporation device for the delivery of SCIB1
  • ImmunoVaccine Technologies Inc.: signed a research agreement to explore using IVT’s DepoVax™ delivery system for Scancell’s future ImmunoBody® DNA infectious disease and animal health vaccines
  • Zeus Capital appointed as Corporate Advisor

David Evans, Non-Executive Chairman of Scancell, commented:

“I am pleased to report on Scancell’s first successful year as a public company. The Company continues to make good progress towards commencing Phase 1 clinical trials on its first therapeutic cancer vaccine SCIB1 in 2010..Scancell has also entered into a number of significant agreements that will support both SCIB1 and the development of future ImmunoBody® vaccines.”

For further information contact:

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

Adam Reynolds/Vikki Krause  -  Hansard Group  -  +44 7515 922906

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

View the full results 

Scancell licenses TriGrid™ electroporation device from Ichor Medical Systems

Scancell Holdings Plc, the parent company of Scancell Limited (‘Scancell’), the developer of therapeutic cancer vaccines based on its patented ImmunoBody® platform, is pleased to announce it has signed an agreement with Ichor Medical Systems (‘Ichor’) to use Ichor’s TriGrid™ electroporation device for the delivery of SCIB1, Scancell’s innovative ImmunoBody® DNA vaccine for melanoma.

In vivo electroporation is a promising means of enhancing the potency of DNA vaccines. Ichor’s TriGrid™ Delivery System uses electroporation to dramatically increase the intracellular delivery of the DNA vaccine at the site of administration, enhancing potency over 100 times compared to conventional methods of delivery. In patients Ichor’s advanced, push-button electroporation system minimises operator error and ensures the safe, rapid, effective and reproducible administration of DNA from one patient to another. Scancell is confident that TriGrid™ will provide the most effective delivery system for its SCIB1 melanoma vaccine as it enters the first phase of its clinical trials. Under the agreement Ichor will supply the TriGrid™ device for Scancell’s forthcoming pre-clinical and clinical studies with SCIB1 and has given Scancell an Option to license TriGrid™ for commercial use on payment of certain undisclosed milestones and royalties. The Option may be exercised at any time over the next five years. In return Ichor has been granted options to subscribe for Scancell shares, at the subscription price paid during Scancell’s next scheduled round of funding, as follows: on regulatory approval to start clinical trials in the UK, 1% of the issued share capital; on starting the first Phase II clinical trial, 2% of the issued share capital and; on completing the first Phase II clinical trial, 2% of the issued share capital.

Scancell’s first cancer vaccine SCIB1 is scheduled to start clinical trials in 2010.

David Evans, chairman of Scancell, commented:

“Scancell is delighted to be collaborating with Ichor on SCIB1. We believe that the use of TriGrid™ to deliver SCIB1 in the forthcoming clinical trials programme will optimise our vaccine’s therapeutic potential in melanoma patients”. Robert Bernard, president and CEO of Ichor stated: “The agreement with Scancell provides an excellent opportunity for Ichor. Scancell’s unique ImmunoBody® vaccine platform is capable of enhancing immune response by both quantitative and qualitative measures. We look forward to clinical testing of the SCIB1 melanoma vaccine candidate as an initial demonstration of the therapeutic potential of Scancell’s ImmunoBody® vaccines administered with Ichor’s TriGrid™ delivery technology.”

The Directors of the issuer accept responsibility for this announcement.

For Further Information:

Professor Lindy Durrant
Scancell Holdings Plc + 44 207 245 1100

Adam Reynolds/Vikki Krause
Hansard Group + 44 7515 922906

Ross Andrews
Zeus Capital + 44 (0)161 831 151

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 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. Ichor’s current research partners include Aaron Diamond AIDS Research Center, Bayhill Therapeutics, Genexine, the International AIDS Vaccine Initiative, the Johns Hopkins Bloomberg School of Public Health, Memorial Sloan-Kettering Cancer Center, the Pasteur Institute, Pharmexa-Epimmune, Rockefeller University, The Scripps Research Institute, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Naval Medical Research Center (NMRC) and the Vaccine and Infectious Disease Organization (VIDO).

Scancell licenses key ImmunoBody® patents from Merck Serono

Scancell Holdings Plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody® platform, is pleased to announce it has signed a licensing agreement with Merck KGaA, Darmstadt, Germany, acting for its division Merck Serono, for two key patents required for the further development and commercialisation of protein ImmunoBody® vaccines. Under the agreement, Scancell has non-exclusive worldwide rights to use the two patents to further develop and commercialise ImmunoBody® vaccines in all therapeutic areas in both humans and animals.

In addition, Scancell has granted Merck Serono an option to negotiate an exclusive license under Scancell's ImmunoBody® platform technology for up to five Merck Serono targets.

Scancell's ImmunoBody® is a breakthrough patent-protected platform technology that aims to overcome the current limitations of cancer vaccines by generating the high-avidity T-cells that kill cancer cells.

By re-engineering the vector, the Immunobody® platform technology can be adapted to provide the basis for treating any tumour type and may also be of utility in the development of vaccines against chronic infectious diseases including hepatitis and HIV.

Scancell's first cancer vaccine SCIB1 is being developed to treat melanoma, with clinical trials commencing in 2010.

David Evans, chairman of Scancell, commented:

"We are delighted to have forged this association with Merck Serono. The agreement will add further strength to Scancell's IP position, as it continues to progress its development of therapeutic vaccines based on the Immunobody® platform."

For Further Information:

Professor Lindy Durrant   Scancell Holdings Plc + 44 207 245 1100  
Adam Reynolds/Vikki Krause    Hansard Group   + 44 7515 922906   
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 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 Receives GBP250,000 emda Grant

Scancell Holdings plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, is pleased to announce that it has been awarded a £250,000 Grant for Research and Development (`GRD') by the East Midlands Development Agency (`emda'). The GRD will be used towards the costs of progressing Scancell's SCIB1 ImmunoBody DNA vaccine as it commences Good Manufacturing Practice (`GMP') production in 1Q2009 and applies for Clinical Trial Authorisation (`CTA') to commence clinical trials of SCIB1 in the UK in 1Q2010.

Scancell is developing SCIB1, a DNA vaccine for the potential treatment of late-stage melanoma cancer patients. There are 8000 new cases of melanoma every year in the UK with 1800 deaths per year. Early stage melanoma is often cured by surgery but advanced disease has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately 6 months. SCIB1 was developed using Scancell's ImmunoBody(tm) technology and is engineered to express the TRP-2 and gp100 cytotoxic T-cell epitopes from tumour antigens. In animal models, SCIB1 prevented the development of lung metastases and significantly inhibited the growth of established tumours.

The emda grant will be used to help fund the preparatory programme for phaseI/ IIa clinical trials that are anticipated to commence in 2010. The programme includes: optimisation of the ImmunoBody(tm); GMP process manufacture, formulation, stability and scale-up; pre-clinical efficacy and safety testing, and; toxicological assessment. The data derived from these studies will be utilised by Scancell in order to obtain CTA to allow the first clinical trial of SCIB1 in melanoma patients.

emda is one of nine Regional Development Agencies in England, set up in 1999 to bring a regional focus to economic development. Its primary goal is to increase the economic growth of the region while reducing disparities between the East Midlands and other English regions. The key role of emda is to be the strategic driver of sustainable economic development, working in partnership with public, private and voluntary organisations to deliver the goals of the Regional Economic Strategy.

David Evans, Chairman of Scancell, commented:

"We are delighted to have received a £250,000 grant from emda, the proceeds of which will be used to further progress SCIB1 and to further explore the manifold opportunities we expect that our ImmunoBody(tm) platform will present for the treatment of cancer, and other serious diseases. We are also pleased to be recognised by emda as a contributor to the economic growth prospects of the East Midlands region and appreciate the support that emda is providing towards building our business and the successful development of our innovative technology."

John O'Reilly, Business Support Director at emda, commented:

"Scancell is just the kind of innovative company that we are looking to support through the Grant for Research and Development. The grant will help it to develop a revolutionary new treatment which will not only help thousands of people affected by cancer, but which will also enable the business to develop and grow, creating new jobs for the region."

The Directors of the issuer accept responsibility for this announcement.

GMP Manufacture Deal With Cobra

Scancell Holdings Plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, is pleased to announce that it has signed a deal with Cobra Biomanufacturing Plc (`Cobra Biomanufacturing') for Good Manufacturing Practice (`GMP') manufacture of its SCIB1 DNA vaccine. Scancell plan to commence clinical trials of SCIB1 in the UK in 1Q2010.

Scancell is developing SCIB1, a DNA vaccine for the potential treatment of late-stage melanoma cancer patients. There are 8000 new cases of melanoma every year in the UK with 1800 deaths per year. Early stage melanoma is often cured by surgery but advanced disease has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately 6 months. SCIB1 was developed using Scancell's ImmunoBody(tm) technology and is engineered to express the TRP-2 and gp100 cytotoxic T-cell epitopes from tumour antigens. In animal models, SCIB1 prevented the development of lung metastases and significantly inhibited the growth of established tumours.

Cobra Biomanufacturing is an AIM-listed contract manufacturer of biopharmaceuticals that is compliant with cGMP standards worldwide.

David Evans, chairman of Scancell, commented:

"We are delighted to sign a deal with Cobra Biomanufacturing to manufacture our SCIB1 DNA vaccine. That we are commencing GMP manufacture of SCIB1 on schedule is testament to the progress the Company continues to achieve."

Simon Saxby, Chief Executive of Cobra Biomanufacturing said:

"We are very pleased to be have been selected by Scancell as a result of Cobra's abilities and reputation as a leading cGMP compliant manufacturer of DNA. This agreement also underscores Cobra's long term commitment to the manufacture of therapeutic vaccines."

The Directors of the issuer accept responsibility for this announcement.