Scancell Partners With ImmunoVaccine Technologies to Advance DNA Vaccine Delivery

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 research agreement with ImmunoVaccine Technologies Inc. (‘IVT’), a Canadian vaccine development company to explore the potential of using IVT’s DepoVax™ delivery system for Scancell’s novel ImmunoBody® DNA vaccines.

DNA-based vaccines such as those being developed by Scancell have gained popularity due to promising results reported in the clinic, their relative ease of manufacture and potential for enhanced stability. There is currently a need for simple alternative methods of delivering DNA vaccines.

DepoVax™ is a vaccine-enhancement and delivery platform comprised of liposomes, adjuvants and oil.  DepoVax™ enhances the immunogenicity of antigens in general, and can be used to dramatically enhance the delivery of polynucleotide-based antigens and SiRNA to lymph nodes. IVT has proven its scale-up capabilities at a contract manufacturing plant, making DepoVax™ amenable to commercialisation.

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 using electroporation technology in early 2010.

David Evans, chairman of Scancell, commented:

"IVT’s DepoVax™ represents a potentially attractive future delivery system for our ImmunoBody® DNA vaccines, especially those for certain infectious diseases where alternative delivery methods such as electroporation may be less suitable."

Dr. Marc Mansour, vice president of R&D at IVT, remarked:

“Scancell is developing an exciting DNA vaccine technology and we are delighted to enter into this collaboration. Our DepoVax™ technology has the potential to better deliver DNA vaccines to draining lymph nodes to produce high levels of immune response using conventional immunization techniques.”

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 1512

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).

Change of Advisor

Scancell Holdings Plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody® platform, announces today that it has appointed Zeus Capital as Corporate Advisor to the Company with immediate effect.                     

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 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.  

Interim Results for the six month period to 31 October 2008

The Directors of Scancell Holdings plc, the parent company of Scancell Limited (‘Scancell’),
the developer of cancer vaccines based on its patented ImmunoBody™ platform, are pleased
to announce the interim results for Scancell for the six month period ended 31st October 2008
(‘the period’).

Highlights:

  • Admitted to Plus markets on 24 September 2008 and raised £1.559,502 on 24th September 2008
  • Issue of equity raised £43,999.8 on the 19th of December 2008
  • Following the placing of shares in September, the Company has £2,220,479 cash reserves
  • Continued make good progress towards its goal of starting Phase 1 clinical trials with SCIB1 in 2010
  • Agreement to license key components of SCIB1 from National Institute for Health (‘NIH’) in the final phase of negotiation
  • Negotiations to secure development and commercial rights to an injection device to deliver SCIB1 to patients progressing wel
  • Experienced Development Advisor appointed for SCIB1
  • Presented at the Genesis 2008 Oncology Showcase

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

“I am delighted to report a very successful first six months as a public company. In 2008, we raised £1.6m in conjunction with being admitted to Plus markets. The funds raised will provide the ability to further develop Scancell’s core technology; the ImmunoBodyTM platform and to achieve its aim of starting Phase 1 clinical trials of SCIB1 in 2010.”

For further information contact:

Company:
Scancell Holdings Plc  -  Professor Lindy Durrant/Dr Richard Goodfellow  -  Tel: 020 7245 1100

Corporate Advisers:
St Helen's Capital Plc  -  Duncan Vasey/Barry Hocken  -  Tel: 020 7628 5582

Financial PR:
Hansard Group  -  Adam Reynolds/Vicky Krause  -  Tel: 020 7245 1100

View the full results

Issue of Equity

The Directors of Scancell are pleased to announce that on 19 December 2008, the Company issued 73,333 new ordinary shares of 1p each in lieu of advisory fees relating to the admission of the Company onto the PLUS-quoted market at a price of 60 pence per share.

The trading of the new ordinary shares on PLUS is expected to commence on 22 December 2008.

Following the issue of shares as detailed above the total number of ordinary shares in issue as at 19 December 2008 will be 10,275,551 ordinary shares. The total Directors' Shareholding as a result of the Issue of Equity is 2,627,892 ordinary shares representing 25.57% of the current issued share capital.

The Directors of the issuer accept responsibility for this announcement.

Notice of Results

Notification of Interim Results

Scancell Holdings Plc, the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, today announces that it will release its Interim Results for the six months ended 31 October 2008 during the week commencing
Monday 12th January 2009.

Audited Final Results for the Year Ended 30 April 2008

The Directors of Scancell Holdings Plc are pleased to announce the audited results for Scancell Limited for the year ended 30 April 2008.

Chairman's Statement

In the last financial year we have consolidated our position in relation to the science and the finances of the Company.

In November, I was elected Non-Executive Chairman and brought my considerable experience in listed companies to the board. A decision was made at the beginning of 2008 to list the Company on the PLUS Market (www.PLUSmarketsgroup.com) and successfully achieved on the 24th of September 2008.This has attracted new finance to progress our lead product SCIB1 into the clinic and continue the development of the ImmunoBody platform. A decision was made by the directors that they are not paying a dividend for the period.

We look forward to updating shareholders with developments over the coming months.

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