Posts in Category: Immunobody

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.

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.

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.

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 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.