Posts in Category: SCIB1

AGM Statement

At the Annual General Meeting of Scancell Holdings Plc, (AIM: SCLP), to be held later today, David Evans, Chairman will give shareholders an update and review of the business. This will include the following statement:

This has been an exciting and busy year for Scancell in which the Company has successfully achieved all of its commercial and scientific aims in line with its strategy. Of particular note is the successful progression of Scancell’s first vaccine, SCIB1 for melanoma, which entered clinical trials in June 2010. The Company also successfully raised £2.5 million in April 2010 and moved from PLUS to AIM in July 2010.

SCIB1 Phase I Clinical Trial

Clearly, a move into clinical trials for SCIB1 represents an important milestone. This followed Clinical Trial Approval from the Gene Therapy Advisory Committee and by the Medicines and Healthcare Products Regulatory Agency Medicines Division. The approvals enabled Scancell to commence its Phase I clinical trial of SCIB1 in June 2010, to evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma. To date, four patients have been enrolled on the trial which is currently taking place at three centres. Recruitment has been slower than anticipated due to the fact that a number of patients with advanced melanoma - the patients we require - are either being recruited into B-raf* studies or offered ipilimumab** on a compassionate use basis. By the time the patients have failed to respond to either (or both) of these treatments, they are often too ill to enter our study. Overall this has had an impact on the recruitment rates for the Phase I study, however the Company still expects to complete the clinical trial by the end of 2012.

To accelerate the advancement of the trial, two further centres will be opened, and Scancell has also filed protocol amendments to recruit patients with less severe disease. These earlier stage patients should make better immune responses which should ultimately have a positive effect on the outcome on our trial. The issue of patient recruitment is not expected to apply to the Phase II trial which will be conducted in less severely ill patients. The delay to patient recruitment may also have resource implications. Without Phase I clinical results (due in late 2011), it may be difficult to generate revenues from a commercial deal on the ImmunoBody® technology and it may therefore be necessary to augment the Company’s capital resources to complete the Phase II study.

Agreements and Collaborations

Scancell secured two key agreements during the year: a worldwide non-exclusive licensing agreement with the National Institutes of Health, an agency of the United States Department of Health and Human Services, for use of two melanoma antigens as key components of SCIB1; and, a licensing agreement with Cancer Research Technology Ltd, Cancer Research UK's commercialisation and development arm to use a human antibody for the development of new ImmunoBody® vaccines for any immunotherapy indication.

The Company also entered two important strategic collaborations: with ImmuneRegen BioSciences, Inc.®, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC BB:IRBS.OB) to investigate the synergy between ImmuneRegen's Homspera® and Scancell's ImmunoBody® vaccine technologies; and with immatics biotechnologies GmbH to explore the development of novel ImmunoBody® vaccines for colorectal cancer.

The Directors are pleased with Scancell’s progress during 2010 and look forward to updating shareholders on the future advancements in due course.

For further information contact:

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

Hansard Communications
Kirsty Corcoran + 44 (0)207 245 1100

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

Matrix Corporate Capital LLP - Joint Broker
Robert Naylor/Stephen Waterman +44 (0)20 3206 7340

Notes to Editors

During the past year, data has emerged from studies of two new treatments in Stage IV patients.

* Firstly, a study of a B-raf inhibitor in patients with advanced melanoma demonstrated tumour regression in 80% of patients (although this did not result in a long-term survival advantage).

** Secondly, a Phase III trial of the anti-CTLA4 monoclonal antibody ipilimumab has demonstrated prolonged survival of Stage IV melanoma patients, with 23.5% still alive after two years. This is the first drug to have a positive impact on survival and is likely to receive approval for use in patients with advanced metastatic melanoma next year. Even if this drug is approved, this still leaves 75% of patients with no appropriate therapy and in potential need of our vaccine.

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 has recently entered clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

Collaboration With ImmuneRegen BioSciences® Yields Positive Results in Cancer Vaccine Studies

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that a treatment utilising a DNA vaccine based on its ImmunoBody® technology, in combination with ImmuneRegen BioSciences, Inc.®’s lead compound, Homspera®, has significantly improved the immune response of the vaccine in an animal model. Follow-up studies are currently being performed to optimize the effects of Homspera in enhancing the next generation of Scancell’s cancer vaccines.

Scancell recently announced the commencement of a Phase I clinical trial utilizing its SCIB1 product being developed for the treatment of melanoma. SCIB1 is a novel DNA vaccine being developed using Scancell’s patented ImmunoBody® technology. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. A unique advantage of Scancell’s Immunobody® technology is that it specifically targets dendritic cells, leading to a significant enhancement of the immune response.

ImmuneRegen’s Homspera has previously been found to improve the efficacy of a melanoma 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. Both applications are being aggressively developed by ImmuneRegen in combination with significant academic and industry partners.

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

“I am pleased with the results achieved by this collaboration to date and look forward to continuing to work with ImmuneRegen as we progress with follow-up studies.”

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

“We are pleased to see if we can positively augment immune responses elicited by Scancell’s ImmunoBody® vaccines. Based on our previous demonstration of enhanced dendritic cell responses to TRP2-encoding DNA vaccine following Homspera exposure, Scancell’s ImmunoBody® vaccine technology presents a very desirable developmental opportunity. We are very happy with our ongoing relationship and recognize that ongoing studies could potentially benefit both companies.”

ImmuneRegen BioSciences, Inc.® is a wholly owned subsidiary of IR
BioSciences Holdings, Inc. (OTC BB:IRBS.OB)

For further information contact:

Scancell Holdings Plc - Professor Lindy Durrant

  • + 44 (0)207 245 1100

Hansard Communications - John Bick/Kirsty Corcoran

  • + 44 (0)207 245 1100

Zeus Capital - Nominated Adviser/Joint Broker - Ross Andrews/Tom Rowley

  • + 44 (0)161 831 1512

Matrix Corporate Capital LLP - Joint Broker - Robert Naylor/Stephen Waterman

  • +44 (0)20 3206 7340

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 has recently entered clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

View the full Document

Antibody Licence Agreement with Cancer Research Technology

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, and Cancer Research Technology Ltd (‘CRT’) - Cancer Research UK’s commercialisation and development arm today announce that they have signed an agreement under which Scancell has been granted a licence to use a human antibody known as 105AD7.

105AD7 is a human monoclonal antibody that mimics the complement regulatory protein, CD55. The antibody was discovered and originally developed at the University of Nottingham with support from Cancer Research UK and has previously been evaluated in clinical trials for osteosarcoma. The agreement will give Scancell a worldwide licence to use 105AD7 for the development of new ImmunoBody® vaccines for any immunotherapy indication. The licence will be restricted to the use of the antibody as a framework for future ImmunoBody® vaccines.

Scancell’s current ImmunoBody® vaccines, such as SCIB1, its vaccine currently in Phase I clinical trials for the treatment of melanoma, use a deimmunised* antibody as the framework. 105AD7 will allow Scancell to use a fully human framework for the development of future ImmunoBody® vaccines.

Under the terms of the agreement, Scancell will make an upfront payment to CRT in addition to development milestone payments, and royalty payments on future sales. Scancell will exclusively fund the development work, and have sub-licensing rights on agreed terms.

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

“I am pleased that we have secured this important agreement with Cancer Research Technology. By utilising antibody 105AD7, Scancell will be able to further enhance the clinical utility and safety of Scancell’s ImmunoBody® platform both in cancer and other immunotherapy indications.”

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said:

“Through this deal with Scancell we are able to take forward this antibody arising from research from our worldclass scientists into commercial development to potentially make new vaccines to treat a range of diseases.”

*Deimmunization is a technology for location and removal of T-cell epitopes through the combined use of immunological and molecular biology techniques to reduce the immunogenicity of an antibody.

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/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 has recently entered clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

About Cancer Research Technology Ltd

Cancer Research Technology Limited (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world.

CRT's discovery laboratories build on exploratory research to create attractive commercial opportunities through collaboration with research institutes worldwide. Therapeutic programmes are then out-licensed for further development following identification of a suitable partner.

For more information visit the web site www.cancertechnology.com

About Cancer Research UK

Cancer Research UK is the world’s leading charity dedicated to beating cancer through research.

The charity’s groundbreaking work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. This work is funded entirely by the public.

Cancer Research UK has been at the heart of the progress that has already seen survival rates double in the
last forty years.

Cancer Research UK supports research into all aspects of cancer through the work of more than 4,800
scientists, doctors and nurses.

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

For further information about Cancer Research UK's work or to find out how to support the charity, please call
020 7121 6699 or visit www.cancerresearchuk.org.uk

Withdrawal from PLUS and Admission to AIM

The Board of Scancell Holdings plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that it intends to apply for the Company’s Ordinary Shares to be admitted to trading on AIM and, immediately prior to the Admission to AIM, it intends to withdraw the Company’s Ordinary Shares from trading on PLUS.

During 2010, the Company has raised £2.54 million, before expenses, to fund its foreseeable working capital requirements. The Directors believe that the existing funds held by or available to the Group together with future anticipated revenues will be sufficient to allow completion of the Phase I/IIa clinical trial of SCIB1, its lead melanoma therapeutic vaccine.

The Ordinary Shares of the Company were originally admitted to trading on PLUS in September 2008. However, now that the Company has further strengthened its financial position and progressed the development of SCIB1, the Directors believe that it would be in the best interests of the Company and its shareholders for the Ordinary Shares to be admitted to trading on the AIM market of the London Stock Exchange.

The Directors believe that this represents a natural transition for the Company and that the potential benefits of an AIM listing will include an increased public profile for the Company.

Under the AIM Rules, prior to Admission, the Company is required to publish an admission document. The Company is therefore sending an admission document to Shareholders to inform them that the Ordinary Shares of the Company will be withdrawn from trading on PLUS from the close of business on 29 July 2010 and that the Ordinary Shares of the Company are expected to be admitted to trading on AIM at 8.00 a.m. on 30 July 2010.

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant, (CEO)  -  Scancell Holdings Plc:

  • +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications

  • +44 (0)207 245 1100
  • +44 (0)7872 061 007

Ross Andrews/Tom Rowley  -  Zeus Capital

  • +44 (0)161 831 1512

View the full document

Final Results for the year ended 30 April 2010

Scancell Holdings plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, announces its final results for the year ended 30 April 2010.

Highlights:

  • Strong progress in the development of the Company’s lead therapeutic melanoma vaccine SCIB1
  • Successful fundraising of £2.54 million (gross) during 2010
  • Loss before tax for the year of £1.80 million (2009: £0.8 million)
  • Cash at year end of £2.83 million
  • Since the year end the Company commenced Phase I/IIa clinical trials in humans for SCIB1

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant, (CEO)  -  Scancell Holdings Plc:

  • +44 (0)207 245 1100

John Bick/Kirsty Corcoran  -  Hansard Communications

  • +44 (0)207 245 1100
  • +44 (0)7872 061 007

Ross Andrews/Tom Rowley  -  Zeus Capital

  • +44 (0)161 831 1512

View the full document

Research collaboration with immatics to develop novel ImmunoBody® vaccines for colorectal cancer

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, today announces a research collaboration with immatics biotechnologies GmbH (“immatics”) to explore the development of novel ImmunoBody® vaccines for colorectal cancer.

immatics discovers and develops tumor-associated peptides (TUMAPs) for the immunotherapy of cancer. TUMAPs with the highest specificity for particular cancers are identified directly from primary human tumour tissue samples. From thousands of identified TUMAPs the most suitable ones are selected and combined to a single multi-peptide product to form a therapeutic cancer vaccine. The goal is to provoke a number of specific T-cell responses which finally result in the destruction of tumour cells presenting the TUMAPs.

immatics’ most advanced product, IMA901, has been evaluated in a Europe-wide multi-centre Phase II clinical trial in renal cancer. Positive data of this Phase II study have recently been published at the ASCO 2010 meeting. immatics’ pipeline also includes IMA910 for the treatment of colorectal carcinoma which has recently entered a large Phase I/II clinical trial.

Scancell’s first vaccine using its patented ImmunoBody® technology is SCIB1, a novel DNA vaccine being developed for the treatment of melanoma, which is currently in Phase 1 clinical trials. 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 anticipated to lead to the inhibition and regression of both primary and metastatic melanoma tumour growth.

In the research collaboration with immatics, colorectal cancer-specific TUMAPs will be incorporated into ImmunoBody® constructs to create ImmunoBody® vaccines targeted towards colorectal cancer. If the research project is successful, immatics and Scancell will explore the further development of any product candidates.

Paul Higham, CEO of Immatics said

“We are very pleased to enter this research collaboration with Scancell as the colorectal TUMAPs identified by immatics have the potential to complement and enhance Scancell's ImmunoBody technology. We eagerly await the results.”

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

“Our research collaboration with immatics will create the opportunity to bring together two world class technologies. We will be working together with immatics to evaluate the combination of the immatics’ TUMAP technology with Scancell’s ImmunoBody® technology for the development of novel vaccines for the treatment of colorectal cancer.”

* A type of white blood cell that initiates an immune response

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant, (CEO)  -  Scancell Holdings Plc:

  • +44 (0)207 245 1100

Katrin Eckert (Assistant to the Management)  -  immatics biotechnologies GmbH

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 is currently in Phase 1 clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

About immatics

immatics biotechnologies is a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer. immatics’ lead product, IMA901 has completed a successful Phase II trial in renal cell carcinoma. immatics’ pipeline also includes IMA910, in Phase II for colorectal cancer, and IMA950 which is being developed for glioma.

immatics’ technology platform rapidly generates defined therapeutic cancer vaccines which are based on multiple tumor-associated peptides (TUMAPs) with the ability to specifically stimulate the immune system against cancer cells. These vaccines – comprising multiple peptides confirmed to be naturally presented by real tumor tissue – offer the prospect of greater effectiveness than existing cancer vaccine approaches combined with fewer side effects. immatics’ products are ‘drug like’ with stable, off -the- shelf formulations and robust easily scalable manufacturing. www.immatics.com

SCIB1 Phase I Trial Commences - First Patient Treated

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

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

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

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

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

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

Professor Poulam Patel, Lead Researcher, commented:

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

David Evans, Chairman of Scancell Holdings, commented:

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

The Directors of the issuer accept responsibility for this announcement.

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

For further information contact:

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

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

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

About Scancell

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

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

Scancell Enters Strategic Collaboration with ImmuneRegen BioSciences®

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

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

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

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

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

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

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

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

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

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

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

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

About Scancell

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

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

About ImmuneRegen BioSciences, Inc.

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

National Institutes of Health Licensing Agreement

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

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

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

David Evans, Chairman of Scancell, commented:

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

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

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

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

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

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

About Scancell

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

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

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

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.