Scancell Holdings Regulatory News (SCLP)

14 Dec 2010 07:00

14 December 2010 Scancell Holdings Plc ('Scancell' or the 'Company') 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. 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 + 44 (0)20 7245 1100Professor Lindy Durrant Hansard Communications + 44 (0)20 7245 1100Kirsty Corcoran

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

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

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.