Scancell sells antibody pipeline to Peptech

Key points

  • Acquires additional antibody assets
  • Second M&A transaction in 2006
  • Strengthens oncology franchise
  • Purchase consideration of GBP 2 million plus a contingent payment of GBP 2.85 million

Australian biotechnology company Peptech Limited (ASX:PTD) continues to pursue its determined merger and acquisition strategy today announcing its second acquisition for the calendar year with the acquisition of the antibody assets of UK based Scancell Limited through its newly established UK subsidiary, Peptech UK Limited.

The acquisition, in which Peptech assumes control of cancer therapeutic antibodies and related intellectual property from Scancell, provides further validation of Peptech's aggressive growth strategy announced in January this year. The acquisition is consistent with its internationalisation strategy and builds upon the recently announced intention to list on AIM in London.

Peptech acquired Scancell’s two pre-clinical lead cancer-related antibodies, SC101 and SC104, along with a suite of additional anti-cancer antibodies in the early stages of development.

SC101 and SC104 target colorectal cancers, a significant unmet medical need with a market estimated to exceed US$3.2 billion.

Peptech Chief Executive Officer Dr John Chiplin said the additional antibodies substantially strengthened Peptech’s existing cancer product pipeline and substantiate further the company’s recent decision to list on AIM in order to strategically exploit opportunities in Europe.

“The two newly acquired lead antibodies have demonstrated promising preclinical results that can be correlated with direct cancer cell killing properties,” Dr Chiplin said.

“It is our intention to utilise these antibodies to provide additional strength to our existing oncology development program, which includes our relationship with Biosceptre International, to create a world-class anti-cancer franchise.”

“This is an excellent deal for Scancell” said Scancell’s scientific founder, Prof. Lindy Durrant. “The deal with Peptech will enhance the prospects of these exciting antibodies reaching the clinic and improving cancer treatment. Moreover it will allow Scancell to focus its efforts on its innovative ImmunoBody cancer vaccine programme"

The initial consideration will be a cash payment of GBP2 million. Peptech will make a further payment of GBP2.85 million upon any of the acquired products reaching a Phase I clinical trial, to be paid by either cash or shares, at Peptech’s discretion.

Occurring just six months after the acquisition of Promics which strengthened Peptech’s anti-inflammatory franchise, the Scancell acquisition provides Peptech with expanded options in the treatment of various cancers.

“There is a substantial medical need for new cancer products across the world and these new antibodies will provide us with the ability to enter large and growing markets for new therapies in lucrative cancer markets currently estimated to exceed US$30 billion,” Dr Chiplin said.

“By further developing the more advanced lead compounds in our Sydney facility, and continuing the research effort in the UK to further evaluate the suite of less advanced anti-cancer antibodies, we build upon Peptech's strong expertise in evaluating and developing antibody products.”

About Peptech:

Peptech Limited focuses on the research and development of peptides and proteins in the areas of human pharmaceuticals and animal health. The company is positioned to become a globally recognised leader in biopharmaceutical development.

For further information: www.peptech.com

About Colorectal Cancer:

Colorectal cancer is the cancer with second or third highest incidence in both US and Europe. About 155,000 new cases of colorectal cancer and 24,000 cases of stomach cancer are diagnosed each year in the USA, in Europe about 381,000 cases of colorectal cancer were diagnosed in 2004. The market for drugs treating colorectal cancer was about $US3.2 billion in 2004, about 13% of global oncology sales.

GTC Biotherapeutics and Scancell Collaborate on SC101 Antibody

FRAMINGHAM, MA and NOTTINGHAM, UK – July 28, 2005 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and Scancell Limited (“Scancell”) announced that they have signed a collaboration agreement to evaluate the expression of Scancell’s SC101 anti-cancer monoclonal antibody (MAb) using GTC’s transgenic production platform. Their agreement contemplates that both companies will work toward the establishment of a definitive agreement for the potential clinical development of SC101.

“We look forward to demonstrating the value offered by transgenic technology for the production of antibody products such as SC101,” noted Gregory Liposky, GTC’s Senior Vice President, Operations. “GTC’s technology offers significant advantages for the development of proteins that are projected to be required in large commercial production quantities, when approved, and we believe we can assist Scancell in realizing that potential value.”

Commenting on the agreement, Michael Capaldi, Chief Executive Officer of Scancell, said: "We are very pleased to be working with GTC. This agreement offers Scancell the opportunity to establish development of what we believe will be a very large scale product at significantly lower capital investment."

SC101 is a MAb that targets Lewisy/b. Lewisy/b is a cell surface carbohydrate blood group antigen whose xpression is very low in normal tissue but is over-expressed on breast, colorectal, endometrial, kidney, lung, pancreas and stomach tumours. Mouse antibodies recognizing Lewisy/b have induced tumor cell death and inhibited growth of various tumor lines. In animal studies, tumor growth was inhibited by anti-Lewisy/b antibodies alone, and especially when combined with 5-fluorouracil, an antimetabolite that disrupts cancer cell growth.

About GTC Biotherapeutics

GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC currently has five products in its internal pipeline and a portfolio of external program production opportunities. GTC’s lead program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application is under review by the European Medicines Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. In addition to the ATryn® program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a malaria vaccine, and a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors. In its external programs, GTC's technology is used to develop transgenic production of its partners’ proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. One of the external programs is in clinical trials with a transgenically produced product. Additional information is available on the GTC web site, http://www.gtc-bio.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the prospects for anticipated expression of SC101 in a transgenic production system and for a definitive agreement with Scancell for further development of transgenic production for SC101. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports as filed with the Securities and Exchange Commission, including the risks and uncertainties inherent in the development of transgenic expression of compounds and the actions of collaboration partners. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law. GTC specifically disclaims responsibility for information describing Scancell, its business and SC101, other than the collaboration with GTC.

About Scancell

Scancell Ltd is a company focused on the discovery and development of products that harness the immune system in a unique way to treat or prevent cancer. The Company, which currently employs 12 individuals, has secured £4.6million of private equity and commercial funding. The Company has built an early stage product pipeline based upon two platforms: directly killing MAbs (‘killer’ MAbs) and its patent protected ImmunoBody® vaccine platform. ‘Killer’ MAbs are raised against ‘cocktails’ of primary human tumours resulting in MAbs that recognize clinically relevant targets. The Company screens for MAbs that directly kill tumour cells (i.e. without the need for antibody-dependant cellular cytotoxicity (ADCC) or complement mediated cytotoxicity (CDC)) and have an additive and/or synergistic killing effect in the presence of chemotherapeutics. Scancell has three such products in pre-clinical development and a number of further ‘killer’ MAbs in research. Scancell’s ImmunoBody® technology uses human antibodies as vectors to target clinically relevant T-cell epitopes to activated dendritic cells via the high affinity CD64 receptor thereby initiating cellular immunity against cancers or chronic infectious diseases. For more information about Scancell visit www.scancell.co.uk

Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements, e.g. unforeseen exchange rate and interest rate fluctuations, delayed or unsuccessful development projects.

Statements that are not historical facts, including statements preceded by, followed by, or that include the words "believes"; "anticipates"; "plans"; "expects"; "estimates"; or similar statements are forward-looking statements. Scancell is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

Scancell Raises £1.0 Million In Rights Issue

Oxford, UK, 15 June 2005 - Scancell Limited announces the completion of its Rights Issue funding of £1.0m. The round was well supported by Scancell’s existing shareholders who include, Bioscience VCT, Oxford Capital Partners and the Oxford Technology VCTs.

Scancell will use the funds to advance its development programmes as it advances towards the clinic. Based in Biocity, Nottingham, UK, Scancell is one of the leading drug discovery companies focused on cancer therapeutics through the development of its antibody technology. Scancell was founded in 1997 as a spin out of the University of Nottingham by Professor Lindy Durrant.

Cancer remains one of the world’s most significant diseases. A key challenge in the fight against cancer is that many tumours continue to grow by successfully evading the body’s own natural defence mechanism - the immune system. Scancell’s mission is to overcome this breach in our defences by developing products that stimulate the immune system to treat or prevent cancer.

The Company has four therapeutic antibodies in development and a pipeline of improved cancer vaccines based upon its proprietary ImmunoBody® technology. Scancell has already secured major technology-validating collaborations with significant players in the sector including Celltech, Genmab and ISU.

Mike Capaldi, CEO of Scancell, said: “We are pleased to have received strong support from our shareholders. Despite the challenging environment for biotech funding, Scancell has successfully closed this round and is in discussions with a number of commercial partners.”

David Mott, Partner at Oxford Capital Partners, said: “Scancell have made strong scientific progress over the past 18 months and we are confident that the technology will deliver. The new funds will enable Scancell to reach several critical value milestones.”

Scancell Signs New Agreement with Biovation to DeImmunise SC101

Nottingham UK – January 11th 2005 - Scancell Ltd, the Nottingham-based cancer therapeutics company, has announced that it has secured an agreement with Biovation under which Biovation will apply their DeImmunisation technology to up to two further monoclonal antibodies (MAbs) in Scancell’s portfolio, including SC101, Scancell’s anti-cancer MAb against Lewisy/b.

Lewisy/b is a cell surface carbohydrate blood group antigen whose expression is very low in normal tissue but over-expressed on breast, lung, colon and ovarian cancer cells. Mouse antibodies recognising Lewisy/b have induced tumour cell death and inhibited growth of various tumour lines. In animal studies, tumour growth was inhibited by anti-Lewisy/b antibodies alone, and especially when combined with 5-fluorouracil, an antimetabolite that disrupts cancer cell growth.

The DeImmunisationTM technology identifies and removes T-cell epitopes from the therapeutic antibody, which substantially reduces its immunogenicity. Since potentially immunogenic regions of the antibody are removed by single amino acid substitutions, immunogenicity can be eliminated while retaining the biological properties of the starting molecule.

Commenting on the agreement, Professor Lindy Durrant, CSO of Scancell, said: "We are very pleased to be working with Biovation once again. This agreement offers Scancell the opportunity to DeImmunise a further two antibody therapeutics, a vital step in preparing these products for clinical trials."

Dr. Frank Carr, President and Chief Executive Officer at Biovation, commented: "We are delighted to be working with and supporting Scancell in their efforts to develop exciting and innovative anti-cancer therapeutics for the clinic"

Scancell Secures Exclusive Worldwide Licence Agreement

Nottingham, UK – 25th May 2004 – Scancell Ltd, the Nottingham, UK based cancer therapeutics company, has announced that it has secured an agreement with Cancer Research Technology Limited (CRT) under which Scancell has been granted an exclusive worldwide licence to develop and commercialise two cancer vaccines against Tie-2 and CD55 protein targets for the treatment of solid tumours.

Tie-2 and CD55 offer highly promising approaches to the development of novel vaccines using Scancell's ImmunoBody™ technology. Tie-2 is over-expressed on tumour vasculature. Therapeutic vaccines targeting blood vessels can cause vascular collapse and starvation of large tumour areas. CD55 is over-expressed by tumours to protect them from immune attack. A therapeutic vaccine targeting CD55 may therefore destroy tumour cells over-expressing CD55 leaving any remaining cells susceptible to immune clearance through endogenous complement lysis. A combination of both vaccines may lead to dramatic tumour regression by harnessing the body's immune system to 'reject' the tumour.

Commenting on the agreement, Professor Lindy Durrant, CSO of Scancell, said: "We are very pleased that CRT has selected Scancell to develop and commercialise these extremely promising products. This agreement offers Scancell the opportunity to develop two new ImmunoBody™ vaccines for the treatment of solid tumours. The collaboration with CRT is a further example of how we intend to accelerate the development of the ImmunoBody™ programme through partnerships over the next few years."

Dr. Keith Blundy, Chief Operating Officer at CRT, said: "Scancell is well positioned to develop the CD55 and Tie-2 vaccines and we anticipate that this deal will enable cancer patients to benefit from this exciting technology in the future."

Scancell's ImmunoBody® approach involves engineering a human antibody to express epitopes from tumour antigens over-expressed by commercially important solid tumours - in this case Tie-2 and CD55. ImmunoBody™ vaccines efficiently target the dendritic cells in vivo to stimulate effective immunity. They offer the potential to develop more effective vaccines against both cancer and infectious diseases.

Scancell Raises £1.3 Million ($2.34M; €2M) in New Funding Round

Nottingham, UK – 27th April 2004 – Scancell Ltd, the Nottingham, UK based cancer therapeutics company, announced at its annual general meeting (AGM) today the successful completion of a further round of private equity funding totalling ~£1.3 million. Bioscience VCT, and Oxford Technology 3 VCT, an existing investor, acted as co-lead investors for the round. Other new investors in this round included Oxford Capital Partners and Cherwell Capital. Several of Scancell’s existing investors also made additional investments in the company.

The new funding will allow Scancell to accelerate the development of its leading products and to move to dedicated laboratories at the new BioCity Healthcare and Bioscience Innovation Centre in Nottingham, UK.

Commenting on the funding Dr Mike Capaldi, Scancell’s new CEO said:

“Scancell is very pleased to have succeeded in securing this investment in the current difficult market conditions. The company has already demonstrated its ability to develop new products and close commercial deals. The new investment will allow the company to bring its products closer to the clinic and to further develop its ImmunoBody® programme. We are also very excited about the move to BioCity, which will significantly help our growth plans.”

Dr Paul Nicholson, the Chairman of BioScience VCT, said:

“We are pleased to have made an investment in Scancell. The company has built a strong team to lead the development of its antibodies and its platform technologies and we look forward to supporting the company’s progress.”

Lucius Cary, Director of Oxford Technology 3 VCT, and the Managing Director of Seed Capital Ltd, the Investment Adviser to the Oxford Technology 3 VCT added:

“We are very pleased to have invested further in Scancell and continue to support the company and the research of its founder, Professor Lindy Durrant. This is a company that has developed a diverse pipeline of anti-cancer targets and platform technologies and assembled an outstanding team to deliver these to the clinic.”

Scancell Appoints Dr Michael Capaldi as CEO

Nottingham, UK – 21st April 2004 – Scancell Ltd, the pioneering Nottingham-based therapeutics company that is harnessing the power of the immune system to fight cancer, has announced the appointment of Dr Michael Capaldi as Chief Executive Officer. Dr Capaldi brings to Scancell extensive commercial and management experience in the pharmaceutical and life sciences industries, together with a strong scientific background.

Commenting on his new position, Dr Capaldi said:

“Scancell is at an exciting stage of development and I look forward to contributing to the future success of the Company. I am convinced that Scancell can make a major contribution towards developing new cancer therapies that harness the power of the immune system.”

Dr Capaldi was previously CEO of Synaptica Ltd where he served from 2000. He has a broad working knowledge of the biopharmaceutical industry with a strong commercial bias, combined with a solid understanding of pharmaceutical discovery and development. He has first hand experience of raising capital from private and public markets to fund early stage biotechnology companies including an IPO of Core Group as a full listing on the London Stock Exchange (LSE) in 1997. He has over 20 years experience in the pharmaceutical and life sciences industry within the UK, Europe and the USA, including over 17 years commercial and general management experience gained with SmithKline Beecham plc, Amersham plc, Core Group plc, Oxford Asymmetry plc and Synaptica Ltd. Prior to this he gained five years multidisciplinary research experience in academic and applied pharmaceutical research and management with Ciba-Geigy.

Michael holds a PhD in Medical Biophysics from the University of Manchester, and has experience of both academic and applied pharmaceutical research. Welcoming Dr Capaldi to the Company, Chairman Nigel Evans said: “Michael brings significant management, commercial and fund raising experience to Scancell, which will be invaluable as the Company commercialises its therapeutic antibodies and it’s ImmunoBody® technology. Monoclonal antibody technology promises considerable hope for the treatment and prevention of cancer.”

Scancell, Onyvax and CRT Announce Agreement to Facilitate the Development of "ImmunoBody"

Nottingham and London, UK – 12th December 2003 – Scancell Ltd., Onyvax Limited and Cancer Research Technology Limited (CRT), today announced an agreement enabling Scancell to develop and commercialise its proprietary ImmunoBody cancer vaccine technology. Under the terms of the agreement Onyvax, one of the world's leading cancer vaccine companies, will also have a non-exclusive licence to develop the technology.

The ImmunoBody Approach

Cancer vaccines represent a highly attractive approach for cancer therapy as, in contrast to current treatments such as chemotherapy and radiotherapy, small non-toxic doses of a vaccine may be administered to a patient to stimulate an immune response. It is generally accepted that to be effective against cancer, a vaccine needs to target dendritic cells to stimulate both parts of the cellular immune system, the helper cell system (known as the CD4-mediated response) which stimulates inflammation at the tumour site, and the cytotoxic T-lymphocyte or CTL response (known as the CD8-mediated response) in which cells of the immune system 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's ImmunoBody approach involves engineering a human antibody to express helper cell and CTL epitopes from tumour antigens over-expressed by commercially important solid tumours. These ImmunoBodies efficiently target dendritic cells in vivo via the CD64 receptor to stimulate effective immunity. They offer the potential to develop more effective vaccines against both cancer and infectious diseases.

Commenting on the agreement, Professor Lindy Durrant, CEO of Scancell, said: "We are very pleased to have reached agreement with CRT and Onyvax on the ImmunoBody programme. This platform offers Scancell the opportunity to develop new cancer vaccines on its own behalf and in partnership with others. The collaboration with Onyvax is the first exciting example of how we intend to accelerate the development of the ImmunoBody programme through partnerships over the next few years."

Dr Anthony Walker, CEO of Onyvax, commented: "Scancell's ImmunoBody technology is potentially a breakthrough in cancer vaccine design, offering the opportunity to develop more effective vaccines against this disease."

Dr Keith Blundy, Director of Business Management at CRT, said: "We are very pleased that Scancell and Onyvax will be undertaking further development of the ImmunoBody technology and hope that the programme will lead to new therapeutic options for cancer patients."

Scancell and Celltech Announce that they will Collaborate on the Development of Novel Monoclonal

Nottingham, UK – 5th August 2003 – Scancell Ltd., a privately held biotechnology company, and Celltech Group plc announced today that they will collaborate on the development of novel monoclonal antibody therapeutics to Lewisy/b, a promising new cancer target. Under the terms of the agreement, Scancell has granted Celltech the right to evaluate Scancell’s SC101 antibody family and Celltech has acquired an option to an exclusive world-wide licence to any products developed during the collaboration.

Lewisy/b is a cell surface carbohydrate blood group antigen whose expression is very low in normal tissue but over-expressed on breast, lung, colon and ovarian cancer cells. Mouse antibodies recognising Lewisy/b have induced tumour cell death and inhibited growth of various tumour lines. In animal studies, tumour growth was inhibited by anti-Lewisy/b antibodies alone, and especially when combined with 5-fluorouracil.

Dr Melanie Lee, Director of Research and Development of Celltech, commented: "Scancell have generated interesting preclinical data highlighting the potential for SC101 antibodies as cancer fighting drugs. Celltech will explore a range of therapeutic options against the Lewisy/b antigen, particularly the use of its novel antibody fragment platform."

"We are immensely pleased to have signed this agreement with Celltech", said Prof Lindy Durrant, CEO of Scancell. "The collaboration with Celltech, an acknowledged leader in the field of antibody drug development, is an important landmark in Scancell’s development and will offer a great opportunity to fast-track SC101 into the clinic."

Scancell’s expertise lies in the discovery and development of monoclonal antibodies and vaccines for the treatment of cancer. Scancell has identified a large number of novel antigens as potential targets for drug development. Monoclonal antibodies recognising these targets directly induce tumour cell apoptosis and synergise with chemotherapy, thereby reducing toxicity and increasing therapeutic efficacy. Scancell has also developed ImmunoBodies as a platform technology to overcome the present limitations of cancer vaccines. For more information about Scancell visit www.scancell.co.uk

Celltech Group plc (LSE: CCH; NYSE: CLL) is one of Europe's largest biotechnology companies, with an extensive development pipeline and a profitable, cash-generative pharmaceutical business. Celltech also possesses drug discovery capabilities of exceptional strength, including a leading position in antibody engineering. More details can be found at www.celltechgroup.com.