Cambridge Antibody acquires oncology product candidates from Genencor.

Cambridge Antibody Technology (Cambridge, England) acquired product candidates GCR-3888 and GCR-8015 from Genencor (Palo Alto, CA). GCR-3888 has shown efficacy in a Phase I clinical trial and is currently in a Phase II clinical trial for the treatment of hairy cell leukemia (HCL). GCR-8015, an optimized version of GCR-3888, is in pre-clinical development as a potential treatment for B-cell malignancies including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The candidates are both immunotoxins comprising an antibody fragment that targets the CD22 receptor on B-lymphocytes fused to a toxin molecule.

CAT has hired ten key former staff of Genencor who will continue to be responsible for the development of these programs, and has thereby established a CAT operation in the United States for the first time. This will be based in Palo Alto, California.

The consideration for the acquisition is up to US$16 million, of which US$14 million will be paid by CAT on closing. Simultaneously Genencor will subscribe US$14 million for 1,170,277 new CAT ordinary shares (representing 2.27 percent of CAT's existing issued share capital). CAT may be required to pay Genencor additional consideration of up to US$2 million, contingent on the availability for use in a clinical trial of bulk product material of GCR-8015 produced by Genencor.

GCR-3888 and GCR-8015 were discovered and initially developed by the National Cancer Institute (NCI), which is part of the United States National Institutes of Health (NIH). Genencor licensed the candidates for hematological malignancies and entered into a cooperative research and development agreement with the NIH, which will now be continued by CAT. Under the original license agreement with the NIH, CAT will have rights to a portfolio of intellectual property associated with the programs and will pay future royalties to the NIH.

The NCI has demonstrated significant efficacy of GCR-3888 in a Phase I clinical trial in HCL. The results of a trial in 46 patients, performed at the NCI, with CD22+ NHL (n=4), CLL (n=11) and HCL (n=31), were recently published in the Journal of Clinical Oncology (Vol. 23 No. 27 September 20 2005) including data from 265 cycles of treatment. Results showed that GCR- 3888 was active in HCL, with 19 complete remissions (61%) and 6 partial responses (19%) in 31 patients. Lower, but significant, activity occurred in CLL. The publication concluded that the drug was well tolerated and highly effective in HCL even after one cycle of treatment.

CAT intends to file an Investigational New Drug application for GCR-8015 in various CD22 positive B-cell malignancies, including NHL and CLL, following a period of manufacturing development which is expected to be complete by the end of 2006 and to support the NCI's ongoing development of GCR-3888 in HCL and pediatric acute lymphoblastic leukemia (pALL).

GCR-3888 is an immunotoxin fusion protein between a murine anti-CD22 disulphide-linked Fv antibody fragment (dsFv) and the Pseudomonas exotoxin PE38, and GCR-8015 is an optimized version of GCR-3888 with increased affinity for CD22. CD22 is a regulatory molecule that acts to prevent the over activation of the immune system and the development of autoimmune diseases. The anti-CD22 immunotoxins GCR-3888 and GCR-8015 comprise a dsFv that targets the CD22 receptor, fused with a specifically engineered toxin molecule that minimizes non-targeted toxicity, resulting in a highly specific, highly potent therapeutic molecule. The molecule acts by releasing the toxin intracellularly, after the whole immunotoxin has been internalized via the CD22 receptor.

Peter Chambre, Chief Executive Officer of CAT, commented: "The acquisition of these product candidates is a significant step forward, accelerating the development of our proprietary pipeline. In particular, they signal our intention to focus our proprietary research and development activities in oncology indications, where we believe the opportunities are greatest for a company of CAT's resources and technological capabilities. In addition, the transaction has enabled CAT to establish its first presence in the United States. We are delighted to welcome the development team associated with these important product candidates to CAT. They provide a core of oncology development expertise to CAT for the future."

Dr. Patrick Round, Vice President Development of CAT, commented: "Despite the progress that has been made in treating patients with these forms of cancer over the past decade, there remains a significant unmet medical need for those patients who are either refractory to the current treatments or who unfortunately relapse. GCR-3888 has demonstrated the potential opportunity from utilizing this immunotoxin approach in HCL and we look forward to exploring the mechanism in a wider range of B-cell malignancies, including NHL and CLL, and to working in collaboration with the NCI."

Application has been made to the UK Listing Authority for the 1,170,277 new CAT ordinary shares, to be issued to Genencor, to be admitted to the Official List and to be admitted to trading on the London Stock Exchange's market for listed securities.

Cambridge Antibody Technology is a biopharmaceutical company, aiming to bring improvements to seriously ill patients' lives and thereby create outstanding returns for shareholders. CAT seeks to develop products independently and in collaboration with partners, using its capabilities and technologies in the discovery and development of new and innovative antibody medicines in selected therapeutic areas. CAT also seeks to license its technologies to enable others to develop new medicines.

Genencor was formed in 1982 as a protein optimization company to supply enzymes to the industrial, consumer and agri-processing markets. In 2004, the company decided to focus its therapeutic activities on oncology and in December of that year in-licensed two anti-CD22 immunotoxin programs from the National Cancer Institute (NCI) -- GCR-3888 and GCR-8015. A Cooperative Research and Development Agreement with the NCI was also entered to collaborate on the clinical and pre-clinical development of both programs and to create a 'next-generation' anti-CD22 immunotoxin with reduced risk of immunotoxicity.

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