Product Candidate Acquisition
Cambridge Antibody Tech Group PLC
01 November 2005
07.00 GMT, 02.00 EST Tuesday 1 November 2005
For Further Information Contact:
Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700
Peter Chambre, Chief Executive Officer Kevin Smith
John Aston, Chief Financial Officer Yvonne Alexander
Rowena Gardner, Director of Corporate Rachel Taylor
Communications
BMC Communications/The Trout Group
(USA)
Tel: 001 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext.15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGY ACQUIRES ONCOLOGY PRODUCT CANDIDATES FROM GENENCOR
Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announces the acquisition of product candidates GCR-3888 and GCR-8015 from
Genencor, a subsidiary of Dansico, based in Palo Alto, California. GCR-3888 has
shown efficacy in a Phase I clinical trial and is currently in a Phase II trial
for the treatment of hairy cell leukaemia (HCL). GCR-8015, an optimised 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
leukaemia (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 programmes, and has thereby established
a CAT operation in the US 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, expected to be Friday 4 November 2005.
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 US National Institutes of Health
(NIH). Genencor licensed the candidates for haematological malignancies and
entered into a cooperative research and development agreement (CRADA) with the
NIH, which will now be continued by CAT. Under the original licence agreement
with the NIH, CAT will have rights to a portfolio of intellectual property
associated with the programmes 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), was 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 (IND) 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
paediatric acute lymphoblastic leukaemia (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 optimised 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 minimises
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 internalised 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 USA. 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
utilising 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 new 1,170,277 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. It is expected that admission of these shares will become effective
on Friday 4 November 2005.
Notes to Editors:
Cambridge Antibody Technology (CAT):
Business:
• CAT 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 licence its
technologies to enable others to develop new medicines.
Products:
• HUMIRA, licensed to Abbott, is the first CAT-derived antibody to be
approved for marketing. It was isolated and optimised in collaboration
with Abbott and has been approved for marketing as a treatment for
rheumatoid arthritis (RA) in 57 countries, and for psoriatic arthritis
and early RA in some European countries and the US.
• There are six further CAT-derived antibodies licensed to partners at
various stages of clinical development: ABT-874 (Abbott), LymphoStat-B,
HGS-ETR1, HGS-ETR2, ABthrax (all Human Genome Sciences (HGSI)) and
MYO-029 (Wyeth). CAT has also licensed its proprietary technologies and
patents to several companies. CAT's licensees include Abbott, Amgen,
Chugai, Dyax, Genzyme, HGSI, Merck & Co, Micromet, Pfizer and Wyeth, and
three antibody drug candidates are in clinical development at patent
licensees.
• There are two further human therapeutic antibody product candidates in
clinical development - CAT-354, a proprietary CAT product and GC-1008,
in collaboration with Genzyme.
Collaborations:
• CAT has a broad collaboration with Genzyme for the development and
commercialisation of antibodies directed against TGF beta, a family of
proteins associated with fibrosis and scarring, and with potential
application in the treatment of some cancers.
• CAT has a major strategic alliance with AstraZeneca to discover and
develop human antibody therapeutics, principally in inflammatory
disorders. This provides CAT with the opportunity to build a substantial
pipeline of antibody therapeutics with a significant pharmaceutical
partner.
• CAT has a co-development collaboration with Zenyth (formally Amrad)
against GM-CSF Receptor, a potential drug target in the development of
RA.
Science:
• CAT has an advanced proprietary technology for rapidly isolating human
monoclonal antibodies using Phage Display and Ribosome Display systems.
CAT has extensive phage antibody libraries, currently incorporating more
than 100 billion distinct antibodies, which form the basis for the
Company's strategy to develop a portfolio of antibody-based drugs.
Business Background:
• CAT is based near Cambridge, UK, with a new site in Palo Alto, USA. CAT
currently employs around 290 people.
• CAT is listed on the London Stock Exchange (CAT) and on NASDAQ (CATG).
• More information can be found at www.cambridgeantibody.com
Genencor Background:
• Genencor was formed in 1982 as a protein optimisation company to supply
enzymes to the industrial, consumer and agri-processing markets.
• In 2001, Genencor entered the healthcare sector and floated on the US
stock exchange as Genencor, Inc.
• In 2004, the company decided to focus its therapeutic activities on
oncology and in December of that year in-licensed two anti-CD22
immunotoxin programmes from the National Cancer Insitute (NCI) -
GCR-3888 and GCR-8015. A Cooperative Research and Development Agreement
(CRADA) with the NCI was also entered to collaborate on the clinical and
pre-clinical development of both programmes and to create a
'next-generation' anti-CD22 immunotoxin with reduced risk of
immunotoxicity.
• In early 2005, Danisco, a global supplier of food ingredients, acquired
Genencor as a strategic move to help position Danisco as a major player
in industrial enzymes. Danisco stated that it had no interest in
maintaining Genencor's healthcare division and announced its intention
to divest the assets on 1 August 2005.
Application of the Safe Harbor of the Private Securities Litigation Reform Act
of 1995: This press release contains statements about Cambridge Antibody
Technology Group plc ("CAT") that are forward looking statements. All statements
other than statements of historical facts included in this press release may be
forward looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934. These forward looking statements are based on numerous
assumptions regarding the company's present and future business strategies and
the environment in which the company will operate in the future. Certain factors
that could cause the company's actual results, performance or achievements to
differ materially from those in the forward looking statements include: market
conditions, CAT's ability to enter into and maintain collaborative arrangements,
success of product candidates in clinical trials, regulatory developments and
competition. We caution investors not to place undue reliance on the forward
looking statements contained in this press release. These statements speak only
as of the date of this press release, and we undertake no obligation to update
or revise the statements.
This information is provided by RNS
The company news service from the London Stock Exchange