CAMBRIDGE, England, Nov. 1 /PRNewswire-FirstCall/ -- Cambridge Antibody
Technology (London: CAT); (Nasdaq: CATG) today announces the acquisition of
product candidates GCR-3888 and GCR-8015 from Genencor, a subsidiary of
Danisco, based in Palo Alto, California. 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
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 U.S. for the first time. This will be based in Palo
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 November
4, 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 U.S. National Institutes
of Health (NIH). Genencor licensed the candidates for hematological
malignancies and entered into a cooperative research and development agreement
(CRADA) 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 (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 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
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 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. It is expected that admission of these shares
will become effective on Friday November 4, 2005.
Notes to Editors:
Cambridge Antibody Technology (CAT):
* 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 license its
technologies to enable others to develop new medicines.
* HUMIRA(R), licensed to Abbott, is the first CAT-derived antibody to be
approved for marketing. It was isolated and optimized 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 U.S.
* There are six further CAT-derived antibodies licensed to partners at
various stages of clinical development: ABT-874 (Abbott),
LymphoStat-B(TM), HGS-ETR1, HGS-ETR2, ABthrax(TM) (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.
* CAT has a broad collaboration with Genzyme for the development and
commercialization 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
* CAT has a co-development collaboration with Zenyth (formally Amrad)
against GM-CSF Receptor, a potential drug target in the development of
* 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.
* 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 http://www.cambridgeantibody.com
* Genencor was formed in 1982 as a protein optimization company to supply
enzymes to the industrial, consumer and agri-processing markets.
* In 2001, Genencor entered the healthcare sector and floated on the
U.S. 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 programs from the National Cancer Institute (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 programs and to create a
'next-generation' anti-CD22 immunotoxin with reduced risk of
* 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.
SOURCE Cambridge Antibody Technology