TIDMABZA
RNS Number : 1636T
Abzena PLC
02 July 2018
Abzena plc
Abzena and Telix sign strategic manufacturing and bioconjugation
agreement
Cambridge, UK and Melbourne, Australia, 2 July 2018 - Abzena plc
(AIM: ABZA, 'Abzena'), the life sciences group providing services
and technologies to enable the development and manufacture of
biopharmaceutical products, has signed GMP manufacturing and
bioconjugation agreements with Telix Pharmaceuticals Limited
('Telix'). The agreements have a combined value of $5.9 million and
these projects are expected to be substantially completed within a
15 month period.
Telix is a biopharmaceutical company specialising in the
development and commercialisation of radiopharmaceuticals for
diagnostic imaging and therapeutic use.
Under the terms of the agreements Abzena will progress two
PSMA-targeting monoclonal antibodies for the purposes of targeted
treatment of metastatic prostate cancer. This agreement builds on
the July 2017 announcement in which it was disclosed that Abzena
had granted a license to specific antibody-related IP that has been
incorporated into Telix's PSMA radiopharmaceutical program, which,
subject to successful development, could deliver significant
licence fees and milestone payments to Abzena over its
lifetime.
On completion of cell line development, currently being
performed by Abzena using its Composite CHO(TM) platform, the
research cell banks for both antibodies will be transferred to
Abzena's San Diego facility for further process development,
generation of master cell banks and scale-up for manufacturing up
to 500L utilising Abzena's recently upgraded biomanufacturing
platform.
Abzena will also develop a bioconjugation process for one of the
antibodies. The bioconjugation process and analytical development
will be performed in Cambridge, UK before the process is
transferred to Abzena's GMP manufacturing facility in San Diego for
clinical batch production.
More than 1.1 million cases of prostate cancer were recorded in
2012, accounting for around 8 percent of all new cancer cases and
15 percent in men. It is one of the four most common cancers
occurring worldwide, with a significant unmet clinical need.1 The
global market for the prevention and treatment of prostate cancer
was expected to reach $50.3 billion in 2017.(2)
John Burt, CEO of Abzena, said:
"Taking forward another clinical product containing Abzena's
intellectual property, including through to GMP manufacturing,
demonstrates the scope of Abzena's integrated offering, with all
our business areas providing scientific expertise and input as well
as use of our proprietary technologies.
"Our upgraded capabilities in San Diego will enable us to
quickly scale-up production of this product. It is very pleasing
for our technology and expertise to be involved in a project with
great potential in such an important disease area."
Christian Behrenbruch, CEO of Telix Pharmaceuticals,
commented:
"Taking these products through to the next stage of
manufacturing development is a milestone for us and Abzena is a
trusted partner with proven expertise and a strong track record.
Our aim is to deliver the next generation of highly-targeted
radiation oncology therapy, focusing on prostate cancer as an area
of critical need.
"This agreement with Abzena is key to us achieving that aim,
expanding on our collective technologies to create and manufacture
an effective and optimised PSMA antibody-directed radiation
product."
-Ends-
Enquiries:
Abzena plc
John Burt, Chief Executive Officer +44 1223 903498
Numis (Nominated Adviser and Broker)
Clare Terlouw / James Black / Paul Gillam +44 20 7260 1000
N+1 Singer (Joint Broker)
Aubrey Powell / Liz Yong +44 20 7496 3000
Instinctif Partners +44 20 7457 2020
Melanie Toyne Sewell / Rozi Morris / abzena@instinctif.com
Alex Shaw
Notes to Editors
About Prostate-Specific Membrane Antigen (PSMA)
PSMA is a cell surface antigen that has relatively little normal
expression in normal tissues and represents a validated and highly
promising target for a range of therapeutic strategies, especially
radiopharmaceuticals. PSMA expression has been detected in a
limited range of normal tissues including benign prostatic
epithelium, renal proximal tubule, pancreas, small bowel and brain
(a subset of astrocytes). However, these normal sites express PSMA
at levels 2-3 orders of magnitude lower than that observed in
prostate cancer.(3)
Antibody-directed cytotoxicity (whether from conjugated
radiation or other therapeutic payloads) offers several advantages
over small molecule or peptide-based delivery approaches. Normal
tissue PSMA sites are effectively inaccessible to circulating mAbs
(monoclonal antibodies) and PSMA expression by astrocytes in the
brain is similarly sequestered behind the blood-brain barrier.
Consequently, antibodies to PSMA are functionally tumour-specific,
whereas small molecule and peptide therapies targeting PSMA, with
various isotopes, have demonstrated serious off-target effects,
such as pancreatitis, nephrotoxicity and permanent salivary gland
ablation. These considerations are particularly important for
developing PSMA-targeting agents with high-energy nuclides such as
alpha-particle emitters.(3)
About Abzena
Abzena (AIM: ABZA) provides proprietary technologies and
complementary services to enable the development and manufacture of
biopharmaceutical products.
The term 'ABZENA Inside' is used by Abzena to describe products
that have been created using its proprietary technologies and are
being developed by its partners, and include Composite Human
Antibodies(TM) and ThioBridge(TM) Antibody Drug Conjugates (ADCs).
Abzena has the potential to earn future licence fees, milestone
payments and/or royalties on ABZENA Inside products.
Abzena offers the following services and technologies across its
principal sites in Cambridge (UK), San Diego, California (USA) and
Bristol, Pennsylvania (USA):
-- Biology research studies, including immunogenicity assessment
of candidate biopharmaceutical products and bioassay
development;
-- Protein engineering to create humanized antibodies and deimmunised therapeutic proteins;
-- Cell line development for the manufacture of recombinant proteins and antibodies;
-- Contract process development and GMP manufacture of
biopharmaceuticals, including monoclonal antibodies and recombinant
proteins for preclinical and clinical studies;
-- Contract synthetic chemistry and bioconjugation research
services, focused on antibody-drug conjugates (ADCs);
-- Proprietary site-specific conjugation technologies and novel payloads for ADC development;
-- GMP manufacturing of ADC linkers, payloads & combined linker-payloads; and
-- GMP analytical services for biopharmaceutical manufacturing projects.
For more information, please see www.abzena.com.
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited (Telix Group, Telix) is a global
biopharmaceutical company focused on the development of diagnostic
and therapeutic products based on targeted radiopharmaceuticals or
"molecularly-targeted radiation" (MTR). The company is
headquartered in Melbourne with international operations in
Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is
developing a portfolio of clinical-stage oncology products that
address significant unmet medical need in renal, prostate and brain
(glioblastoma) cancer. Telix is listed on the Australian Securities
Exchange (ASX:TLX). For more information visit
www.telixpharma.com.
1 World Cancer Research Fund International
2 BCC Research
3 Source: Holland et. al. J Nucl Med. 2010 August ; 51(8):
1293-1300
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END
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