Cambridge, UK and Melbourne, Australia – 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™ 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. The global market for the prevention and treatment of prostate cancer was expected to reach $50.3 billion in 2017.
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.”
John Burt, Chief Executive Officer
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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.1
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.
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.
 World Cancer Research Fund International
 BCC Research
 Source: Holland et. al. J Nucl Med. 2010 August ; 51(8): 1293–1300