– Master Services and Clinical Supply agreement to enable process development and manufacturing by Abzena
Cambridge, UK, Taipei, Taiwan, 11 July 2017 – Abzena plc (AIM: ABZA, ‘Abzena’ or the ‘Group’), the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has signed a licensing agreement and a master services and clinical supply agreement with OBI Pharma, a Taiwanese biopharmaceutical company (‘OBI’, TPEx: 4174).
The licensing agreement is for Abzena’s novel site-specific ThioBridge™ antibody drug conjugate (ADC) linker technology to develop OBI’s proprietary ADC, OBI-999 and a series of further ADCs as potential treatments for cancer.
ThioBridge™ links antibodies and other proteins to drugs. The technology platform is unique in its ability to maintain the stability of the antibody and a consistent Drug-to-Antibody Ratio (DAR), which provides a more uniform product.
OBI-999 specifically targets cancer cells overexpressing the cancer antigen Globo H. The Globo series comprises a group of cancer-associated carbohydrate antigens including Globo H, SSEA3 and SSEA4 that are over-expressed in more than 14 types of cancers, including breast, lung, gastric and colorectal. By releasing the cytotoxic payload to the targeted cancer cells, the aim is to trigger cancer apoptosis while minimising the drug’s toxicities to normal cells.
OBI has observed encouraging results for OBI-999 in preclinical studies and plans to accelerate the development of OBI-999 and other Globo series ADCs. Phase I IND preparations are underway including Chemistry Manufacturing Control (CMC) planning and toxicology study design.
Concurrent with the signing of the licence agreement, Abzena and OBI have entered into a Master Services and Clinical Supply Agreement for Abzena to provide OBI with further manufacturing process development and GMP manufacture of OBI-999 and further ADCs.
Under the terms of this agreement, OBI will receive a worldwide exclusive licence to use the ThioBridge technology to research, develop and commercialize ADCs targeting the Globo series. Abzena will receive a small initial up-front payment from OBI and has the potential, subject to successful development, to receive up to £128 million, in aggregate, which may become payable upon achievement of certain development, regulatory and commercialisation milestones. In addition, Abzena will also receive royalties on sales of any approved ADC products that incorporate the ThioBridge™ technology.
Amy Huang, General Manager of OBI Pharma, Inc., said:
“OBI is pleased to collaborate with Abzena for our OBI-999 and other potential pipeline candidates using Abzena’s innovative ThioBridge technology. The collaboration enhances our ADC development programme and we hope to develop effective cancer treatments for patients with cancers that express Globo series antigens.”
Dr John Burt, CEO of Abzena, commented:
“This latest licence deal follows on from a successful evaluation programme of the ThioBridge™ technology for OBI by Abzena.
“The overall ADC development programme for OBI draws on Abzena’s chemistry research and manufacturing capabilities across the Cambridge (UK) and Bristol (Pennsylvania) facilities, and reaffirms the value of Abzena’s integrated offering.
“The expansion of our offering to include GMP manufacturing for ADCs has been enabled by our recent fundraising and this deal is a good example of our ability to continue to support our partners with our broader chemistry research services, process development and manufacturing capabilities.”
John Burt, Chief Executive Officer Julian Smith, Chief Financial Officer
|+44 1223 903498|
|Numis (Abzena’s Nominated Adviser and Broker)
Clare Terlouw / James Black / Paul Gillam
|+44 20 7260 1000|
|N+1 Singer (Abzena’s Joint Broker)
Aubrey Powell / Liz Yong
|+44 20 7496 3000|
|Instinctif Partners (Abzena’s PR advisors)
Melanie Toyne Sewell / Alex Shaw
|+44 20 7457 2020|
Gus Adapon, Director, Investor Relations
|+886 (2) 2786-6589|
Notes to Editors
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™ and ThioBridge™ 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):
- Immunology research studies, including immunogenicity assessment of candidate biopharmaceutical products;
- 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; and
- GMP manufacturer of ADC linkers, payloads & combined linker-payloads.
For more information, please see www.abzena.com
About OBI Pharma
OBI Pharma, Inc. is a Taiwan biopharmaceutical company that was established in 2002. Its mission is to develop and license novel therapeutic agents for unmet medical needs, including cancer targets such as the Globo series antigens, AKR1C3 and other promising targets. The company’s flagship product is Adagloxad Simolenin (formerly OBI-822), a first-in-class active immunotherapy for metastatic breast cancer. OBI is also developing next generation immunotherapies for difficult to treat cancers, including lung, colorectal, pancreatic, gastric, and ovarian cancer.
Additional information can be found at www.obipharma.com/en.