Abzena Regulatory News (ABZA)

Abzena plc

Licensed product candidate update

Cambridge, UK, 6 January 2016 - Abzena plc (AIM:ABZA, 'Abzena'), a life sciences group providing services and technologies enabling the development and manufacture of biopharmaceutical products, notes that Gilead Sciences, Inc. (Nasdaq:GILD, 'Gilead') has announced that it is stopping its Phase II clinical study of the investigational monoclonal antibody, simtuzumab, in patients with idiopathic pulmonary fibrosis (IPF).

Simtuzumab is one of Abzena's portfolio of ten products created using Abzena's Composite Human Antibody™ technology that Abzena's partners are progressing in clinical development. Further detail on the portfolio of Composite Human Antibodies™ - 'Abzena Inside' products - that are in clinical development, and Abzena's services and technologies, can be found here: http://www.abzena.com.

Gilead's decision follows an analysis by the study's Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. Gilead's announcement can be found here: http://www.gilead.com/news/press-releases/2016/1/gilead-terminates-phase-2-study-of-simtuzumab-in-patients-with-idiopathic-pulmonary-fibrosis.

The study termination only affects one indication and Gilead is continuing its Phase II studies of simtuzumab in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The DMC for these studies recommended the continuation of the studies, which have a 96-week endpoint.

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About Abzena

Abzena provides proprietary technologies and complementary services in the UK and US to enable the development and manufacture of biopharmaceutical products. The development of biopharmaceuticals is a growing area and requires specialist technology and expertise.

The Group comprises Antitope, PacificGMP, PolyTherics and TCRS, which between them have built a global customer base including the majority of the top 20 biopharmaceutical companies as well as large and small biotech companies and academic groups.

Antitope provides immunogenicity assessment, protein engineering to create humanized antibodies and deimmunised therapeutic proteins, and cell line development for manufacture.

PacificGMP provides contract process development and manufacture of biopharmaceuticals, including monoclonal antibodies, recombinant proteins, vaccines, and gene therapy and cell therapy products, for preclinical and clinical studies.

PolyTherics specializes in proprietary site-specific conjugation technologies for antibody drug conjugate development and solutions for optimizing the therapeutic properties of biopharmaceuticals.

TCRS is a contract chemistry and bioconjugation business focused on ADCs and is establishing the capability to manufacture ADCs to GMP standards.

Abzena (AIM: ABZA) has its main operations in Cambridge, UK, San Diego, CA, US and Bristol, Pennsylvania, US . For more information, please see www.abzena.com.