Abzena PLC Licensed product candidate update (5512K)

TIDMABZA

RNS Number : 5512K

Abzena PLC

22 September 2016

Abzena plc

Licensed product candidate update

Cambridge, UK, 22 September 2016 - Abzena plc (AIM:ABZA, 'Abzena' or the 'Group'), 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/III clinical study of GS-5745 in patients with ulcerative colitis.

The study termination only affects one indication out of five and Gilead has confirmed that its Phase II and III studies of GS-5745 in patients with gastric cancer, Crohn's disease, rheumatoid arthritis and cystic fibrosis will continue as planned.

Gilead's decision follows a planned interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee which recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. No safety concerns were noted in this interim analysis. Gilead's announcement can be found here: http://www.gilead.com/news/press-releases/2016/9/gilead-terminates-phase-23-study-of-gs5745-in-patients-with-ulcerative-colitis

GS-5745 includes Abzena's Composite Human Antibody(TM) technology. It is one of 12 products within the Group's 'Abzena inside' portfolio that are progressing in clinical development, from over 40 licence and licence option agreements. The pipeline of other 'Abzena inside' products in the clinic can be seen here: https://www.abzena.com/about/abzena-inside-products

Enquiries:

 
   Abzena plc 
    John Burt, Chief Executive 
    Officer Julian Smith, Chief 
    Financial Officer                      [phone] 
   Numis Securities (Nominated 
    Adviser and Broker) 
    Clare Terlouw / Paul Gillam 
    (Corporate Finance)                    [phone] 
    James Black (Corporate Broking)         1000 
   N+1 Singer (Joint Broker)               [phone] 
    Aubrey Powell / Liz Yong                3000 
   Instinctif Partners                     [phone] 
    Melanie Toyne Sewell / Rozi             2020 
    Morris                                  [e-mail] 
 

About Abzena

Abzena (AIM: ABZA) provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products, a growing area that requires specialist knowledge and expertise. The Group has a global customer base which includes the majority of the top 20 biopharmaceutical companies as well as large and small biotech companies and academic groups.

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).

-- Immunogenicity assessment, protein engineering to create humanized antibodies and deimmunised therapeutic proteins, and cell line development for manufacture.

-- 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.

-- Proprietary site-specific conjugation technologies for antibody drug conjugate development and solutions for optimizing the therapeutic properties of biopharmaceuticals.

-- Contract chemistry and bioconjugation business focused on ADCs and is establishing the capability to manufacture ADCs to GMP standards.

For more information, please see www.abzena.com

This information is provided by RNS

The company news service from the London Stock Exchange

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September 22, 2016 04:30 ET (08:30 GMT)