Abzena Regulatory News (ABZA)

ABZENA PLC

("Abzena", the "Company" or the "Group")

Abzena provides an update on progress with biopharmaceutical products created using its technologies

9 February 2015

Cambridge, UK - Abzena plc (AIM:ABZA), a life sciences company providing services and technologies that enable the development of biopharmaceutical products, provides an update on products that have been created with its technologies, including the humanized antibodies in clinical development that have been created with Antitope's Composite Human Antibody™ technology.

Six humanized therapeutic antibodies created using the Composite Human Antibody™ technology are in Phase 1 or 2 clinical development. Development of these products is funded by Abzena's partners and Abzena incurs no costs in relation to their development but does have the potential to earn royalties on the sales revenues for these products if successfully developed and approved. Since its interim results announcement on 11 December 2014, the following updates have been provided for four of these antibodies: GS-5745, simtuzumab, OPN-305 and SDP051.

Based on promising safety and efficacy data, Gilead Sciences (Foster City, CA, USA) has announced1 that it anticipates moving its anti-MMP9 antibody GS-5745 forward in clinical development for ulcerative colitis and gastric cancer in 2015. In addition, Phase 2 studies are planned in Crohn's Disease. Gilead also announced that simtuzumab had not shown efficacy in Phase 2 studies of myelofibrosis or colorectal cancer, although it was well-tolerated.Gilead considers myelofibrosis to be biologically different from liver and pulmonary fibrosis and stated that it thus has some confidence that the results will be different in the ongoing Phase 2 studies in non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and idiopathic pulmonary fibrosis (IPF). Simtuzumab received Orphan Drug designation in the US for PSC in January 2015.

Opsona Therapeutics (Dublin, Ireland) has announced2 that it had initiated a second clinical study with OPN-305, in myelodysplastic syndrome (MDS). The Phase 1/2 clinical trial in second-line lower risk MDS patients will be led by Professor Guillermo Garcia-Manero at MD Anderson Cancer Center, Houston, USA, one of the premier cancer centres in the world. Its evaluation in MDS will be the first of a range of oncology indications that Opsona Therapeutics plans to explore. OPN-305 is already being evaluated in a Phase 2 study for its potential to prevent delayed graft function (DGF) following renal transplantation, an indication for which it has Orphan Drug designation in both the US and EU.

Further to the completion of the Phase 1 study showing that SDP051 is safe and well-tolerated, Adheron Therapeutics (Berkeley, CA, USA) has conducted a series of preclinical studies that demonstrate its activity in a number of indications including cancer, rheumatoid arthritis, and a range of fibrotic conditions including NASH3.

In addition, Novartis AG (Basel, Switzerland) has recently reported results from its use of two of Abzena's other technologies:

Results of EpiScreen™ in vitro immunogenicity assessment of secukinumab, Novartis' anti-IL-17A antibody, were presented in a conference poster in London in December 2014.

In January 2015, a joint online publication by Novartis and Abzena scientists in the journal Bioconjugate Chemist reported on the use of Abzena's low viscosity polymer, PolyPEG™ to produce protein conjugates with longer half-lives and similar potency compared to a reference clinical product.

John Burt, CEO of Abzena, said: "We are encouraged by the clinical progress we are seeing with products enabled by Abzena's technology platforms. Our portfolio of licences and licence option agreements for Composite Human Antibodies and for the other Abzena technologies has the potential to contribute significant value to the Abzena business."

1. Gilead Sciences Q4 2014 Earnings Conference Call (3 February 2015)

2. Opsona press release, 26 January 2015

3. Hari Kumar, CEO Adheron Therapeutics, personal communication

4. Secukinumab, a Novel Anti-IL-17A Antibody, Exhibits Low Immunogenicity Potential According to Human In Vitro Assays, Karle et al.; Psoriasis from Gene to Clinic 7th International Congress, 11-13 December 2014, London, UK.

5. Conjugation of PolyPEG to Interferon Alpha Extends Serum Half-Life While Maintaining Low Viscosity of the Conjugate, Podobnik et al. Bioconjugate Chemistry, publication date (web) 28 January 2015 (DOI: 10.1021/bc500523t) 

About Abzena

Abzena provides proprietary technologies and complementary services to enable the development of better biopharmaceuticals. The Group comprises PolyTherics and Antitope which have established a broad suite of services and technologies that are designed to improve the chances of successful development of antibodies and proteins with enhanced therapeutic benefits.

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

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

The Group has built a global customer base over the past decade which includes the majority of the top 20 biopharmaceutical companies, many large and small biotech companies, and academic groups.

Abzena is quoted on the AIM segment of the London Stock Exchange under the symbol ABZA.

www.abzena.com

For more information, please contact:

John Burt (Chief Executive Officer)

Julian Smith (Chief Financial Officer)

Abzena plc

Tel: +44 (0)1223 903498

Email: john.burt@abzena.com or julian.smith@abzena.com

Christopher Golden and Bobbie Hilliam

Cenkos Securities (Nominated Adviser and Broker)

Tel: +44 (0)20 7397 8900

Mark Swallow or Chris Gardner

Citigate Dewe Rogerson (Corporate and Financial PR)

Tel: +44 (0)20 7638 9571

Email: abzena@citigatedr.co.uk