Avacta Group Regulatory News (AVCT)

22 September 2016

Avacta Group plc

("Avacta" or "the Group" or "the Company")

Positive results from first preclinical in-vivo studies of Affimer therapeutics

Affimer PD-L1 inhibitor significantly reduces tumour growth in mouse model

· Good pharmacokinetic properties observed

· Affimer molecules well tolerated at all dosing levels

· No adverse effects observed

· Confirms the potential of the Affimer technology as a therapeutic platform

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and research reagents, is pleased to announce positive results from the first preclinical in-vivo studies of its therapeutic Affimer molecules. The results meaningfully de-risk the development of the technology as a therapeutic platform; demonstrating that Affimer molecules possess good drug-like properties in terms of efficacy, serum half-life and tolerability.

Two parallel in-vivo pre-clinical studies have been completed. The first, a pharmacokinetics study looking at both human and mouse PD-L1 Affimer inhibitors1 engineered as Fc fusions2, showed that Affimer molecules have good in-vivo serum half-lives and are well tolerated at the clinically relevant doses used in the study.

The second was an efficacy study using a mouse PD-L1 specific Affimer molecule in a syngeneic tumour model3. In this study the Affimer PD-L1 inhibitor produced a statistically significant reduction in tumour growth demonstrating the bioavailability and functionality of the Affimer molecule in tumours in-vivo. No adverse effects were observed.

Alastair Smith, Avacta Group Chief Executive commented: 

"These results demonstrate that Affimer molecules possess good -in-vivo drug-like properties in terms of efficacy, serum half-life and tolerability which is a hugely important milestone in the development and de-risking of the technology as a therapeutic platform. From the initial screening process for the Affimer binders we have been able to rapidly progress to evaluating them in in-vivo models, highlighting another major advantage of the technology. We are very encouraged by these initial positive results and will continue to focus on developing both our internal and partnered therapeutic programs towards clinical validation."

ENDS

Notes to Editors

This work was partly supported by an Innovate UK grant funding.

1. About PD-L1

PD-L1 (Programmed Death-Ligand 1) is part of the 'immune checkpoint' (ICs) target family. The normal function of ICs is to help to regulate the immune system and to prevent its over-activation towards healthy cells. Tumour cells often can take advantage of this system to "switch-off" and evade the immune system. By specifically targeting certain proteins involved with these pathways, it is possible to reactivate the patients' own immune system and so destroy the cancer cell.

2. About Fc fusions

Fc (fragment crystallisable region of an antibody) fusions are a well-established approach to artificially extend the in vivo serum half-life of small therapeutic protein scaffolds. The Affimer biotherapeutic is genetically fused to the Fc region, replacing the normally larger antigen binding arms usually found in the antibody. In this way the Affimer biotherapeutic Fc fusion is maintained in the circulation by being captured and recycled back into the bloodstream in a similar manor to an antibody.

3. About the Syngeneic Tumour Model

A syngeneic tumour model uses tumour tissues derived from the same strain of mouse as that being used to run the disease model. In this case, cancerous mouse cells (CT26 cell line derived from BALB/c mice) were implanted into healthy BALB/c mice to create the cancer model. This allows the pre-clinical efficacy evaluation of cancer immunotherapeutic leads, including immune checkpoint inhibitors and cancer vaccines, to be evaluated.

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About Avacta Group plc (www.avacta.com)

Avacta's principal focus is on its proprietary Affimer® technology which is a novel engineered alternative to antibodies that has wide application in Life Sciences for diagnostics, therapeutics and general research and development.

Antibodies dominate markets worth in excess of $75bn despite their shortcomings. Affimer technology has been designed to address many of these negative performance issues, principally; the time taken to generate new antibodies, the reliance on an animal's immune response, poor specificity in many cases, and batch to batch variability. Affimer technology is based on a small protein that can be quickly generated to bind with high specificity and affinity to a wide range of targets to enable diagnostics, research assays and therapeutics.

Avacta has a pre-clinical therapeutic development programme with an in-house focus on immuno-oncology and bleeding disorders as well as partnered development programmes. Avacta is commercialising non-therapeutic Affimer reagents through licensing to developers of life sciences research tools and diagnostics.