3rd April 2017
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Excellent results for Affimer technology in Industry-standard immunogenicity study using human samples
Major value inflection point for Affimer technology as a therapeutics platform
Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and research reagents, is pleased to report that the first major immunogenicity study of Affimer technology using human ex-vivo samples has concluded successfully with a range of Affimer proteins shown to have low immunogenicity comparable with the marketed antibody Avastin®.
Unwanted immunogenicity occurs when a patient has an immune response to a drug which can lead to reduced effectiveness of the drug and possibly lead to serious adverse side effects. It is therefore essential that a new drug platform, such as Affimer technology, is shown not to cause a significant intrinsic immunogenic response.
The Company has now completed the first major study of immunogenicity for the Affimer technology using samples from fifty healthy volunteers. Multiple versions of the Affimer technology were tested in the study and benchmarked against the marketed monoclonal antibody Avastin.
All versions of the Affimer scaffold showed a low response in these industry-standard tests comparable to Avastin confirming that the Affimer technology has no significant immunogenicity.
For further information please download the presentation "Affimer Technology: Results of PBMC Immunogenicity Testing" from the Company's web site (www.avacta.com).
Dr Alastair Smith, Avacta Group Chief Executive Officer, commented:
"This excellent data significantly de-risks the Affimer technology as a therapeutic platform addressing the multi-billion dollar biotherapeutics market and is a major milestone and value inflection point for the Company.
Immunogenicity is a key concern for any protein-based therapeutic in development, especially for a new therapeutic platform such as that based on our Affimer technology. I am delighted that the results of this extensive study shows unequivocally that none of the Affimer scaffolds induce a significant immunogenic response. This bodes well for their further development as therapeutics, as there is an accepted correlation between this type of ex-vivo study and a patient's immunogenic response when dosed with the drug in the clinic.
In the past year Avacta has hit multiple key milestones for the Affimer technology including successful outcomes of the first in vivo pharmacokinetics and efficacy studies and now the successful outcome of a critical immunogenicity trial. Together this significant progress supports both our conversations with potential pharma partners and our objective to take the first Affimer candidate into clinical development in 2019."
NOTES
For further information from Avacta Group plc, please contact:
Avacta Group plc Alastair Smith, Chief Executive Officer Tony Gardiner, Chief Financial Officer
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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.
Affimer technology has been designed to address many of the negative performance issues of antibodies, 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.
Avacta has a pre-clinical biotech 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.