Avacta Group said on Monday that the first major immunogenicity study of Affimer technology using human ex-vivo samples was successful with a range of Affimer proteins shown to have low immunogenicity comparable with the marketed antibody Avastin.
Avacta has now completed the first major study of immunogenicity for the Affimer technology using samples from fifty healthy volunteers.
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.
Dr Alastair Smith, Avacta Group Chief Executive Officer, said that the 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 technologym said Smith.
“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.”
Smith added that this progress conversations with potential pharma partners and Avata’s objective to take the first Affimer candidate into clinical development in 2019.