Sustained production of Affimer drugs by muscle tissue in vivo could lead to major patient and commercial benefits

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that its research collaboration with FIT Biotech Oy (FITBIO:FN Finland) has successfully completed a proof-of-concept study with very encouraging data, showing sustained production of Affimer molecules by the muscle tissue of mice.  This was achieved from a single dosing of the Affimer DNA using the FIT technology.

Key findings:

• The study shows clinically relevant levels of Affimer drug in the blood stream of mice for over one month following a single dose of Affimer DNA into the leg muscle tissue
• Due to the simple structure of the Affimer the study showed significantly higher levels of Affimer production when compared to an antibody used in this study.
• Patient benefits lie in less frequent dosing because of sustained production of the therapeutic by the patient’s body and potentially better efficacy in some cases.
• A significant commercial benefit of delivering drugs in this way is the substantially lower cost of goods.

Therapeutic proteins such as monoclonal antibodies are routinely administered to patients by injection at regular time intervals.  One way of avoiding this protein production step is to trigger the patient’s own body to make the protein by injecting the “recipe” in the form of DNA (called “gene delivery”).  The commercial benefit of this approach is that the production of DNA is substantially cheaper and quicker than the production of the protein itself, leading to substantially lower cost of goods.

The ideal protein for gene delivery must be produced easily by the patient’s cells, in order that a clinically relevant dose is achieved, and the technology for delivering the genes to patients should ensure stable and prolonged production of the proteins in a safe manner.

A proof-of-concept study was carried out in mice to assess the effectiveness of combining Avacta’s Affimer proteins with FIT Biotech’s gtGTU® gene delivery technology.  The DNA of two different Affimer proteins was delivered into muscle tissue, and the amount of Affimer produced and entering the blood stream of the mice over time was monitored.  The combination of the two technologies resulted in clinically relevant levels of therapeutic Affimer in the blood stream for over a month following a single dose of DNA.  The levels of Affimer were between three and twelve times greater than that achieved using an antibody in the study.

Sustained production of an Affimer therapeutic in patients would allow for less frequent dosing, fewer visits to hospital, and potentially, lower overall treatment costs.  It is also possible that patients could benefit from improved therapies by gene delivery directly into a solid tumour, potentially leading to high localised doses with reduced toxicity, as the rest of the patient’s system would not be exposed to the therapeutic.

Dr Alastair Smith, Avacta Group Chief Executive Officer, commented:

“The potential commercial and patient benefits of achieving sustained production of Affimer therapeutics by the body through delivery of just the Affimer DNA are vast, and it is very exciting to see such encouraging results of this exploratory study.  From this initial data, the combination of the two companies’ technologies appears to be very effective and we will now explore the different opportunities to take this forward collaboratively, and with larger partners.”

Erkki Pekkarinen, FIT Biotech Chief Executive Officer, commented:

“We are very excited to work with Avacta in developing safer and better biological drugs. The combination of our respective platforms shows great potential, and further demonstrates that FIT Biotech’s gtGTU platform shows promise in developing a wide range of next-generation biological drugs that bring added value to suppliers, healthcare professionals, and most importantly, to patients.  Our technology has huge potential in the biological drugs market that is expected to grow to $480 billion by 2024."

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