Affinity Reagents: The Landscape and Affimer Technology Competitive Advantages

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1 Affinity Reagents: The Landscape and Affimer Technology Competitive Advantages

2 Introduction It is well accepted that the limitations of antibodies present valuable commercial opportunities for alternative technologies The landscape is complex but is simplified when you consider which alternatives actually work well in the real-world This document discusses the different antibody alternative technologies and sets out why the Company believes Affimers are competitive or differentiated in this landscape Most technologies have some merits and it is therefore difficult to make general statements but without some generalisation the level of detail required would be immense This document provides technical detail in places for those who need it, but the Key Messages slides provide the high level summary 2

3 The Competitive Landscape Human or humanised antibodies and fragments thereof are the dominant binding protein platform. A number of alternative protein binding technologies, or protein scaffolds have been developed in academia. Many have not proven useful in real-world applications but some have established themselves. fab ScFv dabs Anticalins Pieris AG DARPins Molecular Partners Nanobodies* Ablynx Affimers Avacta Nucleic acid (DNA, RNA) and peptide (very small proteins) binding molecules have also been developed for some applications. Centyrins/Fynomers Janssen Affibodies Affibody Kunitz Domain Dyax Adnectins BMS 3 * NB: A Nanobody is a humanised llama antibody

4 Properties of a Good Binding Technology 4 Specificity (selectivity) binding the chosen target, or targets, with no off-target binding Binding affinity the strength with which the target is bound Immunogenicity therapeutic applications require the basic scaffold to have a low immunogenic response Stability to temperature, chemical conditions, biological environment Ease of modification addition of payloads such as drugs or fluorescent tags, attachment to multiple copies of itself or other proteins Ease of production good production yields with minimal purification requirements of the molecule itself and modified forms are required both in a manufacturing process and by a cell in vivo Rapid generation short time to create molecules that bind to a new target Small size allows deeper penetration of tissue and greater packing density on a surface Target space able to address a wide range of targets from proteins to small chemicals, toxic materials and targets that do not illicit an immune response in animals Clear IP ideally the technology should have clear unencumbered IP

5 Antibodies Antibodies are a well established and well understood technology Alternatives are not going to displace antibodies in applications where they work well Antibodies have significant limitations though: Specificity their specificity cannot be controlled if they are generated by immunisation of an animal such as a rabbit, sheep or mouse Stability they are quite stable molecules but many applications require conditions under which they are damaged or destroyed Modification methods to modify antibodies are well established but they are large and complex and controlling some modifications precisely is not straightforward Production antibodies are large and complex and manufacturing can be challenging and expensive; antibodies and antibody fragments chemical structure makes them more difficult for a cell to express Generation high quality antibodies take a long time (months to a year) to generate Size antibodies are very large which makes them less ideal for some applications e.g. solid tumor therapies Targets some targets cannot be hit using antibodies generated in animals because they do not illicit an immune response or are toxic for example IP the antibody IP landscape is complex: some key processes needed for antibody development and production require licenses and many applications have IP restrictions around the use of antibodies 5

6 Antibodies: Key Messages So, antibodies are great and where they work well they will remain the dominant technology But they have significant limitations which creates many valuable opportunities for alternatives 6

7 Nucleic Acid and Peptide Aptamers DNA (or RNA) and peptide aptamers are technologies that have been around for a long time Their advantage is that they are very simple and cheap to make and huge libraries of them can be generated which can be screened quickly to generate binders to new targets without relying on an immune response in animals There are a few examples of aptamer technologies working well in some applications But generally there are issues with: Specificity and affinity the small area of interaction with the target, and in the case of nucleic acids the limited number of chemical diversity, lead to difficulties in achieving the desired specificity and binding strength; target shape as well as chemistry may also present challenges for a small flexible aptamer that is relatively unconstrained Stability the resistance to chemical, thermal and biological degradation is a problem in may applications 7

8 Aptamers: Key Messages If aptamers worked well in a wide range of real-world applications (therapeutic and nontherapeutic) then they would have become widely adopted and there would be little interest in protein scaffolds or any other alternatives Aptamers have been developed by adding non-natural bases which mimic protein interactions more closely i.e. they have been made to look more protein scaffold-like Aptamers have had limited success despite many years of development but there are some areas in which they can excel 8

9 Protein Scaffolds Protein scaffolds are small proteins that present peptide loops (mimicking the binding loops of an antibody) to bind a target Protein scaffolds have the general benefit of being small and generated rapidly in the lab (which allows specificity to be controlled). Over the past twenty years or so many protein scaffolds have been developed in academia and most of these have disappeared or are of limited use because of poor performance in one way or another Issues with affinity, stability, immunogenicity and production have meant that interesting academic science has not cut it in real-world applications There are around ten protein scaffolds currently in existence that appear to work well in the real-world; all have either been acquired by pharma or developed by biotechs for therapeutics 9

10 Examples of Successful Protein Scaffolds Anticalins Pieris AG DARPins Molecular Partners Nanobodies Ablynx Affimers Avacta Centyrins/Fynomers Janssen Affibodies Affibody Kunitz Domain Dyax Adnectins BMS 10

11 Protein Scaffolds Most protein scaffolds are addressing the therapeutic market because this offers the greatest potential rewards Avacta is exploiting Affimers both as a therapeutic platform and as research/diagnostic reagents In the research and diagnostic reagents market the only competition is antibodies The Company has made clear its strategy in the non-therapeutic market: Avacta is addressing those applications where antibodies struggle and not trying to displace well established antibody products The Affimer technology s principal benefits which differentiate it from antibodies in a range of applications in this market are high specificity, stability, ease of modification, ease of production and hitting targets that are difficult or impossible for antibodies So, let s focus on how Affimer technology is differentiated from antibodies and other scaffolds as a therapeutic platform 11

12 Differentiated Affimer Medicines The Company believes, based on our own data, third party data in the public domain and our knowledge of antibodies and other scaffold technologies, that Affimers have competitive advantages in two key areas: 1 Ease of creating and manufacturing 2 multimers, flexible formatting Small size, stability and ease of expression in cells These advantages permit differentiated medicines for immuno-oncology to be developed in the following areas: 1 2 T-cell recruitment: multi-targeting to improve specificity and reduce tumour escape Agonism: multimers required Drug conjugates (solvent stability) Gene delivery (ease of expression) CAR-T (ease of expression of multimers) 12

13 Avacta s Immuno-oncology Strategy Based on the technical advantages that differentiate Affimer technology, we are focusing on T-cell recruitment and agonists in-house and collaborating with others to demonstrate the potential in gene delivery, CAR-T and drug conjugates T-cell recruiters In-house programme: Key Strength: Ease of multimerisation to create multi-targeting constructs T-cell A A A A Key Strength: Ease of multimerisation to generate agonists Collaboration with: Memorial Sloan Kettering Cancer Centre In-house programme: A Key Strength: Ease of expression to generate multiple CAR targeting B C B Tumor Gene Therapy/Intra-tumoral Delivery Collaboration with: Key Strength: Ease of 13 CAR-T Combination Therapies and Agonists expression and intracellular stability Drug Conjugates Key Strengths: Small size and solvent stability Collaboration with:

14 Protein Scaffolds: Key Messages There are a sufficient number of disease areas and treatment modalities, as well as potential pharma partners, for there to be space for several successful protein scaffolds Ablynx, Molecular Partners and Pieris (as well a several scaffolds acquired by large pharma) are in clinical stages of development Avacta has rapidly developed, and begun to commercialise, the Affimer protein scaffold since it acquired the patents to this technology in 2012 Affimer technology is clearly differentiated from antibodies in many non-therapeutic applications by its high specificity, stability, ease of modification, ease of production and hitting targets that are difficult or impossible for antibodies Affimer technology is differentiated as a therapeutic platform from antibodies, and is competitive with and may outperform the leading scaffolds because Affimer multimers can be easily manufactured and because Affimer proteins are stable and easily expressed by cells In the coming few years these technical benefits should translate into clinical progress (first in human), generation of valuable therapeutic assets and licensing/co-development agreements 14

15 Download the technical note: Affimer non-antibody Binders for Affinity Applications: Introduction and Key Feature Comparison here: goo.gl/v9wz3e

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