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About us RadTag technology Proof of concept

B i oPercept AB innovative imaging solutions. Enabling for the first time rapid and general radiolabelling of biologicals. About us RadTag technology Proof of concept. Samuel Svensson , PhD

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About us RadTag technology Proof of concept

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  1. BioPercept AB innovative imaging solutions Enabling for the first time rapid and general radiolabellingof biologicals • Aboutus • RadTag technology • Proof of concept

  2. Samuel Svensson, PhD • Principal scientist AstraZeneca R&D. Professor of pharmacology, LiU. Project leader for three PET ligand projects to FTIM (AZD2184, 2995, 4694). Peter Ström, MSc • Radiochemist with 20+ years experience within AstraZeneca. Carl M Andersson, PhD, associate professor • Organic chemist. Consultant with 20+ years experience from senior managerial positions within biotech and pharma. Asset: ”Agents and methods for visualisinganalytes” PCT/EP2011/070172 . IPR fullyowned by BioPercept AB.

  3. Growing market potential for PET radioligands 2010: Lilly acquires Avid Radiopharmaceuticals for an upfront $300 million and $500 million in additional payments 2011: Navidea acquires AZD4694, an amyloid imaging PET ligand from AstraZeneca 10-Jun-14 3

  4. Biologicals are must have for pharma • Radiolabellingwithin development of biologicals very limited • -- lack of generalised radiochemical methodology • Sixout of 21 new approvals by the FDA were for biologicals in 2010 • -- sharewillincrease; typical ambition calls for 30-40% of pipeline • Increasingdemand for ability to monitor, visualise, perform PK studies and implementing personal healthcare • Biosimilars market estimated at USD 4,000 million in 2017 RadTags suggest a new paradigm

  5. FlAsH technology – a fluorescence labeling technology developed for live cell imaging (R Tsien Nobel prize 2008) FlAsH-based protein detection available from

  6. Easily constructed six-amino acid tags The CCPGCC tag can be incorporated by standard techniques • During peptide synthesis • Using Polymerase chain reaction (PCR) • Using cloning vectors commercially available from Life Technologies Gene CCPGCC tag (in frame) Promotor Expression vector

  7. RadTags bind to same consensus sequence as FlAsH

  8. RadTags enable radiolabelling using different isotopes at the same site Precursor for 18F, 121I, 125I, 131I, Precursor for 13C, 14C, 11C, 3H, 19F

  9. Fit-for-purposeradiolabellingof biologicalsusingidenticalRadTags 18F 3H 14C Autoradiography ex vivo mice human PET

  10. (1) (2) (3) + Radtag-peptide Peptide Radtag Molecular structure of a RadTag and RadTag bound to target protein sequence (-CCPGCC-). The graphs show HPLC peaks of peptide (1), RadTag (2), and RadTag covalently bound to peptide (3). Peptide-RadTag stable at RT.

  11. Peptide [3H]RadTag-peptide uv [3H]RadTag + Peptide (in excess) 3H incubate [3H]RadTag-peptide + Peptide (free) Reaction mix: peptide & [3H]RadTag-peptide purify (HPLC) uv [3H]RadTag-peptide 3H MS ID on radio peak confirms [3H]RadTag-peptide Pure [3H]RadTag-peptide following HPLC

  12. RadTagssimplifyradiolabelling of biologicals Enabling • Increasedflexibility and specificbinding • Stablebinding–small tag size reduces interference with target protein • PKPD studies with labelled proteins • Microdosingdiagnostics (peptides/antibodies) • Quantitativeautoradiography • Companiondiagnostics • Potential for pretargeting

  13. PoCstudyI Melanoma tumors Ac-Nle-Asp-His-(D)Phe-Arg-Trp-Gly-Lys-Arg-Trp-Cys-Cys-Pro-Gly-Cys-Cys-Lys-Thr-Phe MW aMSH 2614g/mol RadTag 480 g/mol Cheng et al J Nucl Med 2007; 48:987–994

  14. PoCstudyII Breast cancer tumors Molecularimaging for personalized & targeted anticancer therapy Trastuzumab (Herceptin) (Roche) 111In-DPTA-trastuzumab 111In-DPTA-trastuzumab (Fab) 89Zr-trastuzumab 64Cu-DOTA-trastuzumab (Fab) 89Zr-trastuzumab 99mTc-MORFs-streptavidin-trastuzumab 18F-MORFs-streptavidin-trastuzumab

  15. Financing and partners • Innovationsbron • Innovationskontoret, LiU • Competence Network AB, Södertälje • TBD Biodiscovery, Estonia • Selcia Ltd, UK • Maria Swartz Innovationskontoret LiU • Prof Peter Konradsson, LiU

  16. Contact • info@biopercept.se

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