Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Bell Potter Healthcare Conference (November 2023)
24 slides from Clarity Pharmaceuticals's conference presentation, Nov 15, 2023
Slide 1: Bell Potter Healthcare Conference
Bell Potter Healthcare Conference Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer 15th November 2023 Dr Alan Taylor Executive Chairperson E: alan.taylor@claritypharm.com
Slide 2: Disclaimer
Disclaimer Introduction This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) (Clarity or the Company) No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking and contains summary information about Clarity and t
Slide 3: Corporate Snapshot
Corporate Snapshot Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next-generation products to address the growing need for better diagnostics and treatments in oncology ASX code: CU6 Proprietary Global leader in Significant supply, SAR Technology: a true Targeted
Slide 4: Clarity – The Copper Theranostics Company
Clarity – The Copper Theranostics Company SAR Technology Targeted Copper Theranostics are the next- generation disruptive platform in Radioisotope Copper isotopes for Positron Emission radiopharmaceuticals that employ the “perfect Tumour Tomography (PET) imaging (64Cu) or therapy (67Cu) pairing” of
Slide 5: Why Copper?
Why Copper? The physical properties of copper-64 and copper-67 have optimal characteristics for global commercialisation Diagnostic radionuclides Therapeutic radionuclides Copper-64 Gallium-68 Fluorine-18 Copper-67 Lutetium-177 Half life 12.7 hours 1.1 hours 1.83 hours Half life 2.6 days 6.7 days Ty
Slide 6: Three key product areas
Three key product areas SAR-bisPSMA SAR-Bombesin SARTATE Theranostic Diagnostic Theranostic Diagnostic ftheenceic P sccne us COBRA COMBAT
Slide 7: SAR-bisPSMA market opportunity
SAR-bisPSMA market opportunity PSMA based diagnostics SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation with a best-in-class • Current US patient pool for PSMA-PET imaging is ~355k agent for imaging and treating prostate cancer scans per year between initial-staging, suspect
Slide 8: Clarity's three areas of focus in prostate cancer
Clarity’s three areas of focus in prostate cancer Prostate cancer is the second largest oncology indication in men; there are three stages of prostate cancer Primary Biochemical recurrence (BCR) Metastatic castration-resistant (mCRPC) • PC localised in the prostate gland with • PC that persists afte
Slide 9: SAR-bisPSMA
SAR-bisPSMA Superior performance of bisPSMA compared to monomer PSMA 64Cu/67Cu Radioisotope Cage SAR “chelator” securely holding the bisPSMA has higher uptake in radioisotope Targeting tumours and strong retention Molecules Two PSMA compared to PSMA monomers binding motifs Tumor specific receptors (
Slide 10: 67Cu-SAR therapeutics
67Cu-SAR therapeutics
Slide 11: Therapy program with 67Cu-SAR-bisPSMA
Therapy program with 67Cu-SAR-bisPSMA Trial highlights to date Currently recruiting into cohort 3 in the US-based study • Now recruiting in cohort 3 at 12GBq dosing (Pluvicto dose capped at 7.4GBq) Trial overview • Third of patients in cohort 1 had a PSA decline greater than 50% from a single cycle
Slide 12: 67Cu-SAR-bisPSMA therapy Phase I/II SECuRE trial in mCRPC
67Cu-SAR-bisPSMA therapy Phase I/II SECURE trial in mCRPC : 64Cu-SAR-bisPSMA PET/CT imaging before and after a single cycle of 8GBq 67Cu-SAR-bisPSMA Cohort 2 PSA decrease following (n=3) single therapy cycle 1 >95% PSA 47.2 May 23 2 >99% 3 >80% Considerable reduction in uptake of 64Cu-SAR-bisPSMA on
Slide 13: US FDA Expanded Access Program
US FDA Expanded 4GBq 67Cu-SAR-bisPSMA over 4 cycles Access Program • Additional therapy cycles of 67Cu-SAR- bisPSMA at the lowest 4GBq dose level have been requested under the US FDA Expanded Access Program (EAP) • Early data indicates positive effects • SPECT-CT images (on the right) demonstrate a
Slide 14: 64Cu-SAR diagnostics
64Cu-SAR diagnostics
Slide 15: Copper brings significant additional advantages
Copper brings significant additional advantages Beyond the supply chain advantages of a 12.7 hour half-life PET imaging agent, SAR-bisPSMA allows patients to be imaged from 1 hour to >24 hours post administration 64Cu-SAR-bisPSMA PET has the ability to image both on the day of administration and at
Slide 16: Next-generation SAR-bisPSMA diagnostic is coming
Next-generation SAR-bisPSMA diagnostic is coming Improved uptake of SAR-bisPSMA may support better diagnosis compared to first-generation PSMA PET agents. Significant market opportunity to displace currently approved products, which are set to generate >US$1Bn in 2023. Lantheus: PYLARIFY® (18F-DCFPy
Slide 17: CLARIFY – registrational Phase III trial
CLARIFY – registrational Phase III trial CLARIFY is a Phase III diagnostic trial assessing diagnostic performance of 64Cu- SAR-bisPSMA in detecting pelvic lymph node metastases of prostate cancer using PET/CT in 383 participants. Recruitment to commence Q4 2023. 5 6 1. Patients with untreated, 1 3 4
Slide 18: The Supply Differentiator
The Supply Differentiator
Slide 19: Current industry challenges
Current industry challenges Combined with a history of supply issues Additional demands on existing supply as industry grows Time sensitive products with Inability to control short shelf-lives the entire supply chain Reliance on ageing Manufacturing Complex international nuclear reactor fleet outage
Slide 20: Current industry challenges with 68Ga & 177Lu
Current industry challenges with 68Ga & 177Lu Clarity’s TCT Solution with 64Cu & 67Cu Additional demands on existing supply as industry grows Global scale commercial Time sensitive capacity for diagnostics Inability to control products with and therapeutics short shelf-lives the entire supply chain
Slide 21: Next-generation theranostics provide solutions
Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals Opportunities with 64Cu (half-life = 12.7h) Opportunities with Rhodotron produced 67Cu • Can be mass produced on cyclotrons with solid targetry • Commercially available • Every US zip code c
Slide 22: Accelerating clinical progress
Accelerating clinical progress PROPELLER CLARIFY CLARIFY Full results Phase III trial Phase III 50% published commences recruitment PSMA Dx Au PSMA Dx US/Au PSMA Dx US/Au SECuRE Advance to cohort COMBAT COBRA 4 (multi-dose) Advance to cohort 2 PSMA Tx US BBN Tx US COMBAT Topline data Advance to coho
Slide 23: Summary
Summary Global leader in Targeted Copper Theranostics (TCTs) • Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy • Multiple therapeutic and diagnostic trials in progress with Phase III clinical trials commencing from 2023 • TCTs address the current manufacturing and logisti
Slide 24: Thank you
Thank you Contact details Dr Alan Taylor Dr Colin Biggin Executive Chairperson Managing Director and CEO E: alan.taylor@claritypharm.com E: colin.biggin@claritypharm.com
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