Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Jefferies Healthcare Conference 2023
30 slides from Clarity Pharmaceuticals's conference presentation, Jun 13, 2023
Slide 1: Media Release: Jefferies Healthcare Conference
MEDIA RELEASE 13 June 2023 Jefferies Healthcare Conference Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to
Slide 2: Jefferies Healthcare Conference
Jefferies Healthcare Conference Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Alan Taylor, Executive Chairperson 9 June 2023
Slide 3: 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 4: 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 Proprietary Global leader in Significant supply, ASX code: CU6 SAR Technology: a true Targeted
Slide 5: Clarity – The Copper Theranostics Company
Clarity – The Copper Theranostics Company SAR Technology Targeted Copper Theranostics are the next- generation disruptive platform in Radioisotope radiopharmaceuticals that employ the “perfect Copper isotopes for Positron Emission Tomography (PET) imaging (64Cu) or pairing” of copper-64 (64Cu) and c
Slide 6: 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 7: Prostate cancer
Prostate cancer Two product areas: bisPSMA & Bombesin Four products for diagnosis and therapy
Slide 8: SAR-bisPSMA
SAR-bisPSMA Superior performance of bisPSMA compared to monomer PSMA 64Cu/67Cu Radioisotope Cage SAR “chelator” securely bisPSMA has higher uptake in tumours and holding the radioisotope strong retention compared to PSMA Targeting monomers Molecules PSMA binding motif Significant anti-tumour effect
Slide 9: SAR-Bombesin
SAR-Bombesin SAR-Bombesin targets Gastrin Releasing Peptide receptor (GRPr) that is overexpressed in a number of cancers including prostate, breast, colon, gastric, glioma, pancreatic, small cell lung and non-small cell 64Cu SAR-Bombesin is retained in the tumours while quickly clearing lung cancer,
Slide 10: Clarity – Three areas of focus in prostate cancer
Clarity – Three areas of focus in prostate cancer PC is the second largest oncology indication in men with a high unmet need. There are three stages of PC. Primary Biochemical recurrence (BCR) Metastatic castration-resistant (mCRPC) • PC that is localised in the prostate • PC that persists after pri
Slide 11: Next-generation bisPSMA diagnostic is coming
Next-generation 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 DCFPyL)
Slide 12: SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer
SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer Comparison of 64Cu-SAR-bisPSMA PET/CT and Uptake of 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 in concordant lesions 68Ga-PSMA-11 PET/CT by Reader in all cohorts Median All Cohorts Parameter Imaging N Median IQR Min Max p-value* Difference 64 Cu
Slide 13: SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer
SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer PET/CT demonstrated uptake of 64Cu SAR-bisPSMA (F) in a left pelvic lymph node according to both readers and PC was confirmed via histopathology. Readers did not detect uptake in pelvic lymph nodes on the 68Ga PSMA-11 PET/CT (E). Time be
Slide 14: 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 Cu-64 SAR-bisPSMA PET has the ability to image both on the day of administration and at
Slide 15: SAR-Bombesin in BCR PC
SAR-Bombesin in BCR PC SAR-Bombesin was able to locate tumours in PSMA-negative prostate cancers that are not visible with approved PSMA diagnostics Benefits • A number of PC lesions do not express PSMA or have low 68Ga PSMA-11 68Ga PSMA-11 expression of the receptor • In patients with BCR PC, their
Slide 16: Clinical development in multiple cancers
Clinical development in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the US and Australia Clinical development pipeline as of 7 June 2023 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND 15
Slide 17: 67Cu therapeutics in prostate cancer
67Cu therapeutics in prostate cancer
Slide 18: Metastatic castration-resistant prostate cancer
Metastatic castration-resistant prostate cancer Clarity is conducting two theranostic clinical trials in mCRPC with two products to treat PSMA-positive, PSMA-negative lesions and those with low PSMA expression SAR-bisPSMA SAR-Bombesin • Phase I/IIa study of 64Cu/67Cu SAR-bisPSMA for identification a
Slide 19: Cohort 1 (4GBq dose level)
Co MCLARITY hort 1 (4GBq dose level) SEfSyRE ©4Cu-SARbisPSMA PET- CT Fused Images ©7Cu-SARbisPSMA SPECT-CT Fused Images (Fixed Scaling) Shr 24hr 48hr 96hr [ T4 Vertebral Lesion SUVmax- 78.64 l| 4 Vertebral Lesion | [ 4 Vertebral Lesion [ 14 Vertebral Lesion | [ 4 Vertebral Lesion C1 Vertebral Lesion
Slide 20: US FDA Expanded Access Program
US FDA Expanded Access Program • Additional therapy cycles of 67Cu SAR-bisPSMA have been requested under the US FDA Expanded Access Program (EAP) • Early data indicates positive effects • SPECT-CT images (on the right) demonstrate a reduction in the intensity of product uptake at the tumour sites af
Slide 21: 67Cu SAR-Bombesin in mCRPC
67Cu SAR-Bombesin 64Cu SAR-Bombesin and 68Ga PSMA-11 PET and PET/CT images in a participant in the BOP IIT (mCRPC cohort) conducted by Prof Emmett at St Vincent's hospital in Sydney, Australia. in mCRPC Benefits • 67Cu SAR-Bombesin could be used in combination with PSMA-based therapies to ensure bot
Slide 22: The Differentiator: Supply
The Differentiator: Supply
Slide 23: Current industry challenges combined with a history of supply issues
Current industry challenges Combined with a history of supply issues Additional demands on existing supply as industry grows Inability to Time sensitive control the products with entire supply short shelf-lives chain Reliance on Manufacturing Complex international ageing nuclear outages supply chain
Slide 24: TCTs: Universal access to diagnostics and therapy
TCTs: Universal access to diagnostics and therapy Solving the challenges of current generation diagnostic radiopharmaceuticals Cu-64 produced daily on 2 cyclotrons • >100Ci/day possible • >3500 patients doses/day • >900,000 patient doses a year Cu-67 produced daily on Rhodotrons Manufactured in less
Slide 25: Enabling universal access to PET imaging with 64Cu
Enabling universal access The future of PET radioisotope supply is dependable, to PET imaging with 64Cu scalable and customer focused 68Ga and 18F • Regional availability issues • Limited scope for future upscaling • Little patient flexibility with 3-12 hour product shelf life • No opportunity for d
Slide 26: Next generation of therapeutics with 67Cu
Next generation of Eliminating dependency on the limited number of aging therapeutics with 67Cu nuclear reactors for therapeutic radioisotope supply 177Lu 67Cu • Relies on antiquated, • Commercially unreliable and available high government powered rhodotron subsidised nuclear with a small reactor in
Slide 27: Targeted Copper Theranostics
Targeted Copper Theranostics Clarity’s solution to theranostic isotope supply threats The environmental considerations of TCT • No reactors • As the number of patient treatments increases, environmental • No time sensitive international supply chains factors will impact the selection of theranostic
Slide 28: Inflection points in the next 12 months
Inflection points in the next 12 months Dx = Diagnostics Tx = Theranostics BBN Tx US SARTATE Tx US COMBAT SARTATE Tx US BBN Tx US CL04 1st patient treated CL04 SARTATE Tx US COMBAT Advance to Cohort 3 fully CL04 Advance to cohort Phase II expansion recruited Cohort 4 open for 2 Cu-67 recruitment PSM
Slide 29: Summary
Summary Global leader in Targeted Copper Theranostics (TCTs) • Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy • Seven clinical trials and an IIT in development with Phase III clinical trials commencing from 2023 • TCTs address the current manufacturing and logistical lim
Slide 30: Thank you
Thank you Contact details Dr Alan Taylor Executive Chairperson E: alan.taylor@claritypharm.com
Clarity Pharmaceuticals — Jefferies Healthcare Conference 2023 on 6ix