Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — E&P Small Cap Healthcare Conference 2023
32 slides from Clarity Pharmaceuticals's conference presentation, Sep 13, 2023
Slide 1: E&P Small Cap Healthcare Conference
E&P Small Cap Healthcare Conference Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Colin Biggin, Managing Director and CEO 8th September 2023
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 radiopharmaceuticals that employ the “perfect Copper isotopes for Positron Emission pairing” of copper-64 (64Cu) and copper-67 (67Cu) Tumour Tomography (
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: Dual development strategy
Dual development strategy SAR Technology enables a synergistic development of stand- alone diagnostics as well as paired theranostics Diagnostics based on 64Cu Theranostics based on 64Cu/67Cu • Broad market opportunities Future Dx revenue pays for late- • High precision, high accuracy stage Tx clini
Slide 7: Three key product areas
Three key product areas SAR-bisPSMA SAR-Bombesin SARTATE Poses] sop =a =a os oe recruitment closed
Slide 8: 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 8 September 2023 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND
Slide 9: Prostate cancer
Prostate cancer Two product areas: bisPSMA & Bombesin Four products for diagnosis and therapy
Slide 10: 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 • PC that persists after pri
Slide 11: SAR-bisPSMA
SAR-bisPSMA Superior performance of bisPSMA compared to monomer PSMA 64Cu/67Cu Radioisotope Cage SAR “chelator” securely bisPSMA has higher uptake in holding the radioisotope Targeting tumours and strong retention Molecules compared to PSMA monomers Two PSMA binding motifs Significant anti-tumour ef
Slide 12: SAR-Bombesin
SAR-Bombesin 68Ga PSMA-11 (top) images of a PSMA- SAR-Bombesin targets Gastrin Releasing Peptide negative patient with clinical signs of receptor (GRPr) that is overexpressed in a number of prostate cancer (a cancers including prostate, breast, colon, gastric, rising PSA score of glioma, pancreatic,
Slide 13: 64Cu-SAR diagnostics
64Cu-SAR diagnostics
Slide 14: 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 DCFP
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 Cu-64 SAR-bisPSMA PET has the ability to image both on the day of administration and at
Slide 16: 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. 1 3 4 5 6 1. Patients with untreated,
Slide 17: SAR-Bombesin in PSMA-negative prostate cancer
SAR-Bombesin SAR-Bombesin in PSMA- SAR-Bombesin targets Gastrin negative prostate cancer Releasing Peptide receptor (GRPr) that is overexpressed in a number of • Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA- cancers including prostate, breast, negative biochemi
Slide 18: 67Cu-SAR therapeutics
67Cu-SAR therapeutics
Slide 19: 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 20: SECuRE cohort 1 - 4GBq dose level
SECuRE cohort 1 - 4GBq dose level 20
Slide 21: 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 22: SECuRE cohort 2 - 8GBq dose level (single cycle)
SECuRE cohort 2 - 8GBq dose level (single cycle) • No Dose Limiting Toxicities with single cycle at 8GBq • All 3 participants had a PSA drop of > 70% • Significant reduction in uptake of the diagnostic dose after a single 8GBq therapy cycle • No Dose Limiting toxicities with single cycles at 8GBq •
Slide 23: 67Cu SAR-bisPSMA in mCRPC: Now in cohort 3
67Cu SAR-bisPSMA in mCRPC: Now in cohort 3 64Cu SAR-bisPSMA PET/CT imaging before and after a single cycle of 8GBq 67Cu SAR-bisPSMA (cohort 2) • No Dose Limiting toxicities with single cycles at 8GBq • All 3 participants had a PSA drop of > 70% • Additional 8GBq doses requested under FDA EAP • Now a
Slide 24: 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 both
Slide 25: Neuroblastoma therapy with 67Cu SARTATE
Neuroblastoma therapy with 67Cu SARTATE CL04 trial is a 67Cu-SARTATE peptide receptor radionuclide CL04: 64Cu/67Cu SARTATE Phase I/IIa trial in high- therapy administered to paediatric patients with high-risk, risk neuroblastoma in the US with up to 34 patients relapsed, refractory neuroblastoma Tri
Slide 26: The Supply Differentiator
The Supply Differentiator
Slide 27: 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 28: Current industry challenges Clarity’s TCTs Solution
Current industry challenges Clarity’s TCTs Solution 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 100% control of end- 48-hour shelf
Slide 29: Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals
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 30: Key upcoming milestones
Key upcoming milestones Dx = Diagnostics Tx = Theranostics BBN Tx US COMBAT SARTATE Tx US CL04 1st patient treated PSMA Tx US SECuRE Advance to Phase II expansion Advance to SARTATE Tx US cohort 4 BBN Tx US CL04 COMBAT PSMA Tx US Cohort 4 open for Advance to SECuRE recruitment cohort 2 Advance to co
Slide 31: 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 32: Thank you
Thank you Contact details Dr Colin Biggin Managing Director and CEO E: colin.biggin@claritypharm.com
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