Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Technical Presentation (November 2022)
17 slides from Telix Pharmaceuticals's technical presentation, Nov 7, 2022
Slide 1: ZIRCON Phase III Study Top-Line Data
ZIRCON Phase III Study Top-Line Data Telix Pharmaceuticals (ASX:TLX) 7 November 2022
Slide 2: Disclaimer
Disclaimer The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied,
Slide 3: ZIRCON
ZIRCON A confirmatory, prospective, open-label, multi-centre phase III study to evaluate diagnostic performance of 89Zirconium- labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with in
Slide 4: Summary: ZIRCON Phase III study meets primary endpoints
Summary: ZIRCON Phase III study meets primary endpoints Highly positive results support potential for TLX250-CDx to change standard of care Top-line data Key takeaways • Primary endpoint met: Sensitivity of ≥84% and • Positive results demonstrate that TLX250-CDx provides specificity of ≥84% in all t
Slide 5: Carbonic Anhydrase IX (CAIX) program
Carbonic Anhydrase IX (CAIX) program Phase III imaging study complete, potential to develop as a pan-cancer target Product Candidate Scientific Rationale Targeting Agent: girentuximab TLX250-CDx (89Zr-DFO-girentuximab) • TLX250-CDx has high affinity for CAIX, a tumour-associated IgG1 monoclonal anti
Slide 6: Targeting CAIX: the scientific journey
Targeting CAIX: the scientific journey TLX250-CDx builds on a strong scientific pedigree REDECT CAIX published, ZIRCON Ph III ZIRCON Girentuximab identified as demonstrates study of study of Identification of licensed to marker of CAIX as high sensitivity TLX250-CDx Ph III TLX250-CDx anti-CAIX murin
Slide 7: ZIRCON study overview
ZIRCON study overview Study design and goals Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx to detect ccRCC in patients with renal masses, using histology from surgical resection as standard of truth ZIRCON PHASE III STUDY Study goal: A sensitivity/specificity thresh
Slide 8: ZIRCON study participation
ZIRCON study participation A large-scale global study 300 patients enrolled | 36 sites | 9 countries Europe | 17 sites North America | 13 sites Australia | 6 sites 8
Slide 9: What do clinicians around the world say?
What do clinicians around the world say? Results reinforce the broad clinical applicability and potential of TLX250-CDx A/Prof. Brian Shuch, Mr Gregory Jack, Prof. Françoise MD F.R.A.C.S. Kraeber-Bodéré, MD, Director, Kidney Cancer General Urological PhD Program, UCLA Institute Surgeon, Austin Healt
Slide 10: TLX250-CDx in action: a case study
TLX250-CDx in action: a case study Austin Health (Melbourne, Australia) 18F-FDG TLX250-CDx • 57-year-old male with a single kidney (prior nephrectomy) • FDG scan was equivocal • FDG is typically of limited value in understanding of renal cell carcinoma owing to high urinary clearance, decreased cont
Slide 11: The clinical and commercial opportunity
The clinical and commercial opportunity
Slide 12: The indeterminate renal mass “epidemic”
The indeterminate renal mass “epidemic” Widespread imaging has led to an increase in incidental detection of renal masses △ >7 cm ◯ 4-7 cm ▲ 2-4 cm ● < 2 cm Since the 1980s – incidental detection of renal masses There is an “epidemic” of indeterminate small renal has increased – in line with greater
Slide 13: Improving outcomes for patients with small renal masses
Improving outcomes for patients with small renal masses Five-year survival rates increase dramatically if diagnosed early Gerota’s facia Adrenal gland Stage I Early disease is often asymptomatic, can be Tumour ≤7 cm in greatest targeted surgically or with ablative therapy, dimension and limited to s
Slide 14: The role of TLX250-CDx in the patient journey
The role of TLX250-CDx in the patient journey • Most patients will be referred to a urologist for Core Suspected Incidental renal cancer IDM additional imaging study to better characterise renal masses indication a renal mass – but a biopsy or surgery is TLX250-CDx PET currently the only method to d
Slide 15: U.S. market opportunity >$500M
U.S. market opportunity Potential for clinical and commercial leadership CI 123,240 Ultrasound 79,000 RCC + 56% benign1 49,296 73,994 U.S. total addressable 40% focused diagnosis 60% incidental findings2 market (TAM) value (USD): 41,902 7,394 62,852 11,092 >$500M 85% T1a3 15% T1b 85% T1a3 15% T1b 5,
Slide 16: TLX250-CDx indication expansion
TLX250-CDx indication expansion Potential for applications beyond kidney cancer Current clinical studies of TLX250-CDx Telix’s Planned Phase II ‘STARBURST’ study will explore TLX250-CDx in other tumour types OPALESCENCE (IIT)1 PHASE A prospective, open-label, Phase II study to explore CAIX expressio
Slide 17: Contact
Contact Kyahn Williamson SVP Investor Relations and Corporate Communication kyahn.williamson@telixpharma.com
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